Skip to content

The PRISM Intervention: a Multi-site Randomized Controlled Trial for Adolescents and Young Adults With Advanced Cancer

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03668223
Acronym
PRISM-AC
Enrollment
195
Registered
2018-09-12
Start date
2019-04-15
Completion date
2025-10-31
Last updated
2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Cancer, Communication, Coping Skills, Depression, Hope, Quality of Life

Brief summary

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

Detailed description

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. 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. While national guidelines call for integrated palliative care in AYA oncology, 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. These resources may mitigate negative outcomes, facilitate engagement in goals of care discussions, and improve quality of life. 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, affirmed associations between resilience resources and outcomes, and developed a novel resilience resources intervention (Promoting Resilience in Stress Management, PRISM). 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 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. 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. 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.

Interventions

Manualized skills training targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making

Sponsors

Children's Hospital Los Angeles
CollaboratorOTHER
Baylor College of Medicine
CollaboratorOTHER
University of Pittsburgh Medical Center
CollaboratorOTHER
Seattle Children's Hospital
CollaboratorOTHER
National Cancer Institute (NCI)
CollaboratorNIH
Dana-Farber Cancer Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to 24 Years
Healthy volunteers
No

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 * 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)

Design outcomes

Primary

MeasureTime frameDescription
Pediatric Quality of Life Cancer Module3-monthsPediatric Quality of Life (PedsQL) Cancer Module -This scale was designed to assess pediatric cancer-specific health related quality of life. This is a 27 item scale, with each item rated on a 5-point Likert scale where 0=never and 4=almost always. Higher scores represent better health-related quality of life. Scale range is 0-100.

Secondary

MeasureTime frameDescription
Hospital Anxiety and Depression Scale (HADS) Total Score3-monthsThe Hospital Anxiety and Depression Scale total score is a 14 items scale on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression. The total score is the sum of all 14 items, ranging from 0-42. Higher scores indicate higher total anxiety/depression.
Snyder Hope Scale3-monthsHope: The Snyder Hope Scale measures the overall perception that one's goals can be met. The instrument scored on an 8-point Likert scale (score range 0-64). Higher scores imply greater levels of hopeful thought patterns.
Connor Davidson Resilience Scale3-monthsResilience: The Connor-Davidson Resilience Scale (CD-RISC) measures inherent resiliency. This is a 10-item scale ranging from 0-40 where higher scores reflect greater perceived resilience.

Countries

United States

Participant flow

Participants by arm

ArmCount
Promoting Resilience in Stress Management (PRISM)
Resilience Skills Training Promoting Resilience in Stress Management (PRISM): Manualized skills training targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making
99
Usual Care
Standard psychosocial care
96
Total195

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath105
Overall StudyLost to Follow-up1212
Overall StudyWithdrawal by Subject83

Baseline characteristics

CharacteristicPromoting Resilience in Stress Management (PRISM)Usual CareTotal
Age, Continuous16.51 years
STANDARD_DEVIATION 3.79
16.51 years
STANDARD_DEVIATION 3.99
16.51 years
STANDARD_DEVIATION 3.88
Connor-Davidson Resilience Scale27.34 units on a scale
STANDARD_DEVIATION 7.41
29.05 units on a scale
STANDARD_DEVIATION 8.45
28.18 units on a scale
STANDARD_DEVIATION 7.96
Ethnicity (NIH/OMB)
Hispanic or Latino
40 Participants37 Participants77 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
55 Participants59 Participants114 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants0 Participants4 Participants
Pediatric Quality of Life Cancer Module65.12 units on a scale
STANDARD_DEVIATION 15.78
63.53 units on a scale
STANDARD_DEVIATION 16.16
64.34 units on a scale
STANDARD_DEVIATION 15.95
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Asian
5 Participants5 Participants10 Participants
Race (NIH/OMB)
Black or African American
9 Participants7 Participants16 Participants
Race (NIH/OMB)
More than one race
22 Participants19 Participants41 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants2 Participants6 Participants
Race (NIH/OMB)
White
58 Participants62 Participants120 Participants
Region of Enrollment
United States
99 participants96 participants195 participants
Sex: Female, Male
Female
43 Participants52 Participants95 Participants
Sex: Female, Male
Male
56 Participants44 Participants100 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
10 / 995 / 96
other
Total, other adverse events
0 / 990 / 96
serious
Total, serious adverse events
0 / 990 / 96

Outcome results

Primary

Pediatric Quality of Life Cancer Module

Pediatric Quality of Life (PedsQL) Cancer Module -This scale was designed to assess pediatric cancer-specific health related quality of life. This is a 27 item scale, with each item rated on a 5-point Likert scale where 0=never and 4=almost always. Higher scores represent better health-related quality of life. Scale range is 0-100.

Time frame: 3-months

ArmMeasureValue (MEAN)Dispersion
Promoting Resilience in Stress Management (PRISM)Pediatric Quality of Life Cancer Module66.89 score on a scaleStandard Deviation 18.07
Usual CarePediatric Quality of Life Cancer Module68.41 score on a scaleStandard Deviation 18.07
Secondary

Connor Davidson Resilience Scale

Resilience: The Connor-Davidson Resilience Scale (CD-RISC) measures inherent resiliency. This is a 10-item scale ranging from 0-40 where higher scores reflect greater perceived resilience.

Time frame: 3-months

ArmMeasureValue (MEAN)Dispersion
Promoting Resilience in Stress Management (PRISM)Connor Davidson Resilience Scale28.05 score on a scaleStandard Deviation 7.94
Usual CareConnor Davidson Resilience Scale27.45 score on a scaleStandard Deviation 10.16
Secondary

Hospital Anxiety and Depression Scale (HADS) Total Score

The Hospital Anxiety and Depression Scale total score is a 14 items scale on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression. The total score is the sum of all 14 items, ranging from 0-42. Higher scores indicate higher total anxiety/depression.

Time frame: 3-months

ArmMeasureValue (MEAN)Dispersion
Promoting Resilience in Stress Management (PRISM)Hospital Anxiety and Depression Scale (HADS) Total Score8.27 score on a scaleStandard Deviation 6.79
Usual CareHospital Anxiety and Depression Scale (HADS) Total Score9.94 score on a scaleStandard Deviation 7.77
Secondary

Snyder Hope Scale

Hope: The Snyder Hope Scale measures the overall perception that one's goals can be met. The instrument scored on an 8-point Likert scale (score range 0-64). Higher scores imply greater levels of hopeful thought patterns.

Time frame: 3-months

ArmMeasureValue (MEAN)Dispersion
Promoting Resilience in Stress Management (PRISM)Snyder Hope Scale48.06 score on a scaleStandard Deviation 12.15
Usual CareSnyder Hope Scale46.89 score on a scaleStandard Deviation 14.46

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026