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Optimizing expectations to prevent side effects and enhance quality of life in breast cancer patients undergoing endocrine therapy: study protocol of a randomized controlled trial.

ABSTRACT: Adjuvant endocrine therapy can improve disease-free survival and time before recurrence in breast cancer patients. However, it is associated with considerable side effects that negatively affect patients' quality of life and cause non-adherence. The recently demonstrated effect of individual expectations on side-effect development (nocebo effect) suggests that psychological factors play a role in the prevention of side effects. The aim of this study is to evaluate cognitive-behavioral side-effect prevention training (SEPT) for breast cancer patients. This article describes the study protocol and applied research methods.In a randomized controlled trial, 184 female breast cancer patients are assigned to receive either SEPT, standard medical care or a manualized supportive therapy at the start of adjuvant endocrine treatment. SEPT consists of three sessions of cognitive-behavioral training including psychoeducation to provide a realistic view of endocrine therapy, imagination-training to integrate positive aspects of medication into daily life, and side-effect management to enhance expectations about coping ability. Side effects three months after the start of endocrine therapy serve as primary outcomes. Secondary outcomes include quality of life, coping ability and patients' medication adherence. Patients' expectations (i.e., expectations about side effects, coping ability, treatment and illness) are analyzed as mediators.The optimization of expectations might be a potential pathway in health care to improve patients' quality of life during long-term medication intake. The results will provide implications for a possible integration of evidence-based prevention training into clinical practice.ClinicalTrials.gov, (NCT01741883).

SUBMITTER: von Blanckenburg P

PROVIDER: S-EPMC3848828 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

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Optimizing expectations to prevent side effects and enhance quality of life in breast cancer patients undergoing endocrine therapy: study protocol of a randomized controlled trial.

von Blanckenburg Pia P Schuricht Franziska F Albert Ute-Susann US Rief Winfried W Nestoriuc Yvonne Y

BMC cancer 20130918

<h4>Background</h4>Adjuvant endocrine therapy can improve disease-free survival and time before recurrence in breast cancer patients. However, it is associated with considerable side effects that negatively affect patients' quality of life and cause non-adherence. The recently demonstrated effect of individual expectations on side-effect development (nocebo effect) suggests that psychological factors play a role in the prevention of side effects. The aim of this study is to evaluate cognitive-be ...[more]

PMID: 24047450

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Project description:BACKGROUND:Despite compelling evidence linking physical activity and quality of life among adults with spinal cord injury (SCI), exercise participation rates are extremely low in this population. Unfortunately, a lack of behavioral exercise interventions, in particular theory-based randomized controlled trials (RCT), exists within the SCI literature. A pilot RCT is needed to first examine the feasibility to conduct such interventions and determine the appropriate effect size to inform future full-scale interventions. OBJECTIVE:The overall goal of this pilot RCT is to test an 8-week innovative, video-based telerehabilitation intervention based on self-determination theory and aimed at enhancing the basic psychological needs, motivation, exercise participation, and quality of life?related outcomes of adults with paraplegia. The objectives are to (1) determine if individuals in the intervention group have greater increases in their basic psychological needs and autonomous motivation and a decrease in controlled motivation compared to the control group, (2) determine whether the intervention group reports greater increases in exercise participation and quality of life?related variables (eg, life satisfaction, participation in daily/social activities, depressive symptoms) compared to the control group, and (3) examine if adults with paraplegia who received the intervention report improved scores on psychosocial predictors of exercise (eg, action planning) and well-being (eg, positive affect) compared to the control group. We also aimed to examine the implementation characteristics of the intervention (eg, satisfaction with the technology, counselor's ability to foster the psychological needs). METHODS:Adults with paraplegia (N=24) living in the community will be recruited. All participants will be invited to complete assessments of their psychological needs, motivation, exercise, and quality of life?related variables at three time points (baseline, 6, and 10 weeks). Following the baseline assessment, participants will be randomly assigned to the intervention or control group. Participants in the intervention group will participate in 8 weekly, 1-hour video-based telerehabilitation sessions with a trained physical activity counselor, while participants in the control group will be asked to continue with their regular routine. RESULTS:We expect higher ratings of the basic psychological needs and autonomous motivation and lower scores for controlled motivation for the intervention group compared to the control group (Objective 1). We also expect that our video-based intervention will have moderate effects on exercise participation, as well as small-to-moderate positive effects on the quality of life?related variables (Objective 2). Finally, we expect the intervention to have a small positive effect on psychosocial predictors of physical activity and well-being (Objective 3). CONCLUSIONS:We anticipate that the results will show that the intervention is appropriate for adults with paraplegia and feasible to test in a full-scale RCT. TRIAL REGISTRATION:ClinicalTrials.gov NCT02833935; https://clinicaltrials.gov/ct2/show/NCT02833935 (Archived by WebCite at http://www.webcitation.org/6u8U9x2yt).

Project description:BackgroundSeveral outcome measures can be utilised to measure social participation and Quality of Life (QoL) in research and clinical practice. However there have been few large-scale trials of these tools in community care to identify their value to clients and providers. This study aims to evaluate the implementation of the Australian Community Participation Questionnaire (ACPQ) and the ICEpop CAPability measure for Older people (ICECAP-O) as tools to measure social participation and QoL for clients receiving community aged care services. The specific research questions focus on determining: (1) the levels and predictors of social participation and QoL among older adults using community aged care services; (2) the acceptability and feasibility of implementation of ACPQ and ICECAP-O tools into routine community aged care assessments; (3) if implementation of the tools change service provision and outcomes for older adults receiving community aged care services.MethodsA mixed method design will be used to collect data from a large Australian aged care provider. Community aged care clients' ACPQ and ICECAP-O scores, as well as other key outcomes (e.g. services used, hospitalisation and admission to permanent residential care), will be examined at baseline and 12-monthly follow-up assessments. Interviews and focus groups with community aged care clients and staff who administer the tools will also be completed. Descriptive statistics and multiple linear regression will be used to examine the levels and predictors of social participation and QoL. Thematic analysis of interviews and focus groups will be used to determine the acceptability and feasibility of implementing the ACPQ and ICECAP-O into routine needs assessments in community aged care. Case-controlled analyses will be used to determine whether the implementation of the ACPQ and ICECAP-O changes service use and outcomes.DiscussionThe novel use of the ACPQ and the ICECAP-O tools as part of routine needs assessments for community aged care clients has the potential to improve the quality and effectiveness of community aged care services and outcomes.Trial registrationAustralian and New Zealand clinical trial registry number: ACTRN12617001212347 . Registered 18/08/2017.

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Optimizing expectations to prevent side effects and enhance quality of life in breast cancer patients undergoing endocrine therapy: study protocol of a randomized controlled trial.

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Optimizing expectations to prevent side effects and enhance quality of life in breast cancer patients undergoing endocrine therapy: study protocol of a randomized controlled trial.

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