Complementary and Alternative Medicine Usage Among Participants Enrolled in Phase I Oncology Clinical Trials
| Tracking Information | |||||
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| First Received Date ICMJE | July 28, 2009 | ||||
| Last Updated Date | March 20, 2013 | ||||
| Start Date ICMJE | August 2009 | ||||
| Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Prevalence of CAM use among patients enrolled in Phase I clinical trials (Questionnaire Response Rate) [ Time Frame: 1 Year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00949390 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Complementary and Alternative Medicine Usage Among Participants Enrolled in Phase I Oncology Clinical Trials | ||||
| Official Title ICMJE | Complementary and Alternative Medicine Usage Among Participants Enrolled in Phase I Oncology Clinical Trials | ||||
| 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 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Current participation in a UT MDACC Phase I Clinical trial with a clinical diagnosis of advanced malignancy. |
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| Condition ICMJE | Advanced Cancer | ||||
| Intervention ICMJE | Behavioral: Questionnaire
Survey given at appointment time, then dropped in specified box anonymously. |
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| Study Group/Cohort (s) | Phase I and CAM Survey
Complementary and alternative medicine (CAM) in patients with advanced malignancies currently treated on UT MDACC Phase I clinical trials.
Intervention: Behavioral: Questionnaire |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 600 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: 1) Patients with a clinical diagnosis of advanced malignancy who are seen in the Phase I 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. |
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00949390 | ||||
| Other Study ID Numbers ICMJE | 2009-0369 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | M.D. Anderson Cancer Center | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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