NCT07489053

Optimizing Functional Recovery After Breast Cancer Treatment

Optimization of a Multicomponent Intervention to Foster Functional Recovery After Breast Cancer Treatment

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 352 (estimated)
• Sponsor: MGH Institute of Health Professions · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to determine the best way to promote participation in vocational, social, physical, and instrumental activities of daily living in people who have completed treatment for early stage breast cancer. The main question it aims to answer is: Which of the intervention components, alone or in combination, most effectively promote participation in vocational, social, physical, and instrumental activities of daily living? Participants will be asked to try one of 8 combination of three intervention components that have been shown to promote activity participation: (1) priority elicitation, (2) education, and (3) guided application involving goal setting, problem-solving and action planning.

Detailed description

Breast cancer treatment creates physical, emotional, and practical challenges that disrupt routines and activities. After completion of curative treatment, one-third of cancer survivors report participation restrictions, defined as difficulties performing valued activities that reflect life roles. Participation restrictions can persist two to six years after breast cancer treatment, imposing personal and societal costs by hindering one's ability to fulfill career, civic, and caregiving roles. Addressing participation restrictions reflects the Cancer Moonshot Initiative call for research on ways to reduce the debilitating effects of cancer, yet there are no evidence-based interventions that are ready for large scale implementation. Most survivorship research has targeted symptom management, yet that does not always translate into greater participation in role-relevant activities. Recent evidence demonstrates that participation can be enhanced even in the absence of symptom reduction. There are now a number of interventions that aim to increase participation through various combinations of self-management strategies like goal setting and problem-solving, priority elicitation, and education about activity adaptation, environmental modification, and energy management. While studies indicate that these strategies are feasible and appear to enhance participation, each study uses a different blend of strategies that are often not well-specified, creating uncertainty as to which strategies of the multi-component interventions are most potent and which may be unnecessary. This uncertainty reduces reproducibility and limits large-scale implementation. The goal of this study is to identify mechanisms of action that reliably enhance participation in role-relevant activities after breast cancer treatment. The Multiphase Optimization STrategy (MOST) framework of intervention development uses engineering principles to build multi-component interventions that are both potent (i.e., produce clinically relevant outcomes) and parsimonious (i.e., contain no inactive ingredients). The first phase of MOST creates a conceptual model linking intervention components (i.e., strategies) and the intended targets and identifies an optimization criterion by which success will be judged. This study's optimization criterion is to find the combination of intervention components that has the largest effect on participation restrictions. This proposal reflects the second phase of MOST, the optimization phase, where the investigators will evaluate the degree to which each intervention component exerts an independent or synergistic effect on participation restrictions. The optimization phase ensures that the resulting intervention is composed only of components that are contributing to the outcome of interest. This study will use a factorial experiment to test three intervention components that have been used with breast cancer survivors: (1) priority-elicitation and session tailoring; (2) cancer survivorship education; and (3) guided application involving goal setting, problem-solving, and action planning. The components each have a modest evidence base supporting their efficacy to reduce participation restrictions. However, they have different profiles regarding a) the time survivors need to invest and b) the skills practitioners need to successfully deliver. To move the science forward, it is crucial to develop a potent yet parsimonious intervention with empirically-supported mechanisms of action. This study's research question is: Which components alone or in combination have the greatest impact on participation restrictions? Using the MOST framework, the investigators will conduct an optimization trial with a factorial design. The investigators will recruit 352 breast cancer survivors reporting participation restrictions in the first year following curative treatment; participants will be randomized to receive combinations of the 3 components. Aim 1: To identify the intervention components that reduce participation restrictions (primary outcome). Intervention components: a) priority elicitation (priority-elicitation coaching versus following a static menu of goals and topics); b) cancer survivorship education (therapist-administered versus weblink); and c) guided application (included versus not). Criterion: A component will be considered effective if its presence produces a main or interaction effect of Cohen's d of \> 0.30. Aim 2: To test the conceptual model by determining the degree to which each intervention component affects the following proximal targets: H1: Priority elicitation will have the strongest effect on engagement in valued activities. H2: Cancer survivorship education will have the strongest effect on self-efficacy for managing health. H3: Guided application will have the strongest effect on adaptive coping. Aim 3: To assemble an intervention package by evaluating the main effects and interactions with the following optimization criterion: The largest effect on participation restrictions.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
BEHAVIORAL	Individually tailored education and guided application to promote activity participation	This condition has high levels of the three components: (1) priority-elicitation and session tailoring; (2) cancer survivorship education; and (3) guided application involving goal setting, problem-solving, and action planning.
BEHAVIORAL	Individually tailored guided application	This condition contains high levels of priority elicitation and guided application.
BEHAVIORAL	Individually tailored education	This condition contains how levels of the components of priority elicitation and education
BEHAVIORAL	Priority elicitation	This condition contains the high level of the priority elicitation component
BEHAVIORAL	Static education and guided application	This condition has high levels of the education and guided application components
BEHAVIORAL	Static guided application	This condition contains high level of the guided application component
BEHAVIORAL	Static education	This condition contains the high level of the education component
BEHAVIORAL	Information	This condition contains the low levels of the three components

Timeline

• Start date: 2027-01-01
• Primary completion: 2030-09-30
• Completion: 2030-09-30
• First posted: 2026-03-23
• Last updated: 2026-03-25

Locations

1 site across 1 country: United States