Optimizing Functional Recovery After Breast Cancer Treatment

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Neoplasms
• Intervention / Treatment: Behavioral: Individually tailored education and guided application to promote activity participation; Behavioral: Individually tailored guided application; Behavioral: Individually tailored education; Behavioral: Priority elicitation; Behavioral: Static education and guided application; Behavioral: Static guided application; Behavioral: Static education; Behavioral: Information

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.

• Study Type: Interventional
• Enrollment (Estimated): 352
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathleen D Lyons, ScD; Phone Number: 617-643-5372; Email: KLyons2@mghihp.edu
• Study Contact Backup: Name: Sheel Singh, MA; Phone Number: 617-724-9835; Email: ssingh@mghihp.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02129
      • MGH Institute of Health Professions
      • Contact: Sheel Singh, MA; Phone Number: 617-724-9835; Email: ssingh@mghihp.edu
      • Contact: Kathleen Lyons, ScD; Phone Number: 617-643-5372; Email: carelab@partners.org
      • Principal Investigator: Kathleen Lyons, ScD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age of 18 years or older,
2. Diagnosed with Stage 1-3 breast cancer and within one year of completion of locoregional treatment and/or adjuvant therapy with curative intent and absence of disease recurrence,
3. Experiencing reduced participation (i.e., a score of > 10 on the Work and Social Adjustment Scale).

Exclusion Criteria:

1. Non-English speaking.
2. Non-correctable hearing loss.
3. Moderate-severe cognitive impairment indicated by a score < 3 on a 6-item cognitive screener.
4. History of severe mental illness (i.e., schizophrenia, bipolar disorder), current major depressive disorder, active suicidal ideation, or active substance misuse documented within the medical record.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Priority elicitation, education, and guided application; Weekly telephone or videoconference sessions with a coach where participants will discuss survivorship information and set goals and action plans that are tailored to personal priorities	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.
Experimental: Priority elicitation and guided application; Weekly telephone or videoconference sessions with a coach where participants will set goals and action plans that are tailored to personal priorities; survivorship information tailored to personal priorities will be emailed to participants	Behavioral: Individually tailored guided application; This condition contains high levels of priority elicitation and guided application.
Experimental: Priority elicitation and education; Weekly telephone or videoconference sessions with a coach where participants will discuss survivorship information that is tailored to personal priorities	Behavioral: Individually tailored education; This condition contains how levels of the components of priority elicitation and education
Experimental: Priority elicitation; Telephone or videoconference sessions with a coach in the first and last week where participants will discuss personal priorities for recovery; survivorship information tailored to personal priorities will be emailed to participants each week	Behavioral: Priority elicitation; This condition contains the high level of the priority elicitation component
Experimental: Education and guided application; Weekly telephone or videoconference sessions with a coach where participants will discuss survivorship information and set goals and action plans from a static menu of six different topics	Behavioral: Static education and guided application; This condition has high levels of the education and guided application components
Experimental: Guided application; Weekly telephone or videoconference sessions with a coach where participants will set goals and action plans from a static menu of six different topics; survivorship information from a static menu of six different topics will be emailed to participants each week	Behavioral: Static guided application; This condition contains high level of the guided application component
Experimental: Education; Weekly telephone or videoconference sessions with a coach where participants will discuss survivorship information from a static menu of six different topics	Behavioral: Static education; This condition contains the high level of the education component
Experimental: Information; Weekly survivorship education will be emailed to participants, from a static menu of six different topics	Behavioral: Information; This condition contains the low levels of the three components

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation satisfaction: PROMIS Satisfaction with Social Roles and Activities Short Form 8a	Scores range from 8 to 40, with higher values representing greater satisfaction with ability to participate in social roles and activities.	Baseline to week 20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation ability: Ability to Participate in Social Roles and Activities Short Form 8a	Scores range from 8 to 40, with lower values representing greater difficulty participating in social roles and activities	Baseline to 20 weeks
Valuing Questionnaire: Engagement in valued activities	Two subscales of five items each. Progress subscale ranges from 0 to 30 with high scores reflecting better concordance between values and actions. Obstruction subscale ranges from 0 to 30 with high scores reflecting more interference between values and actions.	Baseline to 20 weeks
Self-efficacy for health management: Self-Efficacy for Managing Chronic Disease Scale	Scores range from 6 to 60 with higher scores indicating higher self-efficacy	Baseline to 20 weeks
Adaptive coping: Brief COPE subscales	Three subscales of the Brief COPE: planning, active coping, and positive reframing. Scores on each subscale are calculated as the sum of two items, thus possible scores range from 0 to 6, with higher values representing greater use of active coping strategies.	Baseline to 20 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of intervention components	Open-ended questions regarding acceptability and utility of components received	8 weeks post-baseline

Collaborators and Investigators

• Sponsor: MGH Institute of Health Professions
• Collaborators: University of Alabama at Birmingham; Dartmouth-Hitchcock Medical Center; University of South Alabama
• Investigators: Principal Investigator: Kathleen D Lyons, ScD, MGH Institute of Health Professions

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 21, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; rehabilitation; factorial experiment
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 2026P000285

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

This study is expected to generate qualitative and quantitative data from up to 352 people who have finished treatment for Stage 1-3 breast cancer within the past year). Qualitative data include answers to open-ended questions about the acceptability and utility of the intervention components. Qualitative data also include the treatment session documentation (e.g., topics of goals set, education delivered). Quantitative data include participant characteristics (e.g., age, gender, type of treatment, marital status) and answers to the survey outcome assessments of participation restrictions, adaptive coping, meaningful activity engagement, and self-efficacy.

All raw and scored quantitative data will be de-identified, preserved, and made publicly available for at least 7 years post-publication of findings. The qualitative data (which is harder to de-identify and may contain sensitive information that the disclosure of which could negatively affect participants) will not be shared.

• IPD Sharing Time Frame: The cleaned, final dataset will be entered into the Harvard Dataverse prior to the publication of the main outcomes. The dataset will be maintained there for at least seven years after the final publication from the study.for at least seven years post-publication of findings.
• IPD Sharing Access Criteria: There will be no restrictions regarding the access of the quantitative data. The de-identified quantitative dataset will be made freely available, without requiring a request for permission.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No