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

NCT00608933 | Completed Phase 3

• 5 other identifiers: 2006-0198MDA-2006-0198NCI Clinical Trials5U10CA045809-17NCI-2009-00005
• Study Type: interventional
• Target: 1,356
• Locations: 1 country
• Sites: 2

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific; unspecified childhood solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (3)

• 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

Study Arms (2)

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.

Other: educational intervention; Other: questionnaire administration

Arm II (wait-list)

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.

Other: educational intervention; Other: questionnaire administration

Interventions

educational intervention OTHER

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 I (intervention); Arm II (wait-list)

questionnaire administration OTHER

Patients complete questionnaires

Arm I (intervention); Arm II (wait-list)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (2)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Lorenzo Cohen, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2008
• First Posted: February 6, 2008
• Study Start: June 1, 2008
• Primary Completion: December 7, 2020
• Study Completion: December 7, 2020
• Last Updated: December 9, 2020

Record last verified: 2020-12

Locations

US (2)