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

Completed

Conditions studied: Cancer

In brief

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.

Key facts

Study ID: NCT02158637
Run by: Mayo Clinic
People needed: 1100
Starts: 2010-08-01
Expected to finish: 2017-03-13
Last updated by the study team: 2017-05-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

St. Joseph Hospital of Orange — Orange, California, United States
Hartford Hospital — Hartford, Connecticut, United States
Christiana Care Health Services — Wilmington, Delaware, 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
Mayo Clinic — Rochester, Minnesota, United States
Memorial Sloan-Kettering Cancer — New York, New York, United States
Gibbs Cancer Center — Spartanburg, South Carolina, United States
MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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