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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 9, 2014
Last verified: July 2014
  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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 2016 (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
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949390

Contacts
Contact: Aung Naing, MD 713-563-1930

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Aung Naing, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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: July 9, 2014
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 July 20, 2014