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

Completed

• Conditions: Advanced Cancer
• Interventions: Behavioral: Questionnaire

• Registration Number: NCT00949390
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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.

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 Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-28
• Study First Submitted QC: 2009-07-29
• Study First Posted: 2009-07-30
• Status Verified: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-06
• Last Update Posted: 2016-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 309

Inclusion Criteria

1. Patients with a clinical diagnosis of malignancy who are seen in the outpatient oncology clinic.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Phase I and CAM Survey	Questionnaire	Complementary and alternative medicine (CAM) in patients with advanced malignancies currently treated on University of Texas MD Anderson Cancer Center Phase I clinical trials.

Primary Outcome Measures

Name	Time	Method
Prevalence of CAM use among patients enrolled in Phase I clinical trials (Questionnaire Response Rate)	1 Year

Trial Locations

Locations (1)

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States