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OpenTrials
Completed

NCT Number: NCT04923997

The HealthScore Health Coaching Program

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.

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Health Coaching

Behavioral

6 months of integrative health coaching, goal setting, survey administration and physical assessments.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Completed coaching phone calls

    Time frame: 6 months

    Percentage of possible coaching phone calls completed

  3. Survey Completion

    Time frame: 6 months

    Percentage of possible patient-reported surveys completed

  4. Wearable Sensor data

    Time frame: 6 months

    Percentage of possible days using the wearable sensor with evaluable data

  5. Unmet Needs

    Time frame: 6 months

    Number of unmet needs addressed while participating in health coaching

  6. 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.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Acronym: HealthScore

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jun 11, 2021
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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