Preliminary Testing of the MD Anderson Symptom Inventory (Adolescent Version)



Status:Recruiting
Healthy:No
Age Range:13 - 17
Updated:12/16/2018
Start Date:November 2016
End Date:November 2019
Contact:Loretta A. Williams, MD
Phone:713-745-3470

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The goal of this research study is to learn if a symptom questionnaire used for adults at MD
Anderson can be improved to better understand the symptoms experienced by 13-17 year old
patients with cancer.

Interviews and Questionnaires:

If you agree to take part in this study, you will be asked to provide some personal
information, such as your education level and if you are currently attending school. This
information will either be collected from your medical record or a member of the study staff
will ask you.

You will complete a questionnaire about your symptoms. You may also be asked to take part in
an interview about the symptom questionnaire that will be digitally recorded by the
interviewer. During the interview, you will be asked if the questionnaire was easy to
understand and complete, and if you think there are any other questions that should be
included. You will then be asked to complete 2 more questionnaires about your health status
and your quality of life. The study staff will use your opinions and questionnaire responses
to decide if changes should be made to the symptom questionnaire. It should take about 15-30
minutes to complete the questionnaires and the interview.

All interviews will be conducted in a private area in either the ambulatory pediatric
adolescent clinics or in the hospital. The private area may be different, based on which
types of rooms are available (for example, an exam room, conference room, or a
single-occupancy hospital room), but it will always be a closed private space with only you
and a member of the research staff present.

In order to understand how symptoms change during treatment, the research staff may ask you
to complete the symptom questionnaire for a total of 7 times. The first 2 times will be done
1 day apart. The following 5 times will be done approximately 1 week apart. It will take
approximately 5 minutes to complete the symptom questionnaire each time. The first time you
complete the questionnaire you may also be asked to take part in an interview about the
symptom questionnaire that will be digitally recorded by the interviewer. During the
interview, you will be asked if the questionnaire was easy to understand and complete, and if
you think there are any other questions that should be included.

You may complete the questionnaires in the clinic, over the phone, or online. The study staff
will tell you which method you will use to complete the questionnaires. If you are asked to
take part in an interview, the interview will be conducted in a private area in either the
ambulatory pediatric adolescent clinics or in the hospital. The private area may be
different, based on which types of rooms are available (for example, an exam room, conference
room, or a single-occupancy hospital room), but it will always be a closed private space with
only you and a member of the research staff present.

Length of Study:

Your active participation in this study will be over after you have completed the
questionnaires and interview.

This is an investigational study. Up to 105 participants will take part in this study. All
will be enrolled at MD Anderson.

Inclusion Criteria:

1. Age between 13 and 17 years.

2. Ability to speak and read English.

3. Diagnosis of cancer, confirmed pathologically or clinically.

4. Being seen by a healthcare provider at MD Anderson Cancer Center.

5. Written assent by subject and written consent by parent/guardian for participation.

Exclusion Criteria:

1. Medical condition, as determined by the attending physician, that would preclude
participation in the study.

2. Diagnosis of active psychosis, developmental delay, or severe cognitive impairment as
determined by primary physician.

3. Diagnosis of or treatment for a second malignancy within the last 3 years, except
squamous cell skin cancer, cervical cancer in situ, or superficial bladder cancer.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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