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

This study is currently recruiting participants.
Verified May 2017 by M.D. Anderson Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02515383
First Posted: August 4, 2015
Last Update Posted: May 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
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.

Condition Intervention
Adolescent Cancer Behavioral: MD Anderson Symptom Inventory (Adolescent Version) Behavioral: Interview Behavioral: Questionnaires

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preliminary Testing of the MD Anderson Symptom Inventory (Adolescent Version)

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

Primary Outcome Measures:
  • Performance of the MD Anderson Symptom Inventory (MDASI) Modified for Use with Adolescents [ Time Frame: 6 weeks ]
    Study collaborators review the categorization of cognitive debriefing responses and decide if modifications are needed. If no modifications are needed, the face validity of the existing MDASI confirmed.


Estimated Enrollment: 105
Actual Study Start Date: November 2016
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Adolescent Cancer Group

Part 1: Adolescent participants complete the MDASI (adolescent version). Study staff then conduct interview regarding the symptom questionnaire. After the interview participants complete the EQ-5D and a single-item quality of life (QOL) questionnaire.

Part 2: MDASI (adolescent version) administered twice, one day apart, to assess test-retest reliability. MDASI (adolescent version) then administered at 5 additional time points, each a week apart. Participants also complete the EQ-5D and a single item quality of life question only after first MDASI (adolescent version) completion. First 20 participants are interviewed by study staff regarding the symptom questionnaire.

Behavioral: MD Anderson Symptom Inventory (Adolescent Version)

Part 1: Adolescent participants complete the MDASI (adolescent version).

Part 2: MDASI (adolescent version) administered twice, one day apart, to assess test-retest reliability. MDASI (adolescent version) then administered at 5 additional time points, each a week apart.

Other Name: MDASI
Behavioral: Interview

Part 1: Participants are interviewed by study staff regarding the symptom questionnaire.

Part 2: First 20 participants are interviewed by study staff regarding the symptom questionnaire.

Behavioral: Questionnaires

Part 1: Participants complete the EQ-5D and a single-item quality of life (QOL) questionnaire.

Part 2: Participants complete the EQ-5D and a single item quality of life question only after first MDASI (adolescent version) completion.

Other Name: Surveys

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adolescent patients at The University of Texas MD Anderson Cancer Center in Houston, Texas
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02515383


Contacts
Contact: Loretta A. Williams, MD 713-745-3470

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genentech, Inc.
Investigators
Principal Investigator: Loretta A. Williams, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02515383     History of Changes
Other Study ID Numbers: 2015-0271
First Submitted: July 31, 2015
First Posted: August 4, 2015
Last Update Posted: May 12, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Adolescent Cancer
MD Anderson Symptom Inventory (modified for adolescent use)
MDASI
Surveys
Questionnaires
Interviews
Symptoms