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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06434402
• Other study ID #: 2024-0440
• Secondary ID: NCI-2024-04531
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2024
• Est. completion date: September 1, 2026

Study information

• Verified date: June 2024
• Source: M.D. Anderson Cancer Center
• Contact: Qian Lu, MD,PHD
• Phone: (713) 745-8324
• Email: qlu[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion criteria:

• Age 15-39 years at cancer diagnosis
• Age 18-39 years at study entry
• Within 5 years of diagnosis of stage II-IV cancer
• Completed active treatment (participants receiving maintenance therapy remain eligible)
• No evidence of disease
• 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.

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Behavioral Intervention
Write about cancer experiences

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   MD Anderson Cancer Center