The Promoting Resilience in Stress Management (PRISM) Intervention: a Multi-site Randomized Controlled Trial for Adolescents and Young Adults With Advanced Cancer



Status:Not yet recruiting
Conditions:Anxiety, Anxiety, Cancer, Cancer, Depression
Therapuetic Areas:Oncology, Psychiatry / Psychology
Healthy:No
Age Range:12 - 24
Updated:3/23/2019
Start Date:April 1, 2019
End Date:January 1, 2023
Contact:Abby R Rosenberg, MD, MS, MA
Email:abby.rosenberg@seattlechildrens.org
Phone:206-987-2106

Use our guide to learn which trials are right for you!

Multi-Site Randomized Controlled Trial testing the efficacy of the Promoting Resilience in
Stress Management (PRISM) intervention among Adolescents and Young Adults with Advanced
Cancer

Among patients with cancer and their families, early integration of palliative care may
improve quality of life. This is particularly important for Adolescents and Young Adults
(AYAs) because their distinct developmental challenges related to identity, relationships,
and vocation may add to the burden of cancer.1-5 Among AYAs with advanced cancer, most
understand that they may die and report that discussing end-of-life preferences, goals, and
fears would be helpful; however, only 53% engage in such conversations.6-8 While national
guidelines call for integrated palliative care in AYA oncology,9-11 developmentally targeted,
evidence-based interventions designed to meet psychosocial and communication needs are
lacking.

A potential barrier to improving the experiences of AYAs with advanced cancer may be their
limited opportunities to develop "resilience resources" such as stress-management,
goal-setting, positive reframing, and meaning-making skills.12 These resources may mitigate
negative outcomes, facilitate engagement in goals of care discussions, and improve quality of
life.13-15 Furthermore, promoting these resources among AYAs may give them the tools to more
successfully navigate the challenges of the cancer experience.

Our research program is built on the central hypothesis that promoting resilience resources
will improve psychosocial well-being. Over a series of studies, we developed a conceptual
framework of resilience in pediatric cancer,12,16 affirmed associations between resilience
resources and outcomes,17 and developed a novel resilience resources intervention (Promoting
Resilience in Stress Management, PRISM).18 PRISM is a manualized, skills-based training
program comprised of four 30-60 minute, in-person, one-on-one sessions plus a facilitated
parent/caregiver/spouse/significant other family-meeting.

We recently completed a pilot Randomized Controlled Trial (RCT) to test the efficacy of PRISM
among 100 AYAs, 6-months following their diagnosis of new (n=73) or recurrent (n=27) cancer
(manuscript under review). Final results suggest PRISM is feasible, highly acceptable, and
associated with increased patient-reported resilience as well as key clinically significant
patient-centered outcomes such as quality of life and psychological distress. Subgroup
analyses comparing patients with advanced cancer to those with new cancer suggested
differentially stronger positive effects in the advanced cancer group, raising a hypothesis
to be tested in dedicated trials. However, qualitative feedback from patients with advanced
cancer suggested refinements targeting hopes, worries, and contextual meaning-making might
strengthen PRISM's usefulness.

The overall objective of this project is to refine PRISM to meet the distinct needs of AYAs
with Advanced Cancer. We will first adapt and iteratively test the existing PRISM based on
established guidelines for intervention development.19 Then, we will conduct a multi-site
randomized controlled trial to test the efficacy of a new PRISM for Advanced Cancer
(PRISM-AC). Findings will inform the development of larger dissemination studies and
standards of AYA end-of-life and palliative care. Ultimately, this research has the potential
to reduce the burden of cancer in a highly vulnerable population.

Inclusion Criteria:

- Age 12-24 years

- Diagnosed with advanced cancer: progressive, recurrent, refractory disease or any
diagnosis with estimated overall survival <50% at least 2 weeks prior to enrollment

- Receiving cancer care at Seattle Children's Hospital, Children's Hospital Los Angeles,
or Texas Children's Hospital

- Able to speak English

- Able to read English or Spanish

- Cognitively able to participate in interviews

Exclusion Criteria:

- Patient Refusal

- Parent Refusal (if patient <18 years-old)
We found this trial at
4
sites
?
mi
from
Seattle, WA
Click here to add this to my saved trials
4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: David Freyer, MD
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Principal Investigator: Tammy Kang, MD
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
?
mi
from
Houston, TX
Click here to add this to my saved trials
200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials