Breast Cancer Survivor Educational Intervention

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Breast Neoplasms; Breast Carcinoma; Breast Cancer Female
• Intervention / Treatment: Behavioral: Breast Cancer Survivor Education Program

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Massachusetts General Hospital Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Pfizer; American Cancer Society, Inc.
• 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 record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: January 17, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Breast Cancer; Breast Carcinoma; Breast Neoplasms; Breast cancer survivor; Breast Cancer Female
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 22-509

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No