Optimizing Functional Recovery After Breast Cancer Treatment
Optimization of a Multicomponent Intervention to Foster Functional Recovery After Breast Cancer Treatment
1 other identifier
interventional
352
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2027
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2026
CompletedFirst Posted
Study publicly available on registry
March 23, 2026
CompletedStudy Start
First participant enrolled
January 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2030
Study Completion
Last participant's last visit for all outcomes
September 30, 2030
March 25, 2026
March 1, 2026
3.7 years
March 17, 2026
March 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Participation ability: Ability to Participate in Social Roles and Activities Short Form 8a
Baseline to 20 weeks
Valuing Questionnaire: Engagement in valued activities
Baseline to 20 weeks
Self-efficacy for health management: Self-Efficacy for Managing Chronic Disease Scale
Baseline to 20 weeks
Adaptive coping: Brief COPE subscales
Baseline to 20 weeks
Other Outcomes (1)
Acceptability of intervention components
8 weeks post-baseline
Study Arms (8)
Priority elicitation, education, and guided application
EXPERIMENTALWeekly 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
Priority elicitation and guided application
EXPERIMENTALWeekly 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
Priority elicitation and education
EXPERIMENTALWeekly telephone or videoconference sessions with a coach where participants will discuss survivorship information that is tailored to personal priorities
Priority elicitation
EXPERIMENTALTelephone 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
Education and guided application
EXPERIMENTALWeekly 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
Guided application
EXPERIMENTALWeekly 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
Education
EXPERIMENTALWeekly telephone or videoconference sessions with a coach where participants will discuss survivorship information from a static menu of six different topics
Information
EXPERIMENTALWeekly survivorship education will be emailed to participants, from a static menu of six different topics
Interventions
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.
This condition contains high levels of priority elicitation and guided application.
This condition contains how levels of the components of priority elicitation and education
This condition contains the high level of the priority elicitation component
This condition has high levels of the education and guided application components
This condition contains high level of the guided application component
This condition contains the high level of the education component
Eligibility Criteria
You may qualify if:
- Age of 18 years or older,
- 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,
- Experiencing reduced participation (i.e., a score of \> 10 on the Work and Social Adjustment Scale).
You may not qualify if:
- Non-English speaking.
- Non-correctable hearing loss.
- Moderate-severe cognitive impairment indicated by a score \< 3 on a 6-item cognitive screener.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MGH Institute of Health Professionslead
- University of Alabama at Birminghamcollaborator
- University of South Alabamacollaborator
- Dartmouth-Hitchcock Medical Centercollaborator
Study Sites (1)
MGH Institute of Health Professions
Boston, Massachusetts, 02129, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen D Lyons, ScD
MGH Institute of Health Professions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Data collectors and principal investigator will be blind to participant condition; participants will be instructed not to discuss their assignment with data collectors. Trials participants will know their intervention condition as will the coach involved in delivering the intervention.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 17, 2026
First Posted
March 23, 2026
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
September 30, 2030
Study Completion (Estimated)
September 30, 2030
Last Updated
March 25, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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.