Complementary and Alternative Medicine Usage Among Participants Enrolled in Phase I Oncology Clinical Trials

This study is currently recruiting participants.
Verified March 2013 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00949390
First received: July 28, 2009
Last updated: March 20, 2013
Last verified: March 2013

July 28, 2009
March 20, 2013
August 2009
August 2014   (final data collection date for primary outcome measure)
Prevalence of CAM use among patients enrolled in Phase I clinical trials (Questionnaire Response Rate) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00949390 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Complementary and Alternative Medicine Usage Among Participants Enrolled in Phase I Oncology Clinical Trials
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 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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Current participation in a UT MDACC Phase I Clinical trial with a clinical diagnosis of advanced malignancy.

Advanced Cancer
Behavioral: Questionnaire
Survey given at appointment time, then dropped in specified box anonymously.
Phase I and CAM Survey
Complementary and alternative medicine (CAM) in patients with advanced malignancies currently treated on UT MDACC Phase I clinical trials.
Intervention: Behavioral: Questionnaire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
Not Provided
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

1) Patients with a clinical diagnosis of advanced malignancy who are seen in the Phase I 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.

Both
Not Provided
No
Contact: Aung Naing, MD 713-563-1930
United States
 
NCT00949390
2009-0369
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Aung Naing, MD UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP