Health Coaching-Based Navigation at the Conclusion of Treatment for the Support of Black Breast Cancer Survivors

Not Applicable

Completed

• Conditions: Prognostic Stage IB Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8
• Interventions: Behavioral: Patient Navigation; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT05674578
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

This clinical trial evaluates the feasibility of coaching-based navigation for black breast cancer survivors including recruitment, dropout, and survey completion rates. A coaching-based navigation may perform a needs assessment and coach the participant to access relevant supportive content including physical rehabilitation, emotional and psychosocial support, and nutrition and exercise programming. This trial aims to see whether this navigation program may improve the quality of life of black breast cancer survivors.

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate the feasibility of coaching-based navigation for black breast cancer survivors including recruitment, dropout, and survey completion rates.

SECONDARY OBJECTIVES:

I. To evaluate the preliminary impact of health coaching on completion of scheduled survivorship related referrals and participation in support services.

II. To determine the preliminary impact on quality of life and self-efficacy pre and post coaching.

OUTLINE:

Patients are assigned a Black patient navigator for racial concordance and receive coaching from patient navigator over 30 minutes every other week for 3 months and then monthly for 3 months.

Study Timeline

• Study Start: 2022-11-14
• Study First Submitted: 2022-12-21
• Study First Submitted QC: 2022-12-21
• Study First Posted: 2023-01-06
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

Inclusion Criteria

• Black women > 18 years of age with stage I-III primary breast cancer who have completed definitive breast cancer treatment

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Health services research (patient navigator)	Questionnaire Administration	Patients are assigned a Black patient navigator for racial concordance and receive coaching from patient navigator over 30 minutes every other week for 3 months and then monthly for 3 months.
Health services research (patient navigator)	Quality-of-Life Assessment	Patients are assigned a Black patient navigator for racial concordance and receive coaching from patient navigator over 30 minutes every other week for 3 months and then monthly for 3 months.
Health services research (patient navigator)	Patient Navigation	Patients are assigned a Black patient navigator for racial concordance and receive coaching from patient navigator over 30 minutes every other week for 3 months and then monthly for 3 months.

Primary Outcome Measures

Name	Time	Method
Dropout rate	Up to 6 months	Will be calculated as the percentage of women who are enrolled in the study but withdraw before the conclusion of the study.
Patient-Reported Outcomes Measurement Information System score	Up to 6 months	Differences in scoring at the start of the study period and at the end of the trial will also be summarized by mean, standard deviation, and range.
Recruitment rate	Up to 6 months	Will be calculated as the number of new eligible women per month.
Consent rate	Up to 6 months	Will be calculated as the number of consented women (set to 40 for this study) divided by the total number of women approached.
European Organization for Research and Treatment of Cancer Quality of Life-30 score	Up to 6 months	Differences in scoring at the start of the study period and at the end of the trial will also be summarized by mean, standard deviation, and range.
Breast Cancer Self Efficacy Scale score	Up to 6 months	A self reported, unidimensional, 11 item scale designed to show the differences in scoring at the start of the study period and at the end of the trial will also be summarized by mean, standard deviation, and range.

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States