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

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ClinicalTrials.gov Identifier: NCT00949390
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : April 7, 2016
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

July 28, 2009
July 30, 2009
April 7, 2016
July 2009
April 2016   (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 ]
Same as current
Complete list of historical versions of study NCT00949390 on ClinicalTrials.gov Archive Site
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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 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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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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 University of Texas MD Anderson Cancer Center Phase I clinical trials.
Intervention: Behavioral: Questionnaire
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
309
600
April 2016
April 2016   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00949390
2009-0369
No
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M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
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Principal Investigator: Aung Naing, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
April 2016