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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
| Pfizer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Cancer Survivor Education Program | Experimental | Participants will complete study procedures as outlined: - 6 weekly sessions of a modified version of the PAVING the Path to Wellness education program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast Cancer Survivor Education Program | Behavioral | Weekly sessions via Zoom platform with study staff. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Retention Rate | Defined as the number of recruited participants who initiate intervention program. | 6 weeks |
| Time Required to Recruit to Target | Defined as the amount of time to target accrual goal. | 6 weeks |
| Proportion of Eligible Participants | Defined as the number of eligible participants required to recruit required sample size. | 6 weeks |
| Rate of Intervention Completion | Defined as the number of participants who attend at least 5 of 6 sessions. | 6 weeks |
| 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 |
| Data collection feasibility | Proportion of participants completing evaluation surveys each at baseline and week 6. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Intention to Receive post-treatment Surveillance Mammography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erica Warner, MPH, ScD | Massachusetts General Hospital | Principal Investigator |
| Amy Comander, MD | Massachusetts General Hospital | Study Director |
| Naomi Ko, MD | Boston Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02215 | United States |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Partners Innovations team at http://www.partners.org/innovation
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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 |
| 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 |
| 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 |
| Unmet information Needs | Unmet information Needs will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey | 6 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |