Assessing symptoms in adult survivors of childhood cancer
Patient-Reported Outcome Version of the Common Criteria for Adverse Events
This study is trying to find out the best ways to understand and track health symptoms in adults who survived childhood cancer to improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 765 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT04050072 on ClinicalTrials.gov |
What this trial studies
This observational study aims to adapt the Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) to better assess symptomatic adverse events in adult survivors of childhood cancer. By utilizing qualitative research and psychometric methodologies, the study will identify and validate relevant symptoms that impact the quality of life and health outcomes for these survivors. The findings could enhance survivorship care by implementing risk-based symptom screening to monitor and anticipate adverse health events.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16 and older who are at least 5 years post-diagnosis of pediatric cancer and are not currently undergoing cancer treatment.
Not a fit: Patients with severe neurocognitive impairments or those unable to communicate in English may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved symptom management and quality of life for adult survivors of childhood cancer.
How similar studies have performed: Other studies have successfully adapted symptom assessment tools for different populations, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \> or equal to16 years of age at the time of enrollment * \> or equal to 5 years from initial diagnosis of pediatric cancer/malignancy (for CCSS and SJLIFE survivors only) and currently not receiving cancer therapies. Exclusion Criteria: * Have a known severe neurocognitive impairment, which requires proxies/parents to complete the survey * Have \< third grade reading level or are not able to communicate in English * Unable to use and/or access internet or computer/tablet (for survey only) * Unable to communicate and read in English
Where this trial is running
Memphis, Tennessee
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: I-Chang Huang, PhD — St. Jude Children's Research Hospital
- Study coordinator: I-Chang Huang, PhD
- Email: referralinfo@stjude.org
- Phone: 866-278-5833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.