Health Coaching-Based Navigation at the Conclusion of Treatment for the Support of Black Breast Cancer Survivors
Study Details
Study Description
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:
- To evaluate the feasibility of coaching-based navigation for black breast cancer survivors including recruitment, dropout, and survey completion rates.
SECONDARY OBJECTIVES:
-
To evaluate the preliminary impact of health coaching on completion of scheduled survivorship related referrals and participation in support services.
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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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Health services research (patient navigator) 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. |
Behavioral: Patient Navigation
Assigned a patient navigator and receive coaching
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Black women > 18 years of age with stage I-III primary breast cancer who have completed definitive breast cancer treatment
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210 |
Sponsors and Collaborators
- Ohio State University Comprehensive Cancer Center
Investigators
- Principal Investigator: Bridget A Oppong, MD, Ohio State University Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- OSU-21185
- NCI-2021-08425