Functional Assessment Of Cancer Therapy-Breast Scores Research Articles

Abstract B144: Associations between experiences of discrimination and quality of life in a cohort of Black/African American breast cancer survivors

Abstract Introduction: Racism and discrimination have been associated with poorer mental and physical health, and decreased health-related quality of life (QoL) in the general population, however; there are limited studies examining the impact of discrimination in cancer survivors. We examined the relationship between experiences of discrimination and QoL in Black women diagnosed with breast cancer. Methods: Data were obtained from women enrolled in the Women’s Circle of Health Follow-up Study, a population-based cohort study of Black breast cancer survivors in New Jersey, enrolled within 10 months of diagnosis. Women included in these analyses were diagnosed between 2015-2019. Self-reported experiences of discrimination along with information on potential covariates and effect modifiers were collected during baseline in-person interviews. QoL was assessed at follow-up visits approximately 24 months post-diagnosis using a validated self-reported QoL of measure, the Functional Assessment of Cancer Therapy – Breast (FACT-B), which consists of 5 individual domains (emotional, functional, social/family, and physical wellbeing, as well as a disease specific domain for breast cancer). We examined the association of experiences of discrimination (none, low (<median 43%), high (≥ median 43%)) with continuous total QoL score using linear regression, adjusted for age at diagnosis, tumor stage, educational attainment, household income, smoking status, insurance, and body mass index. We also examined statistical interaction by neighborhood socioeconomic index (nSES), coping strategy (assessed using the Brief Resilient Coping Scale), and spirituality (assessed using the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp-12) scale) using cross-product terms with experiences of discrimination. Results: Of 220 study participants, 73% of participants reported experiencing any discrimination. In age adjusted models, women who reported the highest experiences of discrimination had lower QoL for overall FACT-B scores and the subscale scores (no discrimination, mean overall FACT-B:117.7, 95% confidence interval (CI): 112.4, 122.9; high discrimination, mean overall FACT-B: 106.8, 95% CI: 102.1, 111.5). Similar associations were observed in fully adjusted models, where women who reported the highest experiences of discrimination had lower QoL. For example, for women who reported no discrimination the mean overall FACT-B score was 114.7 (95% CI: 107.9, 121.4) and 100.8 (95% CI: 94.2, 107.5) for women who reported the highest level of discrimination. No evidence of statistically significant interaction was observed for nSES, spirituality, or coping strategy. Conclusions: In a population-based study of Black breast cancer survivors, experiences of discrimination were associated with poorer QoL, as measured by FACT-B. Citation Format: Nur Zeinomar, Marley M. Perlstein, Bo Qin, Hari S. Iyer, Jesse J. Plascak, Christine B. Ambrosone, Kitaw Demissie, Chi-Chen Hong, Elisa V. Bandera. Associations between experiences of discrimination and quality of life in a cohort of Black/African American breast cancer survivors [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 B144.

Abstract P4-07-49: Neoadjuvant therapy in Asian breast cancer patients with early & locally advanced breast cancers – A contemporary experience from a large tertiary hospital in Singapore

Abstract Background: Non-metastatic breast cancers (BC) are increasing treated with neoadjuvant therapy (NAT). Complete pathological response (pCR) is associated with improved survival. Early identification of care needs during NAT is crucial. We report our institution’s experience with NAT. Methods: A prospectively recruited cohort diagnosed with BC, referred to NAT program at SingHealth acute hospitals between June 2020 and June 2021. Demographics, clinical data, pCR (absence of invasive carcinoma in breast and axilla), and Functional Assessment of Cancer Therapy Breast (FACT-B) as quality of life (QOL) measure were collected. Definition of young BC (YBC) were ≤40 years, older adults (OA) ≥65 years. Results: Among 119 eligible patients, 7 (6%) were clinically stage 1, 71 (60%) stage 2, and 41 (35%) stage 3. Twenty-eight (24%) were triple negative (TNBC; defined as HER2- hormonal receptor 0-10% [HR-]), 26 (22%) HER2+ HR-, 45 (38%) HER2+ HR+, 20 (17%) HER2- HR+. Among 71 HER2+ BC, two-thirds received anthracycline (A) based chemotherapy, a quarter A-sparing and remaining 9% taxane only. Majority (89%) received dual HER2 blockade. Among TNBC, 28 (71%) received additional platinum and 2 (7%) immunotherapy. Majority (77%; n=92) completed NAT. Toxicity was main reason for incompletion. Three patients did not undergo surgery: 1 defaulted, 1 demised and the last patient’s surgery was not due at analysis. Of the 116 who underwent surgery, 23 (20%) had breast conservation and 93 (80%) mastectomy. Forty-nine (42%) achieved pCR - 12 (43%) TNBC, 17 (65%) HER2+ HR-, 20 (44%) HER2+ HR+ and 0 in HER2- HR+ (p < 0.001). The pCR rates were also lower by increasing age (Multivariable OR 0.93; 95% CI, 0.90-0.97). Baseline median FACT-B scores was 117 (IQR 102-126) for the cohort: 108 for YBC, 116 for OA and 120 for the rest (p=0.200). At baseline, median score was 28, 24, 18, 22 and 27 in physical, social, emotional, functional wellbeing and BC subscale, respectively, and YBC and OA patients had lower social wellbeing scores than the remaining cohort (22 vs 24, p=0.011). Conclusion: Highest pCR were observed with HER2+ followed by TNBC. Pre-operatively, FACT-B scores were comparable by demographics, staging and tumor subtypes. However, care must be paid to social wellbeing for women in age extremes undergoing NAT. Citation Format: Zewen Zhang, Jun Ma, Jasmine Yun Ting Tan, Whee Sze Ong, Sulastri Kamis, Grace Yang, Benita Kiat Tee Tan, Veronique Kiak Mien Tan, Tira J. Tan. Neoadjuvant therapy in Asian breast cancer patients with early & locally advanced breast cancers – A contemporary experience from a large tertiary hospital in Singapore [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P4-07-49.

Abstract P6-05-21: Quality of Life and Perspectives of Older Adults with Early & Locally Advanced Breast Cancers Undergoing Pre-operative Therapy

Abstract Background: Breast cancer (BC) is the commonest diagnosed cancer in Singaporean women. Increasingly, non-metastatic BC are treated aggressively with neoadjuvant therapy (NAT). Early identification and addressing supportive care needs of NAT treated patients is important for effective cancer care whilst maintaining optimal physical, psychological and social function. This project aims to explore the longitudinal trends of quality of life (QOL) of BC patients enrolled in a NAT program. Methods: This was a prospective cohort study of females aged 21 diagnosed with non-metastatic BC, referred to the NAT program at the SingHealth network of acute hospitals. The Functional Assessment of Cancer Therapy-Breast (FACT-B) was used as a health related QOL measure prior to NAT, within 2 months post definitive breast surgery and at 1-year post diagnosis. In older adults (OA) ≥65 years, the Attitude scale, Now vs Later as well as Health Outcome tool were also performed at baseline. Here we report pre-NAT baseline FACT-B and questionnaire results of OA patients recruited into the NAT program between Jun 2020 and Jun 2021. Results: Pre-NAT median FACT-B scores was 117 (IQR 102-126) for the entire cohort (n=119) and 116 (IQR 104-126) for OA (n=22). OA had significantly lower median Social Wellbeing score at baseline compared to patients < 65 years (p=0.01), while Physical, Emotional, and Functional Wellbeing were not significantly different. More than 50% of OA favoured QOL over quantity of life on the Attitude Scale. 68% of patients would rather have QOL now than 1 year later with half expecting their QOL to reduce by 50% in this time period. When the time scale was extended to 5 years, 64% would rather have QOL 5-years from now instead of QOL now with close to 80% expecting their QOL to be lower in 5 years than presently. Of the 4 outcomes, maintaining independence scored the highest, followed by keeping alive, then reducing/eliminating pain and other symptoms. Conclusion: Our study suggests that OA with BC report similar QOL to younger patients at baseline prior to NAT. Majority of OA patients favoured QOL over quantity of life, and viewed the ability to maintain independence as more important than survival prolongation representing their unique attitude towards cancer treatment and outcomes. Citation Format: Jun Ma, Zewen Zhang, Jasmine Yun Ting Tan, Whee Sze Ong, Sulastri Kamis, Benita Kiat Tee Tan, Veronique Kiak Mien Tan, Ravindran Kanesvaran, Tira Jing Ying Tan. Quality of Life and Perspectives of Older Adults with Early & Locally Advanced Breast Cancers Undergoing Pre-operative Therapy [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-05-21.

Validity and reliability of the Chinese version of the Patient-Reported Outcomes Measurement Information System adult profile-57 (PROMIS-57)

BackgroundThe PROMIS-57 is a commonly used self-reported instrument to solve the lack of generalizable and universal measures required to evaluate common symptoms and functions from patients’ perspectives. This study aimed to translate the PROMIS-57 into Chinese and psychometrically test the translated instrument on patients with breast cancer.MethodsTranslation, cross‑cultural adaptation, and psychometric evaluation of the instrument were performed from June 2020 to June 2021. Eligible patients were recruited and completed the PROMIS-57, Functional Assessment of Cancer Therapy-Breast (FACT-B), and a sociodemographic questionnaire.ResultsData from 602 patients with a mean age of 48.83 years were analyzed. Most domains in the PROMIS-57 showed an absence of floor and ceiling effects. Multi-trait scaling analysis demonstrated acceptable convergent and discriminant validity. The correlations between the PROMIS-57 scores and the selected FACT-B scores supported the criterion validity via the Pearson correlation test. Measurement invariance was supported by the absence of differential item functioning for most items. Cronbach’s α of the domains ranged from 0.85–0.95. The unidimensional factor structure of all domains was supported using confirmatory factor analyses. Additionally, most items showed acceptable item information curves and item characteristics curve matrices.ConclusionThe Chinese version of the PROMIS-57 was found to be a reliable and valid tool for assessing common symptoms and functions among patients with breast cancer.

Characterizing Early Changes in Quality of Life in Young Women With Breast Cancer.

IntroductionYounger age at diagnosis is a risk factor for poor health-related quality of life (HRQOL) in long-term breast cancer survivors. However, few studies have specifically addressed HRQOL in young adults with breast cancer (i.e., diagnosed prior to age 40), nor have early changes in HRQOL been fully characterized.MethodsEligible female patients with breast cancer were identified through our local cancer center. To establish HRQOL, patients completed the Functional Assessment of Cancer Therapy-Breast (FACT-B) around diagnosis and 12 months later. Sociodemographic factors, genetic susceptibility to cancer, tumor- and treatment-related factors, and comorbidities (e.g., depression/anxiety) were abstracted from medical records and the local oncology registry. Mixed-effects models were used to identify changes in FACT-B scores during the first year of treatment and to determine whether any demographic/treatment-related factors modulated changes in scores.ResultsHealth-related quality of life in young patients with breast cancer was within normal limits at baseline, with a FACT-B overall well-being score of 108.5 (95% confidence limits [CI] = 103.7, 113.3). Participants reported slight improvements over a 12-month period: FACT-B overall well-being scores increased 6.6 points (95% CI = 2.1, 11.1, p < 0.01), functional well-being improved 3.0 points (95% CI = 2.0, 4.1, p < 0.01), emotional well-being improved 1.9 points (95% CI = 0.9, 2.8, p < 0.01), and physical well-being improved 1.5 points (95% CI = 0.2, 2.8, p = 0.03), on average. Participants with anxiety/depression at baseline reported greater improvements in FACT-B overall well-being (change: 12.9, 95% CI = 6.4, 9.5) and functional well-being (change: 5.2, 95% CI = 3.5, 6.9) than participants who did not have anxiety/depression at baseline (change in FACT-B overall well-being: 4.9, 95% CI = 0.2, 9.7; change in functional well-being: 2.3, 95% CI = 1.1, 3.4). Marital status, reconstructive surgery, and baseline clinical staging were also significantly associated with changes in aspects of HRQOL, although their impact on change was relatively minimal.ConclusionYoung women with breast cancer do not report HRQOL concerns during the first year of treatment. Improvements in HRQOL during the first year of treatment may be attributable to a sense of relief that the cancer is being treated, which, in the short run, may outweigh the negative late effects of treatment.

Comparing Disease-Specific and Generic Quality of Life in Korean Breast Cancer Survivors Using the FACT-B and QLI: The Importance of Instrument Selection.

Background:Quality of life (QOL) has become an important indicator for evaluating patients’ symptoms and their overall satisfaction with life. Thus, examining QOL is essential for fully understanding the life satisfaction of breast cancer survivors (BCS). However, selecting the appropriate instrument for QOL measurement is challenging, and few studies have compared disease-specific and generic QOL measures and how they reflect the impact of cancer-related symptoms on QOL in BCS. We examined QOL in BCS using both disease-specific and generic instruments and compared their representation of the QOL impacts of anxiety, depression, sleep, fatigability, and posttraumatic growth.Methods:This study involved analysis of follow-up data for an exercise intervention called the BLESS (Better Life after cancer, Energy, Strength, and Support) program, which included 40 BCS treated at 1 medical center in South Korea. Their QOL was assessed using both the Functional Assessment of Cancer Therapy-Breast (FACT-B) and Quality of Life Index (QLI).Results:Both FACT-B and QLI total scores revealed that Korean BCS had low levels of QOL. Furthermore, both FACT-B and QLI total scores were significantly related to anxiety, depression, sleep, fatigability, and posttraumatic growth in the participants. Notably, multivariate regression analysis of FACT-B and QLI total scores showed different predictors for QOL: with the FACT-B, depression was the only significant predictor, while with the QLI, posttraumatic growth was the only significant predictor.Conclusion:The selection of a given QOL instrument may affect the overall findings and interpretation of the impacts of related symptoms. The FACT-B should be considered for studies of symptoms such as depression, while the QLI is more appropriate for examining overall QOL and posttraumatic growth.

COMPARISON OF COMPLETE DECONGESTIVE THERAPY AND KINESIOLOGY TAPING FOR UNILATERAL UPPER LIMB BREAST CANCER-RELATED LYMPHEDEMA: A RANDOMIZED CONTROLLED TRIAL

We designed a study to compare effects of complete decongestive therapy (CDT) and kinesiology taping (KT) (with exercise and skin care) on limb circumference, lymphedema volume, grip strength, functional status, and quality of life in patients with unilateral breast cancer-related lymphedema (BCRL). Forty patients with unilateral stage 2 BCRL were randomized to either the CDT group (n=20) or the KT group (n=20). Patients in the CDT group underwent 30-min manual lymphatic drainage (MLD) and multi-layer, short-stretch bandaging once a week for four weeks. Patients in the KT group underwent taping once a week for four weeks. In addition, all patients were informed about skin care and given an exercise program throughout the treatment. Upper extremity circumference and volume differences as primary outcomes and grip strength, Quick-Disabilities of the Arm, Shoulder and Hand (Q-DASH), and Functional Assessment of Cancer Therapy-Breast (FACT-B) scores as secondary outcomes were assessed initially, after treatment (4 weeks), and at the 1st month follow-up. Limb circumference and volume differences were significantly reduced in the CDT group after the 4-week treatment compared with the KT group (p=0.012 and p=0.015, respectively), but there was no difference between the groups in the 1st month follow-up (p>0.05). There was no difference between the groups in terms of grip strength, Q-DASH, and FACT-B scores after treatment and at the 1st month follow-up (p>0.05). Our results show that both KT and CDT were found to significantly reduce limb volume and circumference individually at 4-weeks and the one-month follow-up in patients with BCRL and that CDT significantly reduced both limb volume and circumference compared to KT at the 4- week time point, but not at the follow-up. Further randomized controlled trials with patients at different stages of BCRL are needed to confirm and expand these results.

Quality of life and related risk factors after breast reconstruction in breast cancer patients.

Breast cancer is the most frequently occurring cancer in women globally, using radical mastectomy as the main clinical treatment. This study aims to investigate the quality of life and related factors in patients after breast reconstruction. Female patients undergoing breast reconstruction after radical mastectomy between February 20, 2014 and February 20, 2019 in the Department of Tumor or the Department of Thyroid and Breast Surgery in the Affiliated Hospital of North Sichuan Medical College and Nanchong Central Hospital were surveyed. The patients' basic information was collected using a questionnaire prepared by the research team, and the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire was used to assess the patients' quality of life. Multivariate linear regression analysis was performed to explore the factors impacting the change of FACT-B scores one year after surgery. A total of 150 patients were included. 143 of them had complete data, and 7 patients were lost to follow-up. Compared with the preoperative results, the scores of all dimensions of the FACT-B scale and the overall health status of the patients were significantly reduced at 3 months after surgery, which recovered to the preoperative level at 6 months after surgery (P<0.05), and significantly increased at 12 months after surgery (P<0.05). The results showed that age ≥40 years, menopause, postoperative complications, and endocrine therapy were risk factors for decreased quality of life at 12 months after breast reconstruction. Meanwhile, tumor stage 0 or stage I and immediate breast reconstruction were protective factors for quality of life at 12 months after breast reconstruction (P<0.05). The postoperative quality of life of patients with breast reconstruction is relatively high. Older age, post-menopause, postoperative complications, endocrine therapy, advanced tumor stage, and delayed reconstruction are all risk factors for decreased quality of life of patients. Targeted measures should be taken to improve the postoperative life quality of patients, such as paying more attention to the older or post-menopausal patients, as well as those with postoperative complications, endocrine therapy, high tumor stage, or delayed breast reconstruction.

Abstract P5-12-09: Patient-reported outcomes (PROs) during one year of adjuvant enzalutamide for the treatment of early stage androgen receptor positive (AR+) triple negative breast cancer

Abstract BACKGROUND: A subset of TNBC expresses a luminal signature and demonstrates AR-dependence. Enzalutamide (ENZA), an AR-antagonist, has activity with metastatic AR+ TNBC, with a clinical benefit rate of 33% (Traina et al, JCO 2018). We recently demonstrated that one year (y) of adjuvant ENZA is feasible in early stage, AR+ TNBC, with no new safety signals observed (Traina ASCO 2019). Fatigue was the most common, treatment (tx)-related, adverse event of any grade according to investigator assessment (24%). Here we report per-protocol planned secondary analyses of PROs during one year of ENZA including quality of life (QoL), fatigue, and self-reported physical activity (NCT02750358). METHODS: Eligible patients have Stage I-III, ER/PR &amp;lt;1%, HER2(-), AR ≥1% breast cancer and completed all planned standard of care surgery, chemotherapy and radiation within 6 months of study start. Tx = ENZA 160mg orally daily for 1y with the option to extend tx to 2y as per patient preference. Clinician-reported toxicities (NCI CTCAEv4) were assessed every 4 weeks for 12 weeks, then every 3 months. Total study N=50 patients. PROs were assessed every 12 weeks. We examined serial changes in overall QoL (functional assessment of cancer therapy – breast (FACT-B), fatigue (FACIT-fatigue) and exercise behavior (total exercise minutes/week over past 7 days) from pre-treatment and every 3 months thereafter until month 12. All analyses are exploratory and consist of descriptive summaries. RESULTS: Between 5/2016 and 6/2018, 50 patients were enrolled. As of 6/27/19, 34 patients completed 1y of ENZA; 15 patients are off tx: recurrence (3), toxicity (5), nonadherence (4), and consent withdrawal (3). Patients evaluable for PRO (N): baseline (50), 12 weeks (43) and 52 weeks (34). Median scores on FACT-B and fatigue scales remained stable over the course of adjuvant ENZA in the 1st year of therapy (Table). Self-reported exercise increased during this period. Table. Median scores (range) for PROs during 1 year of adjuvant ENZATime PointBaselineWeek 12Week 52FACT-G88.0 (53.5-105.0)82.0 (36.4-105.0)89.5 (58.0-105.0)Breast Cancer Subscale28.5 (15.6-39.0)29.0 (9.0-40.0)29.0 (19.0-40.0)Total118.0 (77.0-141.0)111.0 (45.4-145.0)121.0 (83.0-145.0)FACT-B trial outcome index73.0 (43.0-92.0)73.0 (25.7-96.0)76.9 (51.0-96.0)FACIT43.0 (17.0-52.0)39.0 (10.0-52.0)43.0 (11.0-52.0)Total Exercise (min/week)120 (0-1260)152 (0-3120)180 (0-2580) CONCLUSIONS: Patient reported outcomes of health related QOL remain stable when ENZA is administered for 1 year in the adjuvant setting. Self-reported time spent engaged in physical exercise increased numerically during 1y of therapy. During presentation, additional analyses will be reported including QOL at additional time points, relationship of FACT-B score with FACIT fatigue score and exercise, and QOL changes in relation to relative dose intensity of ENZA, toxicity and off study reason. Citation Format: Tiffany A Traina, Lee W Jones, Victoria Blinder, Jessica Scott, Leigh Ann Boyle, Artavazd Arumov, Tina Alano, Sujata Patil, Patricia DeFusco, Nicholas Lamparella, Mark Robson, Ayca Gucalp. Patient-reported outcomes (PROs) during one year of adjuvant enzalutamide for the treatment of early stage androgen receptor positive (AR+) triple negative breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P5-12-09.

Stages of breast reconstruction and quality of life after breast cancer

Objective: To evaluate which stage of breast reconstruction promotes improved quality of life for women treated for breast cancer, and to verify the socioeconomic and clinical factors associated with better quality of life. Methods: A cross-sectional study was conducted with 70 women treated for breast cancer in the perioperative period of late breast reconstruction in the Federal District. To assess quality of life, the Functional Assessment of Cancer Therapy — Breast (FACT-B) instrument was used. Results: Half of the women were under 50 years old. Tumor removal surgery had occurred on average 5.4 years ago. Women with axillary dissection had greater impairment in the physical well-being domain (p=0.001) and the breast cancer subscale (p=0.016). Among women who had undergone surgery more than one year previously, there were higher domains of emotional (p=0.006) and functional (p=0.003) well-being. Women who underwent breast reconstruction had higher values in the social/family well-being (p&lt;0.001), emotional well-being (p=0.001), functional well-being (p=0.001), and breast cancer subscale (p=0.005) domains; and on the FACT-B score (p&lt;0.001), right after the first stage. Conclusions: Breast reconstruction favored better quality of life from the first stage, suggesting that this therapeutic modality should be offered promptly, whenever possible, and guaranteed for all women treated for breast cancer.

The association between cancer care coordination and quality of life is stronger for breast cancer patients with lower health literacy: A Greater Plains Collaborative study.

Health literacy (HL) and cancer care coordination (CCC) were examined for their relationship to quality of life (QOL) among breast cancer survivors. CCC was hypothesized to have a stronger relationship to QOL for women with lower HL. Women (N = 1138) who had completed treatment for Stage 0-III, ductal carcinoma breast cancer between January 2013 and May 2014 at one of eight large medical centers responded to a mailed questionnaire. Responses to questions about survivorship care planning and presence of professional care coordinator were combined to form an index of CCC. An index of HL was also derived. QOL was measured using the Functional Assessment of Cancer Therapy-Breast (FACT-B) scales. 74.3% (N = 845) of patients reported having a health professional coordinate their care during treatment and 78.8% (N = 897) reported receiving survivorship care planning. CCC was classified as none, partial, or high for 7.1%, 32.7%, and 60.2% of the patients, respectively. Except for emotional well-being, the interaction between HL and CCC was significant for all QOL domains (p < .05); the effect of CCC on FACT-B scores was largest for people with lower HL. For the 39.8% of patients with less than high CCC, 111 (27.3%) had a level of HL associated with clinically meaningful lower QOL. The association between CCC and later QOL is strongest for people who have lower HL. Prioritizing care coordination for patients with lower health literacy may be an effective strategy in a setting of limited resources.

Effects of cognitive behavioral therapy for depression on improving insomnia and quality of life in Chinese women with breast cancer: results of a randomized, controlled, multicenter trial.

PurposeCognitive behavioral therapy (CBT) for depression had been found to be effective in reducing depressive and anxiety symptoms in breast cancer survivors. It is not known whether CBT for depression would also improve insomnia and quality of life (QOL). The aim of this study was to investigate whether CBT for depression would improve insomnia and QOL in a randomized controlled multicenter trial.Patients and methodsIn this study, breast cancer survivors (n=392) were randomly allocated to the following three groups: CBT (n=98), self-care management (SCM, n=98), and usual care (UC, n=196) in a ratio of 1:1:2. CBT and SCM received a series of nine sessions for 12 weeks, whereas UC received UC only. Insomnia and QOL were evaluated using Athens Insomnia Scale (AIS) and Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire at baseline, 4, 12, and 24 weeks.ResultsThere was a significant intergroup difference in AIS and FACT-B scores (both P<0.01). CBT showed less insomnia problems and better overall QOL compared with those in SCM and UC (both P<0.01). No significant differences were found between SCM and UC in insomnia problems and overall QOL. Moreover, the effects of CBT on insomnia and QOL were maintained during the follow-up period.ConclusionCBT for depression can be effective in improving insomnia problems and QOL in the Chinese breast cancer survivors.

QOL Evaluation of Nab-Paclitaxel and Docetaxel for Early Breast Cancer.

A previous randomized phase II study showed that neoadjuvant nab-paclitaxel (nab-PTX) 100 mg/m2) was effective and well-tolerated in patients with HER2-negative early-stage breast cancer, compared with docetaxel (DTX). We evaluated patient outcomes in terms of the Functional Assessment of Cancer Therapy-Breast (FACT-B), as a measure of health-related quality of life (HRQoL). Stage I-III HER2-negative breast cancer patients from the previous study were included. They received either four cycles of nab-PTX (100 mg/m2 days 1/8/15) every 4 weeks, or DTX (75 mg/m2 day 1) every 3 weeks, both followed by four cycles of 5-fluorouracil/epirubicin/cyclophosphamide (FEC). Patients completed a health-related quality-of-life questionnaire at baseline, after one and four cycles of taxanes, before administration of FEC, and after administration of one and four cycles of FEC. Thirty-six eligible patients were enrolled. The baseline characteristics of the two groups were well balanced. FACT-B scores at baseline and after four cycles of taxanes were 115/108 (DTX/nab-PTX) and 99/92, respectively. There were no significant differences between DTX and nab-PTX for FACT-B, FACT-B-Trial Outcome Index (FACT-B-TOI) and FACT-General. FACT-B and FACT-B TOI scores tended to decrease after one cycle and after four cycles of chemotherapy which did not recover to the baseline scores through the end of chemotherapy in each group. There were no significant safety differences between nab-PTX and DTX. HRQoL tended to decrease during taxane-based anticancer treatment, with no significant differences between the treatments. We suggest that the HRQoL questionnaire has limited ability to evaluate different chemotherapy schedules. Trial registration UMIN000009855. Nov 20, 2012 registered.

Longitudinal Trends in Anxiety, Depression, and Quality of Life During Different Intermittent Periods of Adjuvant Breast Cancer Chemotherapy.

Chemotherapy (CT) is an important adjuvant treatment that has been widely used for breast cancer (BC) patients. However, no research has focused on trends in emotions and quality of life (QOL) during intermittent periods between CT sessions that are critical for recovery. The aim of this study was to investigate longitudinal trends in anxiety, depression, and QOL during the different intermittent periods between adjuvant CT for BC. A longitudinal study design was adopted. Eighty-eight women undergoing CT for BC were selected using a purposive sampling method, and they completed the Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), and Functional Assessment of Cancer Therapy-Breast (FACT-B) at 5 points. A repeated-measures analysis-of-variance model was used to compare anxiety, depression, and QOL at different time points. The results showed a significant difference in SAS (F = 187.78, P < .00), SDS (F = 263.07, P < .00), and FACT-B (F = 140.82, P < .00) scores at the 5 time points. The SAS and SDS scores were highest at T3, whereas the FACT-B score was lowest at T3. The BC patients had psychological distress during intermittent periods between adjuvant CT, as evidenced by anxiety and depression, which were highest in the third cycle. Meanwhile, QOL was lowest at the third CT cycle and highest at the first CT cycle. Clinical staff should focus on critical time periods during CT, particularly during the third cycle, and provide additional support to patients to ensure that CT is delivered in an optimal fashion.

HEART (Heart Evaluation After Radiation Therapy): Novel Detection of Cardiotoxicity in Breast Cancer Patients

Sensitive and reliable tools for the detection and quantification of subclinical cardiotoxicity are critical following RT for primary breast cancer. We prospectively evaluated the association between breast RT and several contemporary measures of cardiac and global cardiovascular function, including cardiopulmonary exercise testing (CPET), in a uniformly-treated cohort with locally-advanced breast cancer. Sixteen patients with HER-2 negative, stage II or III breast cancer were enrolled following completion of neoadjuvant dose-dense anthracycline-containing chemotherapy and mastectomy with immediate reconstruction. Two pre-defined cohorts were analyzed: (1) patients receiving multi-beam IMRT to 50Gy to the reconstructed chest wall and regional nodes (RT) and (2) control group that did not receive RT (No RT). Study assessments were: (1) echocardiogram with speckle tracking (strain), 2) endothelial function - flow-mediated dilatation by brachial artery, (3) CPET, (4) cardiac biomarkers, and 5) Functional Assessment of Cancer Therapy-Breast (FACT-B) and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue questionnaires. Study assessments were performed at baseline (0-4 weeks prior to RT or 4-8 weeks after mastectomy) and follow-up (2-4 weeks post RT or 15-20 weeks after mastectomy). Differences between baseline and follow-up measurements were assessed using the t-test and the Wilcoxon signed-rank test. A total of 11 patients (9 RT, 2 No RT) had complete data sets and were evaluable for the primary endpoints. Median age was 46 yrs (range: 30-63 yrs). In the RT group, median mean heart dose was 4.66 Gy (3.95 Gy for 5 right-sided and 7.73 Gy for 4 left-sided breast plans). For the entire cohort, there were no significant differences in the mean values between baseline and follow-up ejection fraction (61% vs 63%; p=.07), global longitudinal strain (-19.6 vs -20.0; p=.23), FACT-B scores (111 vs 115; p=.67), and FACIT-Fatigue scores (40 vs 38, p=.40). In the RT group, the mean baseline VO2peak and percent age-predicted VO2peak were significantly higher at follow-up (23.8 vs 25.8, p=.03) (89.5% vs 96.2%; p=.03). Results for cardiac biomarkers and flow-mediated dilatation will be reported at the time of presentation. In this signal-seeking study, breast RT was not associated with detrimental changes in any parameter. Conversely, VO2peak significantly increased from pre- to post-RT. These findings require validation of CPET as a predictor of cardiotoxicity after breast RT in a larger cohort.

A Bio-Psychosocial Intervention Program for Improving Quality of Life in Breast Cancer Survivors - Final Outcome of a Prospective Randomized Trial.

Given the 3.1 million breast cancer survivors in America, quality of life (QoL) is a vital issue. Bio-psychosocial milieu of survivorship is increasingly important. This study assesses the impact of Bio-psychosocial Intervention (BPSI) on the QoL of breast cancer survivors utilizing Functional Assessment of Cancer Therapy - Breast (FACT-B) instrument. A prospective randomized trial was designed; intervention arm included a 4-hour BPSI coping skills class; control arm received standard of cancer and follow-up care (SOC). Women diagnosed within 2 years of study initiation were eligible. Sample size was based on 8-point difference in FACT-B score, 90% power, 5% type I error, and 20% attrition. FACT-B questionnaire was administered to all patients at baseline and at 6-month intervals. SAS 9.3 software was used to analyze data using Chi-square test for categorical and Wilcoxon rank sum for ordinal data; linear mixed modeling was used for longitudinal analysis. One-hundred and three of 120 (86%) patients were available for analysis. Forty-seven patients were in BSPI arm, and 56 received SOC. For BPSI arm versus SOC arm, the median (interquartile) age (60 [52.68] versus 58 [52.68] years, p = 0.9135), cancer-stage (0:1:2:3 = 11%:41%:35%:13% versus 18%:46%:22%:15%, p = 0.4645), and biology (ER+:triple negative:HER2+ = 74%:9%:16% versus 72%:7%:20%, p = 0.8454), respectively, was similar. Median (25th to 75th centile) FACT-B scores in BPSI versus SOC arms at baseline were 109 (95.121) versus 112 (95, 122) (p = 0.6125); mean (SE) change since baseline at 6, 12, 18, and 24 months was: 7.42 (2.22) versus 7.04 (1.97) (p = 0.8862); 17.0 (2.64) versus -6.09 (2.37) (p < 0.0001); 16.03 (2.53) versus 3.58 (2.29) (p = 0.0004), and 15.48 (1.89) versus 16.4 (1.71) (p = 0.7966), respectively. The inter-group differences remained after adjusting for confounding variables at baseline. The p-value for interaction among groups over 2 years remained <0.0001 except for breast cancer specific concerns. BPSI coping skills class significantly improved the QoL of breast cancer survivors by 1 year post-intervention time point; this difference narrowed at 18 months and disappeared at 24 months.

Abstract PR02: Randomized controlled trial to increase quality of life and reduce perceived stress among Korean American breast cancer survivors

Abstract Background: Despite large increases in breast cancer incidence among Korean women, there have been remarkably few empirical studies to improve survivorship among Korean American breast cancer survivors (KBCS), many of whom experience linguistic and cultural barriers. According to limited research on Asian Americans, KBCS report low quality of life (QOL) and high perceived stress (henceforth referred to as “stress”). To address this gap, we tested the effectiveness of one of the first linguistically appropriate and culturally sensitive cognitive-behavioral stress management programs that was developed to improve QOL and reduce stress in KBCS. Methods: The TOGETHER (Together Overcome and Get Empowered Through Health Education and Relationships) program consists of seven 2-hour sessions and one follow-up seven weeks post-intervention. These findings are preliminary results based on cycles one to four of the program, consisting of 66 KBCS in the Washington, D.C. metropolitan area of which complete data was available for 61 participants (92.4%). The standard intervention (SI) group (n=28) received linguistically and culturally tailored health information related to breast cancer, while the enhanced intervention (EI) group (n=33) received this and additional information/practice on relaxation, stress reduction techniques, mindfulness, utilizing social support, anger management, and assertiveness training. Outcomes were measured at baseline, upon completion of the program, and at follow-up. QOL was assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B), which includes five subscales (physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and breast cancer subscale (BCS)), while stress was assessed using the Perceived Stress Scale (PSS). Generalized estimating equation (GEE) models were used to examine program effects on QOL and PSS separately. Moreover, the impact of program site (Maryland vs. Virginia), cycle (one to four), and age (less than 65 vs. 65 and over) on these relationships was assessed. Results: Randomization was effective in that SI and EI participants were similar in regards to sociodemographic, breast cancer-related, and acculturation variables. Program site and cycle did not impact program effects on QOL and PSS and were thus not included in subsequent models. For QOL, the SI group had better quality of life at baseline (mean FACT-B score: 103.3) compared to the EI group (mean FACT-B score: 100.7). Changes in mean FACT-B, SWB, and FWB scores significantly differed between the SI and EI group from baseline to the end of the program. Specifically, the EI group had a 7.0 unit greater increase in mean FACT-B scores, 2.6 unit greater increase in mean SWB scores, and 2.5 unit greater increase in mean FWB scores from baseline to the end of the program as compared to the SI group on average. For stress, the EI group had a higher level of stress (mean PSS score: 18.82) than the SI group (mean PSS score: 17.25) at baseline. Changes in mean PSS scores significantly differed across time between the SI and EI groups. Those in the EI group had a 2.7 unit greater decrease in mean PSS scores from baseline to the end of the program as compared to those in the SI group on average. For age, those who were less than 65 showed overall decreases in stress from baseline to follow-up, while those 65 and over showed initial decreases from baseline to the end of the program and then increases from the end of the program to follow-up beyond the baseline values. Conclusions: The TOGETHER program is effective in increasing QOL and reducing stress among KBCS and can potentially be adapted and implemented for other socially or linguistically isolated groups in the U.S. Citation Format: Sunmin Lee, Mary Y. Jung, Jamie H. Sim. Randomized controlled trial to increase quality of life and reduce perceived stress among Korean American breast cancer survivors. [abstract]. In: Proceedings of the Ninth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2016 Sep 25-28; Fort Lauderdale, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2017;26(2 Suppl):Abstract nr PR02.

Anxiety, Depression and Quality of Life in Breast Cancer Patients in the Levant

Background:Limited data are currently available regarding the psychological well-being and quality of life of breast cancer patients after active treatment in Lebanon and the Arab region in general. The objective of this study was to determine the prevalence of anxiety and depression among Arab breast cancer patients and assess the quality of life with reference to socio-demographic and clinical characteristics.Methods:This cross-sectional study was conducted among female breast cancer patients diagnosed between January 2009 and March 2014, who were recruited from the outpatient clinics of Naef K. Basile Cancer Institute at the American University of Beirut Medical Center (AUBMC) from November 2015 till December 2016. An interview was conducted utilizing two validated questionnaires: the Hospital Anxiety and Depression Scale (HADS) and the Functional Assessment of Cancer Therapy-Breast (FACT-B). Socio-demographic and clinical characteristics that might predict patient quality of life were collected and summarized.Results:A total of 150 patients were interviewed (median age 53.5±10.4 years). Most were assessed 3 to 5 years (68.7%) after initial diagnosis and had undergone surgery, chemotherapy, radiation, or hormonal therapy (97.3%, 79.3%, 80.7% and 86.0%, respectively). The median total HADS score was 10.0 ± 8.0, with approximately 41.3% of study participants having abnormal scores on the anxiety subscale and 24.7% on the depression subscale. Significant predictors of total HADS score were nationality and level of education (p=0.001, p=0.001 respectively; R2=0.181). Participants who were Iraqi, had stage IV disease, had a household monthly income below 1000 USD, or had received chemotherapy exhibited significantly lower total FACT-B scores, these being highly negatively correlated with total HADS scores (rs= -0.73, p=0.001).Conclusion:There is a vital need for the development of individualized interventions and psychosocial support programs tailored to the physical and psychological well-being of breast cancer patients in the Levant region.

A bio-psychosocial intervention program for improving quality of life in breast cancer survivors: Results of a prospective randomized trial

Background: Given the 3.1 million breast cancer survivors in America, quality of life (QoL) is a vital issue. Bio-psychosocialmilieu of survivorship is increasingly important. This study assesses the impact of bio-psychosocial intervention (BPSI) on theQoL of breast cancer survivors utilizing Functional Assessment of Cancer Therapy – Breast (FACT-B) instrument. Methods: A prospective randomized trial was designed; intervention arm included a 4-hour BPSI coping skills class; control armreceived standard of cancer (SOC) and follow up care. Women diagnosed within 2 years of study initiation were eligible. Samplesize was based on 8-point difference in FACT-B score, 90% power, 5% type I error, and 20% attrition. FACT-B questionnaire wasadministered to all patients at baseline and at 6-month intervals. SAS 9.3 software was used to analyze data using Chi-square testfor categorical and Wilcoxon rank sum for ordinal data; linear mixed modeling was used for longitudinal analysis. Results: One hundred and three of 120 (86%) patients were available for analysis. Forty-seven patients were in BSPI arm, and 56received SOC. For BPSI arm vs. SOC arm, the median (interquartile) age [60 (52, 68) vs. 58 (52, 68)yrs. P = .9135], cancer-stage(0: 1: 2: 3 = 11%: 41%: 35%: 13% vs. 18%: 46%: 22%: 15%, P = .4645), and biology (triple-negative: HER2+ : ER+ =9%: 74%: 17% vs. 8%: 72%: 20%, P = .8454), respectively, was similar. Mean (SE) FACT-B scores in BPSI vs. SOC arms at6 months and 1 year were 115.1 (2.2) vs. 114.6 (2.0) ( P = .8731) and 124.7(2.8) vs. 101.4 (2.4) ( P = .0001). The inter-groupdifference significantly expanded at 1 year ( P = .0001). The 12-month difference persisted when confounding baseline variableswere adjusted for in in multivariate modeling. Conclusion: BPSI coping skills class significantly improved the QoL of breast cancer survivors by one year post-interventiontime point.

Measurement properties of the Functional Assessment of Cancer Therapy-Breast may depend upon the education levels of patients

ABSTRACTBackground: Education level may vary in older cancer patients. This study aims to compare the measurement properties of the Functional Assessment of Cancer Therapy-Breast (FACT-B) when self-administered by breast cancer patients with various education levels.Methods: An observational study of 244 Singaporean breast cancer patients who self-administered the instrument. FACT-General and FACT-B scores were assessed for the discriminatory ability, responsiveness to change and test–retest reliability. We hypothesized that patients with better performance status would result in higher FACT-General and FACT-B scores. Regression models were constructed, and relative precisions were also examined.Results: The mean baseline FACT-General and FACT-B scores monotonically decreased with performance status in the higher but not lower educated group (relative precision = 1.13 and 1.08, respectively). Stronger responsiveness to deterioration in quality of life were found in the higher (each p < 0.001) than lower e...