NCT06434402

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable cancer

Timeline
4mo left

Started May 2024

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress86%
May 2024Sep 2026

First Submitted

Initial submission to the registry

May 21, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

May 22, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

2.3 years

First QC Date

May 21, 2024

Last Update Submit

January 15, 2026

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

  • Study Completion Rate

    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.

    At 1 month follow-up

  • Intervention Adherence Rate

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

    At the end of intervention (week 8)

Secondary Outcomes (6)

  • Functional Assessment of Cancer Therapy-General

    Baseline, and 1- and 3-month follow-up

  • Perceived Stress

    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

  • Common Humanity & Self-Kindness

    Baseline, and 1- and 3-month follow-up

  • +1 more secondary outcomes

Study Arms (3)

Emerging adults (ages18-25 years)

EXPERIMENTAL

Participants complete questionnaires over 20 minutes about their mood, health, and demographic information at baseline, and 1, and 3 months. Participants are asked to write about their cancer experiences over 20 minutes (non-stop) for 4 weeks.

Behavioral: Behavioral Intervention

Young adults (ages 26-39 years)

EXPERIMENTAL

Participants complete questionnaires over 20 minutes about their mood, health, and demographic information at baseline, and 1, and 3 months. Participants are asked to write about their cancer experiences over 20 minutes (non-stop) for 4 weeks.

Behavioral: Behavioral Intervention

General group (ages 18-39 years)

EXPERIMENTAL

Participants complete questionnaires over 20 minutes about their mood, health, and demographic information at baseline, and 1, and 3 months. Participants are asked to write about their cancer experiences over 20 minutes (non-stop) for 4 weeks.

Behavioral: Behavioral Intervention

Interventions

Behavioral InterventionBEHAVIORAL

Write about cancer experiences

Also known as: Behavior Condition Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Treatment
Emerging adults (ages18-25 years)General group (ages 18-39 years)Young adults (ages 26-39 years)

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Qian Lu, MD,PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Lu, MD,PHD

CONTACT

(713) 745-8324qlu@mdanderson.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2024

First Posted

May 30, 2024

Study Start

May 22, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

US(1)