Validation Study of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Cancer Clinical Trial

Official title:

Validation Study of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02158637
• Other study ID #: 10-002504 / MC1091
• Secondary ID: MC1091
• Status: Completed
• Phase: N/A
• First received: June 4, 2014
• Last updated: May 23, 2017
• Start date: August 2010
• Est. completion date: March 13, 2017

Study information

• Verified date: May 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is being done to try out questions from a large set of questions called the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The PRO-CTCAE is a set of questions which asks patients about their symptoms. This study will look at properties of these questions and will provide information about how these questions can be improved for research studies. PRO-CTCAE questions were developed under a contract from the National Cancer Institute (NCI) to allow patients to self-report symptoms in future cancer clinical trials. Patients with cancer receiving treatment will complete a web-based questionnaire containing PRO-CTCAE questions and a paper booklet containing a commonly used questionnaire for assessing quality of life, functioning, and symptoms at two visits one to six weeks apart. Some patients will additionally complete web-based questionnaires containing PRO-CTCAE questions weekly for four to five weeks, while completing a daily questionnaire containing PRO-CTCAE questions using an automated telephone system. Lastly, a small number of patients will complete only a single visit in which a web-based, telephone-based, and paper-based questionnaire containing PRO-CTCAE items is completed in addition to a paper booklet containing a commonly used questionnaire for assessing quality of life, functioning, and symptoms. The primary hypothesis is that scores for PRO-CTCAE questions will differ between patients with high versus low general well-being as measured by your doctor using a scale called the Eastern Cooperative Oncology Group Performance Score.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: March 13, 2017
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age greater than or equal to 18 years

• Disease and treatment matching 1 of 7 following cohorts: breast cancer receiving chemotherapy or initiating chemotherapy in the next 7 days; lymphoma/myeloma receiving chemotherapy or initiating chemotherapy in the next 7 days; metastatic prostate or bladder cancer receiving chemotherapy or initiating chemotherapy in the next 7 days; metastatic or locally advanced lung cancer receiving chemotherapy or initiating chemotherapy in the next 7 days or receiving radiation therapy for greater than or equal to 21 more days; metastatic colorectal cancer receiving chemotherapy or initiating chemotherapy in the next 7 days; head, neck, or gastroesophageal cancer receiving radiation therapy for greater than or equal to 21 more days; any cancer enrolled through an National Cancer Institute Community Cancer Centers Program site

• Willing to return to registering institution in 1-6 weeks (subset only)

• Eastern Cooperative Oncology Group Performance Status 0-4

• Ability to understand English and read questions on a computer screen

• Ability to hear and respond to questions in English using a telephone keypad (subset only)

• Ability to complete questionnaire(s) by themselves or with assistance

• Provide informed written consent

• Willing to be reached at a single telephone number (without extension or operator involvement) for the next 21 to 28 days (subset only)

• Ability to participate in the study visit lasting 45-60 minutes total, including the informed consent process, being shown by study staff how to use each mode of administration (computer, automated telephone, and paper), and completing questionnaires (subset only)

Exclusion Criteria:

• Clinically significant cognitive or memory impairment in the opinion of clinical or research staff

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
United States	The Cancer Program of Our Lady of the Lake and Mary Bird Perkins	Baton Rouge	Louisiana
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Hartford Hospital	Hartford	Connecticut
United States	MD Anderson Cancer Center	Houston	Texas
United States	Memorial Sloan-Kettering Cancer	New York	New York
United States	St. Joseph Hospital of Orange	Orange	California
United States	Mayo Clinic	Rochester	Minnesota
United States	Gibbs Cancer Center	Spartanburg	South Carolina
United States	Christiana Care Health Services	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in PRO-CTCAE item scores between patients with good and poor performance status at the first visit (study day 1)		1 day