Symptom Burden in Chronic Myeloid Leukemia (CML)

January 4, 2020 updated by: M.D. Anderson Cancer Center

Symptom Burden of Patients With Chronic Myeloid Leukemia (CML)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Length of Study:

After you have completed the interview and questionnaires, your participation on this study will be over.

Additional Information:

The interview will be digitally recorded. The electronic record of the interview will not have your name linked to it and it will be kept on a secure server at M. D. Anderson Cancer Center that is password protected. All study materials will be destroyed after data analysis is completed and study results reported.

Information about your symptoms collected in this study is collected for research purposes only. If you are experiencing severe or troublesome symptoms, you should report them to your doctor or nurse as well as rating them on the symptom assessment questionnaire. If the data collector notices that you have rated a symptom as severe, the data collector will ask you if your doctor or nurse is aware of the symptom or if you intend to report the symptom to your doctor or nurse. If you have not or do not intend to report the symptom, the data collector will let you know that he or she will report the symptom to your doctor or nurse.

This is an investigational study.

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

Part 3:

Symptom Questionnaires:

If you agree to take part in this study, you will complete a questionnaire about any symptoms you are having every 2 weeks for 1 year. On the questionnaire, you will be asked to rate the level of discomfort caused by the symptoms you are having and how the symptoms effect the activities of your daily life. The symptom questionnaire should take about 5 minutes to complete. You will complete the questionnaire during the first study visit and at your clinic visits every 3 months. In between visits, you will be called every 2 weeks to complete the questionnaire by an automated telephone system.

You will decide a convenient time and place for the automated phone system to call you. If you are not available when the automated system calls, it will call you again at a later time. You may also call the automated system if you miss a call. If you are not reached by the automated phone system after several tries, the study staff will call you.

You will be given a secure user name and identification number to use with the automated phone system. You will be shown how the automated phone system works by the study staff.

Two (2) days after the first visit, you will fill out the symptom questionnaire again. You will take it home with you from the clinic with a pre-addressed, stamped envelope given to you by the research staff so you can return it. The research staff will also ask for your telephone number so that they may contact you and remind you to complete the questionnaire.

Quality-of-Life/Demographic Questionnaires:

At the first visit and the 3-month clinic visits, you will also rate your overall quality-of-life. This should take about 1 minute to complete.

At the first visit, you will also be asked some demographic questions (such as your age and marital status). Answering these questions should take about 1 minute.

Opinion Questionnaire:

If you are 1 of the first 30 patients enrolled in the study, at the first visit you will also complete a questionnaire about your opinion of the symptom questionnaire. For example, you will be asked if the symptom questionnaire was easy to understand and to complete and if there were any other questions that should be included. The study staff will use your opinion to decide if other important symptom questions are missing from the questionnaire. This questionnaire should take about 5 minutes to complete.

Length of Study:

You will be on study for 1 year.

Additional Information:

The questionnaires will only use your study number and will not have your name linked to them. All questionnaires and study data will be kept in a locked cabinet at all times. All study materials will be destroyed after data analysis is completed and study results reported.

Information about your symptoms collected in this study is collected for research purposes only. If you are experiencing severe or troublesome symptoms, you should report them to your doctor or nurse as well as rating them on the symptom assessment questionnaire. If the data collector notices that you have rated a symptom as severe, the data collector will ask you if your doctor or nurse is aware of the symptom or if you intend to report the symptom to your doctor or nurse. If you have not or do not intend to report the symptom, the data collector will let you know that he or she will report the symptom to your doctor or nurse.

This is an investigational study.

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

Study Type

Observational

Enrollment (Actual)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)
  3. Active treatment (systemic drug therapy or radiation therapy) for a second malignancy (Patient only Phase 3)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • 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
  • MDASI-CML
  • M. D. Anderson Symptom Inventory
  • MDASI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptom Burden Experienced by CML Patients
Time Frame: Patients followed over 1 year with MDASI-CML questionnaire
Patients followed over 1 year with MDASI-CML questionnaire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

Novartis Pharmaceuticals

Investigators

  • Study Chair: Loretta A. Williams, PHD, MSN, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2009

Primary Completion (Anticipated)

November 30, 2020

Study Completion (Anticipated)

November 30, 2020

Study Registration Dates

First Submitted

January 8, 2010

First Submitted That Met QC Criteria

January 8, 2010

First Posted (Estimate)

January 11, 2010

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 4, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-0728

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Leukemia

Clinical Trials on Interview & Questionnaires

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe