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

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

Interventions

OTHER

Childhood Cancer Survivors (CCSS)

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.

OTHER

SJLIFE

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.

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 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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• St. Jude Children's Research Hospital

  lead OTHER

Principal Investigators

• I-Chang Huang, PhD · St. Jude Children's Research Hospital

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-12-16

Primary Completion

2026-07-31

Completion

2027-07-31

Countries

• United States

Study Locations