MDACC Study Summary 2008-0178 (Archived)

Study Summary
No. 2008-0178:.......Other Studies......Razelle Kurzrock......Investigational Cancer Therapeutics

Study Summary Title



Study Summary Number:	2008-0178

Study Title:	Qualitative Research in Castlemans Disease: Exploring Patients' Perspectives through Interviews

Physician

New Patient Referral



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

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

Phone:	713-563-1930 Contact us about clinical trials

General Information



Disease Group:	Other Studies	Supported By:	Centocor United BioSource Corporation (UBC)

Phase of Study:	N/A	Return Visit:	None.

Treatment Agents:	Questionnaire	Home Care:	The telephone interview will be conducted at the patients' home. In addition, the patients will fill out the questionnaires (MDASI and sociodemographic questionnaire) at home.

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 more about your experiences as a patient with MCD through 2 questionnaires and a one-on-one telephone interview. Researchers also want to learn how easy 1 of the 2 questionnaires is to complete and understand.

Study Objectives / Outcomes

The objective of this study is to gather qualitative data from patients with Multicentric Castlemans Disease (MCD) through semi-structured interviews in order to better understand the disease experience from patients' perspectives, and to assist Centocor with evaluating the content validity of a patient-reported outcome (PRO) instrument for inclusion in their MCD clinical trial program. Specifically, the objectives are (1) to conduct semi-structured interviews with MCD patients in order to better understand disease experience, symptoms, and symptom impact from patients' perspectives; and (2) to evaluate the content validity of the MD Anderson Symptom Inventory (MDASI) for use in a clinical trial program with this patient population.

Study Status Information



Study Activation / Registration Date:	08/08/2008

IRB Review and Approval Date:	08/08/2008

Study Type:	Behavioral

Recruitment Status:	Terminated

Projected Accrual:	10-12

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) Current participation in Centocor's T03 Clinical trial with a clinical diagnosis of MCD.

2) Be willing and able to provide written informed consent at the clinical site and participate in a one-time telephone interview with United BioSource Corporation (UBC) study staff.

3) Be at least 18 years old.

4) Be able to read and understand English.

Exclusion Criteria:

1) Presence of any clinically relevant condition that, in the opinion of the investigator/ coordinator (based on recall or medical record review), would interfere with completing the study including, but not limited to, visual problems, cognitive impairment or acute mental illness.

Links

Registration Number: Not Applicable Clinical Trial