An observational study in Survivorship and Cancer, sponsored by St. Jude Children's Research Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by St. Jude Children's Research Hospital · Observational
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
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 837 is above the median of 204 across 1,683 observational studies indexed under Neoplasms.
Browse Neoplasms studies →St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
All participants who meet eligibility criteria and consent to enrollment on the study.
Exclusion Criteria:
i. PRO-CTCAE-SCC ii.Quality of life assessment
Other: Childhood Cancer Survivors (CCSS)
i. PRO-CTCAE-SCC ii. Quality of life assessment iii. Comprehensive medical evaluation, physical performance evaluation, and neurocognitive evaluation
Other: SJLIFE
i. PRO-CTCAE-SCC ii.Quality of life assessment
Other: Community non-cancer control
To use the PRO-CTCAE-SCC (beta version) to identify symptomatic adverse event (AEs) that are prevalent and clinically meaningful in adult survivors of childhood cancer vs. non-cancer controls, and to create symptomatic AE items that are not included in the current PRO-CTCAE for adult survivors of childhood cancer.
Also known as: Quality of life assessment, Late medical effects and health care utilization, Lifestyle assessment
To use the current PRO-CTCAE to conduct a symptom content creation process for the PRO-CTCAE-SCC by identifying clinically meaningful symptomatic AEs for adult survivors of childhood cancer, to create symptomatic AE items not included in the current PRO-CTCAE, and to perform comprehensive medical evaluation, physical performance evaluation, and neurocognitive evaluation to clinically validate the PRO-CTCAE-SCC.
Also known as: Quality of life assessment, Comprehensive medical evaluation, physical performance evaluation, and neurocognitive evaluation
To use the PRO-CTCAE-SCC (beta version) to identify symptomatic adverse event (AEs) that are prevalent and clinically meaningful in non-cancer controls vs. adult survivors of childhood cancer, and to create symptomatic AE items that are not included in the current PRO-CTCAE for adult survivors of childhood cancer.
Also known as: Quality of life assessment, Late medical effects and health care utilization, Lifestyle assessment
PRO-CTCAE-SCC
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.
Time frame: Years 1-5
Core and Target Scales of the PRO-CTCAE-SCC
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.
Time frame: Years 4 and 5
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
St. Jude Children's Research Hospital