Symptom Burden in Chronic Myeloid Leukemia (CML)
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01046305
First received: January 8, 2010
Last updated: April 22, 2013
Last verified: April 2013
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Purpose
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.
| 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 2014 (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:
|
|
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:
|
Detailed Description:
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.
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:
- 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)
Contacts and Locations
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
Investigators
| Study Chair: | Loretta A. Williams, PHD, MSN | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| 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: | April 22, 2013 |
| 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 Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type |
Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013