Breast Cancer Prevention Trial Symptom Research Articles

Factors influencing 5-year persistence to adjuvant endocrine therapy in young women with breast cancer

PurposeAlthough younger age has been negatively associated with persistence to adjuvant endocrine therapy (ET), factors contributing to non-persistence remain poorly understood. We assessed factors associated with non-persistence to ET and described the 5-year trajectories of quality of life (QoL) and symptoms in young women (≤40 years) with hormone receptor-positive breast cancer (BC). MethodsWe retrieved data on clinical characteristics and non-persistence from the medical annual records in the European cohort of the “Helping Ourselves, Helping Others: The Young Women's BC Study” (IBCSG 43-09 HOHO). Women completed surveys at baseline, biannually for three years, and annually for another seven years. Data collection included sociodemographic information, QoL aspects assessed by the Cancer Rehabilitation Evaluation System-Short Form and symptoms assessed by the Breast Cancer Prevention Trial symptom scales. Cox regression models were applied to identify factors associated with non-persistence. ResultsThe cumulative risk of interrupting ET within 5 years was 27.7 % (95 % CI, 21.5–35.2). The QoL subscale scores remained stable over 5 years, with slight improvements in the physical subscale. Hot flashes decreased (p < 0.001), while vaginal problems intensified (p < 0.001) over time. Being married without children and having difficulties interacting and communicating with the medical team were significantly associated with non-persistence. ConclusionsDiscussing the desire to conceive with partnered childless women and establishing a good relationship with the medical team may be important in addressing the non-persistence in young BC survivors. As recent data suggests the safety of pausing ET to conceive, this approach may be a reasonable future option to limit non-persistence.

Abstract PO3-01-10: Changes in Patient-Reported Outcomes with 3 Months of Pre-operative Endocrine Therapy in the POWER Trial

Abstract Background: The Pre-Operative Window of Endocrine Therapy to Inform Radiation Therapy Decisions Trial (POWER, NCT04272801) aims to determine whether 3 months of pre-operative endocrine therapy (pre-ET) affects decision-making regarding adjuvant radiation therapy (RT) among older women with early-stage, estrogen receptor (ER) positive breast cancer. The goal of the present study is to evaluate changes in patient-reported outcomes (PROs) during the course of pre-ET. We hypothesize that PROs will change over the course of pre-ET and that those changes can be used to identify patients who are at-risk for long-term noncompliance to adjuvant ET and who may benefit from RT. Methods: Participants in the POWER Trial receive 3 months of pre-ET prior to breast-conserving surgery and final treatment decisions regarding adjuvant RT. Health-related quality of life (HRQOL) (EORTC QLQ-C30 and QLQ-BR23), depression (Center for Epidemiologic Studies Depression Scale Revised), and general symptom burden (Breast Cancer Prevention Trial Symptom Checklist (BCPT-SCL)) are assessed at baseline and at day 90 after pre-ET. Perceived sensitivity to medicine (Perceived Sensitivity to Medicine (PSM) survey) is assessed at baseline. The BCPT-SCL was used to examine common ET side effects, including hot flashes, musculoskeletal symptoms, cognitive problems, weight gain, and bladder control. Graphical methods are used to display results. Results: The first 46 participants who completed pre-ET in the POWER trial were included in this preliminary assessment. From baseline to day 90, there was notable variability in HRQOL and no definitive shift towards worsening HRQOL with a median change (IQR) of 0 (-8.33, 8.33). Similarly, the median change in symptom profiles for the whole cohort was 0 over the 90 days of pre-ET. However, a subset of patients experienced changes in symptom burden throughout the 90-day period. Approximately one-fourth of participants reported an increase in hot flashes and musculoskeletal symptoms from baseline to day 90. There does not appear to be worsening fatigue, depression scores, cognitive problems, or weight gain. After stratifying by self-perceived sensitivity to medicine, patients with high PSM scores have a greater median change (0.5 and 0.33) in symptoms compared to those with low PSM scores (0 and 0) for hot flashes and musculoskeletal symptoms, respectively (Figure 1). Conclusions: When looking at this cohort, there was no change in symptoms or quality of life after the 3-month course of pre-ET. Evaluation of the changes in PROs identified a subset of participants with worsening symptoms after pre-ET. Future analyses, when trial accrual is complete, will examine the relationship between PROs and long-term adherence to adjuvant ET and will elucidate if the patients who experience worsening BCPT-SCL symptoms during the 90-day period are more likely to opt for RT. Figure 1 Change in symptoms after pre-ET Change in hot flash burden and musculoskeletal symptom burden is greater in patients with high perceived sensitivity to medicine. Citation Format: Trish Millard, Lena Turkheimer, Christiana Brenin, David Brenin, Patrick Dillon, Einsley Janowski, Anneke Schroen, Gina Petroni, Shayna Showalter. Changes in Patient-Reported Outcomes with 3 Months of Pre-operative Endocrine Therapy in the POWER Trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-01-10.

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.

Symptom burden of patients with breast cancer on adjuvant hormone therapy: A preliminary report.

e12536 Background: Breast cancer (BCa) is the most common cancer in women. Adjuvant hormone therapy (AHT) showed consistent improvements in recurrence and survival rates. AHT use is associated with multiple side effects that cause a lack of adherence. This report aims to describe the symptom burden of BCA patients at treatment initiation from our ongoing RCT, which is directed at improving adherence through the innovative use of smart pill bottles. Methods: Descriptive statistics included socio-demographic information and medication use. Symptom burden and distress are assessed using the breast cancer prevention trial (BCPT) symptom scales. Self-efficacy is assessed using a modified version of Lorig’s Chronic Disease Self-Efficacy Scale for managing symptoms. Results are summarized as means (M), standard deviation (SD), ranges (R), and percentages. The relationship between patients’ symptoms and self-efficacy was analyzed using a multivariable linear regression model controlling for age and race. Results: Of the 119 patients included, the majority were White 80.7 %, with ages ranging from 31-81 with a mean age of 59.74 (SD=11.057). The majority had a college education or higher (61.3 %), married (66.4%), full-time workers (42.9 %) and had incomes of 75,000 USD or higher (59.0 %). The patients were on either Tamoxifen (17.7%), Anastrozole (55.4%), Letrozole (12.3%) or Exemestane (4.6 %). The (BCPT) subscales were; vasomotor symptoms (R=0-12.5, M= 5.8, SD= 3.14), Gastrointestinal symptoms (R=0-7.5, M= 2.97, SD= 1.14), bladder control (R=0-10, M= 3.09, SD= 1.87), Dyspareunia subscale (R=0-10, M= 3.53, SD= 2.27), Musculoskeletal pain (R=0-15, M= 7.5, SD= 3.53), Weight concerns (R=0-10, M= 4.22, SD= 2.16), Cognitive symptoms (R=0-15, M= 6.02, SD= 2.81). For the LORIG scales (R=1- 8.83, M= 6.04, SD=1.61). Patient symptoms were inversely correlated with higher LORIG scores for vasomotor symptoms (β = -.18, t(3) = -2.00, p= .048), Gastrointestinal symptoms (β = -.27, t(3) = -2.92, p= 0.004), Musculoskeletal pain (β = -.378, t(3) = -4.31, p= .000), Weight concerns (β = -.286, t(3) = -3.26, p= .0002), Cognitive symptoms (β = -.34, t(3) = -3.841, p= .000). Conclusions: Our results explore symptom burden and distress for breast cancer patients on AET. Based on the BCPT instrument subscales, musculoskeletal symptoms tend to be the most intrusive, with the highest mean score. Symptom burden was inversely related to higher self-efficacy represented by LORIG scores. This needs to be validated with further analysis in comparison to a control group across time points in the study to determine what would be a minimally important difference or change in score. This will help understand the interrelationships between physical symptoms and adherence to AHT. Clinical trial information: NCT04086875 .

The relationship between anxiety and vaginal-related sexual health in postmenopausal breast cancer survivors on aromatase inhibitors therapies: a cross sectional study.

Sexual health problems and anxiety are disruptive symptoms in breast cancer survivors; however, little is known about these symptoms in postmenopausal breast cancer survivors on aromatase inhibitors therapies. This study aimed to determine the relationship between anxiety and vaginal-related sexual health problems in this population. We analyzed cross-sectional data from a cohort study of postmenopausal women breast cancer survivors receiving aromatase inhibitors. Vaginal-related sexual health problems were assessed with the Breast Cancer Prevention Trial Symptom Checklist. Anxiety was assessed with the anxiety subscale of the Hospital Anxiety and Depression Scale. We used multivariable logistic regression to evaluate relationship between anxiety and vaginal-related sexual health adjusted for clinical and sociodemographic variables. Among 974 patients, 305 (31.3%) reported anxiety and 403 (41.4%) had vaginal-related sexual health problems. Compared to those without anxiety, patients with borderline and clinically abnormal anxiety reported higher rates of vaginal-related sexual health problems(36.8% vs. 49% and 55.7% respectively, p < 0.001). In multivariate analyses adjusted for clinical and sociodemographic factors, abnormal anxiety was associated with a higher rate of vaginal-related sexual health problems, with adjusted odds ratios of 1.69 (95% CI 1.06-2.70, p = 0.03). Vaginal-related sexual health problems were more frequent among patients who were under 65years of age, received Taxane-based chemotherapy, reported depression, and were married/living with a partner (p < 0.05). Among postmenopausal breast cancer survivors on aromatase inhibitors therapies, anxiety was significantly associated with vaginal-related sexual health problems. As treatments for sexual health problems are limited, results suggest that psychosocial interventions for anxiety could potentially be adapted to simultaneously address sexual health needs.

Oxylipins as Biomarkers for Aromatase Inhibitor-Induced Arthralgia (AIA) in Breast Cancer Patients

Aromatase inhibitor-induced arthralgia (AIA) presents a major problem for patients with breast cancer but is poorly understood. This prospective study explored the inflammatory metabolomic changes in the development of AIA. This single-arm, prospective clinical trial enrolled 28 postmenopausal women with early-stage (0-3) ER+ breast cancer starting adjuvant anastrozole. Patients completed the Breast Cancer Prevention Trial (BCPT) Symptom Checklist and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 0, 3, and 6 months. The plasma levels of four polyunsaturated fatty acids (PUFAs) and 48 oxylipins were quantified at each timepoint. The subscores for WOMAC-pain and stiffness as well as BCPT-total, hot flash, and musculoskeletal pain significantly increased from baseline to 6 months (all p < 0.05). PUFA and oxylipin levels were stable over time. The baseline levels of 8-HETE were positively associated with worsening BCPT-total, BCPT-hot flash, BCPT-musculoskeletal pain, WOMAC-pain, and WOMAC- stiffness at 6 months (all p < 0.05). Both 9-HOTrE and 13(S)-HOTrE were related to worsening hot flash, and 5-HETE was related to worsening stiffness (all p < 0.05). This is the first study to prospectively characterize oxylipin and PUFA levels in patients with breast cancer starting adjuvant anastrozole. The oxylipin 8-HETE should be investigated further as a potential biomarker for AIA.

Comparison of Simple-Summated Scoring and Toxicity Index Scoring of Symptom Bother in the NSABP B-30 Clinical Trial

BackgroundLevel of symptom burden for cancer patients can be summarized using simple-summated scoring of multiple patient-reported symptoms. The Toxicity Index (TI) is an alternative that has been used primarily to summarize clinician-reported toxicities.ObjectiveTo compare the TI with simple-summated scoring of 28 patient-reported symptoms.MethodsThis is a secondary analysis of longitudinal data from a clinical trial of women with stage 2 or 3 breast cancer: baseline (n = 2156) and 6 months later (n = 1764). Study participants completed the 28-item Breast Cancer Prevention Trial symptom checklist assessing level of symptom bother in the past 7 days and four criterion items assessing general health and overall quality of life.ResultsAssociations of simple-summated scoring of the 28 cancer-related symptoms with the general health and overall quality of life items tended to be larger than correlations of the TI summary scoring of the symptoms. For example, the Spearman correlation of change in quality of life was − 0.38 with change in the simple-summated score and − 0.23 with change in the TI.ConclusionThe findings suggest that simple-summated scoring and differential weighting of the level of symptom bother yield similar results.Implications for PracticeClinicians can use simple-summated scoring rather than more complicated scoring algorithms to obtain an indication of overall level of symptom burden among cancer patients.

Feasibility Trial to Evaluate Tendon Stiffness Obtained from Shear Wave Elastography Imaging as a Biomarker of Aromatase Inhibitor-Induced Arthralgias

Aromatase inhibitor-induced arthralgia (AIA) comprises significant, activity-limiting musculoskeletal symptoms, including joint pain, myalgia, and joint stiffness. We conducted a prospective feasibility study in postmenopausal women diagnosed with early-stage (0–3) hormone receptor positive (HR+) breast cancer who were candidates for treatment with adjuvant AI therapy (n = 16). Tendons of the hands and wrists and the median nerve were imaged using gray-scale and power Doppler ultrasound (US) and US SWE. Arthralgia symptoms were evaluated using the Breast Cancer Prevention Trial (BCPT) Symptom Checklist musculoskeletal subscale (MS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and stiffness subscales. At baseline, there were significant differences in the SW velocities of tendons between dominant and nondominant hands. Increased velocity in 2 of 6 tendons and the median nerve was associated with greater pain at baseline, whereas slower velocity of the extensor digitorum tendon (suggesting decreased stiffness) was associated with a higher WOMAC stiffness score. Increased SW velocity (suggestive of increased stiffness) at baseline in the abductor pollicis longus tendon was associated with a worsening of all three pain and stiffness measures by 6 months. Future studies should evaluate SWE scores related to AIA outcomes in a larger sample size.

Worry and rumination in breast cancer patients: perseveration worsens self-rated health.

A number of studies have shown that self-rated health reliably predicts mortality. This study assessed the impact of perseveration on self-rated health, physical functioning, and physical symptoms (pain, fatigue, breast cancer symptoms) among breast cancer patients. We hypothesized that cancer-related distress would serve as an intervening variable between both worry and rumination and self-rated health, physical functioning, and physical symptoms. Women (N = 124) who were approximately 7 weeks post-surgery but pre adjuvant treatment completed the Impact of Events Scale, the Penn State Worry Questionnaire, and the Rumination Scale. They also rated their pain, fatigue, physical functioning, and self-rated health using the RAND-36 and breast cancer symptoms with the Breast Cancer Prevention Trial Symptom Checklist (BCPT). Covariates included body mass index, age, cancer stage, menopause status, and physical comorbidities. Worry was associated with higher cancer-related distress, which in turn predicted greater pain and breast cancer symptoms, poorer physical functioning, and lower self-rated health. Rumination also predicted greater cancer-related distress, which ultimately contributed to greater pain along with poorer physical functioning and self-rated health. Models with fatigue as an outcome were not significant. These findings suggest that perseveration can heighten cancer-related distress and subsequent perceptions of physical symptoms and health among breast cancer patients prior to adjuvant treatment. Perseveration early in the cancer trajectory can adversely increase the impact of a cancer diagnosis and treatment on functioning and quality of life.

Symptom Clusters in Women With Breast Cancer During the First 18 Months of Adjuvant Therapy

ContextWomen with breast cancer treated with aromatase inhibitor (AI) therapy experience multiple concurrent symptoms or symptom clusters. Understanding of the symptom experience and identifying symptom clusters before and during AI therapy are important for the development of interventions to improve clinical outcomes. ObjectivesThe aim of this study was to identify symptom clusters experienced by women with breast cancer treated with AI therapy from pre–adjuvant therapy up to 18 months of adjuvant therapy using a broad scope of symptoms assessment. MethodsForty-seven symptoms were evaluated in postmenopausal women with breast cancer (N = 354) who received AI therapy or chemotherapy followed by AI therapy. Symptoms were assessed at four semiannual time points with the Breast Cancer Prevention Trial Symptom Checklist, Patient's Assessment of Own Functioning Inventory, Beck Depression Inventory-II, and Profile of Mood States Tension/Anxiety and Fatigue/Inertia subscales. Exploratory factor analyses were conducted at each time point to identify symptom clusters. ResultsFour stable symptom clusters (i.e., musculoskeletal, vasomotor, urinary, sexual) and three relatively stable symptom clusters (i.e., psychological, neurocognitive, weight) were identified across the 18-month follow-up period. The gastrointestinal symptom cluster only appeared at after six months of adjuvant therapy (postchemotherapy). ConclusionThis study helps us to better understand the most common symptom clusters over the first 18 months of adjuvant therapy among postmenopausal women with early-stage breast cancer. It is critical for health care providers to know the symptom clusters commonly experienced by women receiving AI therapy with or without chemotherapy and manage them properly over time.

The Relationship Between Insomnia and Cognitive Impairment in Breast Cancer Survivors.

BackgroundCancer-related cognitive impairment is an emerging public health burden. Growing research suggests that sleep disturbances contribute to poor cognition. Our study aimed to evaluate the association between insomnia and cognitive impairment in breast cancer survivors.MethodsWe analyzed cross-sectional data from a cohort study of postmenopausal women with stage 0–III hormone receptor-positive breast cancer on aromatase inhibitor therapy. The study was conducted between November 2011 and April 2015 at an academic cancer center (Philadelphia, PA). Insomnia was assessed with the Insomnia Severity Index. Perceived cognitive impairment was assessed with the cognitive subscale of the Breast Cancer Prevention Trial Symptom Checklist. We used linear regression to evaluate the association between insomnia and perceived cognitive impairment.ResultsAmong 1072 patients, 556 (51.9%) reported insomnia and 847 (79.0%) were bothered by cognitive symptoms (forgetfulness, difficulty concentrating, distractibility). Greater perceived cognitive impairment was reported by patients with mild insomnia (regression coefficient [β] = 0.35, 95% confidence interval [CI] = 0.23 to 0.46, P < .001), moderate insomnia (β = 0.51, 95% CI = 0.36 to 0.65, P < .001), and severe insomnia (β = 0.94, 95% CI = 0.67 to 1.21, P < .001), compared with those without insomnia. Greater perceived cognitive impairment was also associated with patients younger than 55 years (β = 0.30, 95% CI = 0.15 to 0.45, P < .001), taxane-based chemotherapy (β = 0.11, 95% CI = 0.004 to 0.22, P = .04), anxiety (β = 0.47, 95% CI = 0.30 to 0.64, P < .001), and depression (β = 0.65, 95% CI = 0.35 to 0.94, P < .001).ConclusionsAmong postmenopausal breast cancer survivors receiving aromatase inhibitor therapy, insomnia and cognitive impairment are prevalent and characterized by a graded association, in which severity of perceived cognitive impairment increases as insomnia severity increases. Our findings warrant further research to determine whether addressing sleep is a strategy to improve management of cancer-related cognitive impairment.

Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial

BackgroundIn the phase III SOLE trial, the extended use of intermittent versus continuous letrozole for 5 years did not improve disease-free survival in postmenopausal women with hormone receptor-positive breast cancer. Intermittent therapy with 3-month breaks may be beneficial for patients’ quality of life (QoL).MethodsIn the SOLE QoL sub-study, 956 patients completed the Breast Cancer Prevention Trial (BCPT) symptom and further QoL scales up to 24 months after randomisation. Differences in change of QoL from baseline between the two administration schedules were tested at 12 and 24 months using repeated measures mixed-models. The primary outcome was change in hot flushes at 12 months.ResultsThere was no difference in hot flushes at 12 months between the two schedules, but patients receiving intermittent letrozole reported significantly more improvement at 24 months. They also indicated less worsening in vaginal problems, musculoskeletal pain, sleep disturbance, physical well-being and mood at 12 months. Overall, 25–30% of patients reported a clinically relevant worsening in key symptoms and global QoL.ConclusionLess symptom worsening was observed during the first year of extended treatment with the intermittent administration. For women experiencing an increased symptom burden of extended adjuvant endocrine therapy, an intermittent administration is a safe alternative.Clinical trial informationClinical trial information: NCT00553410.

Endocrine Therapy-Related Symptoms and Quality of Life in Female Cancer Survivors in the Yale Fitness Intervention Trial.

The aim of the current study was to describe and compare endocrine therapy-related symptoms and quality of life in female cancer survivors taking aromatase inhibitors, tamoxifen, and no endocrine therapy, and to evaluate the effect of an exercise intervention on these symptoms and quality of life. Randomized controlled trial. An aerobic resistance exercise intervention group was compared with a home-based exercise control group over 1 year. The exercise intervention was supervised for the first 6 months, followed by 6 unsupervised months. Perimenopausal and early postmenopausal female cancer survivors within 3 years of completing primary or adjuvant chemotherapy were selected. A total of 154 women were enrolled in the study. Type of endocrine or hormonal therapy was documented. Symptoms were measured by the Breast Cancer Prevention Trial Symptom Checklist and the Functional Assessment of Cancer Therapy-Endocrine Subscale. Quality of life was measured by the Functional Assessment of Cancer Therapy-General. Data were collected at baseline, and at 6 and 12 months. Participants generally had mild symptom distress. There was no difference in symptoms by endocrine therapy group or by exercise group. Participants taking aromatase inhibitors in the aerobic resistance exercise intervention group reported significant improvement in social, family, and functional well-being and better quality of life compared to those in the control group at 6 months but not at 12 months. Findings were similar to those of previous large clinical trials in that no significant differences were found for endocrine therapy-related symptoms and quality of life by type of endocrine therapy taken. However, exercise may improve quality of life outcomes for women taking aromatase inhibitors. Exercise has established efficacy for patient outcomes such as cardiovascular fitness, fatigue, weight management, and quality of life and may provide better quality of life for women who take aromatase inhibitors as adjuvant therapy.

Psychometric Evaluation of the Chinese Breast Cancer Prevention Trial Symptom Scale

Women with breast cancer experience a wide spectrum of symptoms after diagnosis and treatment. Symptoms experienced by this specific population might not be fully assessed using available traditional Chinese-language symptom measures. The aim of this study was to examine the latent constructs and psychometric properties of the Chinese Breast Cancer Prevention Trial (C-BCPT) Symptom Scale. Two hundred women with breast cancer were recruited in Taiwan. Psychometric properties, including construct validity, internal consistency, and test-retest reliability, of the C-BCPT Symptom Scale were tested after translating the original instrument. A 21-item C-BCPT Symptom Scale, with 7 extracted factors accounting for 72.26% of the total variance, resulted from an exploratory factor analysis. Construct validity was confirmed by significant correlations between scores on the C-BCPT Symptom Scale and the Taiwan-version Short Form-36 Health Survey (r = -0.49 to -0.53)/Greene Climacteric Scale (r = 0.81). Reliability coefficients for the overall scale/6 extracted factors (Cronbach's α = 0.72-0.88) and test-retest reliability (intraclass correlation coefficients = 0.77-0.94) of the translated instrument were satisfactory, whereas 1 reliability coefficient for 1 extracted factor was inadequate (Cronbach's α = 0.57). An interpretable structure with preliminary acceptable psychometric properties of the C-BCPT Symptom Scale was obtained; the C-BCPT can help traditional Chinese-speaking healthcare professionals perform adequate assessments of the symptoms experienced by women with breast cancer. The C-BCPT Symptom Scale can be used in clinical practice and research to assess symptoms experienced by this specific population or effects of related interventions.

Disparities in the survivorship experience among Latina survivors of breast cancer.

The authors investigated disparities in the survivorship experience among Latinas with breast cancer (BC) in comparison with non-Latinas. A cross-sectional bilingual telephone survey was conducted among 212 Latina and non-Latina women within 10 to 24 months after a diagnosis of BC (AJCC TNM staging system stage 0-III) at 2 Los Angeles County public hospitals. Data were collected using the Preparing for Life as a (New) Survivor (PLANS) scale, Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI), Breast Cancer Prevention Trial (BCPT) Symptom Checklist, Satisfaction with Care and Information Scale, Consumer Assessment of Healthcare Providers and Systems (CAHPS) tool, Charlson Comorbidity Index adapted for patient self-report, and the 12-item Short Form Health Survey. Controlling variables included age, stage as determined by the American Joint Committee on Cancer (AJCC) TNM staging system, educational level, and study site in multivariate analyses. The mean ages of Latinas and non-Latinas were 51.5 years and 56.6 years, respectively. Compared with non-Latinas, Latinas reported less BC survivorship knowledge (27.3 vs 30.7; P<.0001), were more dissatisfied with BC care information (2.3 vs 3.4; P<.0001), reported lower PEPPI scores (38.2 vs 42.2; P = .03), and experienced more BCPT symptoms (6.4 vs 5.0; P = .04). No differences were noted regarding their confidence in survivorship care preparedness (42.7 vs 41; P = .191), satisfaction with BC survivorship care (9.6 vs 8.8; P = .298), or their discussion with physicians (9.6 vs 8.1; P = .07). These ethnic group differences persisted in multivariate analyses, with the exception of PEPPI. Latina survivors of BC experienced disparities in BC knowledge and satisfaction with information received, but believed themselves to be prepared for survivorship and were as satisfied with providers, care received, and discussions with physicians as non-Latinas. Cancer 2018;124:2373-80. © 2018 American Cancer Society.

Abstract P6-12-22: Sexual health in long-term breast cancer survivors

Abstract Background Significant sexual dysfunction is reported in women with breast cancer (BC) in the years following diagnosis. It is unclear whether symptoms persist over time in BC survivors (BCS) as long-term data compared to healthy controls is lacking. We compared sexual functioning in long-term BCS to controls and explored the impact of adjuvant therapy on sexual health. Methods A cohort of women with localized BC recruited from 1989 to 1996 was prospectively followed as previously described. BCS without recurrence and controls without BC were contacted between 2005 and 2007 and answered self-reported quality of life questionnaires. Sexual health was measured with the Sexual Activity Questionnaire (SAQ). Vasomotor, gynecological and bladder symptoms were scored using the Menopausal Symptom Scale (scale ranges 0-4) based on the Breast Cancer Prevention Trial Symptom Checklist. Regression analysis was used to compare groups, with and without adjustment for age (quadratic) and menopausal status. P values &amp;lt;0.05 were considered significant. Results 248 of 285 BCS and 159 of 167 controls completed the SAQ. The median time from diagnosis of BCS was 12.5 years. BCS were slightly older (61.9 vs 59.1 years, p=0.0004) and somewhat more likely to be post-menopausal (94.4 vs 85.5%, p=0.0025) than controls. Overall, fewer BCS were sexually active than controls (45.2 vs 59.7%, p=0.0041). This difference was no longer significant when adjusted for age and menopausal status (odds ratio 0.68, p=0.075). In those sexually active, no significant differences were noted on the SAQ Pleasure and Discomfort scales.Differences in adjuvant treatment were not significantly associated with being sexually active or the SAQ subscales. BCS scored higher (worse) on the gynecological and bladder symptom scale than controls (0.66 vs 0.43, p=0.0036, adjusted difference 0.24, p=0.0029; 0.60 vs 0.41, p=0.02, adjusted difference 0.18, p=0.029 respectively), but no difference was seen in vasomotor scores. Gynecological symptom scores were greatest in BCS who received adjuvant chemotherapy. Conclusion Despite more frequent long-term gynecological and bladder symptoms, sexual health is similar in BCS and controls. Adjuvant chemotherapy is associated with persistent gynecological symptoms and interventions aimed at improving these could improve quality of life. Citation Format: Soldera SV, Ennis M, Lohmann AE, Goodwin PJ. Sexual health in long-term breast cancer survivors [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-12-22.

Abstract P5-18-01: Extended continuous vs intermittent adjuvant letrozole in postmenopausal women with lymph node-positive, early breast cancer (IBCSG 37-05/BIG 1-07 SOLE): Impact on patient-reported symptoms and quality of life

Abstract Background: SOLE efficacy results presented at ASCO 2017 showed that extended intermittent vs continuous letrozole for 5 years did not improve disease-free survival in postmenopausal women who had received 4-6 years of adjuvant endocrine therapy for hormone-receptor positive (HR+), lymph-node positive breast cancer. Previous studies showed that the burden by symptoms related to endocrine therapy can be substantial. Even if symptoms improve during the treatment course, extending treatment implies continuation of symptoms. We compared differences in patient-reported symptoms (PRS) and quality of life (QoL) between extended continuous and intermittent letrozole over the first two years of trial treatment. Methods: From Nov 2007 to Dec 2010, 956 postmenopausal women who were disease-free following 4-6 years of prior adjuvant endocrine therapy for HR+, node-positive breast cancer were enrolled in the QoL substudy of the randomized phase III trial SOLE at selected centers. Patients receive extended continuous letrozole (2.5 mg daily) for 5 years or intermittent letrozole, taken for the first 9 months of years 1-4, and 12 months in year 5. 955 patients completed the 18-item Breast Cancer Prevention Trial (BCPT) Symptom Scales and further symptom-specific and global QoL indicators at baseline, and at 6, 12, 18 and 24 months after randomization. Differences in change of PRS and QoL from baseline between the two administration schedules were tested at 12 and 24 months for 8 symptom scales, 4 additional symptom and 4 global QoL indicators using mixed models with repeated measures. Results: Small changes in PRS and QoL scores were observed between baseline and 12 months after randomization, i.e. at the end of the first treatment-free interval in the intermittent arm. These changes showed a consistent pattern of greater worsening for patients receiving continuous compared to patients receiving intermittent letrozole. Patients receiving continuous letrozole reported a significantly greater worsening in vaginal problems (p&amp;lt;.02), musculoskeletal pain (p&amp;lt;.03), sleep disturbance (p&amp;lt;.01), physical wellbeing (p&amp;lt;.01) and mood (p&amp;lt;.03). At 24 months (after 2nd treatment-free interval) patients with intermittent letrozole reported a greater improvement in hot flushes (p&amp;lt;.03) than those with continuous letrozole. Changes in the other outcomes did not significantly differ between arms at 24 months. Conclusion: Although changes in PRS and QoL were small, there was a consistent pattern favoring the intermittent arm. For several symptoms and global QoL indicators, significantly less worsening was observed with the intermittent administration, mainly during the first year of extended treatment, due to small improvements during the treatment-free interval. Froma QoL perspective, women who suffer from endocrine side-effects in the extended setting may benefit from an intermittent administration. Citation Format: Ribi K, Luo W, Colleoni M, Karlsson P, Chirgwin J, Aebi S, Jerusalem G, Neven P, Di Lauro V, Gomez HL, Ruhstaller T, Abdi E, Di Leo A, Müller B, Maibach R, Gelber RD, Goldhirsch A, Coates AS, Regan MM, Bernhard J. Extended continuous vs intermittent adjuvant letrozole in postmenopausal women with lymph node-positive, early breast cancer (IBCSG 37-05/BIG 1-07 SOLE): Impact on patient-reported symptoms and quality of life [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P5-18-01.

Late breast cancer treatment-related symptoms and functioning: associations with physical activity adoption and maintenance during a lifestyle intervention for rural survivors.

Physical activity may be difficult for survivors with poorer functioning following primary treatment. The study examined whether late symptoms of breast cancer treatment impact PA adoption (0-6months) and maintenance (6-18months) during a weight management intervention, and whether late symptoms influence PA when accounting for overall functioning. Secondary analyses were conducted using a sample of survivors participating in a weight management intervention and who provided valid weight and accelerometer data at baseline and 6months (N=176). The Breast Cancer Prevention Trial Symptom Checklist (BCPT) assessed late treatment-related symptoms. SF-12 Physical Component Scale (PCS) and Mental Component Scale (MCS) scores assessed functioning. Change in bouted moderate to vigorous physical activity (MVPA) min/week from baseline to 6months was not associated with BCPT scales (all p values>0.05). When adding SF-12 scores to the model, change in bouted MVPA min/week was significantly associated with the PCS (p=0.045). Change in MVPA min/week from 6 to 18months was significantly associated with cognitive symptoms (p=0.004), but not musculoskeletal or vasomotor symptoms (p values>0.05). When adding 6-month SF-12 scores to the model, MVPA min/week was significantly associated with PCS (p=0.001) and MCS (p=0.028); however, BCPT cognitive problems score became non-significant (p>0.05). Poorer physical functioning was associated with lower PA adoption, and poorer mental and physical functioning was associated with lower maintenance of PA, while late symptoms generally were not. Interventionists should consider level of functioning when identifying individual PA goals during weight management interventions.

Problems of breast cancer survivors living in an urban area of Nepal

Objective:The main objective of this study was to identify the problems of Nepalese breast cancer survivors living in an urban area who had completed their treatment for at least 6 months.Methods:A cross-sectional descriptive study was conducted to assess the problems of breast cancer survivors who were registered at the Nepal Cancer Support Group. Fifty-one women who were diagnosed with breast cancer (Stage 0 to III) and were currently disease-free were enrolled in the study. They were interviewed using structured interview schedule using the Breast Cancer Prevention Trial Symptom Scale. Statistical analysis was carried out with SPSS (version 16).Results:The mean age of the women at the time of enrollment was 47.3 years. The most common modality of treatment they received was the combination of surgery, chemotherapy, and radiotherapy (84%). Top five symptoms experienced by the survivors on the basis of frequency and severity were tiredness (61%), lack of energy (57%), forgetfulness (57%), lack of interest in sex (52%), general body aches (49%), and feeling of worrisome and anxiousness about future (49%). Women with age <45 years at diagnosis had higher mean rank score in psychological (24.7) and social problems (23.9) in comparison to women aged ≥45 years. There was a significant relationship between severe psychological (34.9 vs. 19.6; P = 0.001) and social problems (29.1 vs. 21.2; P = 0.03), with the time since primary treatment completion of <1 year.Conclusions:Nepalese breast cancer survivors were found to have multiple physical, psychological, and social problems and might require special attention during follow-up visits.

Abstract C11: Racial differential in pain and nausea during breast cancer chemotherapy

Abstract Introduction: Racial survival disparity in breast cancer persists despite advances in breast cancer screening and treatment. Attention has been recently focused on breast cancer treatment disparity as a causative etiology for breast cancer survival disparity. Our previous work has indicated that symptom related toxicity, specifically pain may interfere with the ability to receive full dose and timely chemotherapy among African American women receiving chemotherapy and that pain and nausea are two symptoms that present in a differential manner between races in the immediate breast cancer post-operative period. Pain and nausea were chosen for this study as possible dose limiting symptoms. We We compared pain and nausea between African American and White women as they underwent breast cancer chemotherapy. Experimental Procedures: Two large cohorts of women undergoing breast cancer treatment were combined. The first cohort of largely Caucasian women were recruited between 2006 and 2013 in order to study cognitive function among woman undergoing Anastrazole treatment for early stage breast cancer (AIM). One cohort underwent chemotherapy before Anastrazole therapy, and another received only chemotherapy. These groups constitute the first cohort for this study, from which baseline (before chemotherapy) and 6 month after initiation of chemotherapy measurements were abstracted. The second cohort was recruited into a study of only African American women recommended to receive breast cancer chemotherapy. Recruitment began December, 2009 and ended September, 2014. Measurement from both cohorts were at baseline (prior to chemotherapy) and at completion of chemotherapy (4-6 months after initiation). Pain was measured in the AIM study by the Brief Pain Inventory (PBI), using an 11-point scale increasing with severity. Nausea was measured using the Breast Cancer Prevention Trial (BCPT) symptom checklist as a 0-4 point scale. Symptoms in the ACTS study were measured with the McCorkle Symptom Scale on a 1-5 scale increasing with severity. Scores for all instruments were rescaled to categorical 0 (none/hardly any), 1 (minimal), 2 (moderate) or 3 (severe) to indicate worsening severity of symptoms. Descriptive analysis was used for demographics and chi square for group differences. Data Results: Data were combined for analysis. There were 297 women between the 2 studies with data for analysis, n=148 (White) and n=149 (African American). The mean age for the AIMS Study was 59.37 (5.74), the mean age for the ACTS study was 53.7 (9.83). At baseline, white women experienced significantly less pain (p &amp;lt; .001) and these differences persisted at 6 months. (p &amp;lt; .001). African American women reporting pain levels at 0 (None/Hardly) at baseline was N=51 and at 6 months N =42. White women reporting pain levels at O (None/Hardly) at baseline was N=90 and at 6 Months N=80. African American women reporting 3 (Severe) was N=31 at baseline and N=28 at 6 month measurement while N=0 white women reported severe pain at baseline and only N=2 at 6 month measurement. There were low levels of nausea with no racial differentiation at baseline and at 6 months. Of the white sample, 93.2 % and 93% of the African American women reported experiencing nausea “not at all” or “hardly ever” at baseline. At 6 months post-baseline, 98% of the white and 90.5% of the African American women reported experiencing nausea not at all or hardly ever. Conclusions and Implications for Practice: The results of this study document racial differences in symptoms in breast cancer. Understanding these differences is imperative, especially knowing that pain may be a primary reason for interruptions in the treatment plan. These interruptions cause treatment disparity in dose and completion rates which may be implicated in breast cancer survival disparity. Citation Format: Margaret Quinn Rosenzweig, Susan Wesmiller. Racial differential in pain and nausea during breast cancer chemotherapy. [abstract]. In: Proceedings of the Eighth AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 13-16, 2015; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2016;25(3 Suppl):Abstract nr C11.