NCT04923997

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2021

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2025

Completed
Last Updated

June 4, 2025

Status Verified

June 1, 2025

Enrollment Period

5 years

First QC Date

June 7, 2021

Last Update Submit

June 3, 2025

Conditions

CancerSurvivorshipQuality of LifeHealth Behavior

Keywords

Health CoachingWellnessIntegrative

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in Physical Function

    6 months

  • Completed coaching phone calls

    6 months

  • Survey Completion

    6 months

  • Wearable Sensor data

    6 months

  • Unmet Needs

    6 months

  • +1 more secondary outcomes

Study Arms (1)

Health Coaching

EXPERIMENTAL

All participants will be in the health coaching group. Participants on study will receive a health coach for 6 months.

Behavioral: Health Coaching

Interventions

Health CoachingBEHAVIORAL

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

Health Coaching

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27519, United States

Location

Related Publications (2)

  • Khairat S, Kent EE, Geracitano J, Mendis K, Zhou Z, Bailey C, Wood WA. Efficacy of Telehealth-Based Coaching to Improve Physical Activity and Overall Experience for Cancer Survivors: Secondary, Mixed Methods Analysis of a Randomized Controlled Trial. JMIR Cancer. 2026 Jan 15;12:e78968. doi: 10.2196/78968.

    PMID: 41538790DERIVED

  • Wood WA, Bailey C, Castrogivanni B, Mehedint D, Bryant AL, Lavin K, Tan X, Richardson J, Qian Y, Tan KR, Kent EE. Piloting HealthScore: Feasibility and acceptability of a clinically integrated health coaching program for people living with cancer. Cancer Med. 2023 Apr;12(7):8804-8814. doi: 10.1002/cam4.5625. Epub 2023 Jan 16.

    PMID: 36647557DERIVED

MeSH Terms

Conditions

NeoplasmsHealth Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • William A Wood, MD, MPH

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2021

First Posted

June 11, 2021

Study Start

May 11, 2020

Primary Completion

May 11, 2025

Study Completion

May 11, 2025

Last Updated

June 4, 2025

Record last verified: 2025-06

Locations

US(1)