Symptom Burden in Chronic Myeloid Leukemia (CML)

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.

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)