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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04050072
• Other study ID #: PROSYM
• Secondary ID: 1R01CA238368-01A
• Status: Recruiting
• Start date: December 16, 2019
• Est. completion date: July 2024

Study information

• Verified date: September 2023
• Source: St. Jude Children's Research Hospital
• Contact: I-Chang Huang, PhD
• Phone: 866-278-5833
• Email: referralinfo[@]stjude.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 765
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Survivorship

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Years 4 and 5

External Links

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