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Recruiting NCT07139769

Adapting Psychosocial Resiliency Intervention for Parents of Adolescents and Young Adults With Cancer

No phase Interventional Caregiving for Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Psychosocial Intervention for Parental Caregivers of AYA with Cancer.
Who it may be relevant to
Registry conditions: Caregiving for Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The RAISE Study: Adapting Psychosocial Resiliency Intervention for Parents of Adolescents and Young Adults With Cancer

Overview

The study team aims to adapt a psychosocial intervention to reduce psychological distress among the caregiving parents of adolescents and young adults (aged 15-39) who have cancer. First, the study team will adapt an evidence-supported, group-based program for improving psychological resiliency (Stress Management and Resiliency Training - Relaxation Response Resiliency Program; SMART-3RP(E. R. Park et al., 2021)), and iteratively incorporate feedback from parents of AYA with cancer using a mixed-methods approach. Next, the study team will pilot the refined intervention to assess for preliminary indicators of feasibility, acceptability, and potential for efficacy in reducing parental distress.

Interventions

  • Behavioral Psychosocial Intervention for Parental Caregivers of AYA with Cancer
    A new adaptation of an evidence-supported intervention, the SMART-3RP program, to address psychological symptoms and promote well-being among parental caregivers of AYA with cancer.

Primary outcome measures

  • Intervention Feasibility: Percent of Identified Prospective Participants Who Enroll [Time frame: Post-treatment completion (enrollment to treatment completion is approximately 3 months)]
  • Intervention Feasibility: Proportion of Participants Completing the Program [Time frame: Post-treatment completion (enrollment to treatment completion is approximately 3 months)]
  • Intervention Acceptability [Time frame: Post-treatment completion (enrollment to treatment completion is approximately 3 months)]

Eligibility criteria

Inclusion criteria

  • Self-identifying parent/guardian who provides a primary informal caregiving role in their child's cancer
  • Recipient of caregiving is aged between 15 and 39 years and is receiving treatment for cancer
  • Participant must score equal to or greater than 2 (out of a possible 10) on the National Comprehensive Cancer Network Distress Thermometer
  • English-speaking
  • Aged over 18 years

Exclusion criteria

  • Having a co-parent or other household member participating in the same study
  • Active symptoms of psychosis or suicidal ideation that would preclude safe participation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Mass General Brigham Cancer Institute at Massachusetts General Hospital — Boston

Identifiers

NCT: NCT07139769 · 25-242 · IRG-21-130-10-IRG-11

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗