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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Behavioral Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qian Lu, MD,PHD; Phone Number: (713) 745-8324; Email: qlu@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
      • Contact: Qian LU, MD,PHD; Phone Number: 713-745-8324; Email: qlu@mdanderson.org
      • Principal Investigator: Qian Lu, MD,PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Emerging adults (ages18-25 years); 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; Write about cancer experiences; Other Names: Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Treatment; Behavior Condition Therapy
Experimental: Young adults (ages 26-39 years); 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; Write about cancer experiences; Other Names: Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Treatment; Behavior Condition Therapy
Experimental: General group (ages 18-39 years); 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; Write about cancer experiences; Other Names: Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Treatment; Behavior Condition Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Assessment of Cancer Therapy-General	The Functional Assessment of Cancer Therapy-General will be used to measure multidimensional quality of life, encompassing physical, social, emotional, and functional well-being, across 27 items. Each item is rated on a 5-point Likert scale ranging from 0 to 4. The overall score can range from 0 to 108, with higher scores indicating a better quality of life.	Baseline, and 1- and 3-month follow-up
Perceived Stress	The Perceived Stress scale will be used to measure perceived stress. This 4-item measure assesses the degree to which situations in one's life are appraised as stressful. The overall score can range from 0 to 16, with higher scores indicating higher perceived stress.	Baseline, and 1- and 3-month follow-up
Coping self-efficacy	The Cancer Behavior Inventory will be used to measure self-efficacy for coping with cancer. Each item is rated on a 9-point Likert scale. The total score ranges from 9 to 81, with higher scores indicating greater self-efficacy for coping with cancer.	Baseline, and 1- and 3-month follow-up
Impact of Event Scale	The 5-item intrusion subscale of the Impact of Event Scale will be used to assess unwanted thoughts related to cancer. Each item is rated on a 4-point Likert scale. The total score ranges from 0 to 25, with higher scores indicating a greater frequency and intensity of intrusive thoughts.	Baseline, and 1- and 3-month follow-up
Common Humanity & Self-Kindness	Common Humanity and Self-Kindness will be measured using the subscales of the Self-Compassion Scale. These subscales capture positive aspects of self-compassion, including self-kindness (e.g., "When I am going through a very hard time, I give myself the caring and tenderness I need") and common humanity (e.g., "When I am down and out, I remind myself that there are lots of other people in the world feeling like me"). Each item is rated on a 5-point Likert scale. The total score for each subscale ranges from 5 to 25, with higher scores indicating a stronger sense of common humanity and self-kindness.	Baseline, and 1- and 3-month follow-up
Posttraumatic growth	The Posttraumatic Growth Inventory will be used to assess perceived positive changes as a result of a specific traumatic event. It includes 9 items, each rated on a 6-point Likert scale. The total score ranges from 0 to 45, with higher scores indicating greater perceived posttraumatic growth.	Baseline, and 1- and 3-month follow-up

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Qian Lu, MD,PHD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Psychotherapy; Behavioral Disciplines and Activities; Behavior Therapy
• Other Study ID Numbers: 2024-0440; NCI-2024-04531 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No