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

Phase 3

Completed

• Conditions: Unspecified Childhood Solid Tumor, Protocol Specific; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Other: educational intervention; Other: questionnaire administration

• Registration Number: NCT00608933
• Lead Sponsor: M.D. Anderson Cancer Center

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.

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 Timeline

• Study First Submitted: 2008-01-30
• Study First Submitted QC: 2008-01-30
• Study First Posted: 2008-02-06
• Study Start: 2008-06
• Status Verified: 2020-12
• Primary Completion: 2020-12-07
• Study Completion: 2020-12-07
• Last Update Submitted: 2020-12-07
• Last Update Posted: 2020-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1356

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm II (wait-list)	questionnaire administration	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.
Arm I (intervention)	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)	educational intervention	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.
Arm I (intervention)	questionnaire administration	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Frequency with which health providers ask about CAM use and referral for CAM use by health providers	Baseline to 2 months
Relationship between personal CAM use among health providers and frequency of asking patients about CAM use	Baseline to 2 months
Frequency and type of CAM use among patients diagnosed with cancer	Up to 2 months

Trial Locations

Locations (2)

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States