The HealthScore Health Coaching Program

Cancer Clinical Trial

— HealthScore  

Official title:

The HealthScore Health Coaching Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04923997
• Other study ID #: LCCC 1948
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2020
• Est. completion date: April 1, 2030

Study information

• Verified date: March 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: Brianna Castrogivanni, MS
• Phone: 919-843-7843
• Email: brianna_castrogivanni[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 1, 2030
• Est. primary completion date: April 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cancer
• Health Behavior
• Quality of Life
• Survivorship

Intervention

Behavioral:
• Health Coaching
6 months of integrative health coaching, goal setting, survey administration and physical assessments.

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Completion	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	Change in Physical Function	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
Secondary	Completed coaching phone calls	Percentage of possible coaching phone calls completed	6 months
Secondary	Survey Completion	Percentage of possible patient-reported surveys completed	6 months
Secondary	Wearable Sensor data	Percentage of possible days using the wearable sensor with evaluable data	6 months
Secondary	Unmet Needs	Number of unmet needs addressed while participating in health coaching	6 months
Secondary	Change in participant self-efficacy using the Lorgis Self-Efficacy Scale	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