MDACC Study Summary 2009-0258

Study Summary
No. 2009-0258:.......Hematologic Disorder......Khanh T. Nguyen......Leukemia

Study Summary Title



Study Summary Number:	2009-0258

Study Title:	Prognostic Significance and Longitudinal Assessment of Patient-Reported Quality of Life and Symptoms in Higher-Risk Myelodysplastic Syndromes. A Large-Scale International, Observational Study.

Physician

New Patient Referral



Name:	Khanh T. Nguyen	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

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

Phone:	713-563-0295 Contact us about clinical trials

General Information



Disease Group:	Hematologic Disorder	Supported By:	GIMEMA Foundation, Rome

Phase of Study:	N/A	Return Visit:	N/A (questionnaires are mailed).

Treatment Agents:	None	Home Care:	N/A

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

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this research study is to learn more about the symptoms of the disease and/or its treatment of as well as the quality of life of patients with myelodysplasia.

Study Objectives / Outcomes

The primary objective is to investigate the prognostic value of baseline (i.e. pre-treatment) patients' reported fatigue for overall survival in two populations of newly diagnosed intermediate-2 and high risk Myelodysplastic syndrome (MDS) patients according to the International Prognostic Scoring System (IPSS) classification.

Secondary objectives are:
-to prospectively evaluate short-term Quality of Life (QoL) and symptoms.
-to establish international QoL and symptoms baseline reference data to be used as benchmarks for comparisons in future therapeutic trials.
-to investigate the prognostic value of early changes of QoL and symptoms (from baseline to week 4) for overall survival and disease progression (i.e., Acute Myeloid Leukemia (AML) transformation; defined as an increase of blasts to a level of > than or = to 20%).
-to investigate the prognostic value of various baseline patients' reported QoL and symptoms for overall survival and AML transformation.
-to devise a prognostic patient-based index.
-to evaluate accuracy of clinical prediction of survival.
-to assess patients' preferences for involvement in treatment decision-making and the relationships between preferences and patient characteristics. This project will investigate this issue by helping to understand patient's preferences and possibly identify patients who would benefit most from a shared decision-making approach.
-to compare patient's stated preferences for involvement in treatment decision with the perceptions of their treating physicians.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	09/23/2009

Study Type:	Observational

Recruitment Status:	Open

Projected Accrual:	344

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 with newly diagnosed MDS with IPSS risk score of intermediate-2 and high-risk. The diagnosis of MDS with IPSS risk score of intermediate-2 and high-risk is acceptable within 6 months before date of registration.

2) Patients with IPSS risk score of intermediate-2 and high risk who have progressed from lower IPSS risk scores (intermediate 1 or low) and have received any kind of treatment (except for transplantation).

3) Having a full baseline QoL Evaluation completed (i.e., European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Version 3 (EORTC QLQ-C30); Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) and Control Preference Scale).

4) Adult patients (> or = 18 years old).

5) Written informed consent provided.

6) Patients who have been enrolled into other study therapy protocols (including investigational protocol treatments) are also eligible.

Exclusion Criteria:

1) Patients already diagnosed with MDS with IPSS risk score of intermediate-2 and high-risk who have received treatment except for supportive therapy with transfusions (i.e. RBC or platelets).

2) Prior history of leukemia or other cancers (excluding epithelial basalioma) and patients with secondary MDS.

3) Having any kind of psychiatric disorder or major cognitive dysfunction.

4) Not able to read and understand local language.

Links

Registration Number: NCT00809575
Study Information on Clinical Trials Registry (clinicaltrials.gov)