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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06038318
• Other study ID #: 22-652
• Secondary ID: R01CA269574-01
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2023
• Est. completion date: September 2026

Study information

• Verified date: October 2023
• Source: Dana-Farber Cancer Institute
• Contact: Abby Rosenberg, MD
• Phone: 206-987-6892
• Email: AbbyR_Rosenberg[@]DFCI.HARVARD.EDU
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 325
• Est. completion date: September 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Stress

Intervention

Behavioral:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Connor Davidson Resilience Scale (CDRISC-10) Score	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.	At 6 months
Secondary	CDRISC-10 Score for App-Only Cohort Responders	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. Participant "responders" are defined as having sustained CDRISC scores >29 after PRISM sessions or increased by >2 points at the timepoints.	3 months
Secondary	CDRISC-10 Score for Text Coach Cohort Responders	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. Participant "responders" are defined as having sustained CDRISC scores >29 after PRISM sessions or increased by >2 points at the timepoints.	3 months
Secondary	Change in HOPE Scale Score	Assessed by the HOPE Scale, a 12-item measures scored on an 8-point Likert scale with answers ranging from 1 "Definitely False" to 8 "Definitely True" for a total score of 96. A higher score implies a greater level of hopeful thought patterns.	At Baseline, 3 months, and 6 months
Secondary	Change in Adolescent Participant Quality of Life Total Score	Assessed by the Pediatric Quality of Life (PedsQL) Generic Core Scales Short Form (SF15) (Teen or Child Report) and PedsQL Cancer Module (Child or Teen Report) scales, 42-items to evaluate health-related quality of life. Items are rated on a 5-point Likert scale with answers ranging from 0 "Never" to 4 "Almost Always" for a score range of 0 - 100. A higher score represents better health-related quality of life.	At Baseline, 3 months, and 6 months
Secondary	Change in Young Adult Participant Quality of Life Total Score	Assessed by the Pediatric Quality of Life (PedsQL) Generic Core Scales Short Form (SF15) Young Adult Report and PedsQL Cancer Module Young Adult Report scales, 42-items to evaluate health-related quality of life. Items are rated on a 5-point Likert scale with answers ranging from 0 "Never" to 4 "Almost Always" for a score range of 0 - 100. A higher score represents better health-related quality of life.	At Baseline, 3 months, and 6 months
Secondary	Change in Kessler-6 Psychological Distress Scale Score	Assessed by the Kessler-6, a 6-item measure for the level of psychological distress in the past month. Responses are scored on a 5-point Likert scare with answers ranging from 0 "None of the time" to 4 "All of the time," and with a total score range of 0 - 4. Scores > or = 7 suggest "high" distressed and those > or = 13 meet criteria for serious or debilitating psychological distress.	At Baseline, 3 months, and 6 months
Secondary	Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score	Assessed by the HADS-A subscale which is comprised of 7 items. Items are scored 0-3 with a subscale total score range of 0 - 21. A higher scores represents increasing abnormality (or caseness) for anxiety.	At Baseline, 3 months, and 6 months
Secondary	Change in HADS Depression Subscale Score	Assessed by the HADS-D subscale score which is comprised of 7 items. Items are scored 0-3 with a subscale total score range of 0 - 21. A higher score represents increasing abnormality (or caseness) for depression.	At Baseline, 3 months, and 6 months