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

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00949390
• Other study ID #: 2009-0369
• Status: Completed
• Phase: N/A
• First received: July 28, 2009
• Last updated: April 6, 2016
• Start date: July 2009
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

Behavioral:
• Questionnaire
Survey given at appointment time, then dropped in specified box anonymously.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of CAM use among patients enrolled in Phase I clinical trials (Questionnaire Response Rate)		1 Year	No

External Links

•   University of Texas MD Anderson Cancer Center Website