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

Completed

Intervention / Treatment

Detailed Description

Evaluation and monitoring are used sporadically in routine cancer care, and cancer coaching programs are rare. The potential for these approaches to improve quality of life and clinical outcomes in cancer patients is significant. The HealthScore Health Coaching Program is designed as a way to routinely combine evaluation, monitoring and coaching within a single framework as a six-month intervention for cancer patients or survivors. The primary rationale for the Program is that improvements in physical function, unmet needs identification, and self-efficacy are likely to lead to better patient-centered and overall outcomes for patients and survivors. A secondary rationale is that the framework of the Program and data obtained as part of the Program will facilitate additional quality improvement and research activities to refine the application of evaluation, monitoring and coaching techniques in cancer care. As reimbursement and care delivery in oncology transition to a focus on value and population-based management, the HealthScore Health Coaching Program may provide a model for application to cancer care within and outside UNC. The primary purpose of this study is to provide 6-months of 1:1 home-based health coaching for cancer patients and survivors will improve physical function and address unmet physical, nutritional, psychological, social and other needs which will increase patient and survivor self-efficacy for medical engagement, reduce morbidity, health care utilization, and encourage health lifestyle behaviors.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Chapel Hill, North Carolina, United States, 27519
        • University of North Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: William A Wood, MD, MPH, UNC Lineberger Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2020

Primary Completion (Actual)

May 11, 2025

Study Completion (Actual)

May 11, 2025

Study Registration Dates

First Submitted

June 7, 2021

First Submitted That Met QC Criteria

June 7, 2021

First Posted (Actual)

June 11, 2021

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

June 3, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • LCCC 1948

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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