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Symptom Burden in Patients With Cancer- and Treatment-Related Skin Problems


N/A
18 Years
N/A
Open (Enrolling)
Both
Skin Cancer

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Trial Information

Symptom Burden in Patients With Cancer- and Treatment-Related Skin Problems


Part I:

Interview:

If you agree to take part in this study, while you are at the clinic for a visit, you will
be interviewed about skin problems and other symptoms that you have had since you began
experiencing skin problems. The interview should take about 30 minutes to complete.

Part I:

Questionnaires:

After the interview, you will be asked to answer a general symptom questionnaire, a
quality-of-life questionnaire, a skin-specific questionnaire, and some demographic questions
(such as your age and marital status). It should take about 15 minutes to complete all 4
questionnaires.

Part II:

Symptom Questionnaires:

If you agree to take part in this study, you will complete a questionnaire about skin
problems and other symptoms you are having. This symptom questionnaire will ask you to
rate how severe your skin problems and other symptoms are and how the skin problems and
other symptoms affect the activities of your daily life. It should take about 5 minutes to
complete. You will complete the questionnaire at a routine clinic visit every 2 weeks for 1
year. If you do not have a clinic visit every 2 weeks, you will be called by an automated
phone system so you may complete the questionnaire at least 1 time every 2 weeks.

You can decide what time is most convenient 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 will be given a secure user name and identification number to use with the
automated phone system. The study staff will teach you how to use the automated phone
system.

Two (2) days after you begin the study, you will fill out the symptom questionnaire again.
You will take home a paper copy of the questionnaire 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, you will also be asked some demographic questions (such as your age and
employment status). Answering these questions should take about 1 minute. Some of these
questions (such as employment status) will be repeated at regular clinic visits. You will
not be asked to do this more often than every 3-5 weeks.

At the first visit and at regular clinic visits, you will also rate your overall
quality-of-life. This should take about 1 minute to complete. You will not be asked to do
this more often than every 3-5 weeks.

At the first visit and at regular clinic visits, you will be asked to complete a second
questionnaire that asks specific questions about how problems with your skin affect the
quality of your life. This should take about 5 minutes to complete. You will not be asked to
do this more often than every 3-5 weeks.

Opinion Questionnaire:

If you are 1 of the first 20 participants enrolled in Part 2 of this study, you will be
asked questions about your opinion of the symptom questionnaire after you have completed it
for the first time. For example, you will be asked if the symptom questionnaire was easy to
understand and complete, and if there were any other questions that should be included. The
study staff will use your opinion to decide if changes should be made to the questionnaire
or if important symptom questions are missing from the questionnaire. This questionnaire
should take about 5 minutes to complete.

Part I:

Length of Study:

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

Part II:

Length of Study You will be on study for 1 year. You will be off study after you complete
the last symptom questionnaire.

This is an investigational study. Up to 60 participants will take part in this study. Up to
20 will be enrolled in Part 1 of this study. Up to 40 participants will be enrolled in Part
2 of this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. 18 years of age or older

2. Ability to read and speak English

3. Receiving treatment and/or follow up at M. D. Anderson Cancer Center

4. Residing where IVR service is available (Validation part of study only)

5. Rating of skin problem at its worse in the last 24-hours of at least 1 on a 0 to 10
scale where 0 is no skin problem and 10 is the skin problem as bad as can be imagined

6. Written consent to participate

Exclusion Criteria:

1. Medical condition (impaired speech that would preclude taking part in a 30 minute
interview, deafness that would impair the ability to use the IVR system) or impaired
performance status that would preclude participation in the study

2. Diagnosis of active psychosis or severe cognitive impairment as determined by
physician

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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Severity of Multiple Symptoms/Impact of Symptoms on Daily Functioning

Outcome Description:

MDASI-Derm measure of severity + impact of 13 cancer-related core symptoms that cause most interference with daily activities; Severity of symptoms rated (with amount of interference with daily living) on scales from 0 to 10, with 0 meaning no symptom or interference and 10 meaning as severe or complete interference.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Loretta A. Williams, PhD, MSN

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2010-0551

NCT ID:

NCT01193036

Start Date:

August 2010

Completion Date:

Related Keywords:

  • Skin Cancer
  • Psychosocial
  • Skin Problems
  • Supportive Care
  • Melanoma
  • Questionnaire
  • Skin Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030