Adjuvant Endocrine Therapy Adherence Research Articles

Acceptability of Four Intervention Components Supporting Medication Adherence in Women with Breast Cancer: a Process Evaluation of a Fractional Factorial Pilot Optimization Trial.

Adjuvant endocrine therapy (AET) reduces mortality in early-stage breast cancer, but adherence is low. We developed a multicomponent intervention to support AET adherence comprising: text messages, information leaflet, acceptance and commitment therapy (ACT), and side-effect website. Guided by the multiphase optimization strategy, the intervention components were tested in the ROSETA pilot optimization trial. Our mixed-methods process evaluation investigated component acceptability. The pilot optimization trial used a 24-1 fractional factorial design. Fifty-two women prescribed AET were randomized to one of eight experimental conditions, containing unique component combinations. An acceptability questionnaire was administered 4months post-randomization, and semi-structured interviews with 20 participants further explored acceptability. Assessments were guided by four constructs of the theoretical framework of acceptability: affective attitude, burden, perceived effectiveness, and coherence. Quantitative and qualitative findings were triangulated to identify agreements/disagreements. There were high overall acceptability scores (median = 14-15/20, range = 11-20). There was agreement between the qualitative and quantitative findings when triangulated. Most participants "liked" or "strongly liked" all components and reported they required low effort to engage in. Between 50% (leaflet) and 65% (SMS) "agreed" or "strongly agreed," it was clear how each component would help adherence. Perceived effectiveness was mixed, with 35.0% (text messages) to 55.6% (ACT) of participants "agreeing" or "strongly agreeing" that each component would improve their adherence. Interview data provided suggestions for improvements. The four components were acceptable to women with breast cancer and will be refined. Mixed-methods and triangulation were useful methodological approaches and could be applied in other optimization trial process evaluations.

Associations between HIV infection status, psychosocial factors, and adjuvant endocrine therapy adherence among South African women with early-stage breast cancer.

We aimed to evaluate for associations between HIV status, psychosocial factors, and adjuvant endocrine therapy (AET) adherence in South African (SA) women with estrogen receptor positive (ER+) breast cancer (BC). We enrolled South African women with early-stage ER + BC in remission and prescribed tamoxifen or an aromatase inhibitor to the prospective observational study. We performed AET pill counts at enrollment, 12 weeks, and 24 weeks, and calculated adherence ratios of pills consumed between visits to days between visits. Women completed questionnaires on social support, attitude towards medication, health literacy, self-efficacy, mental health, and AET toxicity. We collected household wealth data. We used hierarchical linear (HLM) and structural equation modelling (SEM) to compare adherence ratios between women with and without HIV while adjusting for psychosocial factors. We collected adherence data from 239 women, 63 (26.4%) with co-morbid HIV. Comparing women with and without HIV, median AET adherence ratio was 0.88 vs 0.89, respectively (HLM p = 0.31). In our SEM model for the full cohort, mental health, healthcare savvy, and side effect burden latent variables were not significantly associated with adherence. In the subgroup of women living with HIV, lower SES quintile (β 0.04, SE 0.02, p = 0.08) and poorer mental health (β -0.02, SE 0.01, p = 0.10) showed trends toward association with adherence. HIV status is not predictive of AET adherence among SA women with ER + BC, though decreasing SES status and increasing mental health symptoms are marginally associated with adherence in women with BC and HIV.

Social Characteristics and Adherence to Adjuvant Endocrine Therapy in Premenopausal Women With Breast Cancer.

Social characteristics, including cohabitation/marital status and socioeconomic position (SEP)-education level, employment status, and income-influence breast cancer prognosis. We investigated the impact of these social characteristics on adherence to adjuvant endocrine therapy (AET) from treatment initiation to 5 years after diagnosis. We assembled a nationwide, population-based cohort of premenopausal women diagnosed in Denmark with stage I-III, estrogen receptor-positive breast cancer during 2002-2011. We ascertained prediagnostic social characteristics from national registries. AET adherence was based on information from the Danish Breast Cancer Group and operationalized as (1) adherence trajectories (from group-based trajectory modeling) and (2) early discontinuation. We computed odds ratios (ORs) and associated 95% CI to estimate the association of cohabitation and SEP with AET adherence using multinomial and logistic regression models adjusted according to directed acyclic graphs. Among 4,353 patients, we identified three adherence trajectories-high adherence (57%), slow decline (36%), and rapid decline (6.9%). Compared with cohabiting women, those living alone had higher ORs of slow (1.26 [95% CI, 1.08 to 1.46]) or rapid decline (1.66 [95% CI, 1.27 to 2.18]) versus high adherence. The corresponding ORs for women not working versus employed women were 1.22 (95% CI, 1.02 to 1.45) and 1.76 (95% CI, 1.30 to 2.38). For early discontinuation (17%), the ORs were 1.48 (95% CI, 1.23 to 1.78) for living alone and 1.44 (95% CI, 1.17 to 1.78) for women not working. Adherence to AET was lower among women living alone or unemployed than cohabiting or employed women, respectively. These women may benefit from support programs to enhance AET adherence.

Remote Monitoring App for Endocrine Therapy Adherence Among Patients With Early-Stage Breast Cancer

Adjuvant endocrine therapy (AET) use among women with early-stage, hormone receptor-positive breast cancer reduces the risk of cancer recurrence, but its adverse symptoms contribute to lower adherence. To test whether remote monitoring of symptoms and treatment adherence with or without tailored text messages improves outcomes among women with breast cancer who are prescribed AET. This nonblinded, randomized clinical trial (RCT) following intention-to-treat principles included English-speaking women with early-stage breast cancer prescribed AET at a large cancer center with 14 clinics across 3 states from November 15, 2018, to June 11, 2021. All participants had a mobile device with a data plan and an email address and were asked to use an electronic pillbox to monitor AET adherence and to complete surveys at enrollment and 1 year. Participants were randomized into 3 groups: (1) an app group, in which participants received instructions for and access to the study adherence and symptom monitoring app for 6 months; (2) an app plus feedback group, in which participants received additional weekly text messages about managing symptoms, adherence, and communication; or (3) an enhanced usual care (EUC) group. App-reported missed doses, increases in symptoms, and occurrence of severe symptoms triggered follow-ups from the oncology team. The primary outcome was 1-year, electronic pillbox-captured AET adherence. Secondary outcomes included symptom management abstracted from the medical record, as well as patient-reported health care utilization, symptom burden, quality of life, physician communication, and self-efficacy for managing symptoms. Among 304 female participants randomized (app group, 98; app plus feedback group, 102; EUC group, 104), the mean (SD) age was 58.6 (10.8) years (median, 60 years; range, 31-83 years), and 60 (19.7%) had an educational level of high school diploma or less. The study completion rate was 87.5% (266 participants). There were no statistically significant differences by treatment group in AET adherence (primary outcome): 76.6% for EUC, 73.4% for the app group (difference vs EUC, -3.3%; 95% CI, -11.4% to 4.9%; P = .43), and 70.9% for the app plus feedback group (difference vs EUC, -5.7%; 95% CI, -13.8% to 2.4%; P = .17). At the 1-year follow-up, app plus feedback participants had fewer total health care encounters (adjusted difference, -1.23; 95% CI, -2.03 to -0.43; P = .003), including high-cost encounters (adjusted difference, -0.40; 95% CI, -0.67 to -0.14; P = .003), and office visits (adjusted difference, -0.82; 95% CI, -1.54 to -0.09; P = .03) over the previous 6 months compared with EUC participants. This RCT found that a remote monitoring app with alerts to the patient's care team and tailored text messages to patients did not improve AET adherence among women with early-stage breast cancer; however, it reduced overall and high-cost health care encounters and office visits without affecting quality of life. ClinicalTrials.gov Identifier: NCT03592771.

Associations between HIV infection status, psychosocial factors, and adjuvant endocrine therapy adherence among South African women with early-stage breast cancer.

522 Background: South African (SA) women living with comorbid estrogen receptor positive (ER+) breast cancer (BC) and HIV have higher mortality than other SA women with ER+ BC. We aimed to evaluate for associations between HIV status, psychosocial factors, and adjuvant endocrine therapy (AET) adherence as a potential contributor to this disparity. Methods: From Chris Hani Baragwanath Hospital, Johannesburg, we enrolled adult women with stage I-III ER+ BC in remission and currently prescribed tamoxifen or an aromatase inhibitor to a prospective cohort study. We performed AET pill counts at enrollment, 12 weeks, and 24 weeks, and calculated adherence ratios from the difference in pills between visits divided by the number of days between visits. Women completed questionnaires on sources of social support, beliefs about medication, health literacy, and self-efficacy at enrollment and questionnaires about mental health (depression, anxiety, and acute stress) symptom burden and AET-related side effects at the 12- and 24-week visits. We also collected household wealth data and clinical data on BC and HIV. AET adherence ratios were compared between women with and without comorbid HIV using Wilcoxon rank sum testing. We also used structural equation modeling techniques to refine and evaluate an a priori model of AET adherence with latent variables for mental health, socioeconomic (SES) status, healthcare savvy, and AET side effect burden and subgroup analyses of the resulting model in women with and without HIV. Results: Between April 26, 2022, and July 11, 2023, we enrolled 239 women, 63 (26.4%) of whom had co-morbid HIV. Adherence data was available from 106 women at 12 and 24 weeks, from 22 women at 12 weeks only, and from 111 women at 24 weeks only. Comparing women with and without HIV, median AET adherence ratio was 0.88 vs 0.89, respectively (p = 0.65). Our final model of AET adherence achieved good fit (comparative fit index = 0.96, RMSEA 90% CI: 0.03-0.06). In the full cohort, SES quintile showed a trend towards association with AET adherence (β 0.02, SE 0.01, p=0.09); mental health, healthcare savvy, and side effect burden latent variables were not significantly associated with adherence. In the subgroup of women living with HIV, SES quintile (β 0.04, SE 0.02, p=0.08) and mental health (β -0.02, SE 0.01, p=0.10) showed trends toward association with adherence; these relationships did not persist for women without HIV. Conclusions: HIV status is not predictive of AET adherence among SA women with ER+ BC, but in women with both diagnoses, decreasing SES status and increasing mental health symptoms trended towards an association with decreased adherence. Interventions to improve the mental health of SA breast cancer patients living with HIV may promote AET adherence.

Assessment of endocrine therapy adherence in a nurse-led cancer survivorship clinic: Results from the Linking You to Support and Advice (LYSA) trial.

1627 Background: The care of those living with and beyond a cancer diagnosis requires dedicated cancer survivorship services to ensure optimal symptom control and quality of life. Supporting adherence to adjuvant endocrine therapy is also an essential component of care. We examined endocrine therapy adherence rates, and factors associated with non-adherence, in patients with early-stage breast cancer enrolling in a survivorship trial (LYSA). Methods: Women with early-stage hormone positive breast (n=168) cancers within 12 months of completing primary therapy, were enrolled in a randomized control trial with parallel arms (PMID 36357934). Experimental arm had access to nurse-led symptom management, dietetic consultation, and undertook bimonthly electronic patient reported outcome (ePRO). Active comparator group had access to conventional care and ePRO was completed at beginning and end of study. Endocrine therapy adherence was reported as the ability to take medication as prescribed over prior 4 weeks (Michigan Oncology Quality Consortium Adherence Tool), with response quantified as Excellent (adherence close to 100%), Very Good (80%), Good (60%), Fair (40%) and Poor (20%). Adherence Objective (Secondary) was adherence rate at 12 months after study entry in both arms, and factors associated with non-adherence. Results: A total of 148/168 women with breast cancer who completed the LYSA study reported adjuvant endocrine therapy use (74 experimental arm, 74 active comparator) during study conduct. Therapies included aromatase inhibitors (53%), tamoxifen (39%) and ovarian suppression combinations (8%). At study entry ≥ 80% adherence was reported in 74% of overall cohort (75% experimental, 72% comparator, p=0.7), with 1.6% reporting not taking any medication. By end of study (12 months), ≥ 80% adherence was reported in 74% overall (77% experimental, 71% comparator, p=0.4), while non-adherence rates were 2.9%. Among the pre-specified reasons for non-adherence at study end, “simply missing it” ranked highest (10%), and 5% “experienced side effects”. Post-menopausal patients were more likely than pre-menopausal to report excellent (versus sub-excellent) adherence at study end (OR 4.60, 95%CI 1.45 – 16.13, p = 0.012, adjusted for arm, age, and ECOG). Additional exploration of reasons for non-adherence will be presented. Conclusions: Adjuvant endocrine therapy adherence rates in both arms at 12 months after study entry collected via ePRO were good (≥ 90% reporting excellent or very good adherence). Additional factors potentially associated with non-adherence are being analyzed including self-care agency, symptom burden and quality of life. Clinical trial information: NCT05035173 .

Development and psychometric evaluation of the adjuvant endocrine therapy beliefs scale for breast cancer survivors.

Adjuvant endocrine therapy has a vital role in reducing breast cancer mortality. The beliefs in adjuvant endocrine therapy is a very important factor in the medication adherence of breast cancer survivors. Therefore, it is necessary to develop a standardized scale for assessment of adjuvant endocrine therapy. The purpose of this study was to identify the attributes of adjuvant endocrine therapy beliefs, and to evaluate adjuvant endocrine therapy beliefs scale psychometric properties. A hybrid model was applied to identify the concept of adjuvant endocrine therapy beliefs and measurement question were developed by the scale development process. Statistical analysis using validity analysis and Rasch analysis based on item response theory were performed. A total of 228 breast cancer survivors in South Korea participated in the study. The finally developed adjuvant endocrine therapy beliefs scale consisted of 22 items. The items extracted by 4 factors explained 59.72% of the total variance. The model fit showed an acceptable level. The adjuvant endocrine therapy beliefs scale was excellent in convergent and discriminant validity with reliability. This scale is expected to be practical and useful in identifying adjuvant endocrine therapy beliefs and developing intervention strategies to promote adjuvant endocrine therapy adherence. In addition, continuous education and support should be accompanied so that breast cancer survivors can maintain positive beliefs in adjuvant endocrine therapy adherence.

Pilot randomized controlled trial of a program to enhance experience and adherence with adjuvant endocrine therapy among women with non-metastatic breast cancer: 12-month quantitative results.

Adjuvant endocrine therapy (AET) reduces recurrence risk after hormone receptor-positive breast cancer, but non-adherence is common. We pilot-tested SOIE, a program to enhance AET experience and adherence, to assess its acceptability, feasibility, and effects on psychosocial precursors of AET adherence. We conducted a 12-month pilot randomized controlled trial among women who had a first AET prescription. Intervention group received SOIE while control group received usual care. Psychosocial factors from the Theory of Planned Behavior (TPB) (intention-primary outcome-, attitude, subjective norm, behavioral control), additional constructs (AET knowledge, social support, coping planning), impact of AET services received, and adherence were measured by questionnaires at baseline, 3-month, and 12-month endpoints. Group patterns were compared using repeated measures analyses with generalized estimating equations. A total of 106 women were randomized (participation = 54.9%; intervention n = 52; control n = 54; retention = 93.8%). Among SOIE women, ≥ 90% received the program components and were satisfied. Both groups scored high on adherence intentions and group patterns over time were not statistically different. In the intervention group, AET knowledge and coping planning with side effects increased (group-by-time p-value = .002 and .016), a higher proportion reported that AET services received helped them take their AET (p < .05) and have a consistent daily intake (p = .01). SOIE is feasible and acceptable for survivors with an AET. SOIE did not significantly impact adherence intentions but was beneficial for other program outcomes and daily intake. SOIE may represent an encouraging avenue to enhance supportive care and empower survivors with managing AET.

Clinical factors associated with patterns of endocrine therapy adherence in premenopausal breast cancer patients

IntroductionPatients with hormone receptor positive breast cancer are recommended at least five years of adjuvant endocrine therapy, but adherence to this treatment is often suboptimal. We investigated longitudinal trends in adjuvant endocrine therapy (AET) adherence among premenopausal breast cancer patients and identified clinical characteristics, including baseline comorbidities and non-cancer chronic medication use, associated with AET adherence.MethodsWe included stage I–III premenopausal breast cancer patients diagnosed during 2002–2011 and registered in the Danish Breast Cancer Group clinical database who initiated AET. We used group-based trajectory modeling to describe AET adherence patterns. We also linked patients to Danish population-based registries and fit multinomial logistic models to compute odds ratios (ORs) and 95% confidence intervals (95% CIs) associating clinical characteristics with AET adherence patterns.ResultsWe identified three adherence patterns among 4,353 women—high adherers (57%), slow decliners (36%), and rapid decliners (6.9%). Women with stage I disease (vs. stage II; OR: 1.9, 95% CI 1.5, 2.5), without chemotherapy (vs. chemotherapy; OR: 4.3, 95% CI 3.0, 6.1), with prevalent comorbid disease (Charlson Comorbidity Index score ≥ 1 vs. 0; OR: 1.6, 95% CI 1.1, 2.3), and with a history of chronic non-cancer medication use (vs. none; OR: 1.3, 95% CI 1.0, 1.8) were more likely to be rapid decliners compared with high adherers.ConclusionsWomen with stage I cancer, no chemotherapy, higher comorbidity burden, and history of chronic non-cancer medication use were less likely to adhere to AET. Taking steps to promote adherence in these groups of women may reduce their risk of recurrence.

Adherence to adjuvant endocrine therapy for breast cancer: a qualitative exploration of attribution of symptoms among post-menopausal women.

Oral adjuvant endocrine therapy (AET) is an effective treatment for hormone receptor positive breast cancer to decrease recurrence and mortality, but adherence is poor. This study explored post-menopausal women's experiences with AET, with a particular focus on adherence to AET as well as distress and symptoms experienced prior to and during AET treatment. Participants were recruited from a hospital registry, stratified by adherence to/discontinuation of AET. Telephone interviews followed a semi-structured interview guide and were recorded and transcribed verbatim. Transcripts were systematically coded using team-based coding, with analysis of themes using a grounded theory approach. Thirty-three participants were interviewed; ages ranged from 57 to 86years. Participants included 10 discontinued patients and 23 patients who completed their AET course or were adherent to AET at the time of interviewing. Both adherent and discontinued patients reported symptoms throughout their AET treatment course, and both attributed symptoms to factors other than AET (e.g., older age and pre-existing comorbidities). However, discontinued patients were more likely to attribute symptoms to AET and to describe difficulty managing their symptoms, with some directly citing symptoms as the reason for discontinuing AET therapy. Conversely, adherent patients were more likely to describe the necessity of taking AET, despite symptoms. AET adherence was associated with beliefs about AET, symptom attribution, and symptom management. Routine symptom monitoring during AET and addressing both symptoms and patients' understanding of their symptoms may promote adherence to AET.

Abstract 4836: Race differences in symptom burden and medication adherence among women with breast cancer on adjuvant endocrine therapy: A post hoc analysis of a randomized control trial

Abstract Background: Adjuvant endocrine therapy (AET) reduces breast cancer recurrence, but racial differences in nonadherence remains a concern. Differential symptom burden may contribute to disparities in AET adherence. Method: We conducted a post hoc analysis by race among women with breast cancer starting AET who were randomized in THRIVE Study (NCT03592771) to investigate remote symptom monitoring intervention vs. usual care from 11/2018 to 06/2021. Participants completed surveys at baseline, 6- and 12-month. Outcomes were symptom burden measured by FACT-Endocrine Subscale, and adherence measured by electronically monitored pillbox (&amp;gt;80% Proportion of Days Covered). We estimated symptom differences by race using linear regression with and without adjusting for baseline characteristics. To examine whether symptom burden contributed to racial differences in adherence, we conducted multivariable regression for adherence with and without controlling for symptom burden, and Blinder-Oaxaca decomposition. Results: Among 102 (34%) Black and 194 (66%) White women who were randomized, retention was 88% at 12-month. Compared to White participants, Black participants were younger (55 vs. 60 years), more likely to be at poverty (10.8% vs. 4.1%), and had lower health literacy (18.9% vs. 13.4%; p-values&amp;lt;.01). While symptom burden did not differ by study arm, Black participants had worse symptoms than White at baseline (60.8 vs. 64.5, p=.002). This gap became smaller at 6-month (59.7 vs. 61.2, p=.30), but diverged again at 12-month (56.9 vs. 61.8, p&amp;lt;0.01). Differences at 12-month diminished after controlling for baseline characteristics (-1.6, 95%CI=-4.4 to 1.2). Notably, being at poverty and younger age were associated with higher symptoms. Adherence was lower among Black participants at 6-month (0.69 vs. 0.78, p=.13) and 12-month (0.44 vs. 0.60, p=.014) than White participants. Unadjusted differences in adherence at 12-month (-16.0 percentage points [ppts], 95%CI=-28.9 to -3.3, p=.01) attenuated after adjusting for baseline symptoms, symptom changes to 12-month, and other baseline characteristics (-10.4 ppts, 95%CI=-25.6 to 4.8, p=.18). Lower baseline symptoms were associated with better adherence (0.8 ppts, 95%CI=0.1 to 1.4, p=.03). Decomposition indicates that 9.1 ppts (95%CI=-4.8 to 23.0, 57%) of the difference in 12-month adherence was explained by symptoms and baseline characteristics, and remaining unexplained difference was 6.9 ppts (95%CI=-12.6 to 26.4, 43%). Conclusion: Our results add to increasing evidence that Black women with breast cancer have lower AET adherence, which may be partially attributed to worse symptoms than White women. These results highlight the need for new strategies to promote equitable symptom management and adherence strategies between Black and White women to reduce disparities in outcomes. Citation Format: Xin Hu, Rebecca A. Krukowski, Ed Stepanski, Lee S. Schwartzberg, Gregory A. Vidal, Ilana Graetz. Race differences in symptom burden and medication adherence among women with breast cancer on adjuvant endocrine therapy: A post hoc analysis of a randomized control trial [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 4836.

Concurrent factors associated with adherence to adjuvant endocrine therapy among women with non-metastatic breast cancer.

Adjuvant endocrine therapy (AET) reduces breast cancer morbidity and mortality, yet women often report suboptimal adherence. Though correlates of AET adherence are well-documented, few studies examine the relative importance of multi-level factors associated with adherence. The aim of this study was to identify factors most strongly associated with AET adherence in women with breast cancer. Between 10/2019 and 6/2021, women (N = 100) with non-metastatic, hormone receptor-positive breast cancer, taking AET who reported AET-related distress enrolled into a clinical trial. Participants completed baseline measures, including the Medication Adherence Rating Scale-5, sociodemographics, and validated measures of anxiety, depression, medication-taking self-efficacy, social support, and treatment satisfaction. We created a latent factor and tested associations between sociodemographic, medical, and psychosocial characteristics and adherence. Associated predictors (p < .10) were entered into a structural model, which was corroborated via multivariate regression modeling. A four-indicator latent adherence factor demonstrated good model fit. Participants (Mage = 56.1years, 91% White) who were unemployed (B = 0.27, SE = 0.13, p = .046) and reported greater treatment convenience (B = 0.01, SE = 0.01, p = .046) reported greater adherence. Scores of participants who reported greater medication-taking self-efficacy (p = .097) and social support (p = .062) approached better adherence. Greater medication-taking self-efficacy (B = 0.08, SE = 0.02, p < .001) and being unemployed (B = 0.28, SE = .14, p = .042) were most strongly associated with greater adherence, independent of other predictors. Multivariate modeling confirmed similar findings. Medication-taking self-efficacy and employment status were associated with AET adherence above other related factors. Enhancing patients' confidence in their ability to take AET for breast cancer may represent an important intervention target to boost adherence.

Silent suffering: the impact of sexual health challenges on patient-clinician communication and adherence to adjuvant endocrine therapy among Black women with early-stage breast cancer.

Adjuvant endocrine therapy (AET) increases sexual health challenges for women with early-stage breast cancer. Black women are more likely than women of other racial/ethnic groups to report adverse symptoms and least likely to initiate and maintain AET. Little is known about how sexual health challenges influence patient-clinician communication and treatment adherence. This study explores facilitators of and barriers to patient-clinician communication about sexual health and how those factors might affect AET adherence among Black women with early-stage breast cancer. We conducted 32 semi-structured, in-depth interviews among Black women with early-stage breast cancer in the U.S. Mid-South region. Participants completed an online questionnaire prior to interviews. Data were analyzed using thematic analysis. Participants' median age was 59 (range 40-78 years, SD = 9.0). Adverse sexual symptoms hindered participants' AET adherence. Facilitators of patient-clinician communication about sexual health included female clinicians and peer support. Barriers included perceptions of male oncologists' disinterest in Black women's sexual health, perceptions of male oncologists' biased beliefs about sexual activity among older Black women, cultural norms of sexual silence among Southern Black women, and medical mistrust. Adverse sexual symptoms and poor patient-clinician communication about sexual health contribute to lower AET adherence among Black women with early-stage breast cancer. New interventions using peer support models and female clinicians trained to discuss sexual health could ameliorate communication barriers and improve treatment adherence. Black women with early-stage breast cancer in the U.S. Mid-South may require additional resources to address sociocultural and psychosocial implications of cancer survivorship to enable candid discussions with oncologists.

Abstract A006: A randomized controlled trial of a mobile symptom monitoring app and tailored messages: Differences in outcomes among Black and White women with breast cancer on adjuvant endocrine therapy

Abstract Black women with early-stage, hormone receptor-positive breast cancer have lower adjuvant endocrine therapy (AET) adherence and higher symptom burden than White women. We compared the effects of a symptom monitoring app and tailored messages on treatment-relevant outcomes among Black and White women with breast cancer starting AET. Patients prescribed AET for early-stage breast cancer at a cancer center from November 2018 until June 2021 were randomized into: (1) an “App” group that received instructions and access to the study app and weekly text reminders to use it (n=94); (2) an “App+Feedback (AF)” group that received additional weekly tailored messages about managing symptoms, adherence, and communication (n=100); or (3) a “Usual Care (UC)” group without app access (n=102). The intervention lasted 6-months, and participants completed surveys at enrollment and 12-months. Increasing/severe symptoms and missed doses triggered alerts that prompted follow-ups from the oncology team. Outcomes included AET adherence, captured with an electronically monitored pillbox, app use, alerts, symptom burden (FACT-ES), quality of life (SF-12), self-efficacy for managing symptoms (PROMIS 1.0), and healthcare utilization (6-month count of emergency department visits/urgent care/hospitalizations, and office visits). Analyses stratified by self-reported race. Overall, 102 (34%) Black and 194 (66%) White women were randomized. Retention at 12-months was 88%. Median age was higher among White participants (60 vs. 55 years, p&amp;lt;0.01). Number of weeks with app use was higher among White intervention participants (15.5 vs. 11.8, p&amp;lt;0.01), but resulted in fewer alerts (2.7 vs. 8.1, p&amp;lt;0.01) compared with Black participants. AET adherence over 12-months was lower among Black women (69% vs 76%, p=0.06), and such difference was similar across study arms. Black AF participants had fewer higher cost healthcare encounters compared to UC (0.27 vs. 0.97, p=0.03) but not for App only vs. UC. Black App participants had more office visits 6 to 12-months post enrollment compared to UC (4.4. vs. 2.6, p=0.04). White App participants reported 4.3 points higher physical health scores compared to UC (51.7 vs. 47.4, p=0.04). There were no significant differences by study arm in AET adherence, mental health score, symptom burden, or self-efficacy for managing symptoms among White or Black participants. Although Black intervention participants used the symptom monitoring app less often, they were more likely to report severe symptoms that triggered an alert to their oncology team than White participants. Among Black participants, the app combined with tailored messages resulted in fewer higher cost healthcare encounters, while App only resulted in more frequent office visits compared to UC. White participants did not have any differences in healthcare utilization, but App only participants reported higher physical health compared with UC. Symptom monitoring apps with tailored text messages improved different outcomes among Black and White patients with breast cancer on AET. Citation Format: Ilana Graetz, Xin Hu, Rebecca A. Krukowski, Mehmet Kocak, Janeane N. Anderson, Teresa M. Waters, Andrea N. Curry, Andrew Robles, Andrew Paladino, Edward Stepanski, Gregory A. Vidal, Lee S. Schwartzberg. A randomized controlled trial of a mobile symptom monitoring app and tailored messages: Differences in outcomes among Black and White women with breast cancer on adjuvant endocrine therapy [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A006.

Managing Symptom Distress: Key Factors for Patients on Adjuvant Endocrine Therapy for Breast Cancer

ContextPatients with breast cancer taking adjuvant endocrine therapy (AET) experience significant symptoms impacting mood, quality of life (QOL), and AET adherence and satisfaction. ObjectivesThe aim of this study was to examine the extent to which coping ability and self-efficacy for symptom management moderate the relationships between patients’ symptom distress and their mood, QOL, and AET adherence and satisfaction. MethodsAs part of a randomized controlled trial, participants completed baseline measures including: sociodemographics, symptom distress (breast cancer prevention trial symptom checklist), coping skills (measure of current status), self-efficacy (self-efficacy for managing symptoms), anxiety and depression (hospital anxiety and depression scale), QOL (functional assessment of cancer therapy - general), AET adherence (medication adherence report scale), and AET satisfaction (cancer therapy satisfaction questionnaire). We conducted moderated regression analyses to examine whether coping and self-efficacy moderated the associations of symptom distress with baseline measures. ResultsCoping skills moderated the associations of symptom distress with depression and QOL. Among those with lower coping, higher symptom distress was associated with worse depression symptoms (p=.04) and worse QOL (p < 0.001). Self-efficacy moderated the associations of symptom distress with depression symptoms and AET adherence and satisfaction. Among those with higher self-efficacy, higher symptom distress was associated with worse depression symptoms (p < 0.001), worse AET adherence (p < 0.001), and less AET satisfaction (p = 0.01). ConclusionCoping skills may buffer the effect of AET symptom distress. Findings indicate the relationship between symptom distress and self-efficacy is more nuanced and requires further research to better understand.

A Systematic Review and Meta-Analysis of Interventions to Promote Adjuvant Endocrine Therapy Adherence Among Breast Cancer Survivors.

Adjuvant endocrine therapy (AET) adherence among breast cancer survivors is often suboptimal, leading to higher cancer recurrence and mortality. Intervention studies to promote AET adherence have burgeoned, more than doubling in number since this literature was last reviewed. The current aim is to provide an up-to-date systematic review and meta-analysis of interventions to enhance AET adherence and to identify strengths and limitations of existing interventions to inform future research and clinical care. Systematic searches were conducted in three electronic databases. Studies were included in the systematic review if they examined an intervention for promoting AET adherence among breast cancer survivors. Studies were further included in the meta-analyses if they examined a measure of AET adherence (defined as compliance or persistence beyond initiation) and reported (or provided upon request) sufficient information to calculate an effect size. Of 5,045 unique records, 33 unique studies representing 375,951 women met inclusion criteria for the systematic review. Interventions that educated patients about how to manage side effects generally failed to improve AET adherence, whereas policy changes that lowered AET costs consistently improved adherence. Medication reminders, communication, and psychological/coping strategies showed varied efficacy. Of the 33 studies that met the inclusion criteria for the systematic review, 25 studies representing 367,873 women met inclusion criteria for the meta-analysis. The meta-analysis showed statistically significant effects of the adherence interventions overall relative to study-specified control conditions (number of studies [k] = 25; odds ratio, 1.412; 95% CI, 1.183 to 1.682; P = .0001). Subgroup analyses showed that there were no statistically significant differences in effect sizes by study design (randomized controlled trial v other), publication year, directionality of the intervention (unidirectional v bidirectional contact), or intervention type. To our knowledge, this is the first known meta-analysis to demonstrate a significant effect for interventions to promote AET adherence. The systematic review revealed that lowering medication costs and a subgroup of psychosocial and reminder interventions showed the most promise, informing future research, policy, and clinical directions.

Development of the HT&Me intervention to support women with breast cancer to adhere to adjuvant endocrine therapy and improve quality of life.

Breast cancer is the most common cancer in women worldwide. Approximately 80% of breast cancers are oestrogen receptor positive (ER+). Patients treated surgically are usually recommended adjuvant endocrine therapy (AET) for 5-10 years. AET significantly reduces recurrence, but up to 50% of women do not take it as prescribed. To co-design and develop an intervention to support AET adherence and improve health-related quality-of-life (QoL) in women with breast cancer. Design and development of the HT&Me intervention took a person-based approach and was guided by the Medical Research Council framework for complex interventions, based on evidence and underpinned by theory. Literature reviews, behavioural analysis, and extensive key stakeholder involvement informed 'guiding principles' and the intervention logic model. Using co-design principles, a prototype intervention was developed and refined. The blended tailored HT&Me intervention supports women to self-manage their AET. It comprises initial and follow-up consultations with a trained nurse, supported with an animation video, a web-app and ongoing motivational 'nudge' messages. It addresses perceptual (e.g. doubts about necessity, treatment concerns) and practical (e.g. forgetting) barriers to adherence and provides information, support and behaviour change techniques to improve QoL. Iterative patient feedback maximised feasibility, acceptability, and likelihood of maintaining adherence; health professional feedback maximised likelihood of scalability. HT&Me has been systematically and rigorously developed to promote AET adherence and improve QoL, and is complemented with a logic model documenting hypothesized mechanisms of action. An ongoing feasibility trial will inform a future randomised control trial of effectiveness and cost-effectiveness.

A randomized controlled trial of a mobile app and tailored messages to improve outcomes among women with breast cancer receiving adjuvant endocrine therapy.

512 Background: Adjuvant endocrine therapy (AET) use among women with early-stage, hormone receptor-positive breast cancer reduces the risk of cancer recurrence, but adverse symptoms contribute to lower adherence. We evaluated the effectiveness of an app that integrates patient-reported outcomes with electronic health records and tailored messages. Methods: Women with early-stage breast cancer initiating AET (November 2018-June 2021) were randomized into three arms: (1) an “App” group that received instructions and access to the study app and weekly text reminders to use it; (2) an “App+Feedback (AF)” group received additional weekly tailored messages about managing symptoms, adherence, and communication; or (3) a “Usual Care (UC)” group without access to the app. The intervention lasted 6-months and participants completed surveys at enrollment, 6-, and 12-months. Increasing/severe symptoms and missed doses triggered alerts that prompted follow-ups from the oncology team. Outcomes included AET adherence, captured using an electronically monitored pillbox and self-reported adherence, symptom burden (FACT-ES), mental and physical health quality of life (SF-12), self-efficacy for managing symptoms (PROMIS 1.0), and 6-month count of emergency department visits/urgent care/hospitalizations [higher cost encounters] and office visits. Results: Overall, 300 women were randomized (102 UC, 96 App, and 102 AF). Median age was 60 years (range: 31–83), 34% identified as Black, 21% had incomes below 200% of the federal poverty level, and 20% had a high school degree or less education. Retention at 12-months was 88% ( N=264). Mean app logins were 14.4 among intervention participants, which resulted in 4.2 mean alerts, with 58.0% having at least one alert during the 6-month intervention. AET adherence over 12-months measured using the pillbox was similar across groups: 76% for UC, 73% for App, and 71% for AF ( p=0.57). At 12-months, AF participants had fewer higher cost care encounters over the previous 6 months (0.30, 95%CI: 0.15 to 0.45, p=0.01) compared to UC (0.71, 95%CI: 0.44 to 0.97) but not for App only vs. UC (0.46, 95% CI: 0.25 to 0.66, p=0.15). Mean mental health scores were 2.0 points better (95% CI: 0.21 to 3.84) at 6-months for AF (43.0) compared to UC (41.0). There were no statistically significant differences by group in self-reported adherence, symptom burden, physical health, self-efficacy for managing symptoms, and office visits at 6- or 12-months. Conclusions: While the intervention did not improve AET adherence, the app combined with tailored messages resulted in better self-reported mental health during the intervention and fewer higher cost care encounters at 12-months without increasing office visits. Symptom monitoring apps with tailored messages may be scalable and effective strategies for improving outcomes for patients with breast cancer. Clinical trial information: NCT03592771 .

Adjuvant endocrine therapy adherence changes among patients after a virtual behavioral intervention.

12131 Background: Adjuvant endocrine therapy (AET) reduces risk of breast cancer (BC) recurrence; however, adherence is suboptimal and interventions are needed. We conducted a randomized controlled trial of a novel telehealth intervention (STRIDE), which led to improvements in symptom distress, coping, quality of life, and mood. Here we examine which patients had improved adherence following STRIDE by exploring characteristics that may moderate intervention effects. Methods: Women (n = 100) with nonmetastatic BC who reported AET-related distress were randomized to receive STRIDE or a medication monitoring control (MM) between 10/2019-6/2021. STRIDE consisted of six weekly, small-group cognitive behavioral telehealth sessions to enhance symptom management and adherence. All patients stored their AET in electronic MEMS Caps bottles to measure objective adherence. We collected patient characteristics (i.e., months on AET, education) and self-report measures at baseline. Patients completed the Medication Adherence Report Scale (MARS-5) and Cancer Therapy Satisfaction Questionnaire to report adherence behaviors (e.g., “I alter the dose”) and AET perceptions (e.g., convenience, expectations, satisfaction), respectively. We conducted hierarchical linear modeling to test moderators of intervention effects on adherence rates (MEMS Caps) across months 1-3, controlling for ovarian suppression receipt and baseline distress due to group differences/stratification. We report the ‘time X group X moderator’ effects here. Results: Among participants reporting greater difficulty (lower MARS-5) with their AET regimen at baseline, STRIDE participants had greater improvement in adherence over time compared to MM participants ( b= -13.80, SE = 4.56, p &lt; .01). Greater expectations of therapeutic benefit predicted improvements in adherence for STRIDE versus MM participants ( b= 0.25 SE = 0.10, p = .01). Additionally, among participants who reported greater convenience of taking AET ( b= 0.33 SE = 0.17, p = .06), had lower education levels ( b= -4.02, SE = 2.12, p = .06), and had been taking AET for fewer months ( b= -0.43 SE = 0.25, p = .09), STRIDE participants showed adherence increases that approached significance. Other moderators were not significant. Conclusions: STRIDE demonstrated effects of a behavioral intervention on AET adherence. Participants reporting greater difficulty adhering to their AET regimen and who expected more benefit showed improved adherence following STRIDE. Gains in adherence from STRIDE were also more pronounced among those who reported that AET was convenient, started the medication more recently, and had lower levels of education. Patient-level and socioeconomic factors influence response to AET adherence interventions. Clinicians may play a key role in addressing modifiable targets at AET initiation (e.g., logistical barriers, perceived benefit) to enhance adherence. Clinical trial information: NCT03837496 .

Codevelopment of a Text Messaging Intervention to Support Adherence to Adjuvant Endocrine Therapy in Women With Breast Cancer: Mixed Methods Approach.

Adjuvant endocrine therapy (AET) reduces breast cancer recurrence and mortality in women with early-stage breast cancer. Unintentional nonadherence to AET is common (eg, forgetting to take medication). Forming habits surrounding medication taking could reduce reliance on memory and improve AET adherence. SMS text messaging interventions may offer a low-cost approach for promoting medication-taking habits. To optimize the likely effectiveness of such SMS text messages, the content should be developed using a transparent approach to ensure fidelity to relevant psychological theory and with user input to increase acceptability. This study aimed to develop a pool of brief SMS text messages promoting habit formation to support AET adherence, which are acceptable to women with breast cancer and show fidelity to theory-based behavior change techniques (BCTs). According to published literature, we selected 6 BCTs derived from the habit formation model: action planning, habit formation, restructuring the physical environment, adding objects to the environment, prompts/cues, and self-monitoring of behavior. In study 1, behavior change experts (n=10) created messages, each based on 1 of the 6 BCTs, in a web-based workshop and rated the fidelity of the messages to the intended BCT. In study 2, women with experience of taking AET discussed the acceptability of the messages in a focus group (n=5), and the messages were refined following this. In study 3, women with breast cancer rated the acceptability of each message in a web-based survey (n=60). In study 4, additional behavior change experts rated the fidelity of the remaining messages to the intended BCT in a web-based survey (n=12). Finally, a consultant pharmacist reviewed a selection of messages to ensure that they did not contradict general medical advice. In study 1, 189 messages were created targeting the 6 BCTs. In total, 92 messages were removed because they were repetitious, unsuitable, or >160 characters, and 3 were removed because of low fidelity (scoring <5.5/10 on a fidelity rating scale). Following study 2, we removed 13 messages considered unacceptable to our target population. In study 3, all remaining messages scored above the midpoint on an acceptability scale (1-5); therefore, no messages were removed (mean 3.9/5, SD 0.9). Following study 4, we removed 13 messages owing to low fidelity (scoring <5.5/10 on a fidelity rating scale). All the remaining messages showed fidelity to the intended BCTs (mean 7.9/10, SD 1.3). Following the pharmacist review, 2 messages were removed, and 3 were amended. We developed a pool of 66 brief SMS text messages targeting habit formation BCTs to support AET adherence. These showed acceptability to women with breast cancer and fidelity to the intended BCTs. The delivery of the messages will be further evaluated to assess their effect on medication adherence.