NCT05975333

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
14mo left

Started Aug 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Aug 2023Jul 2027

First Submitted

Initial submission to the registry

July 27, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

August 2, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2024

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Expected
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

July 27, 2023

Last Update Submit

March 27, 2026

Conditions

Keywords

AdolescentsYoung AdultsWriting InterventionInterview

Outcome Measures

Primary Outcomes (3)

  • Number of touchpoints that participants have with the narrative medicine expert/guide

    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

    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

    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

Study Arms (1)

Participants

EXPERIMENTAL

Adolescents and young adults (AYA) patients aged 15-25 years currently receiving cancer-directed therapy at St. Jude Children's Research Hospital

Behavioral: WritingBehavioral: Interview

Interventions

WritingBEHAVIORAL

Participants will be asked to write about their experiences with cancer, guided by several specific open-ended writing prompts to spark ideas.

Participants
InterviewBEHAVIORAL

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.

Also known as: Questions
Participants

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • If the parents have not responded or not interviewed till July 31, 2027.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Related Links

MeSH Terms

Interventions

Functional LateralityInterviews as Topic

Intervention Hierarchy (Ancestors)

Dominance, CerebralNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Erica Kaye, MD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2023

First Posted

August 3, 2023

Study Start

August 2, 2023

Primary Completion

May 17, 2024

Study Completion (Estimated)

July 1, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be made available at the time of article publication.
Access Criteria
Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.

Locations