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Trial Title:
Health Coaching-Based Navigation at the Conclusion of Treatment for the Support of Black Breast Cancer Survivors
NCT ID:
NCT05674578
Condition:
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
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Patient Navigation
Description:
Assigned a patient navigator and receive coaching
Arm group label:
Health services research (patient navigator)
Other name:
Patient Navigator Program
Intervention type:
Other
Intervention name:
Quality-of-Life Assessment
Description:
Ancillary studies
Arm group label:
Health services research (patient navigator)
Other name:
Quality of Life Assessment
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Health services research (patient navigator)
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Black women > 18 years of age with stage I-III primary breast cancer who have
completed definitive breast cancer treatment
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bridget A. Oppong, MD
Phone:
614-293-6408
Email:
bridget.oppong@osumc.edu
Investigator:
Last name:
Bridget A. Oppong, MD
Email:
Principal Investigator
Start date:
November 14, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Ohio State University Comprehensive Cancer Center
Agency class:
Other
Source:
Ohio State University Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05674578
http://cancer.osu.edu
