Breast Cancer Survivor Educational Intervention
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Behavioral: Breast Cancer Survivor Education Program
Weekly sessions via Zoom platform with study staff.
|
Outcome Measures
Primary Outcome Measures
- 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.
- Proportion of Eligible Participants [6 weeks]
Defined as the number of eligible participants required to recruit required sample size.
- Rate of Intervention Completion [6 weeks]
Defined as the number of participants who attend at least 5 of 6 sessions.
- 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.
- Data collection feasibility [6 weeks]
Proportion of participants completing evaluation surveys each at baseline and week 6.
Secondary Outcome Measures
- 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
- 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
- Unmet information Needs [6 weeks]
Unmet information Needs will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Female
-
Self-identified Black or African American race
-
Age 22-79
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Diagnosis of Stage I, II, or III invasive breast cancer
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Completed active treatment at least 6 months ago, but within the past five years
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Speaks English
Exclusion Criteria:
-
Undergoing active treatment (i.e., surgery, chemotherapy, radiation)
-
Undergoing evaluation for suspected recurrence
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital Cancer Center | Boston | Massachusetts | United States | 02215 |
Sponsors and Collaborators
- Massachusetts General Hospital
- American Cancer Society, Inc.
- Pfizer
Investigators
- Principal Investigator: Erica Warner, MPH, ScD, Massachusetts General Hospital
- Study Director: Amy Comander, MD, Massachusetts General Hospital
- Study Director: Naomi Ko, MD, Boston Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-509