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

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT02158637

Collaborator

National Cancer Institute (NCI) (NIH)

1,100

Enrollment

Locations

79.4

Actual Duration (Months)

122.2

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cancer

Study Design

Study Type:

Observational

Actual Enrollment :

1100 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 13, 2017

Arms and Interventions

Arm	Intervention/Treatment
Cancer patients receiving treatment Patients receiving active treatment for cancer or initiating treatment for cancer in the next 7 days

Outcome Measures

Primary Outcome Measures

Difference in PRO-CTCAE item scores between patients with good and poor performance status at the first visit (study day 1) [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Joseph Hospital of Orange	Orange	California	United States	92868
2	Hartford Hospital	Hartford	Connecticut	United States	06102
3	Christiana Care Health Services	Wilmington	Delaware	United States	19899
4	The Cancer Program of Our Lady of the Lake and Mary Bird Perkins	Baton Rouge	Louisiana	United States	70809
5	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
6	Mayo Clinic	Rochester	Minnesota	United States	55905
7	Memorial Sloan-Kettering Cancer	New York	New York	United States	10065
8	Gibbs Cancer Center	Spartanburg	South Carolina	United States	29303
9	MD Anderson Cancer Center	Houston	Texas	United States	77030