Optimization of a multicomponent intervention to foster functional recovery after breast cancer treatment

The National Cancer Institute awarded The MGH Institute of Health Professions, Inc. $696,498 on May 1, 2026, under the Cancer Cause and Prevention Research program (CFDA 93.393) to develop and optimize a multicomponent intervention for improving functional recovery and participation in life roles among breast cancer survivors.

The research uses the Multiphase Optimization Strategy (MOST) framework to systematically test three remotely delivered intervention components: priority elicitation to activate self-management, cancer survivorship education to build self-efficacy, and guided application involving goal setting, problem-solving, and action planning. The study will conduct a 2³ factorial optimization trial randomizing 352 breast cancer survivors to one of eight conditions representing unique combinations of the three components. Aim 1 tests main effects and interactions on participation restrictions measured by the PROMIS satisfaction with social roles and activities item bank. Aim 2 evaluates mechanisms of action by testing each component's effect on its hypothesized proximal target. The research addresses the gap in scalable, accessible, evidence-based interventions, given that nearly one-third of breast cancer survivors report inability to participate fully in vocational, social, physical, and instrumental activities of daily living, which correlates with lower quality of life, greater depression, and shortened survival risk.

Performance occurs in Charlestown, Massachusetts, from May 1, 2026, through April 30, 2031. The recipient passes work to two sub-recipients. Dartmouth-Hitchcock Clinic (award date July 4, 2026) recruits a minimum of 50 participants from Dartmouth Cancer Center, conducts fidelity monitoring of a random sample of intervention sessions, supervises clinical research staff, and supports regulatory compliance and data collection. University of Alabama at Birmingham (award date June 29, 2026) contributes to the intervention development and optimization testing framework.

Abstract

Almost one-third of breast cancer survivors report an inability to fully participate in vocational, social, physical, and instrumental activities of daily living. Breast cancer survivors who report lower participation in these activities report lower quality of life, greater depression, and are at risk for shortened survival. The long-term goal of this research is to address the absence of scalable, accessible, evidence-based interventions that improve cancer survivors' participation in life roles and activities. The objective of this R01 project is to systematically develop an intervention package ready for efficacy testing. We used the multiphase optimization strategy (most) framework to create a conceptual model of three remotely-delivered intervention components that have the potential to increase breast cancer survivors' engagement in role-relevant, valued activities: (1) priority elicitation, (2) education, and (3) guided application involving goal setting, problem-solving and action planning. The proposal will answer the research question: which of the intervention components, alone or in combination, most effectively reduce participation restrictions? We will conduct a most optimization trial using a 23 factorial design, randomizing 352 breast cancer survivors to one of eight conditions that offers a unique combination of the three intervention components. Aim 1 will test the main effects and interactions among the three components. Aim 2 will evaluate the mechanisms of action by testing the effect of each component on its hypothesized proximal target that can catalyze participation in social roles and activities. We hypothesize that priority elicitation will have the strongest effect on engagement in meaningful activities, education will have the strongest effect on self- efficacy for managing health and activity, and guided application will have the strongest effect on adaptive coping. Aim 3 will provide the analysis to assemble an optimized intervention package by evaluating the main effects and interactions using the following optimization criterion: the largest effect on participation restrictions. The approach is innovative because IT targets an area that reflects a priority of cancer survivors: helping them to find ways to fully and comfortably engage in the idiosyncratic activities that make life worth living. IT uses the most framework to better understand the mechanisms of action that can reduce participation restrictions. The project reflects not-OD-22-203 which calls for "systematic development… of behavioral interventions and their components" using "innovative…designs for building… and optimizing… interventions." the proposed research is significant because IT helps breast cancer survivors develop strategies to enhance productivity at home, in the workplace, and in the community, and to create sustainable lifestyle changes that foster health, participation, and functional well-being. As such, the knowledge gained from this study has the potential to advance the mission of the division of cancer control and population sciences of the national cancer institute by reducing disability and improving the quality of life of cancer survivors.