NCT02340884

Brief Summary

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. 1.Patient-reported resilience at 2, 4, and 12 months
  2. 2.Patient-reported self-efficacy, benefit-finding, psychological distress, quality of life, and health-behaviors at 6 and 12 months.
  3. 3.Qualitative assessment of patient-reported goals at 6 and 12 months
  4. 4.Development of a cohort of AYA cancer survivors for assessment of long-term psychosocial outcomes

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_2 cancer

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_2 cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

January 30, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2017

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2021

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

2.6 years

First QC Date

January 9, 2015

Last Update Submit

April 8, 2024

Conditions

CancerAcute Lymphoblastic LeukemiaLymphomaSarcomaAcute Myelogenous LeukemiaBrain TumorsGerm Cell Tumor

Outcome Measures

Primary Outcomes (1)

  • Patient-Reported Resilience

    6 months

Secondary Outcomes (6)

  • Patient-Reported self-efficacy

    6 months

  • Patient-Reported benefit-finding

    6 months

  • Patient-Reported goal-setting skills

    6 months

  • Patient-Reported quality of life

    6 months

  • Patient-Reported health behaviors

    6 months

  • +1 more secondary outcomes

Other Outcomes (1)

  • Patient-reported resilience

    4- and 6- months

Study Arms (2)

PRISM

EXPERIMENTAL

Promoting Resilience In Stress Management Intervention (skills-based intervention designed to teach stress-management, goal-setting, cognitive reframing, and meaning-making skills)

Behavioral: Promoting Resilience In Stress Management (PRISM)

Control

NO INTERVENTION

Standard psychosocial supportive care

Interventions

Promoting Resilience In Stress Management (PRISM)BEHAVIORAL

The brief format of the PRISM intervention involves 4, 50-minute, one-on-one sessions approximately 2 weeks apart, plus a 5th parent-inclusive session 2-4 weeks following session #4. These are complimented with age-specific handouts describing the skills and opportunities to practice them, as well as weekly (text- or email based) check-ins from study staff and in-person "booster" sessions once monthly. Specifically, the intervention incorporates four primary skills: 1) stress management/mindfulness; 2) goal-setting; 3) cognitive restructuring; and, 4) meaning-making/benefit finding.

PRISM

Eligibility Criteria

Age13 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 13-25 years
  • Patient aged 13-17 years: has signed informed assent and their parent/legal guardian has signed informed consent for study participation.
  • Patient aged 18-25 years: has signed informed consent for study participation.
  • Diagnosis of malignancy treated with chemotherapy and/or radiation therapy at Seattle Childrens Hospital (SCH)
  • New diagnosis of malignancy within 1-10 weeks of enrollment
  • New diagnosis of recurrent disease (after initial remission) within 1-10 weeks of enrollment
  • Ability to speak and read English language
  • Cognitively able to participate in interactive interviews

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (4)

  • Rosenberg 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: 34817581DERIVED

  • Steineck 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: 33960833DERIVED

  • Lau 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: 31680625DERIVED

  • Lau 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: 31037789DERIVED

MeSH Terms

Conditions

NeoplasmsPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphomaSarcomaLeukemia, Myeloid, AcuteBrain NeoplasmsNeoplasms, Germ Cell and Embryonal

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Connective and Soft TissueLeukemia, MyeloidCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Abby R Rosenberg, MD, MS

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Pediatrics

Study Record Dates

First Submitted

January 9, 2015

First Posted

January 19, 2015

Study Start

January 30, 2015

Primary Completion

September 19, 2017

Study Completion

December 19, 2021

Last Updated

April 9, 2024

Record last verified: 2024-04

Locations

US(1)