Breast Cancer Survivor Educational Intervention

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05700396
• Other study ID #: 22-509
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: Massachusetts General Hospital
• Contact: Erica Warner, MPH, ScD
• Phone: 617-724-9516
• Email: ewarner[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Female
• Breast Carcinoma
• Breast Neoplasms

Intervention

Behavioral:
• Breast Cancer Survivor Education Program
Weekly sessions via Zoom platform with study staff.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	American Cancer Society, Inc., Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Retention Rate	Defined as the number of recruited participants who initiate intervention program.	6 weeks
Primary	Time Required to Recruit to Target	Defined as the amount of time to target accrual goal.	6 weeks
Primary	Proportion of Eligible Participants	Defined as the number of eligible participants required to recruit required sample size.	6 weeks
Primary	Rate of Intervention Completion	Defined as the number of participants who attend at least 5 of 6 sessions.	6 weeks
Primary	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
Primary	Data collection feasibility	Proportion of participants completing evaluation surveys each at baseline and week 6.	6 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Unmet information Needs	Unmet information Needs will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey	6 weeks