Educational Interventions for Recovery After Breast Cancer Treatment

Overseen By Sheel Singh, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MGH Institute of Health Professions

Disqualifiers: Non-English, Hearing loss, Cognitive impairment, Severe mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Kathleen D Lyons, ScD

Principal Investigator

MGH Institute of Health Professions

Are You a Good Fit for This Trial?

Inclusion Criteria

Experiencing reduced participation (i.e., a score of > 10 on the Work and Social Adjustment Scale)

I have Stage 1-3 breast cancer and finished treatment within the past year with no recurrence.

I am 18 years old or older.

Exclusion Criteria

I have hearing loss that cannot be corrected.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Optimization Phase

Participants receive one of 8 combinations of intervention components to promote activity participation

20 weeks

Weekly telephone or videoconference sessions

Follow-up

Participants are monitored for satisfaction and ability to participate in social roles and activities

8 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Individually tailored education, Priority elicitation, Guided application

How Is the Trial Designed?

Group I: Priority elicitation, education, and guided application Experimental Treatment 1 Intervention

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

Group II: Priority elicitation and guided application Experimental Treatment 1 Intervention

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

Group III: Priority elicitation and education Experimental Treatment 1 Intervention

Weekly telephone or videoconference sessions with a coach where participants will discuss survivorship information that is tailored to personal priorities

Group IV: Priority elicitation Experimental Treatment 1 Intervention

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

Group V: Information Experimental Treatment 1 Intervention

Weekly survivorship education will be emailed to participants, from a static menu of six different topics

Group VI: Guided application Experimental Treatment 1 Intervention

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

Group VII: Education and guided application Experimental Treatment 1 Intervention

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

Group VIII: Education Experimental Treatment 1 Intervention

Weekly telephone or videoconference sessions with a coach where participants will discuss survivorship information from a static menu of six different topics

Who Is Running the Clinical Trial?

MGH Institute of Health Professions

Lead Sponsor

Trials

19

Recruited

2,200+

University of South Alabama

Collaborator

Trials

44

Recruited

15,800+

Dartmouth-Hitchcock Medical Center

Collaborator

Trials

548

Recruited

2,545,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+