- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00608933
Education Intervention in Encouraging Health Providers to Talk With Cancer Patients About the Use of Complementary and Alternative Medicine
CAM USE and Cancer
RATIONALE: Educating health providers on talking with cancer patients about complementary and alternative medicine (CAM) may help encourage health providers to talk more often with cancer patients about the use of CAM.
PURPOSE: This randomized phase III trial is studying how well an education intervention works in encouraging health providers to talk with cancer patients about the use of CAM.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
- Examine the efficacy of an education intervention designed to increase the frequency with which health providers ask cancer patients about their use of complimentary and alternative medicine (CAM).
Secondary
- Examine the frequency with which health providers ask about CAM use and referral for CAM use by health providers.
- Evaluate whether personal CAM use among health providers is related to the frequency of asking patients about CAM use.
- Assess the frequency and type of CAM use among patients diagnosed with cancer.
OUTLINE: This is a multicenter study. Stratification is based on the number of health providers at each CCOP component site (< 3 health providers per component site vs 3 to 6 health providers per component site vs 7 to 9 health providers per component site vs 10 or more health providers per component site). The CCOP component sites are randomized to 1 of 2 intervention groups.
- Arm I (intervention): Health providers receive educational materials comprising a brief video about communicating with and providing guidance to patients regarding complimentary and alternative medicine (CAM) and a list of resources they can access to obtain information about herbs, CAM modalities, and drug/herb interactions. Approximately 2 weeks after the educational intervention, health providers receive a follow-up e-mail reminding them to ask patients about CAM use. The e-mail also includes a brief update regarding current research findings on CAM modalities and drug/herb interactions.
- Arm II (wait-list): Health providers are enrolled on a wait-list. After 2 months, the educational materials in arm I are made available to the wait-list health providers.
Health providers in both arms complete questionnaires at baseline and at 2 months to assess the effectiveness of the educational intervention, personal CAM use, and level of knowledge about CAM and to determine if they are asking patients about CAM use. Patients of the health providers also complete questionnaires at the same time points to assess personal CAM use before and after cancer diagnosis as well as the level of their interaction with health providers regarding CAM use.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
-
-
Texas
-
Houston, Texas, United States, 77030-4009
- University of Texas MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Health provider meeting the following criteria:
Has regular contact with cancer patients by initially talking with patients, taking their histories, and conveying pertinent information to their physician at a participating CCOP site
- Must be actively seeing patients at a participating University of Texas (UT) MD Anderson Cancer Center Community Clinical Oncology Program (CCOP) site
- Must not be employed at more than one participating CCOP site
- Not a temporary employee
Patient of a health provider at a participating CCOP site meeting the following criteria:
Current diagnosis of cancer including amyloidosis
- Diagnosed at least 1 week ago
- Finished treatment within the past 6 months
- Able to speak or read English
- No prior participation in this study at an earlier assessment
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm I (intervention)
Health providers receive educational materials comprising a brief video about communicating with and providing guidance to patients regarding complimentary and alternative medicine (CAM) and a list of resources they can access to obtain information about herbs, CAM modalities, and drug/herb interactions.
Approximately 2 weeks after the educational intervention, health providers receive a follow-up e-mail reminding them to ask patients about CAM use.
The e-mail also includes a brief update regarding current research findings on CAM modalities and drug/herb interactions.
|
Health providers receive educational materials comprising a brief video about communicating with and providing guidance to patients regarding complimentary and alternative medicine (CAM) and a list of resources they can access to obtain information about herbs, CAM modalities, and drug/herb interactions.
Approximately 2 weeks after the educational intervention, health providers receive a follow-up e-mail reminding them to ask patients about CAM use.
The e-mail also includes a brief update regarding current research findings on CAM modalities and drug/herb interactions.
Patients complete questionnaires
|
Other: Arm II (wait-list)
Health providers are enrolled on a wait-list.
After 2 months, the educational materials in arm I (educational intervention) are made available to the wait-list health providers.
|
Health providers receive educational materials comprising a brief video about communicating with and providing guidance to patients regarding complimentary and alternative medicine (CAM) and a list of resources they can access to obtain information about herbs, CAM modalities, and drug/herb interactions.
Approximately 2 weeks after the educational intervention, health providers receive a follow-up e-mail reminding them to ask patients about CAM use.
The e-mail also includes a brief update regarding current research findings on CAM modalities and drug/herb interactions.
Patients complete questionnaires
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients who report that the health provider discussed complimentary and alternative medicine (CAM) use
Time Frame: Baseline to 2 months
|
The Complementary and Alternative Medicine Patient Survey administered to patients to assess personal use of CAM before and after the cancer diagnosis as well as the level of interaction with providers regarding CAM use.
Baseline survey assessment at one week and follow up assessment at 2 months.
|
Baseline to 2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency with which health providers ask about CAM use and referral for CAM use by health providers
Time Frame: Baseline to 2 months
|
Baseline to 2 months
|
Relationship between personal CAM use among health providers and frequency of asking patients about CAM use
Time Frame: Baseline to 2 months
|
Baseline to 2 months
|
Frequency and type of CAM use among patients diagnosed with cancer
Time Frame: Up to 2 months
|
Up to 2 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006-0198
- MDA-2006-0198
- NCI Clinical Trials (Other Identifier: CDR0000584715)
- 5U10CA045809-17 (U.S. NIH Grant/Contract)
- NCI-2009-00005 (Registry Identifier: NCI CTRP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Unspecified Childhood Solid Tumor, Protocol Specific
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)RecruitingCollection and Storage of Tissue Samples From Patients Undergoing Surgery For Suspected Solid TumorsUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Kantonsspital GraubuendenUnknownUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificSwitzerland
-
National Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Vanderbilt UniversityNational Cancer Institute (NCI)TerminatedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
University of ChicagoNational Cancer Institute (NCI)CompletedSirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed By SurgeryUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)WithdrawnUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol Specific
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyWithdrawnUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol Specific | Hematopoietic/Lymphoid CancerUnited States
-
Children's Cancer and Leukaemia GroupUnknownUnspecified Childhood Solid Tumor, Protocol SpecificIreland, United Kingdom
-
Georgetown UniversityNational Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol SpecificUnited States
Clinical Trials on educational intervention
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedBacterial Infection | Clostridium DifficileUnited States
-
McGill University Health Centre/Research Institute...University of Manitoba; Sunnybrook Health Sciences Centre; University of Alberta and other collaboratorsCompletedPeptic Ulcer Hemorrhage
-
Universidad de GranadaNot yet recruitingAsthma | Allergy
-
Roswell Park Cancer InstituteCompletedCervical Cancer | Breast CancerUnited States
-
US Department of Veterans AffairsDuke UniversityCompletedAccidental FallsUnited States
-
Gary MorrowNational Cancer Institute (NCI)CompletedMalignant NeoplasmUnited States
-
Azienda Unità Sanitaria Locale Reggio EmiliaCompletedMelanoma (Skin) | Educational ProblemsItaly
-
Goethe UniversityUnknownHealth Knowledge, Attitudes, PracticeGermany
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedBreast Cancer | LymphedemaUnited States
-
Claudia AristizábalUniversidad Nacional de Colombia; Universidad de Santander; Fundación Universitaria...Enrolling by invitationBurnout, Psychological | CaregiversColombia