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Breast Cancer Survivor Educational Intervention

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05700396
Enrollment
7
Registered
2023-01-26
Start date
2023-02-28
Completion date
2023-12-31
Last updated
2025-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Breast Cancer Female, Breast Carcinoma, Breast Neoplasms

Keywords

Breast Cancer, Breast Neoplasms, Breast Carcinoma, Breast Cancer Female, Breast cancer survivor

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.

Interventions

BEHAVIORALBreast Cancer Survivor Education Program

Weekly sessions via Zoom platform with study staff.

Sponsors

American Cancer Society, Inc.
CollaboratorOTHER
Pfizer
CollaboratorINDUSTRY
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
22 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Data collection feasibility6 weeksProportion of participants completing evaluation surveys each at baseline and week 6.
Recruitment Retention Rate6 weeksDefined as the number of recruited participants who initiate intervention program.
Time Required to Recruit to Target6 weeksDefined as the amount of time to target accrual goal.
Proportion of Eligible Participants6 weeksDefined as the number of eligible participants required to recruit required sample size.
Rate of Intervention Completion6 weeksDefined as the number of participants who attend at least 5 of 6 sessions.
Success Rate of Educational Intervention6 weeksProportion of participants very satisfied or completely satisfied with intervention. Defined successful if true of 80% of participants.

Secondary

MeasureTime frameDescription
Intention to Receive post-treatment Surveillance Mammography6 weeksIntention 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 Change6 weeksPhysical Activity Goal Change will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey
Dietary Behavior Goal Change6 weeksDietary Behavior Goal Change will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey
Unmet information Needs6 weeksUnmet information Needs will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey
Self-Efficacy for symptom self-management6 weeksSelf-Efficacy for symptom self-management will be assessed using Symptom-Management Self-Efficacy Scale-Breast Cancer

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026