Clinical trial 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
Official title: New York Prevention Care Manager Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Cervical Cancer
Colorectal Cancer
Keywords: breast cancer
cervical cancer
colon cancer
rectal cancer
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-09-15
Enrollment: 2729
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Follow-up patient cancer 3 months after completion of study treatment
measure: Screening rates as measured by mammography, Pap test, hfoBT, sigmoidoscopy, barium enema and colonoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: Clinical Directors Network, Incorporated
state: New York
Study officials:
affiliation: Norris Cotton Cancer Center
name: Allen J. Dietrich, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.