Symptom Burden in Chronic Myeloid Leukemia (CML)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01046305
First received: January 8, 2010
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Leukemia
Behavioral: Interview & Questionnaires
Behavioral: Rating Questionnaire
Behavioral: MDASI-CML Questionnaire

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Symptom Burden of Patients With Chronic Myeloid Leukemia (CML)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Symptom Burden Experienced by CML Patients [ Time Frame: Patients followed over 1 year with MDASI-CML questionnaire ] [ Designated as safety issue: No ]

Estimated Enrollment: 218
Study Start Date: November 2009
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other Names:
  • Survey
  • MDASI-CML
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.
Other Names:
  • Survey
  • M. D. Anderson Symptom Inventory
  • MDASI
  • MDASI-CML

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Chronic myeloid leukemia (CML) patients and their caregivers, 18 years of age or older, physicians and nurses.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046305

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Novartis Pharmaceuticals
Investigators
Study Chair: Loretta A. Williams, PHD, MSN UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided by M.D. Anderson Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01046305     History of Changes
Other Study ID Numbers: 2008-0728
Study First Received: January 8, 2010
Last Updated: March 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Chronic Myeloid Leukemia
CML
Symptom Burden
M. D. Anderson Symptom Inventory
MDASI-CML
Severity
Interference
Questionnaire
Interview

Additional relevant MeSH terms:
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on September 16, 2014