Increasing Engagement With Digital Behavioral Health

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer Survivorship
• Intervention / Treatment: Behavioral: Live Virtual Coaching

• Study Type: Interventional
• Enrollment (Estimated): 13
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gary Kwok, PhD; Phone Number: 2018803057; Email: gary.kwok@hmh-cdi.org

Study Locations

• United States
  • New Jersey
    • Nutley, New Jersey, United States, 07110
      • HMH Center for Discovery and Innovation
      • Contact: Gary Kwok, PhD; Phone Number: 201-880-3057; Email: gary.kwok@hmh-cdi.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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) ;

Exclusion Criteria:

• outside age range
• closer to treatment completion than specified above

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Mindful Peer Coaching; Mindful Peer Coach consists of 1) live virtual and 2) text message coaching.

Behavioral: Live Virtual Coaching; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minutes use per day (User engagement)	Minutes use per day with the mindfulness-based mobile app obtained from the Happier Meditation dashboard.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the end of the 8-week intervention period

Collaborators and Investigators

• Sponsor: Hackensack Meridian Health
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Gary Kwok, PhD, Hackensack Meridian Health Center for Discovery and Innovation

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2026
• Primary Completion (Estimated): December 14, 2029
• Study Completion (Estimated): March 15, 2030

Study Registration Dates

• First Submitted: September 17, 2026
• First Submitted That Met QC Criteria: September 17, 2026
• First Posted (Actual): September 23, 2026

Study Record Updates

• Last Update Posted (Actual): September 23, 2026
• Last Update Submitted That Met QC Criteria: September 17, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Cancer survivorship; digital health intervention; user engagement; supporting care for cancer survivors
• Other Study ID Numbers: Pro2024-0069; K01CA308858 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No