Symptom Burden in Chronic Myeloid Leukemia (CML)

Status unconfirmed

Conditions studied: Leukemia

In brief

Objectives: The objective of this study is to measure and delineate the symptom burden experienced by patients with chronic myeloid leukemia (CML). The Primary Aim is to develop and validate an M. D. Anderson Symptom Inventory (MDASI) module (the MDASI-CML), compliant with FDA standards for patient-reported outcomes (PROs), to measure the severity of multiple symptoms and the impact of these symptoms on daily functioning in patients with CML. The Secondary Aims are: 1. to develop a detailed description of the severity and interference with daily activities of symptoms experienced by patients with CML; 2. to assess the impact of symptom severity in CML on standard functioning and quality of life (QOL) measures including Eastern Cooperative Oncology Group (ECOG) Performance Status and single-item QOL scale; 3. to evaluate the MDASI-CML as an estimate of functional status and QOL in patients with CML; 4. to identify common clusters of symptoms and symptom patterns occurring over multiple measurement time points in patients with CML; 5, to define the qualitative symptom burden of patients with CML; 6\. to explore the feasibility of the Interactive Voice Response (IVR) system in measuring symptom severity and interference with daily activities over time in patients with CML.

Key facts

Study ID

NCT01046305

Run by

M.D. Anderson Cancer Center

People needed

210

Starts

2009-11-01

Expected to finish

2020-11-30

Last updated by the study team

2020-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18 years of age or older (Patient and family caregiver only)
• Ability to speak and read English (All participants)
• Live in the United States (Patient Phase 3 only)
• Diagnosis of Philadelphia chromosome positive CML confirmed by pathological and cytogenetic analysis (Patient only)
• Being followed at M.D. Anderson Cancer Center (Patient only)
• Consent to participate (All participants)
• Treatment for CML for at least 1 year (Patient Phase 2 only)
• Family caregiver also willing to receive packet for expert panel participation (Patient Phase 2 only)
• Physician or nurse with at least 5 years experience caring for patients with CML (Professional expert only)
• At least one publication in the last 5 years dealing with CML (Physician professional expert only)
• Identification as a family caregiver by a patient with CML (Family caregiver only)
• Patient also willing to receive packet for expert panel participation (Family caregiver only)

You may not qualify if…

• Medical condition or impaired performance status that would preclude participation in the study (Patient only)
• Diagnosis of active psychosis or severe cognitive impairment as determined by primary physician (Patient only)
• Active treatment (systemic drug therapy or radiation therapy) for a second malignancy (Patient only Phase 3)

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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