Clinical trial NCT04923997: The HealthScore Health Coaching Program
Official title: The HealthScore Health Coaching Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Survivorship
Quality of Life
Health Behavior
Keywords: Health Coaching
Wellness
Integrative
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 140
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Percent Completion
timeFrame: 5 years
Secondary outcomes:
measure: Change in Physical Function
timeFrame: 6 months
measure: Completed coaching phone calls
timeFrame: 6 months
measure: Survey Completion
timeFrame: 6 months
measure: Wearable Sensor data
timeFrame: 6 months
measure: Unmet Needs
timeFrame: 6 months
measure: Change in participant self-efficacy using the Lorgis Self-Efficacy Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: William A Wood, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: