Functional Assessment Of Cancer Therapy-Breast Research Articles

Effects of the ACTIVity And TEchnology (ACTIVATE) intervention on health-related quality of life and fatigue outcomes in breast cancer survivors.

The ACTIVATE Trial examined the efficacy of a wearable-based intervention to increase physical activity and reduce sedentary behavior in breast cancer survivors. This paper examines the effects of the intervention on health-related quality of life (HRQoL) and fatigue at 12 weeks (T2; end of intervention) and 24 weeks (T3; follow-up). Inactive and postmenopausal women who had completed primary treatment for stage I-III breast cancer were randomized to intervention or waitlist control. Physical activity and sedentary behavior were measured by Actigraph and activPAL accelerometers at baseline (T1), end of the intervention (T2), and 12 weeks follow-up (T3). HRQoL and fatigue were measured using the Functional Assessment of Cancer Therapy-Breast (FACT-B) and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue). Primary intervention effects were evaluated comparing intervention and waitlist group at T2 using repeated measures mixed effects models. Overall, 83 women were randomized and trial retention was high (94%). A 4.6-point difference in fatigue score was observed between groups at T2 (95% CI: 1.3, 7.8) indicating improvement in fatigue profiles in the intervention group. In within groups analyses, the intervention group reported a 5.1-point increase in fatigue from baseline to T2 (95% CI: 2.0, 8.2) and a 3.3-point increase from baseline to T3 (95% CI: 0.1, 6.41). Despite small improvements in fatigue profiles, no effects on HRQoL were observed. While the ACTIVATE Trial was associated with improvements in physical activity and sedentary behavior, more intensive or longer duration interventions may be needed to facilitate changes in HRQoL.

Mapping function from FACT-B to EQ-5D-5\u2009L using multiple modelling approaches: data from breast cancer patients in China

BackgroundThe Functional Assessment of Cancer Therapy-Breast (FACT-B) is the most commonly used scale for assessing quality of life in patients with breast cancer. The lack of preference-based measures limits the cost-utility of breast cancer in China. The goal of this study was to explore whether a mapping function can be established from the FACT-B to the EQ-5D-5 L when the EQ-5D health-utility index is not available.MethodsA cross-sectional survey of adults with breast cancer was conducted in China. All patients included in the study completed the EQ-5D-5 L and the disease-specific FACT-B questionnaire, and demographic and clinical data were also collected. The Chinese tariff value was used to calculate the EQ-5D-5 L utility scores. Five models were evaluated using three different modelling approaches: the ordinary least squares (OLS) model, the Tobit model and the two-part model (TPM). Total scores, domain scores, squared terms and interaction terms were introduced into models. The goodness of fit, signs of the estimated coefficients, and normality of prediction errors of the model were also assessed. The normality of the prediction error is determined by calculating the root mean squared error (RMSE), the mean absolute deviation (MAD), and the mean absolute error (MAE). Akaike information criteria (AIC) and Bayes information criteria (BIC) were also used to assess models and predictive performances. The OLS model was followed by simple linear equating to avoid regression to the mean.ResultsThe performance of the models was improved after the introduction of the squared terms and the interaction terms. The OLS model, including the squared terms and the interaction terms, performed best for mapping the EQ-5D-5 L. The explanatory power of the OLS model was 70.0%. The AIC and BIC of this model were the smallest (AIC = -705.106, BIC = -643.601). The RMSE, MAD and MAE of the OLS model, Tobit model and TPM were similar. The MAE values of the 5-fold cross-validation of the multiple models in this study were 0.07155~0.08509; meanwhile, the MAE of the TPM was the smallest, followed by that of the OLS model. The OLS regression proved to be the most accurate for the mean, and linearly equated scores were much closer to observed scores.ConclusionsThis study establishes a mapping algorithm based on the Chinese population to estimate the EQ-5D-5 L index of the FACT-B and confirms that OLS models have higher explanatory power and that TPMs have lower prediction error. Given the accuracy of the mean prediction and the simplicity of the model, we recommend using the OLS model. The algorithm can be used to calculate EQ-5D scores when EQ-5D data are not directly collected in a study.

CN49 - Implementing a cancer survivorship program for individuals with recurrent breast cancer

BackgroundPatients are living longer with recurrent breast cancer, yet there is a lack of survivorship programs for these individuals. They face unique challenges due to the lack of curative treatments and limited supportive care resources. Challenges include fluctuations in functional status, changes in relationships, communication with loved ones, and existential concerns. Health related quality of life has been found to be different, further widening the gap in care. MethodsSurvivors were referred for a one-hour coaching intervention tailored to their needs based upon results of their Functional Assessment of Cancer Therapy-Breast (FACT-B) survey. Patient satisfaction was assessed immediately after and at two weeks post the intervention. A paired t-test was used to evaluate quality of life sores before and two weeks following participation in the survivorship session. ResultsStatistically significant (p=.000) improvements were observed overall and in each subscale of the FACT-B survey. Patient satisfaction was high immediately post the intervention and remained high at the two-week assessment. ConclusionsThis project successfully demonstrated that an individual coaching intervention can be implemented to improve the quality of life in patients with recurrent breast cancer. The key findings support that integration of a survivorship program is associated with high patient satisfaction and increased quality of life. As chronic breast cancer survivors encompass a broad and heterogeneous population, survivorship programs should be developed that address the needs of this unique patient population. Creation of an infrastructure that promotes individualized care to survivors with recurrent breast cancer is an essential component of providing holistic care across the cancer continuum. Oncology nurse navigators have a unique relationship with their patients and implementing this program provides an opportunity to address these important and clinically relevant unmet needs. Legal entity responsible for the studyThe author. FundingGraduate scholarship in Cancer Nursing Practice GSCNP-18-07501 from the American Cancer Society and a Clinical Doctoral Scholarship from the Oncology Nursing Foundation Endowment. DisclosureAll authors have declared no conflicts of interest.

Health-Related Quality of Life among Egyptian Female Breast Cancer Patients at the National Cancer Institute, Cairo University.

Background:To measure the quality of life (QoL) of Egyptian females with breast cancer (BC) at the National Cancer Institute (NCI), Cairo University (CU) and its relations with the socio-demographic and clinical characteristics.Methods:A total of 200 female BC patients were recruited from the medical oncology outpatient clinic during a period from December 2015 to March 2018. The instrument of this study consisted of two parts: the first for Socio-demographic and clinicopathological characteristics, and the second was the Functional Assessment of Cancer Therapy-Breast for patients with Lymphedema (FACT-B+4) questionnaire. Results:The majority of the study participants were married, housewives, and without a family history of cancer (70.0%, 93.0%, and 63.0%, respectively). Most of them presented with breast mass, had IDC, grade II and disease stage III at diagnosis (89.0%, 84.5%, 85.6% and 56.8%, respectively) and had undergone modified radical mastectomy, received adjuvant chemotherapy, radiation, and hormonal therapy (62.0%, 83.8%, 73.5% and 60.5%, respectively). The median FACT-B score was 81 (range 35-133). The medians of subscales were: physical well-being 13 (range 0-28), social well-being 20 (range 0-28), emotional well-being 15 (range 2-24), and functional well-being 16 (range 2-28). The median score for breast subscale was 19 (range 2-32). Many factors affected the QoL scores, including age, marital status, occupation, smoking, residence, comorbidities, symptoms, grade, chemotherapy, radiation, and recurrence. Conclusion:QoL of Egyptian females with BC was influenced by several factors like age, marital status, occupation, smoking, residence, comorbidities, symptoms, grade, chemotherapy, radiation, and recurrence.

CN83 - Symptom cluster of fatigue, sleep disturbance and depression and its impact on quality of life among Chinese breast cancer patients undergoing adjuvant chemotherapy: A cross-sectional study

BackgroundBreast cancer (BC) itself and curative treatments can cause various concurrent distressing symptoms. These symptoms may “cluster” together and create a synergistic impact compared to a single symptom on patients’ quality of life (QoL). Among various symptom clusters identified in BC population, the cluster of fatigue, sleep disturbance and depression (F-S-D) is frequently reported during active adjuvant chemotherapy. A cross-sectional study was conducted to evaluate this symptom cluster in Chinese BC patients and explore its impact on QoL. MethodsFemale adults currently receiving adjuvant chemotherapy for BC in two tertiary public hospitals in Xi’an, China were recruited in this study. Four validated measurements were used: Chinese version of Brief Fatigue Inventory, Pittsburgh Sleep Quality Index, Patient Health Questionnaire-Depression, and Functional Assessment of Cancer Therapy-Breast. Patient-rated outcomes were measured on day-8 of recently received chemotherapy via face-to-face or telephone call. Descriptive statistics, Spearman correlation and One way ANOVA were used in data analysis. ResultsA total of 372 consented subjects with a mean age of 50.1±9.2 years completed the survey. Most of them were married, diagnosed with I-II stage BC, and undergone mastectomy. 99.2% of subjects experienced with fatigue, 87.4% were poor sleepers, while 93.3% had depressive symptom. The proportions of subjects who experiencing 0, 1, 2 and 3 symptoms were 0.8%, 3.0%, 11.8% and 84.4%, respectively. Spearman correlation analysis showed that fatigue, sleep disturbance and depression were significantly correlated with each other (RFS=.45, RFD=.57, RSD=.50, all P<0.001), and each of the single symptoms was negatively related to QoL (RFQ=-.57, RSQ=-.35, RDQ=-.60, all P<0.001). When using One way ANOVA to explore the influence of symptom cluster on QoL, we found that there was a significant (F=34.76, P<0.001) decreasing trend in QoL across BC patients experiencing an increased number of symptoms (F-S-D). ConclusionsThe symptom cluster of F-S-D exists in most BC patients and it adversely affects their QoL. Legal entity responsible for the studyXiaole He. FundingHas not received any funding. DisclosureAll authors have declared no conflicts of interest.

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.

Complex supportive care of patients with breast cancer. The preliminary results of a psychological intervention study

Introduction: Interdisciplinary studies confirm that the traumatic nature of cancer diagnosis and the long course of treatment may often lead to a series of emotional problems among cancer patients, this way precluding physical and psychological recovery. Aim: The aim of the study was to create a complex psychosocial intervention program for breast cancer patients and to present our preliminary results. Method: In our 6 week long study, 50 breast cancer patients were assessed. The intervention group comprised of 20 patients, the control group comprised of 30 patients. Measurements included the Beck Depression Inventory (BDI), the Spielberger State and Trait Anxiety Inventory (STAI), the Surgical Fear Questionnaire (SFQ), the Visual Analogue Scale (VAS), the Functional Assessment of Cancer Therapy - Breast (FACT-B) and the Breast-Impact of Treatment Scale (BITS). Therapeutic tools used were the PRISM-D and the Body-Sculpture Test. Results: Our results indicate that the psychological interventions may have an instant stress-relieving and calming effect on our patients, this way providing social support. The type of surgery significantly influenced the levels of body change stress. Conclusion: Our results highlight the importance of early psychological screening among breast cancer patients before and after surgery as well. Orv Hetil. 2019; 160(18): 700-709.

Effects of mindfulness-based stress reduction on post-traumatic growth and quality of life among postoperative breast cancer patients

Objective To explore the effects of mindfulness-based stress reduction on post-traumatic growth and quality of life among postoperative breast cancer patients. Methods From June 2017 to December 2017, we selected 112 postoperative breast cancer patients of breast department at a classⅢ grade A cancer hospital in He'nan Province as subjects by convenience sampling. All of the patients were divided into control group and observation group with the method of random number table, 56 cases in each group. Control group adopted routine nursing intervention. On the basis of routine nursing, observation group carried out mindfulness-based stress reduction for 8 weeks. The intervention effects were evaluated with the Posttraumatic Growth Inventory (PTGI) and the Functional Assessment of Cancer Therapy-Breast (FACT-B) . Results Before intervention, there were no statistical differences in the total score and dimension scores of PTGI of patients between two groups (P>0.05) . After intervention, the total score and dimension scores of PTGI of patients in observation group were higher than those in control group with statistical differences (P 0.05) . After intervention, the total score and dimension scores of life quality of patients in observation group were higher than those in control group with statistical differences (P<0.01) . Conclusions Mindfulness-based stress reduction can improve post-traumatic growth and quality of life among postoperative breast cancer patients. Key words: Breast neoplasms; Quality of life; Mindfulness-based stress reduction; Posttraumatic growth, psychological

The detrimental effects of ambivalence over emotional expression on well‐being among Mainland Chinese breast cancer patients: Mediating role of perceived social support

Recent research has documented the harmful effects of ambivalence over emotional expression (AEE) on psychological well-being, but few studies to date have examined AEE among Mainland Chinese breast cancer patients, an ethnic group that prioritizes emotion restraint to preserve social harmony. The present study examined the relationship between AEE and well-being (viz, anxious and depressive symptoms and quality of life) and evaluated perceived social support as a potential mediator of this relationship in a sample of Mainland Chinese breast cancer patients. Three hundred twenty-seven Chinese breast cancer patients recruited from Weifang, China, completed a self-reported questionnaire containing the Ambivalence over Emotional Expression Questionnaire (AEQ), the Medical Outcomes Study Social Support Scale (MOS-SSS), the Self-rating Anxiety Scale (SAS), the Self-rating Depression Scale (SDS), and the Functional Assessment of Cancer Therapy-Breast (FACT-B). Overall, Mainland Chinese breast cancer patients endorsed high levels of AEE. A series of mediation analyses revealed perceived social support served as a partial mediator of the relationship between AEE and well-being. Specifically, AEE was associated with lower perceived social support (βs=-.13, P<.001), which in turn, was associated with greater anxious symptoms (β=.23, P<.001), depressive symptoms (β=.20, P<.001) and lower quality of life (β=-.30, P<.001). The harmful relationship between AEE and well-being is partially explained by reduced social support. Psychosocial interventions that facilitate emotional disclosure without harming social harmony may be culturally effective for mainland Chinese breast cancer patients.

Effects of neratinib on health-related quality of life in women with HER2-positive early-stage breast cancer: longitudinal analyses from the randomized phase III ExteNET trial

BackgroundWe report longitudinal health-related quality-of-life (HRQoL) data from the international, randomized, double-blind, placebo-controlled phase III ExteNET study, which demonstrated an invasive disease-free survival benefit of extended adjuvant therapy with neratinib over placebo in human epidermal growth factor receptor-2-positive early-stage breast cancer. Patients and methodsWomen (N = 2840) with early-stage HER2-positive breast cancer who had completed trastuzumab-based adjuvant therapy were randomly assigned to neratinib 240 mg/day or placebo for 12 months. HRQoL was an exploratory end point. Patients completed the Functional Assessment of Cancer Therapy–Breast (FACT-B) and EuroQol 5-Dimensions (EQ-5D) questionnaires at baseline and months 1, 3, 6, 9, and 12. Changes from baseline were compared using analysis of covariance with no imputation for missing values. Sensitivity analyses used alternative methods. Changes in HRQoL scores were regarded as clinically meaningful if they exceeded previously reported important differences (IDs). ResultsOf the 2840 patients (intention-to-treat population), 2407 patients were evaluable for FACT-B (neratinib, N = 1171; placebo, N = 1236) and 2427 patients for EQ-5D (neratinib, N = 1186; placebo, N = 1241). Questionnaire completion rates exceeded 85%. Neratinib was associated with a decrease in global HRQoL scores at month 1 compared with placebo (adjusted mean differences: FACT-B total, –2.9 points; EQ-5D index, −0.02), after which between-group differences diminished at later time-points. Except for the FACT-B physical well-being (PWB) subscale at month 1; all between-group differences were less than reported IDs. The FACT-B breast cancer-specific subscale showed small improvements with neratinib at months 3–9, but all were less than IDs. Sensitivity analyses exploring missing data did not change the results. ConclusionsExtended adjuvant neratinib was associated with a transient, reversible decrease in HRQoL during the first month of treatment, possibly linked to treatment-related diarrhea. With the exception of the PWB subscale at month 1, all neratinib-related HRQoL changes did not reach clinically meaningful thresholds. ClinicalTrials.gov: NCT00878709.

Effectiveness of therapeutic inflatable ball self-exercises for improving shoulder function and quality of life in breast cancer survivors after sentinel lymph node dissection.

The survival rate of breast cancer survivors (BCSs) is > 90%. Particular issues are upper arm dysfunction caused by surgery and treatments. Physical activity has been recommended to improve shoulder function and quality of life (QoL) in BCSs. However, rehabilitation programs tend not to be continuous. To explore the effectiveness of therapeutic inflatable ball self-exercise for improving shoulder function and QoL in breast cancer survivors (BCSs) following breast cancer surgery. Seventy-two BCSs were allocated to two groups, conventional self-exercise (CSE; n = 34; age, 48.9 ± 7.2years) and therapeutic inflatable ball self-exercise (IBE; n = 38; age, 47.7 ± 8.9years); 22 in the CSE and 23 in the IBE group completed the interventions. Both groups performed intervention for 12weeks, three times per week and 15min a day at least. Measurement was performed three times for shoulder range of motion (ROM), handgrip strength, Shoulder Pain and Disability Index (SPADI), and Functional Assessment of Cancer Therapy-Breast (FACT-B). Flexion and extension ofshoulder ROM showed significant differences between the two groups at 12weeks. Flexion and extension of shoulder ROM showed significant differences for t1-t2 (p = 0.02) and t0-t1 (p = 0.04). Abduction showed a significant difference for t0-t1 (p = 0.03), t1-t2 (p = 0.02), and t0-t2 (p = 0.01). CSE (7 points) and IBE (20 points) satisfied the MDC in FACT-B total score. The MDC of the SPADI total score was 13 points in the CSE group and 9 points in the IBE group. IBE would be more appropriate to start the rehabilitation for BCSs and CSE would be effective after the pain has improved.

Psychometric Performance of the Arabic Versions of the Cancer Behavior Inventory-Brief and the Functional Assessment of Cancer Therapy-Breast.

Valid and reliable instruments in Arabic are needed to measure self-efficacy and quality of life for Arabic patients with cancer. The aim of this study was to test the psychometric performance of the Cancer Behavior Inventory-Brief Arabic (CBI-BA), including participant understanding of items, and the Functional Assessment of Cancer Therapy-Breast Arabic (FACT-BA). Using a cross-sectional design, 438 cancer patients completed the CBI-BA, 30 of whom completed cognitive interviews. A subsample 167 women with breast cancer also completed the FACT-BA. Internal consistency evidence was assessed with Cronbach's α and construct validity with principal axis factoring. Internal consistency estimates were acceptable for the total CBI-BA (α = .81) and FACT-BA (α = .88) scales. Exploratory factor analyses showed evidence of construct validity for the CBI-BA; 1 factor was derived, compared with four in the original English version. Cognitive interviews indicated satisfactory patient understanding of CBI-BA items. The Arabic version of the general FACT-General scale had 4 factors according to expectation. The CBI-BA has adequate psychometric performance for the measurement of self-efficacy for coping with cancer in Arabic patients. The FACT-General Arabic has adequate evidence of reliability and validity for the measurement of quality of life in Arabic women with breast cancer. The availability of culturally sensitive and psychometrically sound instruments for Arabic patients diagnosed with cancer should be valuable for healthcare clinicians and researchers to assess self-efficacy for coping with cancer and quality of life.

Patterns of occurrence and implications of neratinib-associated diarrhea in patients with HER2-positive breast cancer: analyses from the randomized phase III ExteNET trial

BackgroundWe characterized patterns of occurrence and the impact of neratinib-associated diarrhea in the absence of protocol-directed antidiarrheal prophylaxis or a formal diarrhea management plan using data from Extended Adjuvant Treatment of Breast Cancer with Neratinib (ExteNET).MethodsExteNET is a multicenter, double-blind, placebo-controlled, randomized phase III trial involving community-based and academic institutions in 40 countries. Women with HER2-positive early-stage breast cancer with prior standard primary therapy and trastuzumab-based (neo)adjuvant therapy were randomized to neratinib 240 mg/day or placebo for 12 months. Safety, a secondary outcome, was assessed using the National Cancer Institute Common Terminology Criteria version 3.0. Health-related quality of life by diarrhea grade was assessed using Functional Assessment of Cancer Therapy-Breast (FACT-B).ResultsTwo thousand eight hundred sixteen women (1408 per group) were safety-evaluable. Grade 3 and 4 diarrhea occurred in 561 (39.8%) and 1 (0.1%) patients with neratinib versus 23 (1.6%) and 0 patients with placebo, respectively. In the neratinib group, 28.6% of patients had grade 3 events during month 1 decreasing to ≤ 6% after month 3. The median cumulative duration of grade 3/4 diarrhea with neratinib was 5 days (interquartile range, 2–9). Serious diarrheal events (n = 22, 1.6%) and diarrheal events requiring hospitalization (n = 20, 1.4%) were rare with neratinib. Changes in FACT-B total score by diarrhea grade in the neratinib group did not meet the threshold for clinically important differences.ConclusionsIn the absence of antidiarrheal prophylaxis, neratinib-related diarrhea is short-lived and not associated with complications or long-term sequelae. This suggests that targeted preventive management with antidiarrheal prophylaxis early during neratinib treatment is appropriate.Trial registrationClinicalTrials.gov NCT00878709. Registered 9 April 2009.

Abstract P2-13-03: The impact of neratinib with or without anti-diarrheal prophylaxis on health-related quality of life in HER2+ early-stage breast cancer: Analyses from the ExteNET and CONTROL trials

Abstract Background: Neratinib is an irreversible pan-HER tyrosine kinase inhibitor. ExteNET, a randomized placebo-controlled phase III study, showed that neratinib given for 12 months after trastuzumab-based adjuvant therapy significantly improved 2-year (HR 0.67; 95% CI 0.50–0.91; p=0.0091) and 5-year (HR 0.73; 95% CI 0.57-0.92; p=0.008) iDFS in pts with early-stage HER2+ breast cancer. Anti-diarrheal prophylaxis was not mandated by protocol; grade 3/4 diarrhea occurred in 40% of pts with a median cumulative duration of 5 days. The phase II CONTROL study was initiated to investigate the effectiveness of various prophylactic regimens in the prevention of neratinib-associated diarrhea. Loperamide (L) alone or in combination with add-on agents targeting underlying inflammation [i.e. budesonide (BUD)] or bile acid malabsorption [i.e. colestipol (COL)] were tested. We report longitudinal HRQoL findings from both ExteNET and CONTROL. Methods: Pts with early-stage HER2+ breast cancer who had received trastuzumab-based adjuvant therapy were eligible for both studies. In ExteNET, pts received neratinib or placebo for 12 months. In CONTROL, pts received neratinib for 13 x 28-day cycles combined with L, L + BUD or L + COL for 1 or 2 cycles (see table for schedules). HRQoL was assessed using Functional Assessment of Cancer Therapy–Breast (FACT-B), v4.0, at baseline, months 1, 3, 6, 9, 12 (ExteNET) or baseline, cycles 2, 4, 7, 10, 13 (CONTROL). Changes in scores from baseline were considered to be clinically meaningful if greater than the lowest estimate for an 'important difference' (ID) reported in the literature. Evaluable pts were required to have HRQoL assessments at baseline and at least 1 post-baseline. ClinicalTrials.gov: NCT00878709 (ExteNET); NCT02400476 (CONTROL). Results: HRQoL findings are summarized in the table. Hospitalization rates due to diarrhea: 1.5% (neratinib + L), 0% (other cohorts) in CONTROL; and 1.4% (neratinib), 0.1% (placebo) in ExteNET. Mean change from baselineStudyCohort/GroupM1M3M6M9M12 FACT-B TOTAL (ID range: 7–8 points)CONTROLN + La,b (N=40)–3.8–4.5–1.5–2.5–3.3 N + L + BUDa,b,c (N=62)–6.0–4.9–1.6–3.6–4.5 N + L + COLa,b,d (N=125)–3.8–2.0–4.0–4.6–3.6 N + L prn + COLa,d (N=85)–1.8–1.54.0e––ExteNETN + L prna (N=1124)–4.6–3.4–3.5–3.3–3.7 P (N=1188)–1.7–3.5–2.9–2.9–2.8 FACT-B PWB (ID range: 2–3 points)CONTROLN + La,b (N=40)–4.0–2.3–1.9–2.4–2.3 N + L + BUDa,b,c (N=62)–3.2–2.1–1.4–1.7–1.7 N + L + COLa,b,d (N=125)–2.8–2.0–2.4–2.5–2.4 N + L prn + COLa,d (N=85)–2.8–1.80.0e––ExteNETN + L prna (N=1124)–2.9–1.9–1.7–1.6–1.5 P (N=1188)–0.6–0.8–0.7–0.6–0.4C, cycle; L, loperamide; M, month; N, neratinib; prn, as needed; PWB, physical well-being. CONTROL cut-off: 1 May 2018. aN 240 mg qd for 13 x 28d cycles or 12 months; bL 4 mg, then 4 mg tid d1-14, then 4 mg bid d15-28 or d15-56, then prn; cBUD 9 mg qd d1-28; dCOL 2 g qd d1-28; en=1. Conclusions: Adjuvant neratinib with or without anti-diarrheal prophylaxis was associated with small decreases in HRQoL. With the exception of the FACT-B PWB subscale, HRQoL changes did not reach clinically meaningful thresholds. Follow-up in CONTROL is ongoing. Citation Format: Delaloge S, Hurvitz S, Chan N, Bose R, Jankowitz RC, Thirlwell M, Láng I, ten Tije A, Trudeau M, Osborne CR, Shen Z-Z, Lalla D, Xu F, Hunt D, Olek E, Tripathy D, Rugo HS, Chien J, Chan A, Barcenas CH. The impact of neratinib with or without anti-diarrheal prophylaxis on health-related quality of life in HER2+ early-stage breast cancer: Analyses from the ExteNET and CONTROL trials [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P2-13-03.

An Electronic Patient-Reported Outcome Tool for the FACT-B (Functional Assessment of Cancer Therapy-Breast) Questionnaire for Measuring the Health-Related Quality of Life in Patients With Breast Cancer: Reliability Study.

BackgroundThe most frequent malignant disease in women is breast cancer. In the metastatic setting, quality of life is the primary therapeutic goal, and systematic treatment has only a limited effect on survival rates; therefore, the concept of the health-related quality of life (HRQoL) and measurement of patient-reported outcomes (PROs) are gaining more and more importance in the therapy setting of diseases such as breast cancer. One of the frequently used questionnaires for measuring the HRQoL in patients with breast cancer is the Functional Assessment of Cancer Therapy-Breast (FACT-B). Currently, paper-based surveys still predominate, as only a few reliable and validated electronic-based questionnaires are available. ePRO tools for the FACT-B questionnaire with proven reliability are missing so far.ObjectiveThe aim of this study was to analyze the reliability of tablet-based measurement of FACT-B in the German language in adjuvant (curative) and metastatic breast cancer patients.MethodsPaper- and tablet-based questionnaires were completed by a total of 106 female adjuvant and metastatic breast cancer patients. All patients were required to complete the electronically based (ePRO) and paper-based version of the FACT-B. A frequency analysis was performed to determine descriptive sociodemographic characteristics. Both dimensions of reliability (parallel forms reliability using Wilcoxon test and test of internal consistency using Spearman ρ) and agreement rates for single items, Kendall tau for each subscale, and total score were analyzed.ResultsHigh correlations were shown for both dimensions of reliability (parallel forms reliability and internal consistency) in the patients’ response behavior between paper-based and electronically based questionnaires. Regarding the reliability test of parallel forms, no significant differences were found in 35 of 37 single items, while significant correlations in the test for consistency were found in all 37 single items, in all 5 sum individual item subscale scores, as well as in total FACT-B score.ConclusionsThe ePRO version of the FACT-B questionnaire is reliable for patients with breast cancer in both adjuvant and metastatic settings, showing highly significant correlations with the paper-based version in almost all questions all subscales and the total score.

Study of quality of life and its influence factors among post-surgery breast cancer patients undergoing chemotherapy

Objective To investigate the status of anxiety, depression, fatigue, Body Image and quality of life among post-surgery breast cancer patients undergoing chemotherapy, and explore the relationship between these variables and quality of life. Methods Participants meeting the inclusion and exclusion criteria were investigated by the self-designed general information questionnaire, Self-Rating Anxiety Scale(SAS), Self-Rating Depression Scale(SDS), Cancer Fatigue Scale(CFS), Body Image After Breast Cancer Questionnaire (BIBCQ), Functional Assessment of Cancer Therapy-Breast(FACT-B). Statistical analysis included descriptive analysis, variance analysis, correlation and regression analysis. Results Totally 162 participants were investigated. Total score of FACT-B was (91.99±19.90) points, function dimension scored lowest; total score of BIBCQ was (129.49±21.71) points; total score of CFS was (24.42±9.91) points; the percent of anxiety was 12.34% (20/162); the percent of depression was 36.42% (59/162). Score of FACT-B showed differences on religious belief, whether have minor children, family per capita monthly income, ways of medical payment (t=4.882,6.660, F=3.796, 4.771,P<0.05); anxiety, depression, fatigue and body image were all negatively correlated (r=-0.648- -0.179, P<0.05); Stepwise regression analysis showed that the effect of whether have minor children, depression, fatigue and body image on sexual function were significant (F=35.641, P<0.01, adjusted R2=0.601). Conclusions All variables significant should be taken into consideration while caring for post-surgery breast cancer patients undergoing chemotherapy, by providing targeted care to relieve symptom burden, paying attention to psychological health. Nursing interventions including health education, image guidance, supportive psychotherapy, mindfulness reduction, exercise guidance and so on could be concerned, to help patients relieve anxiety and depression, improve fatigue, and self image, and improve their overall quality of life. Key words: Breast neoplasm; Quality of life; Chemotherapy; Anxiety; Depression; Body image

Comparative Study of Aerobic Exercise and Weight training on Metabolic Syndrome among Breast Cancer Survivors

Introduction: Breast cancer is the most frequent-occurring cancer among women and the leading cause deaths. Despite this Breast cancer treatments still have side effects that may negatively impact recovery and quality of life (QOL) after initial treatments. BCRL is a chronic swelling of the arm, hand and associated trunk quadrant. It usually develops after damage to the axillary lymph nodes due to breast cancer therapies. Methods: Participants who had fulfilled the eligibility criteria were randomized to either the aerobic exercise group (n = 20) and weight training group (n = 20). Exercise program was divided into a warm-up period, moderate intensity of aerobic exercises, and cool-down period. Weight-training exercise of low to moderate intensity with relatively slow progression significantly improved the upper limb strength, lower limb strength and incidence of breast cancer-related lymphoedema. Outcomes were assessed at baseline and post intervention. Results: Outcome were assessed by the functional assessment of cancer therapy-breast (FACT-B) scale and 6 min walk test (6MWT) Depressive symptoms are assessed using the CES-D scale. Upper limb musculoskeletal disorders is assessed using the DASH (Disabilities of the Arm, Shoulder, and Hand) The results confirmed the hypothesis that 12 week of moderate-intensity aerobic exercise program significantly reduces BCRL. Conclusion: There have been many studies of resistance exercise in breast cancer survivors, Findings of this trial revels that aerobic exercise will contribute to the reduction of metabolic syndrome in best cancer survivors.

Correlation between Subliminal Depression and the Quality of Life in Patients Preliminarily Diagnosed with Breast Cancer

Objective: To investigate the subthreshold depression and the quality of life in patients preliminarily diagnosed with breast cancer, and to explore their relationship. Methods: A total of 210 patients preliminarily diagnosed breast cancer were recruited by convenience sampling method to complete the self-made general questionnaire, Center for Epidemiological Studies Depression Scale (CES-D), Hamilton Rating Scale for Depression and Functional Assessment of Cancer Therapy-Breast (FACT-B). Results: The incidence rates of subthreshold depression was 48.6% in patients preliminarily diagnosed breast cancer, the total score of FACT-B in patients with subthreshold depression and non-subthreshold depression was (73.92 ± 17.62) and (86.74 ± 16.15). The total score of CES-D was significantly negatively correlated to the total score and factor scores of FACT-B (p < 0.01). Conclusion: The incidence rate of subthreshold depression in preliminarily diagnosed breast cancer patients is high, and it is closely related to the quality of life, so we should pay attention to the psychological status of preliminarily diagnosed breast cancer patients, to increase the psychological intervention, than improve their quality of life.

Effects of mental resilience on fatigue, compliance and quality of life in breast cancer chemotherapy patients

Objective To investigate the effects of mental resilience on fatigue, medication compliance and quality of life in breast cancer patients undergoing chemotherapy. Methods A total of 186 cases of postoperative chemotherapy for breast cancer patients admitted by the second department of tumor in the hospital from June 2014 to December 2015 were selected as the study objects. There were 89 cases in the control group and 97 cases in the experimental group.The control group received only conventional endocrine therapy, while the experimental group received four weeks of mental resilience training on the basis of conventional endocrine therapy. Conner-davidson Resilience Scale (CD-RISC), The Revised Piper Fatigue Scale (PFS-R), compliance scale and Functional Assessment of Cancer Therapy-Breast (FACT-B) were adopted to investigate and evaluate the two groups of patients. Results After 6 months of treatment, the dimensions and total scores of the CD-RISC scale and the PFS-R scale of breast cancer patients in the experimental group were higher than those in the control group and the pre-treatment group, and the differences were statistically significant (P 0.05). At 6 months of treatment, the MPR value of breast cancer patients in the experimental group was higher than that in the control group, and the difference was statistically significant (P 0.05). After 6 months of treatment, the scores and total scores of the other dimensions of FACT-B in the experimental group were higher than those before treatment, except for the two dimensions of social/family status and additional attention.The differences were statistically significant (P<0.05). After 6 months of treatment, the physiological status, emotional status and total score of the experimental group were higher than those of the control group, and the differences were statistically significant (P<0.05). Conclusions Enhancing the mental resilience of breast cancer chemotherapy patients can effectively improve the fatigue condition, improve the patient's medication compliance and quality of life. Key words: Breast cancer; Psychological resilience; Fatigu; Compliance; Quality of life

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.