Unspecified Adult Solid Tumor, Protocol SpecificPhase 3NCT00608933

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

A Phase 3 study testing educational intervention and questionnaire administration in people with Unspecified Adult Solid Tumor, Protocol Specific and Unspecified Childhood Solid Tumor, Protocol Specific, run by M.D. Anderson Cancer Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
What is being tested?: educational intervention and questionnaire administration
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,356 participants
Where: 2 sitesUnited States
Study dates: Jun 2008to 7 Dec 2020
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009

Other trials in United States

About this study

Official title: CAM USE and Cancer

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.

Read the 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.

Conditions: Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
Being tested: educational intervention, questionnaire administration
Keywords: unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

educational interventionOther
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 administrationOther
Patients complete questionnaires

Study groups in NCT00608933
Study group	Role	What they receive
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. Receives: 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. Receives: Other: educational intervention; Other: questionnaire administration

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to 2 months

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 20087 Dec 2020

First posted6 Feb 2008 (estimated)
Study startJun 2008
Primary completion7 Dec 2020
Study completion7 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Other
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 1,356 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00608933
Sponsor's protocol ID: 2006-0198
Other IDs: MDA-2006-0198, NCI Clinical Trials, 5U10CA045809-17, NCI-2009-00005
Status last verified: Dec 2020
First submitted: 30 Jan 2008
Last updated: 9 Dec 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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