Patient-Reported Outcome Version of the Common Criteria for Adverse Events

NCT04050072 | Active Not Recruiting

• 2 other identifiers: PROSYM1R01CA238368-01A1
• Study Type: observational
• Target: 837
• Locations: 1 country
• Sites: 1

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

Conditions

Survivorship; Cancer

Keywords

Adverse Events

Outcome Measures

Primary Outcomes (1)

• 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.

  Years 1-5

Secondary Outcomes (1)

• Core and Target Scales of the PRO-CTCAE-SCC

  Years 4 and 5

Study Arms (3)

Childhood Cancer Survivors (CCSS)

i. PRO-CTCAE-SCC ii.Quality of life assessment

Other: Childhood Cancer Survivors (CCSS)

St. Jude Life (SJLIFE)

i. PRO-CTCAE-SCC ii. Quality of life assessment iii. Comprehensive medical evaluation, physical performance evaluation, and neurocognitive evaluation

Other: SJLIFE

Community non-cancer control

i. PRO-CTCAE-SCC ii.Quality of life assessment

Other: Community non-cancer control

Interventions

Childhood Cancer Survivors (CCSS) OTHER

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

Childhood Cancer Survivors (CCSS)

SJLIFE OTHER

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

St. Jude Life (SJLIFE)

Community non-cancer control OTHER

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

Community non-cancer control

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All participants who meet eligibility criteria and consent to enrollment on the study.

You may qualify if:

• \> 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Neoplasms

Study Officials

• I-Chang Huang, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 8, 2019
• Study Start: December 16, 2019
• Primary Completion: July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

US (1)