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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00608933
Collaborator
National Cancer Institute (NCI) (NIH)
1,356
2
2
150.2
678
4.5

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Other: educational intervention
  • Other: questionnaire administration
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
1356 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
CAM USE and Cancer
Actual Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Dec 7, 2020
Actual Study Completion Date :
Dec 7, 2020

Arms and Interventions

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.

Other: 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.

Other: questionnaire administration
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.

Other: 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.

Other: questionnaire administration
Patients complete questionnaires

Outcome Measures

Primary Outcome Measures

  1. Proportion of patients who report that the health provider discussed complimentary and alternative medicine (CAM) use [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.

Secondary Outcome Measures

  1. Frequency with which health providers ask about CAM use and referral for CAM use by health providers [Baseline to 2 months]

  2. Relationship between personal CAM use among health providers and frequency of asking patients about CAM use [Baseline to 2 months]

  3. Frequency and type of CAM use among patients diagnosed with cancer [Up to 2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill North Carolina United States 27599-7295
2 University of Texas MD Anderson Cancer Center Houston Texas United States 77030-4009

Sponsors and Collaborators

  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Lorenzo Cohen, PhD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00608933
Other Study ID Numbers:
  • 2006-0198
  • MDA-2006-0198
  • NCI Clinical Trials
  • 5U10CA045809-17
  • NCI-2009-00005
First Posted:
Feb 6, 2008
Last Update Posted:
Dec 9, 2020
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Keywords provided by M.D. Anderson Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 9, 2020