scholarly journals Impact of routine assessment of health-related quality of life coupled with therapeutic information on compliance with endocrine therapy in patients with non-metastatic breast cancer: protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Ariane MAMGUEM KAMGA ◽  
Cyril DI MARTINO ◽  
Amélie ANOTA ◽  
Sophie PAGET-BAILLY ◽  
Charles COUTANT ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Endocrine Therapy ◽  
Control Group ◽  
Health Related Quality ◽  
Positive Effects ◽  
Related Quality ◽  
Health Related ◽  
Hrqol Assessment

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.

scholarly journals Impact of routine assessment of health-related quality of life coupled with therapeutic information on compliance with endocrine therapy in patients with non-metastatic breast cancer

2020 ◽  
Author(s):  
Ariane MAMGUEM KAMGA ◽  
Cyril DI MARTINO ◽  
Amélie ANOTA ◽  
Sophie PAGET-BAILLY ◽  
Charles COUTANT ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Endocrine Therapy ◽  
Control Group ◽  
Health Related Quality ◽  
Positive Effects ◽  
Related Quality ◽  
Health Related ◽  
Hrqol Assessment

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.

scholarly journals Investigating Associations Between Health-Related Quality of Life and Endocrine Therapy Underuse in Women With Early-Stage Breast Cancer

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 ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Endocrine Therapy ◽  
Early Stage ◽  
Health Related Quality ◽  
Logistic Regression Models ◽  
Increased Risk ◽  
Related Quality ◽  
Health Related

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.

scholarly journals Effect of Community-Based Occupational Therapy on Health-Related Quality of Life and Engagement in Meaningful Activities of Women with Breast Cancer

2018 ◽  
Vol 2018 ◽  
pp. 1-13 ◽  
Author(s):  
Daiva Petruseviciene ◽  
Deive Surmaitiene ◽  
Daiva Baltaduoniene ◽  
Egle Lendraitiene
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Occupational Therapy ◽  
Control Group ◽  
Health Related Quality ◽  
Community Based ◽  
Related Quality ◽  
Health Related ◽  
Experimental Group

We aimed to evaluate the short-term effects of community-based occupational therapy on health-related quality of life and engagement in meaningful activities among women with breast cancer. An open label randomized controlled trial study design was applied. The participants were members of various societies of women with cancer. In total, 22 women have participated in the study. Participants of the experimental group (n=11) participated in a 6-week community-based occupational therapy program and the usual activities of various societies, whereas the control group (n=11) women participated in the usual activities of the societies only. 1 of the participants withdrew during the course; therefore 21 completed the study successfully. Participants of both groups were assessed for health-related quality of life and the participants of the experimental group were assessed for engagement in meaningful activities. The evaluation was carried out during the nonacute period of the disease—at the beginning of the study and after 6 weeks. Women of the experimental group demonstrated statistically significantly better scores in the global quality of life, role functions, physical, emotional, cognitive, and social functions, fatigue, insomnia, financial impact, systemic therapy side effects, and breast symptoms scales compared to the control group participants (p<0.05) after the 6 weeks, as measured by the EORTC QLQ-C30 questionnaire and its breast cancer module QLQ-BR23. Furthermore, women of the experimental group demonstrated significant greater engagement in meaningful activities when applying community-based occupational therapy (p<0.05), as measured by using the Engagement in Meaningful Activities Survey (EMAS). The evaluation of the associations between the women’s engagement in meaningful activities and changes in health-related quality of life showed that greater engagement in meaningful activities was associated with better emotional functions and a lower level of insomnia (p<0.05). Based on the results of our study, we recommend applying occupational therapy in the field of community healthcare in order to maintain or improve breast cancer patients’ health-related quality of life and suggest involving women into meaningful activities during community-based occupational therapy after clarifying which activities are important to them.

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