Breast Cancer Survivor Educational Intervention

NCT ID: NCT05700396

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-28

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer Breast Neoplasms Breast Carcinoma Breast Cancer Female

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Breast Cancer Survivor Education Program

Intervention Type BEHAVIORAL

Weekly sessions via Zoom platform with study staff.

Interventions

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Breast Cancer Survivor Education Program

Weekly sessions via Zoom platform with study staff.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Erica T. Warner, ScD MPH

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erica Warner, MPH, ScD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Amy Comander, MD

Role: STUDY_DIRECTOR

Massachusetts General Hospital

Naomi Ko, MD

Role: STUDY_DIRECTOR

Boston Medical Center

Locations

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Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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22-509

Identifier Type: -

Identifier Source: org_study_id

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