Overview

This trial is active, not recruiting.

Conditions unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific
Treatments educational intervention, questionnaire administration
Phase phase 3
Sponsor M.D. Anderson Cancer Center
Collaborator National Cancer Institute (NCI)
Start date June 2008
End date August 2017
Trial size 1360 participants
Trial identifier NCT00608933, 2006-0198, 5 U10 CA045809-17, MDA-2006-0198, NCI Clinical Trials, NCI-2009-00005

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (subject)
Arm
(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.
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.
questionnaire administration
Patients complete questionnaires
(Other)
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.
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.
questionnaire administration
Patients complete questionnaires

Primary Outcomes

Measure
Proportion of patients who report that the health provider discussed complimentary and alternative medicine (CAM) use
time frame: Baseline to 2 months

Secondary Outcomes

Measure
Frequency with which health providers ask about CAM use and referral for CAM use by health providers
time frame: 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
Frequency and type of CAM use among patients diagnosed with cancer
time frame: Up to 2 months

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title CAM USE and Cancer
Principal investigator Lorenzo Cohen, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.