Clinical trial NCT05674578: Health Coaching-Based Navigation at the Conclusion of Treatment for the Support of Black Breast Cancer Survivors
Official title: Supporting Black Breast Cancer Survivors: Feasibility Trial of Health Coaching-Based Navigation at the Conclusion of Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage IA Breast Cancer AJCC v8
Anatomic Stage IB Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Anatomic Stage IIIB Breast Cancer AJCC v8
Anatomic Stage IIIC Breast Cancer AJCC v8
Prognostic Stage I Breast Cancer AJCC v8
Prognostic Stage IA Breast Cancer AJCC v8
Prognostic Stage IB Breast Cancer AJCC v8
Prognostic Stage II Breast Cancer AJCC v8
Prognostic Stage IIA Breast Cancer AJCC v8
Prognostic Stage IIB Breast Cancer AJCC v8
Prognostic Stage III Breast Cancer AJCC v8
Prognostic Stage IIIA Breast Cancer AJCC v8
Prognostic Stage IIIB Breast Cancer AJCC v8
Prognostic Stage IIIC Breast Cancer AJCC v8
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Recruitment rate
timeFrame: Up to 6 months
measure: Consent rate
timeFrame: Up to 6 months
measure: Dropout rate
timeFrame: Up to 6 months
measure: Patient-Reported Outcomes Measurement Information System score
timeFrame: Up to 6 months
measure: European Organization for Research and Treatment of Cancer Quality of Life-30 score
timeFrame: Up to 6 months
measure: Breast Cancer Self Efficacy Scale score
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Bridget A Oppong, MD
role: PRINCIPAL_INVESTIGATOR
References: