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Symptom Burden of Patients With Chronic Myeloid Leukemia (CML)

18 Years
Open (Enrolling)

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Trial Information

Symptom Burden of Patients With Chronic Myeloid Leukemia (CML)

There are 3 parts to this study. In Part 1, patients will complete interviews and
questionnaires about CML symptoms once. In Part 2, the importance of some symptoms to
patients with CML will be rated by physicians, nurses, patients, and caregivers. In Part 3,
patients will complete questionnaires about CML symptoms over 1 year.

Up to 218 participants will take part in this study. Up to 40 will be enrolled in Part 1 of
this study. Up to 160 participants will be enrolled in Part 3 of this study. All will be
enrolled at M. D. Anderson.

Inclusion Criteria:

1. 18 years of age or older (Patient and family caregiver only)

2. Ability to speak and read English (All participants)

3. Live in the United States (Patient Phase 3 only)

4. Diagnosis of Philadelphia chromosome positive CML confirmed by pathological and
cytogenetic analysis (Patient only)

5. Being followed at M.D. Anderson Cancer Center (Patient only)

6. Consent to participate (All participants)

7. Treatment for CML for at least 1 year (Patient Phase 2 only)

8. Family caregiver also willing to receive packet for expert panel participation
(Patient Phase 2 only)

9. Physician or nurse with at least 5 years experience caring for patients with CML
(Professional expert only)

10. At least one publication in the last 5 years dealing with CML (Physician professional
expert only)

11. Identification as a family caregiver by a patient with CML (Family caregiver only)

12. Patient also willing to receive packet for expert panel participation (Family
caregiver only)

Exclusion Criteria:

1. Medical condition or impaired performance status that would preclude participation in
the study (Patient only)

2. Diagnosis of active psychosis or severe cognitive impairment as determined by primary
physician (Patient only)

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Symptom Burden Experienced by CML Patients

Outcome Time Frame:

Patients followed over 1 year with MDASI-CML questionnaire

Safety Issue:


Principal Investigator

Loretta A. Williams, PHD, MSN

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

November 2009

Completion Date:

Related Keywords:

  • Leukemia
  • Chronic Myeloid Leukemia
  • CML
  • Symptom Burden
  • M. D. Anderson Symptom Inventory
  • Severity
  • Interference
  • Questionnaire
  • Interview
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive



UT MD Anderson Cancer Center Houston, Texas  77030