CancerNCT07026214
Feasibility, Acceptability, and Preliminary Efficacy of a Remotely-delivered Health Coaching Intervention for Cancer Survivors
A study testing Vitalis Cancer in people with Cancer, run by University of Iowa at 1 site in United States.
Trial summary
This study aimed to evaluate the feasibility, acceptability, and preliminary efficacy of an 8-week, remotely delivered health coaching intervention designed to improve: 1) targeted psychosocial mechanisms of action (behavioral regulation skills, affective attitudes, health habits, and identity); 2) health behaviors… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Vitalis Cancer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 14 Sep 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult cancer survivors aged 18-64 years
- 3-60 months post-treatment
- Not meeting recommendations for physical activity, diet, or sleep.
- Express interest in improving at least one health behavior.
Who cannot join
- Currently receiving cancer treatment
- Metastatic disease
- Pregnancy or plans for pregnancy
- No access to Zoom or a smartphone
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to evaluate the feasibility, acceptability, and preliminary efficacy of an 8-week, remotely delivered health coaching intervention designed to improve: 1) targeted psychosocial mechanisms of action (behavioral regulation skills, affective attitudes, health habits, and identity); 2) health behaviors (physical activity, diet, sleep); and 3) cancer-related health outcomes (physical function, anxiety, depression, fatigue, and pain) among young and middle-aged adult cancer survivors.
Read the detailed description
Almost 17 million Americans today live with cancer. While advances in cancer treatment have resulted in improved survivorship rates, many treatments are associated with negative, long-term side effects including weight gain, physical dysfunction, fatigue, sleep difficulties, and overall reduced quality of life. Consequently, improving quality of survivorship has been identified as an important but understudied area of research. Both the American Cancer Society and the National Comprehensive Cancer Center Network recommend all cancer survivors maintain a healthy lifestyle that includes being physically active, avoiding inactivity, getting adequate sleep, following a healthy eating pattern, and maintaining a healthy weight. Strong evidence suggests engaging in these healthy lifestyle behaviors has been shown to improve cancer-related health outcomes and quality of life. Unfortunately, most cancer survivors do not meet these recommendations. The American Cancer Society and National Academy of Medicine have recommended healthcare providers and health care systems establish comprehensive survivorship programs that follow patients after primary active treatment and include resources that support engaging in healthy lifestyle behaviors . Unfortunately, a lack of trained survivorship care workforce, lack of reimbursement for survivorship programs, and lack of cohesive systems are major barriers to implementing effective lifestyle behavior survivorship care. Therefore, the aims of this study are:
Aim 1: To determine the feasibility (recruitment rate, attrition rate) and acceptability (program satisfaction) of recruiting and delivering an 8-week remotely delivered lifestyle behavior change intervention to adult cancer survivors.
Aim 2: To determine the efficacy of an 8-week remotely delivered lifestyle behavior change intervention on psychosocial mechanisms of action (behavioral regulation skills, habits, identity), health behaviors (physical activity, sedentary behavior, sleep, diet), and cancer-related health outcomes (anxiety, depression, fatigue, pain, physical function, global health) over 8 weeks.
- Conditions
- Cancer
- Being tested
- Vitalis Cancer
- Keywords
- health coaching, cancer survivorship
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitalis CancerBehavioural
Participants receive five free health coaching sessions with a trained student health coach, access to three health education videos, and a free wrist worn activity monitor to keep track of their physical activity and sleep behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Vitalis Cancer Intervention | Experimental | The intervention includes health coaching, health education, and wearable activity monitoring. Receives: Behavioral: Vitalis Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Enrollment
Enrollment rates calculated as percentage of enrolled vs interested participants
Measured: From the first day of study recruitment until the date of the last participant to complete the intervention, assessed up to 36 months
Acceptability
Participants self-reported their acceptability with each intervention feature using an Acceptability Survey. Responses were collected using a 5 point likert scale with higher numbers representing greater satisfaction (1=Very disatisfied, 5=Very Satisfied)
Measured: Post-intervention (8 weeks)
Feasibility Adherence rates
Participate adherence rates to health coaching sessions calculated as sessions attended vs sessions offered
Measured: From the first day the intervention launched until the date of the last participant to complete the intervention, assessed up to 36 months
Feasibility- Retention rate
Retention rate calculated as percentage comparing number enrolled versus number that complete the study
Measured: From the first day of study recruitment until the date of the last participant to complete the intervention, assessed up to 36 months
Secondary outcomes (6)
Behavioral Regulation Skills
Participant's perceived ability to regulate their physical activity, diet, and sleep behaviors using a six item survey that uses a 5 point Likert scale. Scores will range from 6 (low skills) to 30 (high skills).
Measured: From enrollment to 8 weeks
Habit formation skills
Habit formation was measured with a 3 question survey using a 5 point likert scale. Responses will range from 3 (weak habit) to 15 (strong habit).
Measured: From enrollment to 8 weeks
Physical activity
Minutes per day of moderate intensity physical activity measured for 7 days with a ActivPAL
Measured: Enrollment to 8 weeks
Diet behavior
Measured with the Automated Self-Administered Dietary Assessment (ASA24) Tool
Measured: From enrollment to 8 weeks
Sleep behavior
Sleep time and sleep efficiency measured for 7 days with an ActTrust2 actigraph
Measured: From enrollment to 8 weeks
Global Health
Measured with two questions on a 5 point likert scale. Scores will range from 2 (poor) to 10 (excellent)
Measured: From enrollment to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start1 Jan 2023
- Primary completion29 Jun 2023
- Study completion14 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- Holden Comprehensive Cancer Center
- Responsible party
- Principal investigator, Lucas Carr, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026214
- Sponsor's protocol ID
- 202210267
- Status last verified
- Jun 2025
- First submitted
- 30 May 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Preliminary Efficacy of a Remotely-delivered Health Coaching Intervention for Cancer Survivors
- ClinicalTrials.gov ID
- NCT07026214
- Acronym / sponsor ID
- 202210267
- Conditions
- Cancer
- Keywords
- health coaching, cancer survivorship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- Holden Comprehensive Cancer Center
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 18 Jun 2025 (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.
This study aimed to evaluate the feasibility, acceptability, and preliminary efficacy of an 8-week, remotely delivered health coaching intervention designed to improve: 1) targeted psychosocial mechanisms of action (behavioral regulation skills, affective attitudes, health habits, and identity); 2) health behaviors (physical activity, diet, sleep); and 3) cancer-related health outcomes (physical function, anxiety, depression, fatigue, and pain) among young and middle-aged adult cancer survivors.
Detailed description
Almost 17 million Americans today live with cancer. While advances in cancer treatment have resulted in improved survivorship rates, many treatments are associated with negative, long-term side effects including weight gain, physical dysfunction, fatigue, sleep difficulties, and overall reduced quality of life. Consequently, improving quality of survivorship has been identified as an important but understudied area of research. Both the American Cancer Society and the National Comprehensive Cancer Center Network recommend all cancer survivors maintain a healthy lifestyle that includes being physically active, avoiding inactivity, getting adequate sleep, following a healthy eating pattern, and maintaining a healthy weight. Strong evidence suggests engaging in these healthy lifestyle behaviors has been shown to improve cancer-related health outcomes and quality of life. Unfortunately, most cancer survivors do not meet these recommendations. The American Cancer Society and National Academy of Medicine have recommended healthcare providers and health care systems establish comprehensive survivorship programs that follow patients after primary active treatment and include resources that support engaging in healthy lifestyle behaviors . Unfortunately, a lack of trained survivorship care workforce, lack of reimbursement for survivorship programs, and lack of cohesive systems are major barriers to implementing effective lifestyle behavior survivorship care. Therefore, the aims of this study are:
Aim 1: To determine the feasibility (recruitment rate, attrition rate) and acceptability (program satisfaction) of recruiting and delivering an 8-week remotely delivered lifestyle behavior change intervention to adult cancer survivors.
Aim 2: To determine the efficacy of an 8-week remotely delivered lifestyle behavior change intervention on psychosocial mechanisms of action (behavioral regulation skills, habits, identity), health behaviors (physical activity, sedentary behavior, sleep, diet), and cancer-related health outcomes (anxiety, depression, fatigue, pain, physical function, global health) over 8 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitalis Cancer Intervention | Experimental | Behavioral: Vitalis CancerThe intervention includes health coaching, health education, and wearable activity monitoring. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult cancer survivors aged 18-64 years
- 3-60 months post-treatment
- Not meeting recommendations for physical activity, diet, or sleep.
- Express interest in improving at least one health behavior.
Key exclusion criteria (4 listed)
- Currently receiving cancer treatment
- Metastatic disease
- Pregnancy or plans for pregnancy
- No access to Zoom or a smartphone
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 |
|---|---|---|
| Vitalis CancerParticipants receive five free health coaching sessions with a trained student health coach, access to three health education videos, and a free wrist worn activity monitor to keep track of their physical activity and sleep behaviors. | Behavioural | Vitalis Cancer Intervention |
Primary outcome
Feasibility - Enrollment
Time frame: From the first day of study recruitment until the date of the last participant to complete the intervention, assessed up to 36 months
Enrollment rates calculated as percentage of enrolled vs interested participants
Acceptability
Time frame: Post-intervention (8 weeks)
Participants self-reported their acceptability with each intervention feature using an Acceptability Survey. Responses were collected using a 5 point likert scale with higher numbers representing greater satisfaction (1=Very disatisfied, 5=Very Satisfied)
Feasibility Adherence rates
Time frame: From the first day the intervention launched until the date of the last participant to complete the intervention, assessed up to 36 months
Participate adherence rates to health coaching sessions calculated as sessions attended vs sessions offered
Feasibility- Retention rate
Time frame: From the first day of study recruitment until the date of the last participant to complete the intervention, assessed up to 36 months
Retention rate calculated as percentage comparing number enrolled versus number that complete the study
6 secondary outcomes
Behavioral Regulation Skills
Time frame: From enrollment to 8 weeks
Habit formation skills
Time frame: From enrollment to 8 weeks
Physical activity
Time frame: Enrollment to 8 weeks
Diet behavior
Time frame: From enrollment to 8 weeks
Sleep behavior
Time frame: From enrollment to 8 weeks
Global Health
Time frame: From enrollment to 8 weeks
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 18 Jun 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitalis Cancer in people with Cancer, run by University of Iowa 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 4 inclusion and 4 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 18 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?
Feasibility - Enrollment (time frame: From the first day of study recruitment until the date of the last participant to complete the intervention, assessed up to 36 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2025.