Promoting Resilience in Early Survivorship Among Adolescents and Young Adults With Cancer

Обзор

The goal of this study is to find the best way to help participants and families manage the stress of facing a serious illness and be better able to "bounce back" or be resilient after a difficult situation. Participants will take part in the "Promoting Resilience in Stress Management" PRISM program, which is designed to provide skills to change or improve the impact of stress in everyday life. The name of the intervention used in this research study is: -PRISM (a mobile app program comprised of 6 sessions of skills-based, manualized resilience education)

Подробное описание

In this sequential, multiple assignment, randomized trial participants will be randomly selected to participate in PRISM program sessions with a trained research coach either by text or by video sessions, or participants will use the PRISM mobile app program in a self-guided way. Randomization means the group participants are placed in will be decided by chance. All groups will continue to receive all the same care from primary medical, social work, and other care teams.

In this two-stage study, participants will be randomly assigned to either the "app-only" (20% chance), "text" (40% chance) or "video" (40% chance) groups for the first stage. In the second stage, participants may be re-randomized again to the "app-only," or "text," groups, or will be referred to a specialty psychosocial support, social worker or counselor, based on responses to questionnaires. Participants randomized to the "app-only" group in the first stage will not be re-randomized.

The research study procedures include screening for eligibility and completion of questionnaires.

Participation in this research study is expected to last for up to 6 months.

It is expected about 325 people will take part in this research study.

The National Institute for Health (NIH) is funding this research study.

Вмешательства

• Поведенческое PRISM Program Video Coach
  A 6-session, skills-based, manualized resilience education program delivered via video coaching by trained English or Spanish speaking PRISM coaches. Participants will have complete access to the PRISM Program mobile app. Sessions will be delivered by a HIPAA compliant videoconferencing platform, Zoom, approximately every 1-2 weeks based on participant preference. For participants who do not have smartphones, temporary equipment will be provided.
• Поведенческое PRISM Program Text Coach
  A 6-session, skills-based, manualized, resilience education program delivered via text coaching by trained English or Spanish speaking PRISM coaches. Participants will have complete access to the PRISM Program mobile app. Sessions will be delivered by HIPAA compliant SMS text-messaging service, Zoom, approximately every other week. For participants who do not have smartphones, temporary equipment will be provided.
• Поведенческое mPRISM Program App
  6 static modules to practice skills-based, manualized, resilience education program delivered via PRISM Program mobile app. For participants who do not have smartphones, temporary equipment will be provided.

Первичные конечные точки

• Connor Davidson Resilience Scale (CDRISC-10) Score [Срок оценки: At 6 months]

Вторичные конечные точки (8)

• CDRISC-10 Score for App-Only Cohort Responders [Срок оценки: 3 months]
• CDRISC-10 Score for Text Coach Cohort Responders [Срок оценки: 3 months]
• Change in HOPE Scale Score [Срок оценки: At Baseline, 3 months, and 6 months]
• Change in Adolescent Participant Quality of Life Total Score [Срок оценки: At Baseline, 3 months, and 6 months]
• Change in Young Adult Participant Quality of Life Total Score [Срок оценки: At Baseline, 3 months, and 6 months]
• Change in Kessler-6 Psychological Distress Scale Score [Срок оценки: At Baseline, 3 months, and 6 months]
• Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score [Срок оценки: At Baseline, 3 months, and 6 months]
• Change in HADS Depression Subscale Score [Срок оценки: At Baseline, 3 months, and 6 months]

Критерии участия

Participants that have completed their main cancer-directed therapy at one of the study sites affiliated centers who meet all the eligibility criteria will be eligible for participation in this study.

Критерии включения

• All genders ≥ 12 and ≤ 25 years of age at baseline
• Participant is able to speak English or Spanish language (for PRISM sessions)
• Participant is able to read English or Spanish language (for completion of surveys)
• Participant is cognitively able to participate in PRISM sessions and complete written questionnaires and surveys, as judged by the site investigator

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 2 центра

• Boston Children's Hospital — Boston
• Dana-Farber Cancer Institute — Boston

Идентификаторы

NCT: NCT06038318 · 22-652 · R01CA269574-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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