Cancer SurvivorshipNCT07837089
Increasing Engagement With Digital Behavioral Health
A study testing Live Virtual Coaching in people with Cancer Survivorship, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
This is a phased mixed-methods behavioral intervention study that will develop and test Mindful Peer Coach, a peer-supported mindfulness program for adolescent and young adult (AYA) cancer survivors. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Cancer Survivorship
- What is being tested?
- Live Virtual Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2026to 15 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- at least one year from treatment completion
- ability to speak conversational English,
- per self-report, not being treated for posttraumatic stress disorder (PTSD), psychosis, or epilepsy/seizures.
- have experience with mindfulness and/or be willing to attend training and supervision sessions (only for coaches)
- at least two years from treatment completion (only for coaches) ;
Who cannot join
- outside age range
- closer to treatment completion than specified above
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
HMH Center for Discovery and Innovation
Nutley, New Jersey, 07110
Gary Kwok, PhD, 201-880-3057, gary.kwok@hmh-cdi.org
About this study
Official title: Development of a Peer Digital Coach Intervention to Increase Adolescent and Young Adult Cancer Survivors' Engagement With a Digital Behavioral Health Intervention
This is a phased mixed-methods behavioral intervention study that will develop and test Mindful Peer Coach, a peer-supported mindfulness program for adolescent and young adult (AYA) cancer survivors. Phase 1 is a formative qualitative study designed to identify survivor-reported needs and preferences for increasing engagement with a mindfulness meditation app. Phase 2 is a pilot intervention study that will examine the feasibility, acceptability, and preliminary engagement outcomes of the Mindful Peer Coach program using participant surveys, app-use data, peer-coach training, coaching sessions, weekly text-message check-ins, and exit interviews with survivors and coaches.
- Conditions
- Cancer Survivorship
- Being tested
- Live Virtual Coaching
- Keywords
- Cancer survivorship, supporting care for cancer survivors, digital health intervention, user engagement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Virtual CoachingBehavioural
Participants will complete six structured weekly videoconference sessions designed to cultivate mindfulness practice and increase engagement with the Happier Meditation app.
Each session follows a standardized framework outlined in the training manual to ensure consistency and fidelity.
Between sessions, coaches will provide support and accountability via text messaging. The frequency of messages will be determined collaboratively during Session 1.
Each exchange begins with a previously tested mindfulness message, followed by tailored responses to reinforce practice, address questions, and sustain engagement.
| Study group | Role | What they receive |
|---|---|---|
| Mindful Peer Coaching | Experimental | Mindful Peer Coach consists of 1) live virtual and 2) text message coaching. Receives: Behavioral: Live Virtual Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minutes use per day (User engagement)
Minutes use per day with the mindfulness-based mobile app obtained from the Happier Meditation dashboard.
Measured: Minutes used per day will be captured daily through the app and summarized weekly across the full 3-month study period, including the 8-week intervention phase
Number of days used per week (User engagement)
Number of days used per week with the mindfulness-based mobile app obtained from the Happier Meditation dashboard.
Measured: Number of days used per week will be captured daily through the app and summarized weekly across the full 3-month study period, including the 8-week intervention phase.
Depression
Depression symptoms will be assessed using the PROMIS Depression measure. PROMIS Depression is an 8-item scale with each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.
Measured: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Anxiety
Anxiety symptoms will be assessed using the PROMIS Anxiety measure. PROMIS Anxiety is an 7-item scale with each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.
Measured: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Mindfulness
Mindfulness will be assessed using the Mindful Attention Awareness Scale measure. Your score falls into a range of 1 to 6, calculated by taking the average of all 15 responses. Higher average scores indicate greater overall mindfulness.
Measured: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Emotion Regulation
Emotion Regulation will be assessed using the emotional experience subscale from the Emotion Regulation Questionnaire (ERQ) measure. The Emotion Regulation has 6 items on a 7-point Likert scale, with 1 indicating "strongly disagree" and 7 indicating "strongly agree" ranging from 6 to 42 (computed as the mean of the 6 items). Higher scores indicate a greater tendency to alter how you think about a situation to change its emotional impact.
Measured: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Positive and Negative Emotions
Positive and Negative Emotions will be assessed using I-PANAS-SF (International Positive and Negative Affect Schedule Short-Form). It is a 10-item psychological tool that assesses affect. It evaluates both Positive Affect and Negative Affect on two separate 5-item subscales. Each of the 10 emotions is rated on a 5-point Likert scale, resulting in score ranges of 5 to 25 for both the Positive and Negative subscales. Higher scores indicate higher levels of that specific effect.
Measured: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Distress
Distress will be assessed using the Perceived Stress Scale. The Perceived Stress Scale (PSS-10) is a 10 item scale that has a total score range from 0 to 40, with higher scores indicating higher levels of perceived stress.
Measured: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Overall Wellbeing
Overall Wellbeing will be assessed using the PROMIS Global Health scale. For the standard PROMIS Global Health (PROMIS-GH-10) assessment, the 10 items produce two distinct summary scales: Global Physical Health and Global Mental Health. Because both subscales are made up of 4 items measured on a 1-5 point scale, the raw score range for each subscale is 4 to 20. While raw scores are simply the sum of your responses, they are not used directly to interpret health status. Instead, raw scores are converted into standardized T-scores using an established lookup algorithm:
A T-score of 50 represents the average health of the U.S. general population. Every 10 points away from 50 equates to one standard deviation. Higher T-scores indicate better self-reported health, regardless of whether it is the physical or mental subscale.
Measured: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Sleep Disturbance
Sleep Disturbance will be assessed using the PROMIS Sleep Disturbance scale. The raw score range for the PROMIS Sleep Disturbance Scale 4-Item Short Forms: is generally 4 to 20. Higher raw scores correspond to a greater severity of sleep disturbance. These raw scores are then converted into a standardized T-score (where the general U.S. population average is 50, with a standard deviation of 10) using PROMIS Standardized Lookup Tables.
Measured: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Secondary outcomes (1)
Exit Interview
Qualitative feedback collected through semi-structured exit interviews; no quantifiable data will be generated. Themes will be identified and presented using descriptive statistics.
Measured: At the end of the 8-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start15 Dec 2026 (estimated)
- Primary completion14 Dec 2029 (estimated)
- Study completion15 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorshipStudies 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
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gary Kwok, PhD, Principal investigator, Hackensack Meridian Health Center for Discovery and Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837089
- Sponsor's protocol ID
- Pro2024-0069
- Other IDs
- K01CA308858
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Peer Digital Coach Intervention to Increase Adolescent and Young Adult Cancer Survivors' Engagement With a Digital Behavioral Health Intervention
- ClinicalTrials.gov ID
- NCT07837089
- Acronym / sponsor ID
- Pro2024-0069
- Conditions
- Cancer Survivorship
- Keywords
- Cancer survivorship, supporting care for cancer survivors, digital health intervention, user engagement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 14 Dec 2029 (estimated)
- Study completion
- 15 Mar 2030 (estimated)
- First posted
- 23 Sep 2026 (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 is a phased mixed-methods behavioral intervention study that will develop and test Mindful Peer Coach, a peer-supported mindfulness program for adolescent and young adult (AYA) cancer survivors. Phase 1 is a formative qualitative study designed to identify survivor-reported needs and preferences for increasing engagement with a mindfulness meditation app. Phase 2 is a pilot intervention study that will examine the feasibility, acceptability, and preliminary engagement outcomes of the Mindful Peer Coach program using participant surveys, app-use data, peer-coach training, coaching sessions, weekly text-message check-ins, and exit interviews with survivors and coaches.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindful Peer Coaching | Experimental | Behavioral: Live Virtual CoachingMindful Peer Coach consists of 1) live virtual and 2) text message coaching. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- at least one year from treatment completion
- ability to speak conversational English,
- per self-report, not being treated for posttraumatic stress disorder (PTSD), psychosis, or epilepsy/seizures.
- have experience with mindfulness and/or be willing to attend training and supervision sessions (only for coaches)
- at least two years from treatment completion (only for coaches) ;
Key exclusion criteria (2 listed)
- outside age range
- closer to treatment completion than specified above
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 |
|---|---|---|
| Live Virtual CoachingParticipants will complete six structured weekly videoconference sessions designed to cultivate mindfulness practice and increase engagement with the Happier Meditation app. Each session follows a standardized framework outlined in the training manual to ensure consistency and fidelity. Between sessions, coaches will provide support and accountability via text messaging. The frequency of messages will be determined collaboratively during Session 1. Each exchange begins with a previously tested mindfulness message, followed by tailored responses to reinforce practice, address questions, and sustain engagement. | Behavioural | Mindful Peer Coaching |
Primary outcome
Minutes use per day (User engagement)
Time frame: Minutes used per day will be captured daily through the app and summarized weekly across the full 3-month study period, including the 8-week intervention phase
Minutes use per day with the mindfulness-based mobile app obtained from the Happier Meditation dashboard.
Number of days used per week (User engagement)
Time frame: Number of days used per week will be captured daily through the app and summarized weekly across the full 3-month study period, including the 8-week intervention phase.
Number of days used per week with the mindfulness-based mobile app obtained from the Happier Meditation dashboard.
Depression
Time frame: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Depression symptoms will be assessed using the PROMIS Depression measure. PROMIS Depression is an 8-item scale with each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.
Anxiety
Time frame: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Anxiety symptoms will be assessed using the PROMIS Anxiety measure. PROMIS Anxiety is an 7-item scale with each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.
Mindfulness
Time frame: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Mindfulness will be assessed using the Mindful Attention Awareness Scale measure. Your score falls into a range of 1 to 6, calculated by taking the average of all 15 responses. Higher average scores indicate greater overall mindfulness.
Emotion Regulation
Time frame: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Emotion Regulation will be assessed using the emotional experience subscale from the Emotion Regulation Questionnaire (ERQ) measure. The Emotion Regulation has 6 items on a 7-point Likert scale, with 1 indicating "strongly disagree" and 7 indicating "strongly agree" ranging from 6 to 42 (computed as the mean of the 6 items). Higher scores indicate a greater tendency to alter how you think about a situation to change its emotional impact.
Positive and Negative Emotions
Time frame: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Positive and Negative Emotions will be assessed using I-PANAS-SF (International Positive and Negative Affect Schedule Short-Form). It is a 10-item psychological tool that assesses affect. It evaluates both Positive Affect and Negative Affect on two separate 5-item subscales. Each of the 10 emotions is rated on a 5-point Likert scale, resulting in score ranges of 5 to 25 for both the Positive and Negative subscales. Higher scores indicate higher levels of that specific effect.
Distress
Time frame: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Distress will be assessed using the Perceived Stress Scale. The Perceived Stress Scale (PSS-10) is a 10 item scale that has a total score range from 0 to 40, with higher scores indicating higher levels of perceived stress.
Overall Wellbeing
Time frame: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Overall Wellbeing will be assessed using the PROMIS Global Health scale. For the standard PROMIS Global Health (PROMIS-GH-10) assessment, the 10 items produce two distinct summary scales: Global Physical Health and Global Mental Health. Because both subscales are made up of 4 items measured on a 1-5 point scale, the raw score range for each subscale is 4 to 20. While raw scores are simply the sum of your responses, they are not used directly to interpret health status. Instead, raw scores are converted into standardized T-scores using an established lookup algorithm: A T-score of 50 represents the average health of the U.S. general population. Every 10 points away from 50 equates to one standard deviation. Higher T-scores indicate better self-reported health, regardless of whether it is the physical or mental subscale.
Sleep Disturbance
Time frame: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Sleep Disturbance will be assessed using the PROMIS Sleep Disturbance scale. The raw score range for the PROMIS Sleep Disturbance Scale 4-Item Short Forms: is generally 4 to 20. Higher raw scores correspond to a greater severity of sleep disturbance. These raw scores are then converted into a standardized T-score (where the general U.S. population average is 50, with a standard deviation of 10) using PROMIS Standardized Lookup Tables.
1 secondary outcome
Exit Interview
Time frame: At the end of the 8-week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- 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.
Gary Kwok, PhD principal investigator
Hackensack Meridian Health Center for Discovery and Innovation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live Virtual Coaching in people with Cancer Survivorship, run by Hackensack Meridian Health 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 5 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: opening soon, as of the sponsor's last update on 23 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gary Kwok, PhD (2018803057, gary.kwok@hmh-cdi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minutes use per day (User engagement) (time frame: Minutes used per day will be captured daily through the app and summarized weekly across the full 3-month study period, including the 8-week intervention phase). The study lists 10 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 23 Sep 2026.