Clinical trial NCT06038318: Promoting Resilience in Early Survivorship Among Adolescents and Young Adults With Cancer
Official title: Promoting Resilience in Early Survivorship Among Adolescents and Young Adults With Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress
Anxiety
Keywords: Stress Management
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-09-14
Enrollment: 325
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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)

Detailed description: 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.

Eligibility criteria: 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.

Inclusion Criteria:

* 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

Primary outcomes:
measure: Connor Davidson Resilience Scale (CDRISC-10) Score
timeFrame: At 6 months
Secondary outcomes:
measure: CDRISC-10 Score for App-Only Cohort Responders
timeFrame: 3 months
measure: CDRISC-10 Score for Text Coach Cohort Responders
timeFrame: 3 months
measure: Change in HOPE Scale Score
timeFrame: At Baseline, 3 months, and 6 months
measure: Change in Adolescent Participant Quality of Life Total Score
timeFrame: At Baseline, 3 months, and 6 months
measure: Change in Young Adult Participant Quality of Life Total Score
timeFrame: At Baseline, 3 months, and 6 months
measure: Change in Kessler-6 Psychological Distress Scale Score
timeFrame: At Baseline, 3 months, and 6 months
measure: Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score
timeFrame: At Baseline, 3 months, and 6 months
measure: Change in HADS Depression Subscale Score
timeFrame: At Baseline, 3 months, and 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Abby Rosenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: