Breast Cancer Clinical Trial
Official title:
Increasing Receipt of Guideline Concordant Survivorship Care Among Black Breast Cancer Survivors Through Patient Education
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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 22 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital Cancer Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | American Cancer Society, Inc., Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment Retention Rate | Defined as the number of recruited participants who initiate intervention program. | 6 weeks | |
Primary | Time Required to Recruit to Target | Defined as the amount of time to target accrual goal. | 6 weeks | |
Primary | Proportion of Eligible Participants | Defined as the number of eligible participants required to recruit required sample size. | 6 weeks | |
Primary | Rate of Intervention Completion | Defined as the number of participants who attend at least 5 of 6 sessions. | 6 weeks | |
Primary | Success Rate of Educational Intervention | Proportion of participants "very satisfied" or "completely satisfied" with intervention. Defined successful if true of 80% of participants. | 6 weeks | |
Primary | Data collection feasibility | Proportion of participants completing evaluation surveys each at baseline and week 6. | 6 weeks | |
Secondary | Self-Efficacy for symptom self-management | Self-Efficacy for symptom self-management will be assessed using Symptom-Management Self-Efficacy Scale-Breast Cancer | 6 weeks | |
Secondary | Intention to Receive post-treatment Surveillance Mammography | Intention to Receive post-treatment Surveillance Mammography will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey | 6 weeks | |
Secondary | Physical Activity Goal Change | Physical Activity Goal Change will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey | 6 weeks | |
Secondary | Dietary Behavior Goal Change | Dietary Behavior Goal Change will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey | 6 weeks | |
Secondary | Unmet information Needs | Unmet information Needs will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey | 6 weeks |
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