NCT07160933

Brief Summary

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).

Trial Health

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Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
50mo left

Started Apr 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Apr 2026Jun 2030

First Submitted

Initial submission to the registry

August 29, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

4.2 years

First QC Date

August 29, 2025

Last Update Submit

March 30, 2026

Conditions

Post-traumatic Stress Symptoms

Keywords

young adult cancer survivorscancer-related post-traumatic stresspost-traumatic stress

Outcome Measures

Primary Outcomes (3)

  • Intervention Feasibility: Percent of Identified Prospective Participants Who Enroll

    Percent of eligible participants who were offered participation and who enroll in the study by completing consent and baseline assessment.

    Post-treatment completion (enrollment to treatment completion is approximately 3 months)

  • Intervention Feasibility: Proportion of Participants Completing the Program

    Percent of enrolled participants who complete the program, defined as completing 6 out of 8 sessions.

    Post-treatment completion (enrollment to treatment completion is approximately 3 months)

  • Intervention Acceptability

    Acceptability will be assessed by the Client Satisfaction Questionnaire (CSQ-8). The intervention study will be considered acceptable if ≥80% of participants rate it as acceptable (defined as a CSQ-8 score ≥20).

    Post-treatment completion (enrollment to treatment completion is approximately 3 months)

Study Arms (1)

Psychosocial Intervention for Cancer-Related Post-Traumatic Stress in Young Adults

EXPERIMENTAL

The study team aims to evaluate the feasibility and acceptability of the adapted psychosocial intervention through a pilot trial with a group of 80 YACs, followed by mixed-methods data analysis of feasibility and acceptability outcomes.

Behavioral: Psychosocial Intervention for Cancer-Related Post-Traumatic Stress in Young Adults

Interventions

Psychosocial Intervention for Cancer-Related Post-Traumatic Stress in Young AdultsBEHAVIORAL

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.

Psychosocial Intervention for Cancer-Related Post-Traumatic Stress in Young Adults

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mass General Cancer Center

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Psychosocial Intervention

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Zeba N Ahmad, Ph.D.

CONTACT

617-724-1586zahmad2@mgh.harvard.edu

Xinghan Zhu, B.S.

CONTACT

617-724-7593xzhu@mgh.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Staff Psychologist

Study Record Dates

First Submitted

August 29, 2025

First Posted

September 8, 2025

Study Start

April 15, 2026

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

June 30, 2030

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)