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CompletedNCT00949390Updated Apr 7, 2016

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

An observational study in Advanced Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2016-04-07.

Sponsored by M.D. Anderson Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
309
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Advanced Cancer

Keywords

  • Advanced Cancer
  • Advanced Malignancy
  • Complementary and Alternative Medicine
  • CAM
  • Investigational Cancer Therapeutics
  • Phase I Clinical Trials
03

In context

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
309 participants (actual)

Groups and cohorts

  • 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.

    Behavioral: Questionnaire

Interventions

  • BehavioralQuestionnaire

    Survey given at appointment time, then dropped in specified box anonymously.

06

What researchers measure

Primary outcomes

  1. Prevalence of CAM use among patients enrolled in Phase I clinical trials (Questionnaire Response Rate)

    Time frame: 1 Year

07

Study locations

1 site
  • University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00949390
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Jul 30, 2009
Start date
Jul 2009
Primary completion
Apr 2016
Completion
Apr 2016
Last update
Apr 7, 2016

Study contacts

Aung Naing, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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