- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04923997
The HealthScore Health Coaching Program (HealthScore)
Purpose: The HealthScore Health Coaching Program aims to deliver 6-months of 1:1 home-based health coaching to cancer patients receiving treatment and survivors of any diagnosis at UNC Cancer Hospital. This study hopes to preserve physical function, address unmet physical, nutritional, psychological, social and other needs.
Procedures: This will be done through individualized health coaching, weekly symptom survey administration, monthly supportive care questionnaires, and physical assessments at baseline, 3 months and 6 months.
Participants: All cancer patients with appointments at UNC Cancer Hospitals.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27519
- University of North Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients must have an appointment at a cancer center, including if they are an inpatient, if they are seen by a clinical service providing care to patients with cancer or sickle cell disease, and if they are > age 15. They can be receiving active treatment or in survivorship, with no restrictions based on time since the conclusion of active treatment. No exclusions will be made based on gender, ethnicity or race.
- Patient must be willing and able to participate in a 6-month intervention.
- Patients must be willing and able to provide patient-reported survey responses electronically or by telephone.
- Patients must have the ability to use a wearable sensor and view wearable sensor data at home.
- Patients must have a working email address and have the ability to check and respond to email.
- Participation in a research study is allowable by the patient's insurance provider
Exclusion Criteria:
- Patients who do not read and speak English, as program software has not been translated into other languages at this time.
- The patient has concurrent medical or psychiatric conditions that may preclude participation (i.e. moderate to severe dementia, uncontrolled schizophrenia, or other conditions that would render them unable to provide informed consent or complete questionnaires).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Health Coaching
All participants will be in the health coaching group.
Participants on study will receive a health coach for 6 months.
|
6 months of integrative health coaching, goal setting, survey administration and physical assessments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent Completion
Time Frame: 5 years
|
To provide health coaching services for cancer patients and survivors at UNC through the HealthScore Program, measured by calculating numbers of participants enrolled and completing the six-month HealthScore health coaching intervention each year.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Physical Function
Time Frame: 6 months
|
Change in PROMIS (Patient Reported Outcomes Measurement Information System) Physical Function 8b on a scale of 0-60.5.
Higher scores indicate better physical function.
|
6 months
|
|
Completed coaching phone calls
Time Frame: 6 months
|
Percentage of possible coaching phone calls completed
|
6 months
|
|
Survey Completion
Time Frame: 6 months
|
Percentage of possible patient-reported surveys completed
|
6 months
|
|
Wearable Sensor data
Time Frame: 6 months
|
Percentage of possible days using the wearable sensor with evaluable data
|
6 months
|
|
Unmet Needs
Time Frame: 6 months
|
Number of unmet needs addressed while participating in health coaching
|
6 months
|
|
Change in participant self-efficacy using the Lorgis Self-Efficacy Scale
Time Frame: 6 months
|
Magnitude of change in self-efficacy during program participation using the Lorgis Self-efficacy scale.
The score is the mean of six items, scored 0-10.
Higher scores are better.
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: William A Wood, MD, MPH, UNC Lineberger Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- LCCC 1948
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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