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- Klinische proef NCT00376909
A Telephone-Based Prevention Care Manager in Increasing Screening Rates for Breast Cancer, Cervical Cancer, and Colorectal Cancer in Minority and Low-Income Women
New York Prevention Care Manager Project
RATIONALE: Studying the barriers that prevent minority and low-income women from undergoing cancer screening, and offering encouragement to them over the telephone, may help improve cancer screening rates.
PURPOSE: This randomized phase II trial is studying how well a telephone-based Prevention Care Manager increases screening rates for breast cancer, cervical cancer, and colorectal cancer in minority and low-income women.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
OBJECTIVES:
- Determine whether telephone support for patients, provided through a Prevention Care Manager (PCM), can increase breast, cervical, and colorectal cancer screening rates among minority and low-income women.
- Measure the amount of PCM time required to improve early cancer detection provided to age-eligible ethnically diverse women seen in community health centers in the New York City area.
- Learn barriers faced by this population in obtaining indicated services (mammograms, Pap tests, fecal occult blood testing, and sigmoidoscopy).
- Assess at baseline and follow-up the office environment and work processes in each participating center (in PCM randomized controlled study only).
- Develop and implement the PCM intervention to help patients overcome barriers.
- Evaluate the impact and costs of the PCM in a randomized controlled efficacy trial.
OUTLINE: This is a randomized, controlled, single-blind, multicenter study. Patients are randomized according to participating center.
- Part 1: Some patients undergo a series of structured interviews about the obstacles to early cancer detection. Participating sites are assessed for study eligibility.
- Part 2: Pilot testing, training, and competency testing of the Prevention Care Managers (PCM) are conducted.
Part 3: Patients are randomized to 1 of 2 intervention arms.
- Arm I: Patients are offered health education and follow-up services by telephone with a PCM.
- Arm II: Patients receive usual care.
PROJECTED ACCRUAL: A total of 2,729 (1,413 for PCM randomized controlled study and 1,316 for pilot study) patients will be accrued for this study.
Studietype
Inschrijving (Verwacht)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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New Hampshire
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Lebanon, New Hampshire, Verenigde Staten, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New York
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New York, New York, Verenigde Staten, 10018
- Clinical Directors Network, Incorporated
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
DISEASE CHARACTERISTICS:
Patients enrolled in the Prevention Care Manager (PCM) controlled, randomized clinical trial (RCT) must meet the following criteria:
- Registered to receive care at a participating Community Health Center for at least 6 months
Overdue for at least one cancer screening as per the following time periods:
- No mammography within the past 12 months
- No Pap test within the past 12 months
- No home fecal occult blood test within the past 12 months
- No sigmoidoscopy within the past 5 years
- No colonoscopy within the past 10 years
- Must not plan to move out of area or change Community Health Center within 15 months
- No unresolved, urgent abnormal cancer screening result found in medical record
Patients enrolled in the PCM dissemination pilot study through Affinity Health Plan must meet the following criteria:
- Enrolled with Affinity Health Plan for at least 12 months
Overdue for at least one cancer screening as per the following time periods:
- No mammography within the past 2 years
- No Pap test within the past 3 years
- No home fecal occult blood test within the past year for women ≥ 50 years old
- No sigmoidoscopy within the past 5 years
- No colonoscopy within the past 10 years
- Must have received care at 1 of 6 participating Community Health Centers in New York City
PATIENT CHARACTERISTICS:
- Female
- Must not be in acute distress or have an acute illness
- Age 50 to 69 years for controlled study patients
- Age 40 to 69 years for pilot study patients
PRIOR CONCURRENT THERAPY:
- No concurrent chemotherapy or radiotherapy
- No concurrent active cancer treatment
- No concurrent palliative care
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Screening
- Toewijzing: Gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Intervention
Series of telephone support calls from a trained prevention care manager
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Geen tussenkomst: Gebruikelijke zorg
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
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Follow-up patient cancer 3 months after completion of study treatment
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Screening rates as measured by mammography, Pap test, hfoBT, sigmoidoscopy, barium enema and colonoscopy
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Allen J. Dietrich, MD, Norris Cotton Cancer Center
Publicaties en nuttige links
Algemene publicaties
- Dietrich AJ, Tobin JN, Cassells A, Robinson CM, Greene MA, Sox CH, Beach ML, DuHamel KN, Younge RG. Telephone care management to improve cancer screening among low-income women: a randomized, controlled trial. Ann Intern Med. 2006 Apr 18;144(8):563-71. doi: 10.7326/0003-4819-144-8-200604180-00006.
- Dietrich AJ, Tobin JN, Cassells A, Robinson CM, Reh M, Romero KA, Flood AB, Beach ML. Translation of an efficacious cancer-screening intervention to women enrolled in a Medicaid managed care organization. Ann Fam Med. 2007 Jul-Aug;5(4):320-7. doi: 10.1370/afm.701.
- Ogedegbe G, Cassells AN, Robinson CM, DuHamel K, Tobin JN, Sox CH, Dietrich AJ. Perceptions of barriers and facilitators of cancer early detection among low-income minority women in community health centers. J Natl Med Assoc. 2005 Feb;97(2):162-70.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Huidziektes
- Neoplasmata
- Urogenitale neoplasmata
- Neoplasmata per site
- Baarmoeder Neoplasmata
- Genitale neoplasmata, vrouwelijk
- Baarmoederhalsaandoeningen
- Baarmoeder Ziekten
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Borst ziekten
- Colon Ziekten
- Darmziekten
- Intestinale neoplasmata
- Rectale ziekten
- Baarmoeder Cervicale Neoplasmata
- Borstneoplasmata
- Colorectale neoplasmata
Andere studie-ID-nummers
- CDR0000450797
- R01CA087776 (Subsidie/contract van de Amerikaanse NIH)
- DMS-15524
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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