A Pilot RCT of the PRISM Intervention for AYAs With Cancer

Study Title: A Pilot Randomized Controlled Trial of the Promoting Resilience in Stress Management (PRISM) Intervention for Adolescents and Young Adults with Cancer Study Population and Sample Size: Two cohorts of Adolescent and Young Adult (AYA) patients with diagnosis of new or recurrent cancer between 1 and 10 weeks prior to enrollment: those ages 13-17 (N=50); (2) those ages 18-25 (N=50). Study Design: Pilot randomized controlled trial (RCT). Primary Objective: To test the efficacy of the "Promoting Resilience in Stress Management" (PRISM) among Adolescents and Young Adults with cancer. Primary Outcome: Change in patient-reported resilience (based on score of standardized Connor-Davidson Resilience Scale) at 6 months. Secondary Outcomes: 1. Patient-reported resilience at 2, 4, and 12 months 2. Patient-reported self-efficacy, benefit-finding, psychological distress, quality of life, and health-behaviors at 6 and 12 months. 3. Qualitative assessment of patient-reported goals at 6 and 12 months 4. Development of a cohort of AYA cancer survivors for assessment of long-term psychosocial outcomes Study Duration: 3 years

Sex

All

Minimum age

13 Years

Maximum age

25 Years

Inclusion Criteria:

1. Age 13-25 years

   1. Patient aged 13-17 years: has signed informed assent and their parent/legal guardian has signed informed consent for study participation.
   2. Patient aged 18-25 years: has signed informed consent for study participation.
2. Diagnosis of malignancy treated with chemotherapy and/or radiation therapy at Seattle Childrens Hospital (SCH)

   1. New diagnosis of malignancy within 1-10 weeks of enrollment
   2. New diagnosis of recurrent disease (after initial remission) within 1-10 weeks of enrollment
3. Ability to speak and read English language
4. Cognitively able to participate in interactive interviews

Exclusion Criteria:

1. Patient refusal to participate (any age), or parental refusal to participate for patients less than 18 years of age
2. Cognitively or physically unable to participate in interactive interview
3. Unable to speak and read English language
4. Patient without chemotherapy and/or radiation therapy as part of cancer treatment (e.g., surgical resection only patients are not-eligible).

• DERIVEDRosenberg AR, Zhou C, Bradford MC, Salsman JM, Sexton K, O'Daffer A, Yi-Frazier JP. Assessment of the Promoting Resilience in Stress Management Intervention for Adolescent and Young Adult Survivors of Cancer at 2 Years: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021 Nov 1;4(11):e2136039. doi: 10.1001/jamanetworkopen.2021.36039. PMID 34817581
• DERIVEDSteineck A, Barton KS, Bradford MC, Yi-Frazier JP, Rosenberg AR. Tincture of Time: The Evolution of Goals in Adolescents and Young Adults with Cancer. J Adolesc Young Adult Oncol. 2021 Dec;10(6):703-710. doi: 10.1089/jayao.2020.0223. Epub 2021 May 6. PMID 33960833
• DERIVEDLau N, Bradford MC, Steineck A, Scott S, Bona K, Yi-Frazier JP, McCauley E, Rosenberg AR. Examining key sociodemographic characteristics of adolescents and young adults with cancer: A post hoc analysis of the Promoting Resilience in Stress Management randomized clinical trial. Palliat Med. 2020 Mar;34(3):336-348. doi: 10.1177/0269216319886215. Epub 2019 Nov 4. PMID 31680625
• DERIVEDLau N, Bradford MC, Steineck A, Junkins CC, Yi-Frazier JP, McCauley E, Rosenberg AR. Exploratory analysis of treatment response trajectories in the PRISM trial: Models of psychosocial care. Psychooncology. 2019 Jul;28(7):1470-1476. doi: 10.1002/pon.5098. Epub 2019 May 14. PMID 31037789