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

Status:	Completed
Conditions:	Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	5/25/2017
Start Date:	August 2010
End Date:	March 13, 2017

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.

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

We found this trial at

sites

The Mayo Clinic

Rochester, Minnesota 55905

from

Rochester, MN