Clinical trial NCT02158637: Validation Study of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Official title: Validation Study of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: PRO-CTCAE
Patient-Reported Outcomes
Common Terminology Criteria for Adverse Events
Questionnaire
Adverse Events
Symptoms
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-06-09
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients initiating or receiving chemotherapy, radiation therapy, or both at nine U.S.-based cancer centers and community oncology practices were approached in clinical waiting areas and invited to participate in this questionnaire-based study.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in PRO-CTCAE item scores between patients with good and poor performance status at the first visit (study day 1)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: St. Joseph Hospital of Orange
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Wilmington
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Baton Rouge
country: United States
facility: The Cancer Program of Our Lady of the Lake and Mary Bird Perkins
state: Louisiana
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer
state: New York
city: Spartanburg
country: United States
facility: Gibbs Cancer Center
state: South Carolina
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Mayo Clinic
name: Amylou C. Dueck, PhD
role: STUDY_CHAIR
References:
citation: Bennett AV, Dueck AC, Mitchell SA, Mendoza TR, Reeve BB, Atkinson TM, Castro KM, Denicoff A, Rogak LJ, Harness JK, Bearden JD, Bryant D, Siegel RD, Schrag D, Basch E; National Cancer Institute PRO-CTCAE Study Group. Mode equivalence and acceptability of tablet computer-, interactive voice response system-, and paper-based administration of the U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Health Qual Life Outcomes. 2016 Feb 19;14:24. doi: 10.1186/s12955-016-0426-6.