- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Forventet)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
New Hampshire
-
Lebanon, New Hampshire, Forente stater, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
-
-
New York
-
New York, New York, Forente stater, 10018
- Clinical Directors Network, Incorporated
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Intervention
Series of telephone support calls from a trained prevention care manager
|
|
Ingen inngripen: Vanlig omsorg
|
Hva måler studien?
Primære resultatmål
Resultatmål |
---|
Follow-up patient cancer 3 months after completion of study treatment
|
Screening rates as measured by mammography, Pap test, hfoBT, sigmoidoscopy, barium enema and colonoscopy
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Allen J. Dietrich, MD, Norris Cotton Cancer Center
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Hudsykdommer
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Uterine neoplasmer
- Genitale neoplasmer, kvinnelige
- Livmor livmorhalssykdommer
- Livmorsykdommer
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Bryst sykdommer
- Kolonsykdommer
- Tarmsykdommer
- Intestinale neoplasmer
- Rektale sykdommer
- Uterine cervikale neoplasmer
- Brystneoplasmer
- Kolorektale neoplasmer
Andre studie-ID-numre
- CDR0000450797
- R01CA087776 (U.S. NIH-stipend/kontrakt)
- DMS-15524
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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