Optimizing Functional Recovery After Breast Cancer Treatment

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
MGH Institute of Health Professions
Study ID
NCT07489053
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Individually tailored education and guided application to promote activity participation — BEHAVIORAL
    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.
  • Individually tailored guided application — BEHAVIORAL
    This condition contains high levels of priority elicitation and guided application.
  • Individually tailored education — BEHAVIORAL
    This condition contains how levels of the components of priority elicitation and education
  • Priority elicitation — BEHAVIORAL
    This condition contains the high level of the priority elicitation component
  • Static education and guided application — BEHAVIORAL
    This condition has high levels of the education and guided application components
  • Static guided application — BEHAVIORAL
    This condition contains high level of the guided application component
  • Static education — BEHAVIORAL
    This condition contains the high level of the education component
  • Information — BEHAVIORAL
    This condition contains the low levels of the three components

Study Details

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.

Key Dates

Start date
Jan 1, 2027
Status verified
Mar 2026
Primary completion
Sep 30, 2030
Completion
Sep 30, 2030

Study Design

Enrollment
352 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Experimental: Education
    Weekly telephone or videoconference sessions with a coach where participants will discuss survivorship information from a static menu of six different topics
  • Experimental: Information
    Weekly survivorship education will be emailed to participants, from a static menu of six different topics

Primary Outcome Measure

Participation satisfaction: PROMIS Satisfaction with Social Roles and Activities Short Form 8a [ Time Frame: Baseline to week 20 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MGH Institute of Health ProfessionsBostonMassachusetts02129
Sheel Singh, MA
[email protected]
617-724-9835
Kathleen Lyons, ScD
[email protected]
617-643-5372
Kathleen Lyons, ScD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
MGH Institute of Health Professions· Boston, MA

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