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OpenTrials
Active, Not Recruiting

NCT Number: NCT06434402

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

behavioral intervention

Behavioral

Write about cancer experiences

Other names: Behavior Condition Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Treatment

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. Functional Assessment of Cancer Therapy-General

    Time frame: Baseline, and 1- and 3-month follow-up

    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.

  2. Perceived Stress

    Time frame: Baseline, and 1- and 3-month follow-up

    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.

  3. Coping self-efficacy

    Time frame: Baseline, and 1- and 3-month follow-up

    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.

  4. Impact of Event Scale

    Time frame: Baseline, and 1- and 3-month follow-up

    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.

  5. Common Humanity & Self-Kindness

    Time frame: Baseline, and 1- and 3-month follow-up

    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.

  6. Posttraumatic growth

    Time frame: Baseline, and 1- and 3-month follow-up

    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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 30, 2024
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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