Health-Related Quality of Life Coupled With Therapeutic Information on Compliance to Endocrine Therapy in Breast Cancer (COMPLIANCE)

Author(s):  
2017 ◽  
Vol 13 (5) ◽  
pp. e463-e473 ◽  
Author(s):  
Laura C. Pinheiro ◽  
Stephanie B. Wheeler ◽  
Katherine E. Reeder-Hayes ◽  
Cleo A. Samuel ◽  
Andrew F. Olshan ◽  
...  

Purpose: Endocrine therapy (ET) underuse puts women at increased risk for breast cancer (BC) recurrence. Our objective was to determine if health-related quality of life (HRQOL) subgroups were associated with underuse. Methods: Data came from the third phase of the Carolina Breast Cancer Study. We included 1,599 women with hormone receptor–positive BC age 20 to 74 years. HRQOL was measured, on average, 5 months postdiagnosis. Subgroups were derived using latent profile (LP) analysis. Underuse was defined as not initiating or adhering to ET by 36 months postdiagnosis. Multivariable logistic regression models estimated adjusted odds ratios (ORs) between HRQOL LPs and underuse. The best HRQOL LP was the reference. Chemotherapy- and race-stratified models were estimated, separately. Results: Initiation analyses included 953 women who had not begun ET by their 5-month survey. Of these, 154 never initiated ET. Adherence analyses included 1,114 ET initiators, of whom 211 were nonadherent. HRQOL was not significantly associated with noninitiation, except among nonchemotherapy users, with membership in the poorest LP associated with increased odds of noninitiation (adjusted OR, 5.5; 95% CI, 1.7 to 17.4). Membership in the poorest LPs was associated with nonadherence (LP1: adjusted OR, 2.2; 95% CI, 1.2 to 4.0 and LP2: adjusted OR,1.9; 95% CI, 1.1 to 3.6). Membership in the poorest LP was associated with nonadherence among nonchemotherapy users (adjusted OR, 2.1; 95% CI, 1.2 to 5.1). Conclusion: Our results suggest women with poor HRQOL during active treatment may be at increased risk for ET underuse. Focusing on HRQOL, a modifiable factor, may improve targeting of future interventions early in the BC continuum to improve ET initiation and adherence and prevent BC recurrence.


2020 ◽  
Author(s):  
Ariane MAMGUEM KAMGA ◽  
Cyril DI MARTINO ◽  
Amélie ANOTA ◽  
Sophie PAGET-BAILLY ◽  
Charles COUTANT ◽  
...  

Abstract Background: Despite its proven efficacy in reducing recurrence and improving survival, adherence to endocrine therapy (ET) is suboptimal in women with breast cancer (BC). Health-related quality of life (HRQoL) in BC has been widely studied and many positive effects have been highlighted. Recently, a link between HRQoL and compliance with ET has been suggested, which would suggest a potential role for HRQoL assessment in improving compliance with ET. With the advent of digital technologies, electronic collection of HRQoL on a tablet is now possible. Thus, we hypothesize that systematic HRQoL assessment (using a tablet, prior to each consultation, with presentation of scores to clinicians) coupled with therapeutic information could have an impact on 12-month compliance with ET in patients with non-metastatic BC.Methods: In this study, we will include 342 women with non-metastatic hormone receptor positive BC with an indication for treatment with ET. Patients will be randomized 1:1 by minimization and stratified by: age, stage, type of ET prescribed and presence of comorbidities or not, in 2 arms. The intervention will consist of numerical HRQoL assessment using the CHES software before each consultation (with delivery of scores to clinicians) coupled with therapeutic information. Therapeutic information will consist on 3 workshops related to understanding the prescription, nutrition and fatigue. A reminder letter will also be send to patients every month. Patients in the control group will follow standard care. HRQoL will be assessed using a classic “paper-pencil” collection at baseline in both arms to ensure comparability between arms and at 12-month. The primary endpoint is 12-month compliance with ET. Patient satisfaction with care, and clinicians' perception of the usefulness of routine HRQoL assessment will also be assessed. Discussion: This study will allow clinicians to identify and better understand the areas in which patients on ET have difficulties, and thus assist clinicians with patient management. Systematic evaluation of HRQoL could also provide an additional endpoint for measuring patients' health status and treatment-related symptoms, including ET. If the results of this study are positive, this intervention could be proposed as an integral part of daily clinical practice in patients treated with ET.Trial Registration: ClinicalTrials.gov NCT04176809. Registered 25 November 2019, https://clinicaltrials.gov/ct2/show/NCT04176809.


2021 ◽  
Author(s):  
Isis Danyelle D. Custódio ◽  
Fernanda S. Mazzutti ◽  
Mariana T. M. Lima ◽  
Kamila P. de Carvalho ◽  
Paula P. L. Canto ◽  
...  

Abstract Background: Potentially, instruments to manage adverse effects may improve adherence and persistence of treatment, health-related quality of life (HRQL) and breast cancer (BC) outcomes. In this sense, we consider the Cervantes Scale an appropriate option to assess HRQL in BC survivors undergoing adjuvant endocrine therapy with Aromatase Inhibitors (AI), as it is a specific HRQL questionnaire that considers particularities of the perimenopausal and postmenopausal women. The purpose of this study was to analyze the psychometric properties of the 31-item Cervantes Scale (CS-31), 16-item Cervantes Short-Form Scale (CS-16) and 10-item Cervantes Scale (CS-10) and to promote the additional validation for breast cancer (BC) survivors during adjuvant endocrine therapy.Methods: This prospective study included 89 postmenopausal BC survivors in endocrine therapy. The women completed the CS, Functional Assessment of Chronic Illness Therapy - fatigue (FACIT-F) and Hospital Anxiety and Depression Scale (HADS). The internal consistency, convergent validity, responsiveness analyses and known-group validity of CS were evaluated. Also, simple linear regression assessed the predictive capacity of the CS in relation to the FACIT-F.Results: The internal consistency was good (Cronbach's alpha: CS-10=0.76; CS-16=0.80; CS-31=0.89). For convergent validity, in general, we identified negative and strong correlations (r>0.6) with exception of moderate correlation between Social/Family Well-Being of FACIT-F and Sexual (r=-0.453) and Couple (r=-0.436) of CS-31, and weak correlation between Social/Family Well-Being of FACIT-F and Sexual (r=-0.289) and Couple (r=-0.287) of CS-16. A prospective improvement in health-related quality of life (HRQL) were identified, except for domains Sexual and Couple of CS-16/CS-31, as well as FACT-G, Social/Family and Functional Well-Being of FACIT-F. The CSs were able to predict changes in the FACIT-F. Furthermore, women with anxiety and depression by HADS presented worse HRQL by CS (p<0.001).Conclusions: We identified that the CS, highlighting the CS-31, proved to be appropriate for use in routine medical oncology with BC survivors during adjuvant endocrine therapy, although larger studies are needed to confirm these results.


2020 ◽  
Author(s):  
Ariane MAMGUEM KAMGA ◽  
Cyril DI MARTINO ◽  
Amélie ANOTA ◽  
Sophie PAGET-BAILLY ◽  
Charles COUTANT ◽  
...  

Abstract Background: Despite its proven effectiveness in reducing recurrence and improving survival, adherence to endocrine therapy (ET) is suboptimal in women with breast cancer (BC). Health-related quality of life (HRQoL) in BC has been widely studied and many positive effects have been highlighted. Recently, a link between HRQoL and compliance with ET has been suggested, which would suggest a potential role for HRQoL assessment in improving compliance with ET. With the advent of digital technologies, electronic collection of HRQoL on a tablet is now possible. Thus, we hypothesize that systematic HRQoL assessment (using a tablet, prior to each consultation, with presentation of scores to clinicians) coupled with therapeutic information could have an impact on 12-month compliance with ET in patients with non-metastatic BC. Methods: In this study, we will include 342 women with non-metastatic hormone receptor positive BC with an indication for treatment with ET. Patients will be randomized 1:1 by minimization and stratified by: age, stage, type of ET prescribed and presence of comorbidities or not, in 2 arms. The intervention will consist of numerical HRQoL assessment using the CHES software before each consultation (with delivery of scores to clinicians) coupled with therapeutic information. Therapeutic information will consist on 3 workshops related to understanding the prescription, nutrition and fatigue. A reminder letter will also be send to patients every month. Patients in the control group will follow standard care. HRQoL will be assessed using a classic “paper-pencil” collection at baseline in both arms to ensure comparability between arms and at 12-month. The primary endpoint is 12-month compliance with ET. Patient satisfaction with care, and clinicians' perception of the usefulness of routine HRQoL assessment will also be assessed. Discussion: This study will allow clinicians to identify and better understand the areas in which patients on ET have difficulties, and thus assist clinicians with patient management. Systematic evaluation of HRQoL could also provide an additional endpoint for measuring patients' health status and treatment-related symptoms, including ET. If the results of this study are positive, this intervention could be proposed as an integral part of daily clinical practice in patients treated with ET. Trial Registration: ClinicalTrials.gov NCT04176809. Registered 25 November 2019, https://clinicaltrials.gov/ct2/show/NCT04176809.


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