## Protocol Section
### Identification Module
**NCT ID:** NCT06434402

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

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

#### Organization Study ID Info
**ID:** 2024-0440
#### Organization
**Class:** OTHER
**Full Name:** M.D. Anderson Cancer Center
#### Secondary ID Infos
**Domain:** NCI-CTRP Clinical Registry
**ID:** NCI-2024-04531
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2028-09-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** OTHER

**Name:** M.D. Anderson Cancer Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will be asked to write about your experiences 1 time each week for 4 weeks. You will receive prompts for these essays from the study staff.

You will also complete 3 questionnaires about things like your mood, your health, and demographic information (age, race, sex, and so on). These should take about 20 minutes to complete each time. You will complete these at the beginning of the study, and then 1 and 3 months later.

**Intervention Names:**

- Behavioral: Emerging adults (ages18-25 years)

**Label:** Emerging adults (ages18-25 years)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants will be asked to write about your experiences 1 time each week for 4 weeks. You will receive prompts for these essays from the study staff.

You will also complete 3 questionnaires about things like your mood, your health, and demographic information (age, race, sex, and so on). These should take about 20 minutes to complete each time. You will complete these at the beginning of the study, and then 1 and 3 months later.

**Intervention Names:**

- Behavioral: Young adults (ages 26-39 years)

**Label:** Young adults (ages 26-39 years)

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Participants will be asked to write about your experiences 1 time each week for 4 weeks. You will receive prompts for these essays from the study staff.

You will also complete 3 questionnaires about things like your mood, your health, and demographic information (age, race, sex, and so on). These should take about 20 minutes to complete each time. You will complete these at the beginning of the study, and then 1 and 3 months later.

**Intervention Names:**

- Behavioral: General group (ages 18-39 years)

**Label:** General group (ages 18-39 years)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Emerging adults (ages18-25 years)

**Description:** Participants may be randomly selected to participate in a 30-minute interview discussing your experiences with the study activities. The study team will inform you if you are selected and provide further details.

**Name:** Emerging adults (ages18-25 years)

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Young adults (ages 26-39 years)

**Description:** Participants may be randomly selected to participate in a 30-minute interview discussing your experiences with the study activities. The study team will inform you if you are selected and provide further details.

**Name:** Young adults (ages 26-39 years)

**Type:** BEHAVIORAL

#### Intervention 3

**Arm Group Labels:**

- General group (ages 18-39 years)

**Description:** Participants may be randomly selected to participate in a 30-minute interview discussing your experiences with the study activities. The study team will inform you if you are selected and provide further details.

**Name:** General group (ages 18-39 years)

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Assed utilizing the Functional Assessment of Cancer Therapy-General (FACT-G) will be used to measure multidimensional QOL (physical, social, emotional, and functional well-being)

**Measure:** Quality of Life (QoL)

**Time Frame:** Through study completion; an average of 1 year.

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 39 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** qlu@mdanderson.org

**Name:** Qian Lu, MD,PHD

**Phone:** (713) 745-8324

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Houston

**Contacts:**

***Contact 1:***

- **Email:** qlu@mdanderson.org

- **Name:** Qian Lu, MD,PHD

- **Phone:** 713-745-8324

- **Role:** CONTACT

***Contact 2:***

- **Name:** Qian Lu, MD,PHD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** MD Anderson Cancer Center

**State:** Texas

**Status:** RECRUITING

**Zip:** 77030

#### Overall Officials

**Official 1:**

**Affiliation:** M.D. Anderson Cancer Center

**Name:** Qian Lu, MD,PHD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### See Also Links

**Label:** MD Anderson Cancer Center

**URL:** http://www.mdanderson.org

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
