- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05975333
Writing Intervention With Adolescents and Young Adults With Cancer
ChronCan (Chronicling Cancer): Piloting a Novel Writing Intervention With Adolescents and Young Adults With Cancer
Young people with cancer have difficult experiences and writing exercises may help improve their well-being. However, very few studies have examined how a creative writing activity might be useful for young people with cancer. In this pilot study, researchers at St. Jude Children's Research Hospital hope to explore whether teenagers and young adults with cancer want to participate in a writing exercise and whether they find it to be valuable.
Primary Objective
To assess the feasibility and acceptability of a writing-based narrative medicine intervention for adolescent and young adult patients with cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants will be given the opportunity to write about their experiences with cancer, with support and guidance from an expert writer. Participants will meet briefly with the expert at the start of the exercise (15-30 minutes), and they can choose to meet 1-3 additional times with the expert over the next 2 months to receive further support if they wish.
After completing the writing exercise, participants will do an informal interview to share their thoughts about whether the experience of writing felt helpful or not. The post-intervention interview will occur at around 2 months after enrollment, +/- 1 month. Patients may participate in a second informal semi-structured interview 6 to 12 months after completing the first interview. Additionally, bereaved parents may participate in an informal interview on study.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Erica Kaye, MD
- Phone Number: 888-226-4343
- Email: referralinfo@stjude.org
Study Locations
-
-
Tennessee
-
Memphis, Tennessee, United States, 38105
- Recruiting
- St. Jude Children's Research Hospital
-
Principal Investigator:
- Erica Kaye, MD
-
Contact:
- Erica Kaye, MD
- Phone Number: 888-226-4343
- Email: referralinfo@stjude.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 15-25
- Currently receiving cancer-directed therapy
- Active patient at St. Jude Children's Research Hospital
- Parent of a ChronCan participant who has passed away
Exclusion Criteria:
- Does not meet the inclusion criteria
- If the parents have not responded or not interviewed till July 31, 2027.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Participants
Adolescents and young adults (AYA) patients aged 15-25 years currently receiving cancer-directed therapy at St. Jude Children's Research Hospital
|
Participants will be asked to write about their experiences with cancer, guided by several specific open-ended writing prompts to spark ideas.
Following completion of the writing exercise, participants will reflect on their experiences with the writing intervention in a semi-structured private interview with a member of the research team.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of touchpoints that participants have with the narrative medicine expert/guide
Time Frame: During the narrative exercise, up to 2 months after enrollment
|
To determine intervention feasibility, the number of touchpoints that participants have with the narrative medicine expert/guide will be tracked
|
During the narrative exercise, up to 2 months after enrollment
|
|
Number of participants who complete the writing exercise
Time Frame: During the narrative exercise, up to 2 months after enrollment
|
To determine intervention feasibility, the number of participants who complete the writing exercise will be tracked
|
During the narrative exercise, up to 2 months after enrollment
|
|
Intervention acceptability
Time Frame: Post-intervention interview will occur after the narrative exercise is completed at around 2 months after enrollment, +/- 1 month
|
Comparison of acceptability between participants who did/did not participate in the optional check-ins.
Analysis of de-identified semi-structured interviews will be done.
Interviews will be recorded, transcribed, de-identified, and analyzed using content analysis, an inductive approach that includes memo-writing, codebook development, coding, reconciliation, and synthesis to identify emerging patterns and themes.
|
Post-intervention interview will occur after the narrative exercise is completed at around 2 months after enrollment, +/- 1 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Erica Kaye, MD, St. Jude Children's Research Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Health Care Quality, Access, and Evaluation
- Musculoskeletal and Neural Physiological Phenomena
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Nervous System Physiological Phenomena
- Dominance, Cerebral
- Interviews as Topic
- Functional Laterality
Other Study ID Numbers
- ChronCan
- NCI-2023-06074 (Registry Identifier: NCI Clinical Trial Registration Program)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer Patients
-
Jiandong ZhangRecruiting
-
Institute of Liver and Biliary Sciences, IndiaCompleted
-
Canon Medical Systems, USACompleted
-
Milton S. Hershey Medical CenterCompleted
-
Thomas SeufferleinUnknown
-
Hospices Civils de LyonCompleted
-
Beni-Suef UniversityRecruiting
-
Memorial Sloan Kettering Cancer CenterColumbia University; NYU Langone Health; Roswell Park Cancer Institute; Jacobi... and other collaboratorsActive, not recruiting
-
KTO Karatay UniversityCompleted
-
University Hospital, Basel, SwitzerlandCompletedCancer PatientsSwitzerland
Clinical Trials on Writing
-
University of North Carolina, Chapel HillAmerican Cancer Society, Inc.CompletedLeukemia | Multiple Myeloma | Acute Leukemia | Psychological Distress | Acute Lymphocytic Leukemia | Hematological CancersUnited States
-
Kinnaird College for WomenNot yet recruitingPsychological DistressPakistan
-
Minneapolis Veterans Affairs Medical CenterUnited States Department of Defense; US Department of Veterans AffairsCompletedPosttraumatic Stress DisorderUnited States
-
Trustees of Princeton UniversityCompleted
-
University of WaterlooCompletedThe Effects of Expressive Writing and Compassionate Letter Writing on Emotional Distress IntoleranceDistress IntoleranceCanada
-
Intermountain Health Care, Inc.Unknown
-
Universidad Industrial de SantanderUnknown
-
Boston UniversityTakeda Pharmaceuticals North America, Inc.CompletedIrritable Bowel Syndrome
-
Stanford UniversityBrain & Behavior Research FoundationCompleted
-
Virginia Commonwealth UniversityCompleted