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Increasing Engagement With Digital Behavioral Health

17. September 2026 aktualisiert von: Hackensack Meridian 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

13

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

    • New Jersey
      • Nutley, New Jersey, Vereinigte Staaten, 07110
        • HMH Center for Discovery and Innovation
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 39 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Mindful Peer Coaching

Mindful Peer Coach consists of 1) live virtual and 2) text message 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Minutes use per day (User engagement)
Zeitfenster: 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.

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)
Zeitfenster: 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.

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
Zeitfenster: 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.

Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Anxiety
Zeitfenster: 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.

Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Mindfulness
Zeitfenster: 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.

Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Emotion Regulation
Zeitfenster: 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.

Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Positive and Negative Emotions
Zeitfenster: 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.

Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Distress
Zeitfenster: 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.

Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Overall Wellbeing
Zeitfenster: 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.

Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Sleep Disturbance
Zeitfenster: 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.

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Exit Interview
Zeitfenster: At the end of the 8-week intervention period

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Gary Kwok, PhD, Hackensack Meridian Health Center for Discovery and Innovation

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Dezember 2026

Primärer Abschluss (Geschätzt)

14. Dezember 2029

Studienabschluss (Geschätzt)

15. März 2030

Studienanmeldedaten

Zuerst eingereicht

17. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. September 2026

Zuerst gepostet (Tatsächlich)

23. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

23. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • Pro2024-0069
  • K01CA308858 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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