Symptom Burden of Patients With Chronic Myeloid Leukemia (CML)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- Symptom Burden Experienced by CML Patients
Study Overview
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:
- 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;
- 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.
Detailed Description
Part 1:
Interview:
If you agree to take part in this study, while you are at the clinic for a visit, you will be interviewed about what it is like to have CML. The interview should take about 30 minutes to complete.
Questionnaires:
After the interview, you will be asked to answer a symptom questionnaire, a quality-of-life questionnaire, and some demographic questions such as your age and marital status. It will take about 10 minutes to complete all 3 questionnaires.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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)
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Symptom Burden Experienced by CML Patients
Time Frame: Patients followed over 1 year with MDASI-CML questionnaire
Secondary Outcomes
No secondary outcomes reported