CancerNCT06434402
A Virtual, Group-Based, Expressive Writing Intervention for Survivors of Adolescent and Young Adult Cancer
A study testing Behavioral Intervention in people with Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Cancer
- What is being tested?
- Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Nonmelanoma skin cancer
- Major mental health disorder (e.g., schizophrenia or bipolar disorder [determined from patient records or self-disclosure])
- No internet access.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Cancer
- Being tested
- Behavioral Intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
Also called Behavior Condition Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Write about cancer experiences
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral Intervention |
| 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. Receives: Behavioral: Behavioral Intervention |
| 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. Receives: Behavioral: Behavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: At the end of intervention (week 8)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, and 1- and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start22 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Qian Lu, MD,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434402
- Sponsor's protocol ID
- 2024-0440
- Other IDs
- NCI-2024-04531
- Status last verified
- Oct 2026
- First submitted
- 21 May 2024
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Choi E, Roth ME, Hacker E, Li Y, Lu Q. A Virtual, Group-Based Expressive Writing Intervention for Survivors of Adolescent and Young Adult Cancer: Protocol for a Single-Arm Feasibility Study. JMIR Res Protoc. 2026 Jun 12;15:e93460. doi: 10.2196/93460.
PubMed 42284587
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual, Group-Based, Expressive Writing Intervention for Survivors of Adolescent and Young Adult Cancer
- ClinicalTrials.gov ID
- NCT06434402
- Acronym / sponsor ID
- 2024-0440
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Emerging adults (ages18-25 years) | Experimental | Behavioral: Behavioral InterventionParticipants 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. |
| Young adults (ages 26-39 years) | Experimental | Behavioral: Behavioral InterventionParticipants 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) | Experimental | Behavioral: Behavioral InterventionParticipants 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Nonmelanoma skin cancer
- Major mental health disorder (e.g., schizophrenia or bipolar disorder [determined from patient records or self-disclosure])
- No internet access.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral InterventionAlso: Behavior Condition Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior TherapyWrite about cancer experiences | Behavioural | Emerging adults (ages18-25 years), General group (ages 18-39 years), Young adults (ages 26-39 years) |
Primary outcome
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.
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).
6 secondary outcomes
Functional Assessment of Cancer Therapy-General
Time frame: Baseline, and 1- and 3-month follow-up
Perceived Stress
Time frame: Baseline, and 1- and 3-month follow-up
Coping self-efficacy
Time frame: Baseline, and 1- and 3-month follow-up
Impact of Event Scale
Time frame: Baseline, and 1- and 3-month follow-up
Common Humanity & Self-Kindness
Time frame: Baseline, and 1- and 3-month follow-up
Posttraumatic growth
Time frame: Baseline, and 1- and 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Derived from this study: PubMed 42284587Choi E, Roth ME, Hacker E, Li Y, Lu Q. A Virtual, Group-Based Expressive Writing Intervention for Survivors of Adolescent and Young Adult Cancer: Protocol for a Single-Arm Feasibility Study. JMIR Res Protoc. 2026 Jun 12;15:e93460. doi: 10.2196/93460.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qian Lu, MD,PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention in people with Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Completion Rate (time frame: At 1 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06434402, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.