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

NCT ID: NCT04050072

Last Updated: 2025-10-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 837 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-16
• Study Completion Date: 2027-07-31

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.

Conditions

Survivorship; Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Childhood Cancer Survivors (CCSS)

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

Childhood Cancer Survivors (CCSS)

Intervention Type: 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.

St. Jude Life (SJLIFE)

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

SJLIFE

Intervention Type: 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.

Community non-cancer control

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

Community non-cancer control

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Quality of life assessment; Late medical effects and health care utilization; Lifestyle assessment; Quality of life assessment; Comprehensive medical evaluation, physical performance evaluation, and neurocognitive evaluation; Quality of life assessment; Late medical effects and health care utilization; Lifestyle assessment

Eligibility 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

St. Jude Children's Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

I-Chang Huang, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Countries

United States

Related Links

http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

1R01CA238368-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PROSYM

Identifier Type: -

Identifier Source: org_study_id