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Education Intervention in Encouraging Health Providers to Talk With Cancer Patients About the Use of Complementary and Alternative Medicine

This study is not yet open for participant recruitment.
Verified by National Cancer Institute (NCI), September 2008

Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00608933
  Purpose

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.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific
Procedure: educational intervention
Procedure: observation
Phase III

MedlinePlus related topics:   Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Randomized, Single Blind, Active Control
Official Title:   CAM USE and Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Proportion of patients who report that the health provider discussed complimentary and alternative medicine (CAM) use [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency with which health providers ask about CAM use and referral for CAM use by health providers [ Designated as safety issue: No ]
  • Relationship between personal CAM use among health providers and frequency of asking patients about CAM use [ Designated as safety issue: No ]
  • Frequency and type of CAM use among patients diagnosed with cancer [ Designated as safety issue: No ]

Estimated Enrollment:   1360
Study Start Date:   March 2008
Estimated Primary Completion Date:   March 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Arm I (intervention):: Active Comparator
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.
Procedure: educational 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):: No Intervention
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.
Procedure: observation
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.

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.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608933

Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Investigators
Principal Investigator:     Patricia A. Parker, PhD     M.D. Anderson Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000584715, MDA-2006-0198
First Received:   January 30, 2008
Last Updated:   September 22, 2008
ClinicalTrials.gov Identifier:   NCT00608933
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific  
unspecified childhood solid tumor, protocol specific  

ClinicalTrials.gov processed this record on November 03, 2008




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