Symptom Burden in Chronic Myeloid Leukemia (CML)
|ClinicalTrials.gov Identifier: NCT01046305|
Recruitment Status : Active, not recruiting
First Posted : January 11, 2010
Last Update Posted : October 26, 2017
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:
- to develop a detailed description of the severity and interference with daily activities of symptoms experienced by patients with CML;
- 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;
- to evaluate the MDASI-CML as an estimate of functional status and QOL in patients with CML;
- 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.
|Condition or disease||Intervention/treatment|
|Leukemia||Behavioral: Interview & Questionnaires Behavioral: Rating Questionnaire Behavioral: MDASI-CML Questionnaire|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||210 participants|
|Official Title:||Symptom Burden of Patients With Chronic Myeloid Leukemia (CML)|
|Actual Study Start Date :||November 2009|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
Part 1: Interview & Questionnaires
Patients interviews and questionnaires about CML symptoms once.
Behavioral: Interview & Questionnaires
30 Minute Interview about what it is like to have CML, followed by symptom questionnaire, quality-of-life questionnaire, and demographic questions taking another 10 minutes for all 3 questionnaires.
Other Name: Survey
Part 2: Symptoms Rating
Importance of symptoms to CML patients rated by physicians, nurses, patients, and caregivers.
Behavioral: Rating Questionnaire
Questionnaire developed in Part 1 to rate the relevance of symptom items, given to 3-5 physicians, 3-5 nurses, 2-4 patients and their family caregivers, taking about 10 minutes.
Part 3: MDASI-CML Questionnaires
Patients questionnaires about CML symptoms over 1 year using M. D. Anderson Symptom Inventory (MDASI) module (the MDASI-CML)
Behavioral: MDASI-CML Questionnaire
Patient questionnaires about CML symptoms over 1 year, completed in person or using Interactive Voice Response (IVR) system every 2 weeks.
- Symptom Burden Experienced by CML Patients [ Time Frame: Patients followed over 1 year with MDASI-CML questionnaire ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046305
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Loretta A. Williams, PHD, MSN||M.D. Anderson Cancer Center|