Evaluating Coaches for Older Adults Cancer Care and Health (COACH)

This study is currently recruiting participants.
Verified June 2012 by Johns Hopkins Bloomberg School of Public Health
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jean Ford, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01613430
First received: June 5, 2012
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

The overall goal of the COACH study is to conduct a comparative effectiveness trial to assess the effectiveness of trained, participant-designated health coaches versus traditional health education efforts on cancer screening among African American older adults. We hypothesize that members of older adults' extended families can be trained to be effective coaches who support them through the cancer control spectrum, i.e., prevention, screening, diagnosis and treatment.


Condition Intervention
Colorectal Cancer
Breast Cancer
Cervical Cancer
Behavioral: Coach Intervention (COACH)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Evaluating Coaches for Older Adults Cancer Care and Health

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Completing at least one recommended cancer screenings (colorectal, breast, cervical) [ Time Frame: At baseline, mid-year, one year ] [ Designated as safety issue: No ]
    The primary outcome variables will be the change in the proportion completing at least one of the recommended screenings, comparing the COACH group to the PEM group, and the change in the proportion discussing at least one of the recommended screenings with their primary care provider (PCP), comparing the COACH group to the PEM group.


Secondary Outcome Measures:
  • Time to completion of cancer screenings, and the effect of comorbid conditions, health literacy, patient satisfaction,and health care costs on cancer screening [ Time Frame: At baseline, mid-year and one year ] [ Designated as safety issue: No ]
    Secondary outcome variables will include between-group changes in the time to completion of screenings, and the effect of comorbid conditions, health literacy, patient satisfaction, and health care costs on cancer screening.


Estimated Enrollment: 1100
Study Start Date: June 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1. Information group
The participants and their coaches will be provided with educational brochures about cancer screening for colorectal, breast and cervical cancers at the completion of the baseline survey.
Experimental: Coach group
The COACH intervention consists of the educational materials intervention, plus the addition of a trained, patient-designated coach.
Behavioral: Coach Intervention (COACH)
Behavioral: Coach Intervention (COACH) The COACHES will receive a one-hour training session led by a senior level research staff member. The COACHES will be provided basic information about different types of cancer screenings, how to schedule and keep medical visits, and how to communicate with health care providers about cancer screening. The session will be interactive, including short DVD presentations, role plays and exercises. A DVD of the training modules will be provided to trainees, as well as brochures on cancer screening for the three cancer types, a checklist for the coach and a "Things to Remember" diary a checkup list, and a wellness calendar for the participants.
Other Name: COACH GROUP

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  Eligibility

Ages Eligible for Study:   65 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Resident in Baltimore City, MD or Prince George's County, MD
  • African American
  • 65-74 years of age
  • Enrolled in Medicare Parts A and B
  • No screening for breast, cervical and/or colorectal cancers within the recommended time period

Exclusion Criteria:

  • Diagnosis of colon, cervix or breast cancer within the past 5 years
  • A current diagnosis of another cancer
  • Enrollment in Medicare managed care
  • Residence in a chronic care facility, being otherwise institutionalized
  • Inability or unwillingness to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613430

Contacts
Contact: Jean G Ford, MD 443-287-5181 jford@jhsph.edu
Contact: Ilana S Mittman, MS, PhD 443-287-7480 imittman@jhsph.edu

Locations
United States, Maryland
Johns Hopkins Center to Reduce Cancer Disparities Recruiting
Baltimore, Maryland, United States, 21202
Contact: Jean G Ford, MD    443-287-5181    jford@jhsph.edu   
Contact: Ilana S Mittman, MS, PhD    4432877480    imittman@jhsph.edu   
Principal Investigator: Jean G Ford, MD         
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
Principal Investigator: Jean G Ford, MD Johns Hopkins Center to Reduce Cancer Disparities
  More Information

Additional Information:
Publications:

Responsible Party: Jean Ford, Associate Professor; Department of Epidemiology, Director of Johns Hopkins Center to Reduce Cancer Disparities; Associate Director of Community Programs and Research, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01613430     History of Changes
Other Study ID Numbers: U54CA153710, U54CA153710
Study First Received: June 5, 2012
Last Updated: June 18, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Uterine Cervical Neoplasms
Colorectal Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 17, 2014