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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05975333
Other study ID # ChronCan
Secondary ID NCI-2023-06074
Status Recruiting
Phase N/A
First received
Last updated
Start date August 2, 2023
Est. completion date August 2024

Study information

Verified date April 2024
Source St. Jude Children's Research Hospital
Contact Trisha K. Paul, MD
Phone 866-278-5833
Email referralinfo@stjude.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 15 Years to 25 Years
Eligibility Inclusion Criteria: - Aged 15-25 - Currently receiving cancer-directed therapy - Active patient at St. Jude Children's Research Hospital Exclusion Criteria: - Does not meet the inclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States St. Jude Children's Research Hospital Memphis Tennessee

Sponsors (1)

Lead Sponsor Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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