NCT05700396

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

February 28, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

10 months

First QC Date

January 17, 2023

Last Update Submit

March 26, 2025

Conditions

Breast CancerBreast NeoplasmsBreast CarcinomaBreast Cancer Female

Keywords

Breast CancerBreast NeoplasmsBreast CarcinomaBreast Cancer FemaleBreast cancer survivor

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (5)

  • Self-Efficacy for symptom self-management

    6 weeks

  • Intention to Receive post-treatment Surveillance Mammography

    6 weeks

  • Physical Activity Goal Change

    6 weeks

  • Dietary Behavior Goal Change

    6 weeks

  • Unmet information Needs

    6 weeks

Study Arms (1)

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.

Behavioral: Breast Cancer Survivor Education Program

Interventions

Breast Cancer Survivor Education ProgramBEHAVIORAL

Weekly sessions via Zoom platform with study staff.

Breast Cancer Survivor Education Program

Eligibility Criteria

Age22 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Undergoing active treatment (i.e., surgery, chemotherapy, radiation)
  • Undergoing evaluation for suspected recurrence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 17, 2023

First Posted

January 26, 2023

Study Start

February 28, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

April 1, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data can be shared no earlier than 1 year following the date of publication
Access Criteria
Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US(1)