Cancer Prevention and Treatment Among African American Older Adults: Treatment Trial

NCT00509444 | Completed Phase 3

• 1 other identifier: IRB00063
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The Centers for Medicare and Medicaid Services (CMS) has awarded cooperative agreements to 6 sites from across the country (Salt Lake City, UT, Molokai, HI, Houston, TX, Newark, NJ, Detroit, MI, and Baltimore City) to participate in a national 4-year demonstration (September 15, 2006 to September 30, 2010). One goal of the demonstration is to reduce disparities in cancer treatment among seniors from U.S. racial and ethnic minority populations. Each site will focus on a specific racial/ethnic minority group, and collaborate with CMS in project implementation. A Core questionnaire, the Cancer Screening Assessment (CSA) will be administered at baseline to all participants in the demonstration. Participant identification, randomization, and intervention implementation will be standardized across sites. Goal: The proposal developed by the Johns Hopkins Bloomberg School of Public Health in collaboration with the Baltimore City Community Health Coalition is designed to address persistent disparities in breast, cervix, colon/rectum, prostate and lung cancer treatment. Primary Objective: Conduct A CONTROL RANDOMIZED TRIAL within a randomized control demonstration project (N = 200) to compare the efficacy of 2 interventions that differ in intensity to improve continuity and outcomes of care among African Americans seniors. Among African American seniors, compared to a less intensive intervention (general information and educational materials), does the addition of facilitation services delivered by a health coordinator result in a greater improvement in adherence to recommended treatment among those diagnosed with breast, cervix, colon/rectum, prostate, or lung cancer? Study Population: We will recruit African Americans, age 65 years or older, and currently enrolled in Medicare Parts A and B. (Baltimore City's 82,202 seniors represent 13% of its population, and account for 68% of the City's cancer deaths. Among these seniors, 96% have Medicare Parts A and B, 54.5% have income levels at less than 250% of the federal poverty guideline, and 55.6% are African American.) The trial consists of individuals diagnosed with breast, cervical, colorectal, prostate, or lung cancer. Eligible participants will respond to a baseline questionnaire, the Cancer Screening Assessment (CSA). They will then be randomized to receive a less intensive or more intensive intervention. The less intensive group will receive general information about cancer and Medicare covered services and instructions to discuss the information with their primary care doctor. The more intensive group will receive the same information as the less intensive group receives, plus tailored facilitation services delivered by a nurse-supervised community health worker. The primary outcome variable for the trial will be the difference between randomized groups in adherence to treatment for breast, cervix, colon/rectum, prostate and lung cancer. A community advisory committee will guide all aspects of the study and will include important stake holders (both public and private sectors), representatives from the Baltimore City Community Health Coalition, the Baltimore City Department of Health, the Maryland Department of Health and Mental Hygiene, community leaders, consumers, health care providers (physicians, oncologists, nurse practitioners, physician assistants, nurses, social workers, pathologists) and academicians.

Conditions

Breast Cancer; Colon Cancer; Rectum Cancer; Cervix Cancer; Prostate Cancer; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• The primary outcome variable will be difference between the two intervention groups in the time to initiation of therapy, beginning on the date of randomization.

Secondary Outcomes (4)

• The time in days to the first treatment-related visit (with a medical, radiation oncologist, or surgical oncologist) beginning on the date of randomization.

• The rate of completion of recommended courses of chemo and/or radiation therapy.

• The proportion completing recommended surgical treatment.

• The proportion receiving recommended screenings for breast, cervix, colon/rectum and prostate cancer.

Study Arms (2)

Educational materials

ACTIVE COMPARATOR

Behavioral: Educational materials

Educational materials, plus patient navigation

EXPERIMENTAL

Behavioral: educational materials, plus patient navigation

Interventions

Educational materials BEHAVIORAL

Educational materials

educational materials, plus patient navigation BEHAVIORAL

Educational materials, plus patient navigation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 or older
• Enrolled in Medicare Part A
• Enrolled in Medicare Part B of Title XVIII of the Social Security Act
• Provided Informed Consent
• Diagnosed with breast, cervical, colorectal, prostate, or lung cancer AND 1) have not yet begun treatment for this cancer; or 2) are currently receiving treatment or received a last treatment within the past five years; or 3) received a last treatment 5 or more years ago but have been in remission less than 5 years; AND 4) intend to receive cancer treatment from either Johns Hopkins Hospital (JHH) or from Johns Hopkins Bayview Medical Center (JHBMC)

You may not qualify if:

• Age less than 65
• Enrollment in Medicare managed care (Part C)
• Residence in a chronic care facility or otherwise institutionalized
• Planning to move within the next year
• Unable or unwilling to give informed consent
• Another member of the household enrolled in the demonstration project
• Diagnosed with breast, cervical, colorectal, prostate, or lung cancer and received a last treatment for this cancer 5 or more years ago and have been in remission for 5 or more years
• Currently receiving treatment or will be receiving treatment soon for a non-study cancer
• Currently diagnosed with a non-study cancer and have not received treatment yet for this cancer but returning for additional tests and observation
• Diagnosed with a non-study cancer and received the last treatment within the last 5 years
• Diagnosed with a non-study cancer and received the last treatment for this cancer 5 or more years ago and have been in remission less than 5 years
• Diagnosed with a non-study cancer and received the last treatment for this cancer 5 or more years ago and have been in remission for 5 or more years
• Diagnosed with a study cancer and being treated outside of Johns Hopkins Medical Institutions

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Centers for Medicare and Medicaid Services: collaborator

Study Sites (1)

Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms; Rectal Neoplasms; Uterine Cervical Neoplasms; Prostatic Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jean G. Ford, MD

  Bloomberg School of Public Health, Baltimore, Maryland, United States

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 27, 2007
• First Posted: July 31, 2007
• Study Start: October 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 20, 2017

Record last verified: 2017-04

Locations

US (1)