A Virtual, Group-Based, Expressive Writing Intervention for Survivors of Adolescent and Young Adult Cancer
- Conditions
- Cancer
- Interventions
- Behavioral: Behavioral Intervention
- Registration Number
- NCT06434402
- Lead Sponsor
- M.D. Anderson Cancer Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Young adults (ages 26-39 years) Behavioral Intervention 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. Emerging adults (ages18-25 years) Behavioral Intervention 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. General group (ages 18-39 years) Behavioral Intervention 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.
- Primary Outcome Measures
Name Time Method Intervention Adherence Rate 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 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 Outcome Measures
Name Time Method Perceived Stress 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.
Common Humanity & Self-Kindness 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.
Coping self-efficacy 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.
Impact of Event Scale 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.
Functional Assessment of Cancer Therapy-General 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.
Posttraumatic growth 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.
Trial Locations
- Locations (1)
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States