MDACC Study Summary 2009-0182

Study Summary
No. 2009-0182:.......Advanced Cancers; Hematologic Disorder; Solid Tumors......Tito Mendoza......Symptom Research

Study Summary Title



Study Summary Number:	2009-0182

Study Title:	Refinement of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) via Cognitive Interviewing and Usability Testing

Physician

New Patient Referral



Name:	Tito Mendoza	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Symptom Research	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-3470 Contact us about clinical trials

General Information



Disease Group:	Advanced Cancers Hematologic Disorder Solid Tumors	Supported By:	National Cancer Institute

Phase of Study:	N/A	Return Visit:	None

Treatment Agents:	None	Home Care:	Not applicable

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	None


Description/ Intervention:	The goal of this study is to learn if patients can understand a new set of descriptions of symptoms related to cancer and cancer treatment. Researchers want to learn about cancer symptoms from the patients' point of view, in order to plan how healthcare providers can talk to patients using words that patients understand.

Study Objectives / Outcomes

The scientific aim of this study is to evaluate patient comprehension of the 77 newly developed items as well as the extent to which the items correspond to the concepts of interest for each patient reported outcome (PRO).

A secondary aim of this study is to evaluate the usability of the technology interface for collecting the PRO data of the PRO-CTCAE system once it has been built to accommodate the learning garnered during the cognitive interviews.

Study Status Information



Study Activation / Registration Date:	07/24/2009

IRB Review and Approval Date:	07/24/2009

Study Type:	Behavioral

Recruitment Status:	Closed

Projected Accrual:	127

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients must be aged 18 and over

2) Able to read and understand English

3) Patients with a high school education or less

4) Patients who are undergoing chemotherapy or radiotherapy with curative or palliative intent.

5) Patient is able to provide informed consent.

6) All types of cancer diagnosis

Exclusion Criteria:

1) Significant cognitive impairment as determined by research staff's judgment

Links

Registration Number: NCT00909207
Study Information on Clinical Trials Registry (clinicaltrials.gov)