CancerHealthScoreNCT04923997
The HealthScore Health Coaching Program
A study testing Health Coaching in people with Cancer and Survivorship, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Cancer, Survivorship, Quality of Life
- What is being tested?
- Health Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2020to 11 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27519
About this study
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.
Read the 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.
- Conditions
- Cancer, Survivorship, Quality of Life, Health Behavior
- Being tested
- Health Coaching
- Keywords
- Health Coaching, Wellness, Integrative
- Medical subject headings
- Neoplasms, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health CoachingBehavioural
6 months of integrative health coaching, goal setting, survey administration and physical assessments.
| Study group | Role | What they receive |
|---|---|---|
| Health Coaching | Experimental | All participants will be in the health coaching group. Participants on study will receive a health coach for 6 months. Receives: Behavioral: Health Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (6)
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.
Measured: 6 months
Completed coaching phone calls
Percentage of possible coaching phone calls completed
Measured: 6 months
Survey Completion
Percentage of possible patient-reported surveys completed
Measured: 6 months
Wearable Sensor data
Percentage of possible days using the wearable sensor with evaluable data
Measured: 6 months
Unmet Needs
Number of unmet needs addressed while participating in health coaching
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start11 May 2020
- Primary completion11 May 2025
- Study completion11 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William A Wood, MD, MPH, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923997
- Sponsor's protocol ID
- LCCC 1948
- Acronym
- HealthScore
- Status last verified
- Jun 2025
- First submitted
- 7 Jun 2021
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41538790Wood 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.
PubMed 36647557
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HealthScore Health Coaching Program
- ClinicalTrials.gov ID
- NCT04923997
- Acronym / sponsor ID
- HealthScore / LCCC 1948
- Conditions
- Cancer, Survivorship, Quality of Life, Health Behavior
- Keywords
- Health Coaching, Wellness, Integrative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 11 May 2020 (actual)
- Primary completion
- 11 May 2025 (actual)
- Study completion
- 11 May 2025 (actual)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Coaching | Experimental | Behavioral: Health CoachingAll participants will be in the health coaching group. Participants on study will receive a health coach for 6 months. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Coaching6 months of integrative health coaching, goal setting, survey administration and physical assessments. | Behavioural | Health Coaching |
Primary outcome
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.
6 secondary outcomes
Change in Physical Function
Time frame: 6 months
Completed coaching phone calls
Time frame: 6 months
Survey Completion
Time frame: 6 months
Wearable Sensor data
Time frame: 6 months
Unmet Needs
Time frame: 6 months
Change in participant self-efficacy using the Lorgis Self-Efficacy Scale
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Derived from this study: PubMed 41538790Khairat 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.
- Derived from this study: PubMed 36647557Wood 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William A Wood, MD, MPH principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Coaching in people with Cancer and Survivorship, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Completion (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04923997, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.