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Not yet recruiting NCT07160933

Development of a Psychosocial Intervention to Reduce Post Traumatic Stress in Young Adult Survivors of Cancer

No phase Interventional Post-traumatic Stress Symptoms

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 Cancer-Related Post-Traumatic Stress in Young Adults.
Who it may be relevant to
Registry conditions: Post-traumatic Stress Symptoms. Basic parameters: 18 years — 39 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 →

Unsure about the terms? Read our patient guide →

Official title

Adaptation and Refinement of a Psychosocial Intervention to Reduce Post-Traumatic Stress in Young Adult Survivors of Cancer

Overview

The goal of this study is to develop a virtual group intervention to address post-traumatic stress related to cancer in young adult cancer survivors (YACs, aged 18-39). The study team will do this by integrating evidence-guided treatments and expert clinician feedback (N=10) on the content, delivery, and structure of the intervention. Next, the study team will refine this intervention through a pilot trial with a group of YACs (N=80).

Interventions

  • Behavioral Psychosocial Intervention for Cancer-Related Post-Traumatic Stress in Young Adults
    A new group-based virtual intervention to address post-traumatic stress related to cancer in YACs, integrating evidence-guided treatments from Cognitive Processing Therapy and Mind-Body Resiliency interventions.

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: To be eligible for this study, participants will be:

  • Currently aged between 18 - 39;
  • Currently receiving or having completed treatment for cancer at the Mass General Cancer Institute within the past 5 years;
  • Reporting a score denoting at least mild symptoms of PTSD on the Post-traumatic Stress Checklist 5 (PCL-5);
  • English-speaking;
  • Have access to a device with audio/video capabilities to complete virtual intervention sessions.

Exclusion criteria

  • Unable to provide verbal consent
  • Reporting active symptoms of psychosis that preclude safe participation.

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

Healthy volunteers: No

Study design

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

Study locations

United States · 1 center
  • Mass General Cancer Center — Boston

Identifiers

NCT: NCT07160933 · 25-306 · CSDG-24-1319592-01-CTPS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗