Breast Cancer Survivor Educational Intervention

Not Applicable

Completed

• Conditions: Breast Neoplasms; Breast Carcinoma; Breast Cancer Female; Breast Cancer
• Interventions: Behavioral: Breast Cancer Survivor Education Program

• Registration Number: NCT05700396
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The goal of this study is to test a 6-week virtual education program among Black breast cancer survivors. The virtual program includes sessions on physical activity, goal setting, nutrition, sleep, stress, and social connections.

Detailed Description

This six-week feasibility study will evaluate a virtual support and education program among up to 15 Black female breast cancer survivors. Participants will be asked to attend a 90 minute group session once a week for 6 weeks and complete surveys pre and post intervention surveys to ascertain study endpoints. This study is supported by funding from Pfizer and in-kind support from the American Cancer Society, Inc.

Study Timeline

• Study First Submitted: 2023-01-17
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-26
• Study Start: 2023-02-28
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

Inclusion Criteria

• Female
• Self-identified Black or African American race
• Age 22-79
• Diagnosis of Stage I, II, or III invasive breast cancer
• Completed active treatment at least 6 months ago, but within the past five years
• Speaks English

Exclusion Criteria

• Undergoing active treatment (i.e., surgery, chemotherapy, radiation)
• Undergoing evaluation for suspected recurrence

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Breast Cancer Survivor Education Program	Breast Cancer Survivor Education Program	Participants will complete study procedures as outlined: - 6 weekly sessions of a modified version of the PAVING the Path to Wellness education program.

Primary Outcome Measures

Name	Time	Method
Proportion of Eligible Participants	6 weeks	Defined as the number of eligible participants required to recruit required sample size.
Data collection feasibility	6 weeks	Proportion of participants completing evaluation surveys each at baseline and week 6.
Success Rate of Educational Intervention	6 weeks	Proportion of participants "very satisfied" or "completely satisfied" with intervention. Defined successful if true of 80% of participants.
Rate of Intervention Completion	6 weeks	Defined as the number of participants who attend at least 5 of 6 sessions.
Recruitment Retention Rate	6 weeks	Defined as the number of recruited participants who initiate intervention program.
Time Required to Recruit to Target	6 weeks	Defined as the amount of time to target accrual goal.

Secondary Outcome Measures

Name	Time	Method
Self-Efficacy for symptom self-management	6 weeks	Self-Efficacy for symptom self-management will be assessed using Symptom-Management Self-Efficacy Scale-Breast Cancer
Unmet information Needs	6 weeks	Unmet information Needs will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey
Intention to Receive post-treatment Surveillance Mammography	6 weeks	Intention to Receive post-treatment Surveillance Mammography will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey
Physical Activity Goal Change	6 weeks	Physical Activity Goal Change will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey
Dietary Behavior Goal Change	6 weeks	Dietary Behavior Goal Change will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey

Trial Locations

Locations (1)

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States