Anatomic Stage I Breast Cancer AJCC v8NCT05674578
Health Coaching-Based Navigation at the Conclusion of Treatment for the Support of Black Breast Cancer Survivors
A study testing Patient Navigation, Quality-of-Life Assessment and Questionnaire Administration in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
- What is being tested?
- Patient Navigation, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2022to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Black women > 18 years of age with stage I-III primary breast cancer who have completed definitive breast cancer treatment
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Supporting Black Breast Cancer Survivors: Feasibility Trial of Health Coaching-Based Navigation at the Conclusion of Treatment
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.
Read the 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.
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.
- Conditions
- 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
- Being tested
- Patient Navigation, Quality-of-Life Assessment, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NavigationBehavioural
Also called Patient Navigator Program
Assigned a patient navigator and receive coaching
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Patient Navigation; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Will be calculated as the number of new eligible women per month.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start14 Nov 2022
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bridget Oppong, Ohio State University Comprehensive Cancer Center
- Investigators
- Bridget A Oppong, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674578
- Sponsor's protocol ID
- OSU-21185
- Other IDs
- NCI-2021-08425
- Status last verified
- Mar 2025
- First submitted
- 21 Dec 2022
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Black Breast Cancer Survivors: Feasibility Trial of Health Coaching-Based Navigation at the Conclusion of Treatment
- ClinicalTrials.gov ID
- NCT05674578
- Acronym / sponsor ID
- OSU-21185
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 6 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health services research (patient navigator) | Experimental | Behavioral: Patient Navigation, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Black women > 18 years of age with stage I-III primary breast cancer who have completed definitive breast cancer treatment
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient NavigationAlso: Patient Navigator ProgramAssigned a patient navigator and receive coaching | Behavioural | Health services research (patient navigator) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Health services research (patient navigator) |
| Questionnaire AdministrationAncillary studies | Other | Health services research (patient navigator) |
Primary outcome
Recruitment rate
Time frame: Up to 6 months
Will be calculated as the number of new eligible women per month.
Consent rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bridget A Oppong, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigation, Quality-of-Life Assessment and Questionnaire Administration in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Up to 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.