Health TrialsbyHealthPanel

Increasing Engagement With Digital Behavioral Health

ConditionCancer Survivorship
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-39
SponsorHackensack Meridian Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

outside age range

closer to treatment completion than specified above

Trial design

Design model

Single group

Treatments tested in this trial

  • Live Virtual Coaching

    Behavioral

    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.

Treatment groups

13 Participants
are divided into 1 treatment group
Group A: Mindful Peer CoachingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Minutes use per day (User engagement)

Minutes use per day with the mindfulness-based mobile app obtained from the Happier Meditation dashboard.

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
2

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.

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.
3

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.

Time frame
Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
4

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.

Time frame
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.

Time frame
At the end of the 8-week intervention period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hackensack Meridian Health

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: