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

NCT00949390 | Completed

• 1 other identifier: 2009-0369
• Study Type: observational
• Target: 309
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  1 Year

Study Arms (1)

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

Questionnaire BEHAVIORAL

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

Phase I and CAM Survey

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Aung Naing, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2009
• First Posted: July 30, 2009
• Study Start: July 1, 2009
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 7, 2016

Record last verified: 2016-04

Locations

US (1)