NCT05674578

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 21, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

1.6 years

First QC Date

December 21, 2022

Last Update Submit

March 20, 2025

Conditions

Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Prognostic Stage I Breast Cancer AJCC v8Prognostic Stage IA Breast Cancer AJCC v8Prognostic Stage IB Breast Cancer AJCC v8Prognostic Stage II Breast Cancer AJCC v8Prognostic Stage IIA Breast Cancer AJCC v8Prognostic Stage IIB Breast Cancer AJCC v8Prognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8

Outcome Measures

Primary Outcomes (6)

  • Recruitment rate

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

    Up to 6 months

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

Health services research (patient navigator)

EXPERIMENTAL

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 NavigationOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Patient NavigationBEHAVIORAL

Assigned a patient navigator and receive coaching

Also known as: Patient Navigator Program
Health services research (patient navigator)
Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment
Health services research (patient navigator)
Questionnaire AdministrationOTHER

Ancillary studies

Health services research (patient navigator)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Interventions

Patient Navigation

Intervention Hierarchy (Ancestors)

Patient-Centered CarePrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Bridget A Oppong, MD

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 6, 2023

Study Start

November 14, 2022

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

March 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)