Breast Cancer Survivor Educational Intervention

Study Overview
=================
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.

Official Title
-----------------
Increasing Receipt of Guideline Concordant Survivorship Care Among Black Breast Cancer Survivors Through Patient Education

Conditions
-----------------
Breast Cancer, Breast Neoplasms, Breast Carcinoma, Breast Cancer Female

Intervention / Treatment
-----------------
* Behavioral: Breast Cancer Survivor Education Program


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breast Cancer Survivor Education Program<br>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<br>* Weekly sessions via Zoom platform with study staff.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Breast Neoplasms, Breast Carcinoma, Breast Cancer Female, Breast cancer survivor