Promoting Resilience in Early Survivorship Among Adolescents and Young Adults With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 325
- 试验地点
- 4
- 主要终点
- Connor Davidson Resilience Scale (CDRISC-10) Score
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Connor Davidson Resilience Scale (CDRISC-10) Score
时间窗: At 6 months
Assessed by the CDRISC-10, a 10-item measures consisting of a 5-point Likert scale with answers ranging from 0 (not true at all) to 4 (true nearly all the time) for a total of 40 points. Higher scores reflect greater resilience. Evaluation will be based on the scores of the video and text cohorts vs. the self-guided cohort.
次要结局
- CDRISC-10 Score for App-Only Cohort Responders(3 months)
- CDRISC-10 Score for Text Coach Cohort Responders(3 months)
- Change in HOPE Scale Score(At Baseline, 3 months, and 6 months)
- Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score(At Baseline, 3 months, and 6 months)
- Change in Adolescent Participant Quality of Life Total Score(At Baseline, 3 months, and 6 months)
- Change in Young Adult Participant Quality of Life Total Score(At Baseline, 3 months, and 6 months)
- Change in Kessler-6 Psychological Distress Scale Score(At Baseline, 3 months, and 6 months)
- Change in HADS Depression Subscale Score(At Baseline, 3 months, and 6 months)
研究者
Abby Rosenberg
Principal Investigator
Dana-Farber Cancer Institute