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

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05674578
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
13.5
Anticipated Duration (Months)
3
Patients Per Site Per Month

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Patient Navigation
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
 N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. To evaluate the feasibility of coaching-based navigation for black breast cancer survivors including recruitment, dropout, and survey completion rates.
SECONDARY OBJECTIVES:

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

  2. 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

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Supporting Black Breast Cancer Survivors: Feasibility Trial of Health Coaching-Based Navigation at the Conclusion of Treatment
Actual Study Start Date :
Nov 14, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

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:
  • Patient Navigator Program

    • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Recruitment rate [Up to 6 months]

      Will be calculated as the number of new eligible women per month.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. 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

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.
    Responsible Party:
    Bridget Oppong, Principal Investigator, Ohio State University Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05674578
    Other Study ID Numbers:
    • OSU-21185
    • NCI-2021-08425
    First Posted:
    Jan 6, 2023
    Last Update Posted:
    Jan 6, 2023
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Jan 6, 2023