- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00949390
Complementary and Alternative Medicine Usage Among Participants Enrolled in Phase I Oncology Clinical Trials
Primary Objective:
· The primary objective is to estimate the prevalence of use of complementary and alternative medicine (CAM) in patients with advanced malignancies who are seen in the Phase I clinic at MD Anderson Cancer Center (MDACC).
Secondary Objective:
· Examine the association between prevalence of CAM use and demographic and socioeconomic characteristics (age, gender, race, income, and education level), participation in a phase I clinical trial, disease characteristics (diagnosis), patients' perceptions about their prognosis, physicians' information and permission for patients' CAM use, decision-making, and types of CAM used by patients.
Study Overview
Detailed Description
This survey study is intended to estimate the prevalence of use of CAM in patients who are currently being treated in the Phase I Clinical Trials Program at University of Texas MD Anderson Cancer Center. The survey includes questions about socioeconomic characteristics (age, gender, race, income, and education level), patients' diagnosis and patients' perceptions about their prognosis, physicians' information and permission for patients' use of CAM, patients' use of CAM (yes or no), decision-making (purpose of CAM use), resources and types of CAM.
Patients will be asked to drop the questionnaire into a box in a specified location after completion of the questionnaire. Accrual is expected to be 50-100 patients per month. This survey is expected to finish in 6 months.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
1) Patients with a clinical diagnosis of malignancy who are seen in the outpatient oncology clinic.
Exclusion Criteria:
1) Presence of any clinically relevant condition that, in the opinion of the investigator/ coordinator, would interfere with completing the study including, but not limited to, visual problems, cognitive impairment or acute mental illness.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Phase I and CAM Survey
Complementary and alternative medicine (CAM) in patients with advanced malignancies currently treated on University of Texas MD Anderson Cancer Center Phase I clinical trials.
|
Survey given at appointment time, then dropped in specified box anonymously.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prevalence of CAM use among patients enrolled in Phase I clinical trials (Questionnaire Response Rate)
Time Frame: 1 Year
|
1 Year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aung Naing, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2009-0369
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.
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