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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-04531 | Other Identifier | NCI-CTRP Clinical Registry |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Intervention | Behavioral | Write about cancer experiences |
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| 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) |
| 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Lu, MD,PHD | Contact | (713) 745-8324 | qlu@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Qian Lu, MD,PHD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
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| MD Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| 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 |