Symptom Burden in Chronic Myeloid Leukemia (CML)
Symptom Burden of Patients With Chronic Myeloid Leukemia (CML)
1 other identifier
observational
210
1 country
1
Brief Summary
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;
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 8, 2010
CompletedFirst Posted
Study publicly available on registry
January 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedJanuary 7, 2020
January 1, 2020
11.1 years
January 8, 2010
January 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Symptom Burden Experienced by CML Patients
Patients followed over 1 year with MDASI-CML questionnaire
Study Arms (3)
Part 1: Interview & Questionnaires
Patients interviews and questionnaires about CML symptoms once.
Part 2: Symptoms Rating
Importance of symptoms to CML patients rated by physicians, nurses, patients, and caregivers.
Part 3: MDASI-CML Questionnaires
Patients questionnaires about CML symptoms over 1 year using M. D. Anderson Symptom Inventory (MDASI) module (the MDASI-CML)
Interventions
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.
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.
Patient questionnaires about CML symptoms over 1 year, completed in person or using Interactive Voice Response (IVR) system every 2 weeks.
Eligibility Criteria
Chronic myeloid leukemia (CML) patients and their caregivers, 18 years of age or older, physicians and nurses.
You may qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Novartis Pharmaceuticalscollaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Williams LA, Garcia Gonzalez AG, Ault P, Mendoza TR, Sailors ML, Williams JL, Huang F, Nazha A, Kantarjian HM, Cleeland CS, Cortes JE. Measuring the symptom burden associated with the treatment of chronic myeloid leukemia. Blood. 2013 Aug 1;122(5):641-7. doi: 10.1182/blood-2013-01-477687. Epub 2013 Jun 18.
PMID: 23777764DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Loretta A. Williams, PHD, MSN
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2010
First Posted
January 11, 2010
Study Start
November 1, 2009
Primary Completion
November 30, 2020
Study Completion
November 30, 2020
Last Updated
January 7, 2020
Record last verified: 2020-01