An interventional study of Live Virtual Coaching in Cancer Survivorship, sponsored by Hackensack Meridian Health. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Hackensack Meridian Health · Not applicable, Interventional, and Supportive care
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.
Hackensack Meridian Health is the lead sponsor of 113 studies on the registry; 28 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 12 (71%) have results posted.
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Exclusion Criteria:
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.
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
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.
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2029, 35 months later.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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