Complementary and Alternative Medicine Usage Among Participants Enrolled in Phase I Oncology Clinical Trials
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Purpose
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 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.
| Condition | Intervention |
|---|---|
|
Advanced Cancer |
Behavioral: Questionnaire |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Complementary and Alternative Medicine Usage Among Participants Enrolled in Phase I Oncology Clinical Trials |
- Prevalence of CAM use among patients enrolled in Phase I clinical trials (Questionnaire Response Rate) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 600 |
| Study Start Date: | August 2009 |
| Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Phase I and CAM Survey
Complementary and alternative medicine (CAM) in patients with advanced malignancies currently treated on UT MDACC Phase I clinical trials.
|
Behavioral: Questionnaire
Survey given at appointment time, then dropped in specified box anonymously.
|
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 UT 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Current participation in a UT MDACC Phase I Clinical trial with a clinical diagnosis of advanced malignancy.
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.
Contacts and Locations| Contact: Aung Naing, MD | 713-563-1930 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Aung Naing, MD | |
| Principal Investigator: | Aung Naing, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00949390 History of Changes |
| Other Study ID Numbers: | 2009-0369 |
| Study First Received: | July 28, 2009 |
| Last Updated: | May 20, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Advanced Cancer Advanced Malignancy Complementary and Alternative Medicine |
CAM Investigational Cancer Therapeutics Phase I Clinical Trials |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 21, 2013