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Breast Cancer Survivor Educational Intervention

Primary Purpose

Breast Cancer, Breast Neoplasms, Breast Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breast Cancer Survivor Education Program
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer, Breast Neoplasms, Breast Carcinoma, Breast Cancer Female, Breast cancer survivor

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Breast Cancer Survivor Education Program

Arm Description

Participants will complete study procedures as outlined: - 6 weekly sessions of a modified version of the PAVING the Path to Wellness education program.

Outcomes

Primary Outcome Measures

Recruitment Retention Rate
Defined as the number of recruited participants who initiate intervention program.
Time Required to Recruit to Target
Defined as the amount of time to target accrual goal.
Proportion of Eligible Participants
Defined as the number of eligible participants required to recruit required sample size.
Rate of Intervention Completion
Defined as the number of participants who attend at least 5 of 6 sessions.
Success Rate of Educational Intervention
Proportion of participants "very satisfied" or "completely satisfied" with intervention. Defined successful if true of 80% of participants.
Data collection feasibility
Proportion of participants completing evaluation surveys each at baseline and week 6.

Secondary Outcome Measures

Self-Efficacy for symptom self-management
Self-Efficacy for symptom self-management will be assessed using Symptom-Management Self-Efficacy Scale-Breast Cancer
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
Physical Activity Goal Change
Physical Activity Goal Change will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey
Dietary Behavior Goal Change
Dietary Behavior Goal Change will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey
Unmet information Needs
Unmet information Needs will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey

Full Information

First Posted
January 17, 2023
Last Updated
September 22, 2023
Sponsor
Massachusetts General Hospital
Collaborators
American Cancer Society, Inc., Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05700396
Brief Title
Breast Cancer Survivor Educational Intervention
Official Title
Increasing Receipt of Guideline Concordant Survivorship Care Among Black Breast Cancer Survivors Through Patient Education
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
American Cancer Society, Inc., Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Neoplasms, Breast Carcinoma, Breast Cancer Female
Keywords
Breast Cancer, Breast Neoplasms, Breast Carcinoma, Breast Cancer Female, Breast cancer survivor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breast Cancer Survivor Education Program
Arm Type
Experimental
Arm Description
Participants will complete study procedures as outlined: - 6 weekly sessions of a modified version of the PAVING the Path to Wellness education program.
Intervention Type
Behavioral
Intervention Name(s)
Breast Cancer Survivor Education Program
Intervention Description
Weekly sessions via Zoom platform with study staff.
Primary Outcome Measure Information:
Title
Recruitment Retention Rate
Description
Defined as the number of recruited participants who initiate intervention program.
Time Frame
6 weeks
Title
Time Required to Recruit to Target
Description
Defined as the amount of time to target accrual goal.
Time Frame
6 weeks
Title
Proportion of Eligible Participants
Description
Defined as the number of eligible participants required to recruit required sample size.
Time Frame
6 weeks
Title
Rate of Intervention Completion
Description
Defined as the number of participants who attend at least 5 of 6 sessions.
Time Frame
6 weeks
Title
Success Rate of Educational Intervention
Description
Proportion of participants "very satisfied" or "completely satisfied" with intervention. Defined successful if true of 80% of participants.
Time Frame
6 weeks
Title
Data collection feasibility
Description
Proportion of participants completing evaluation surveys each at baseline and week 6.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Self-Efficacy for symptom self-management
Description
Self-Efficacy for symptom self-management will be assessed using Symptom-Management Self-Efficacy Scale-Breast Cancer
Time Frame
6 weeks
Title
Intention to Receive post-treatment Surveillance Mammography
Description
Intention to Receive post-treatment Surveillance Mammography will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey
Time Frame
6 weeks
Title
Physical Activity Goal Change
Description
Physical Activity Goal Change will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey
Time Frame
6 weeks
Title
Dietary Behavior Goal Change
Description
Dietary Behavior Goal Change will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey
Time Frame
6 weeks
Title
Unmet information Needs
Description
Unmet information Needs will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey
Time Frame
6 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erica Warner, MPH, ScD
Phone
617-724-9516
Email
ewarner@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Audra Hite
Email
mghbcss@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erica Warner, MPH, ScD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amy Comander, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Naomi Ko, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erica Warner, MPH, ScD
Phone
617-724-9516
Email
ewarner@mgh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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Breast Cancer Survivor Educational Intervention

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