Patient-Reported Outcome Version of the Common Criteria for Adverse Events
- Conditions
- SurvivorshipCancer
- Interventions
- Other: Community non-cancer controlOther: SJLIFEOther: Childhood Cancer Survivors (CCSS)
- Registration Number
- NCT04050072
- Lead Sponsor
- St. Jude Children's Research Hospital
- Brief Summary
Childhood cancer survivors are vulnerable to treatment-related late effects, including physical and psychosocial morbidities, subsequent malignancies, and premature death. Symptom assessment provides a unique insight into survivorship care since symptoms not only indicate the manifestation for the occurrence of chronic health conditions, but also impact quality of life and survival. The National Cancer Institute (NCI) has developed a Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to assess symptomatic adverse events (AEs) for adult-onset cancer patients who are receiving cancer therapies. However, content-appropriate and clinically validated symptom assessment tools for adult survivors of childhood cancer are not available.
Primary Object 1: Establish content validity for the PRO-CTCAE-SCC
Primary Objective 1A: Conduct a symptom selection process through qualitative research to identify symptomatic AEs for adult survivors of childhood cancer
Primary Objective 1B: Create symptomatic AE items for adult survivors of childhood cancer based on the prevalence and clinical importance ratings on the items
Primary Objective 2: Validate the PRO-CTCAE-SCC using psychometric methods and objective clinical parameters
Primary Objective 2A: Test dimensionality for the PRO-CTCAE-SCC
Primary Objective 2B: Test clinical validity for the PRO-CTCAE-SCC
Primary Objective 2C: Test responsiveness to change for the PRO-CTCAE-SCC
Secondary Objective 1: Increase clinical usefulness of the PRO-CTCAE-SCC
Secondary Objective 2: Establish meaningful cut-points and minimally important differences (MIDs) on symptom burden scores for clinical decision-making
- Detailed Description
We propose to adapt an existing symptomatic adverse event tool, the Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE), to be content appropriate and clinically meaningful for adult survivors of childhood cancer using two well-established childhood cancer survivor cohorts. Psychometric methodologies will be used to validate this tool by incorporating objective clinical anchors collected from medical evaluations. Our symptomatic AE tool has the potential to augment the Children Oncology Group Survivorship Care Guidelines by implementing risk-based symptom screening to track and anticipate adverse health events.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 765
- > 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Community non-cancer control Community non-cancer control i. PRO-CTCAE-SCC ii.Quality of life assessment St. Jude Life (SJLIFE) SJLIFE i. PRO-CTCAE-SCC ii. Quality of life assessment iii. Comprehensive medical evaluation, physical performance evaluation, and neurocognitive evaluation Childhood Cancer Survivors (CCSS) Childhood Cancer Survivors (CCSS) i. PRO-CTCAE-SCC ii.Quality of life assessment
- Primary Outcome Measures
Name Time Method PRO-CTCAE-SCC Years 1-5 Conduct a symptom selection process through qualitative research to identify symptomatic AEs for adult survivors of childhood cancer, create symptomatic AE items for adult survivors of childhood cancer based on the prevalence and clinical importance ratings on the items, test dimensionality for the PRO-CTCAE-SCC, test clinical validity for the PRO-CTCAE-SCC and test responsiveness to change for the PRO-CTCAE-SCC.
- Secondary Outcome Measures
Name Time Method Core and Target Scales of the PRO-CTCAE-SCC Years 4 and 5 Develop tailored versions for survivors of different diagnoses exposed to different therapies and establish meaningful cut-points and minimally important differences (MIDs) on symptom burden scores for clinical decision-making.
Trial Locations
- Locations (1)
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States