- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07837089
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Gary Kwok, PhD
- Telefonní číslo: 2018803057
- E-mail: gary.kwok@hmh-cdi.org
Studijní místa
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New Jersey
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Nutley, New Jersey, Spojené státy, 07110
- HMH Center for Discovery and Innovation
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Kontakt:
- Gary Kwok, PhD
- Telefonní číslo: 201-880-3057
- E-mail: gary.kwok@hmh-cdi.org
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Minutes use per day (User engagement)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
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Overall Wellbeing
Časové okno: 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
|
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Sleep Disturbance
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Exit Interview
Časové okno: 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
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Gary Kwok, PhD, Hackensack Meridian Health Center for Discovery and Innovation
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- Pro2024-0069
- K01CA308858 (Grant/smlouva NIH USA)
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