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Clinical Trials/NCT06434402
NCT06434402
Recruiting
N/A

A Virtual, Group-Based, Expressive Writing Intervention for Survivors of Adolescent and Young Adult Cancer

M.D. Anderson Cancer Center1 site in 1 country30 target enrollmentMay 22, 2024
ConditionsCancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cancer
Sponsor
M.D. Anderson Cancer Center
Enrollment
30
Locations
1
Primary Endpoint
Intervention Adherence Rate
Status
Recruiting
Last Updated
3 months ago

Overview

Brief Summary

To learn more about the experiences of adolescent and young adult cancer survivors and investigate whether a group-based writing intervention can help to improve quality of life of adolescent and young adult cancer survivors.

Detailed Description

Primary Objective: To evaluate the feasibility of a virtual, group-based expressive writing intervention for survivors of adolescent and young adult cancer. Secondary Objective: To preliminarily assess the impact of the study for cancer survivors.

Registry
clinicaltrials.gov
Start Date
May 22, 2024
End Date
September 1, 2026
Last Updated
3 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 15 - 39 years at cancer diagnosis
  • Age 18 - 39 years at study entry
  • Diagnosed between 1 and 5 years ago prior to enrollment
  • Can speak, read, and write in English

Exclusion Criteria

  • Nonmelanoma skin cancer
  • Major mental health disorder (e.g., schizophrenia or bipolar disorder \[determined from patient records or self-disclosure\])
  • No internet access.

Outcomes

Primary Outcomes

Intervention Adherence Rate

Time Frame: At the end of intervention (week 8)

The intervention adherence rate will be calculated as the number of completed writing tasks divided by the total number of assigned tasks (4).

Study Completion Rate

Time Frame: At 1 month follow-up

The Study completion rate is defined as the average proportion of participants who complete follow-up assessments at 1-month follow-up. We will also calculate the 95% confidence intervals for the study completion rate.

Secondary Outcomes

  • Perceived Stress(Baseline, and 1- and 3-month follow-up)
  • Common Humanity & Self-Kindness(Baseline, and 1- and 3-month follow-up)
  • Coping self-efficacy(Baseline, and 1- and 3-month follow-up)
  • Impact of Event Scale(Baseline, and 1- and 3-month follow-up)
  • Functional Assessment of Cancer Therapy-General(Baseline, and 1- and 3-month follow-up)
  • Posttraumatic growth(Baseline, and 1- and 3-month follow-up)

Study Sites (1)

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