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CAM USE and Cancer


Phase 3
N/A
N/A
Open (Enrolling)
Both
Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

CAM USE and Cancer


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.

Inclusion 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 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

Baseline to 2 months

Safety Issue:

No

Principal Investigator

Patricia A. Parker, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2006-0198

NCT ID:

NCT00608933

Start Date:

June 2008

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • unspecified childhood solid tumor, protocol specific
  • Neoplasms

Name

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009