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NCT05674578 Clinical Trial

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

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

Official title:
Supporting Black Breast Cancer Survivors: Feasibility Trial of Health Coaching-Based Navigation at the Conclusion of Treatment

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05674578
Other study ID # OSU-21185
Secondary ID NCI-2021-08425
Status Recruiting
Phase N/A
First received
Last updated
Start date November 14, 2022
Est. completion date December 31, 2024

Study information
Verified date March 2024
Source Ohio State University Comprehensive Cancer Center
Contact The Ohio State Comprehensive Cancer Center
Phone 800-293-5066
Email OSUCCCClinicaltrials@osumc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Black women > 18 years of age with stage I-III primary breast cancer who have completed definitive breast cancer treatment

Study Design

Related Conditions & MeSH terms

  • 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
  • Breast Neoplasms
  • 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

Intervention

Behavioral:
• Patient Navigation
Assigned a patient navigator and receive coaching
Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations
Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recruitment rate Will be calculated as the number of new eligible women per month. Up to 6 months
Primary Consent rate Will be calculated as the number of consented women (set to 40 for this study) divided by the total number of women approached. Up to 6 months
Primary Dropout rate Will be calculated as the percentage of women who are enrolled in the study but withdraw before the conclusion of the study. Up to 6 months
Primary Patient-Reported Outcomes Measurement Information System score 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. Up to 6 months
Primary European Organization for Research and Treatment of Cancer Quality of Life-30 score 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. Up to 6 months
Primary Breast Cancer Self Efficacy Scale score 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. Up to 6 months
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