MDACC Study Summary ID02-567 (Archived)

Study Summary
No. ID02-567:.......Pain......Allen W. Burton......Anesthesiology

Study Summary Title



Study Summary Number:	ID02-567

Study Title:	Development and Validation of a Variant Version of the Treatment Outcomes in Pain Survey (TOPS) for Cancer-Related Pain

Physician

New Patient Referral



Name:	Allen W. Burton	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

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

Phone:	713-792-6070 Contact us about clinical trials

General Information



Disease Group:	Pain	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Only if they did not finish the survey and wish to return to do so.

Treatment Agents:	None	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:

Study Objectives / Outcomes

To assist in a multi-center study using a new pain assessment questionnaire (TOPS) in cancer patients. The TOPS is a 35 item, 10 page symptom assessment questionnaire, which take approximately 30 minutes to complete. This instrument has been validated in chronic pain syndromes (1,2). The objectives are: a) Confirming that patients with advanced cancer can complete the TOPS questionnaire, b) identifying items that may not be relevant or reliable in a cancer population, and c) generating normative data for outpatients with advanced cancer. Collected data will be used to validate various questionnaire items, not to evaluate treatment efficacy.

Study Status Information



Study Activation / Registration Date:	01/07/2003

IRB Review and Approval Date:	12/18/2002

Study Type:	Not Applicable

Recruitment Status:	Terminated

Projected Accrual:	400

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) A sample of 70 adult (18+) patients with cancer-related pain who regularly take opioid analgesics will be recruited and consented for the study. This questionnaire has only been tested in adult patients.

Exclusion Criteria:

1) The survey is not being studied in other languages at this time. It is only available in English, and only English speaking subjects who read and write will be eligible.

2) There are no known risks to participation in our study, although some subjects may experience minor anxiety completing a questionnaire with sensitive information about psychosocial aspects of their lives.

3) Subjects may decline participation if they have difficulty completing the questionnaire.

Links

Registration Number: Not Applicable Clinical Trial