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

April 24, 2018 updated by: Johns Hopkins Bloomberg School of Public Health

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

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. This research objective is guided by the theoretical model of the PRECEDE-PROCEED conceptual framework that has been widely adopted in health promotion. The target jurisdictions for this study are Baltimore City (BC) and Prince George's County (PGC), Maryland. The study is anchored in community-based participatory research (CBPR) principles, involving community members in all its phases. The CBPR component is guided by Community Advisory Groups (CAGs) representing key stakeholders in the two jurisdictions. The CAGs are essential in determining the questions included in data collection instruments, mechanisms of recruitment, interpretation of findings, and dissemination of results within the target communities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This mixed methods study will occur in three phases: (Aim 1) a formative exploratory phase involving in-depth qualitative interviews that will inform Aims 2 and 3; (Aim 2) development and pilot testing of all COACH research protocols, including coach training curriculum, quantitative surveys, recruitment protocols among 50 participants and 50 coaches; and (Aim 3) a full-size randomized trial involving recruitment of total 550 study participants and 550 coaches, randomization, and longitudinal data collection.

Aim 1: Implement formative research to inform COACH intervention (IRB Number 00003825): As of June 2012, we have conducted in-depth interviews reaching saturation with twelve stakeholders; six healthcare providers and six community leaders. The interviews were transcribed and analyzed providing crucial information for the development of the research in Aims 2 and 3.

Aim 2: Development and pilot testing of all COACH protocols among 50 index participants and 50 participant-designated coaches: Using convenience sampling, we will recruit and enroll African American residents of Baltimore City and Prince George's County who are aged 50-74 years. We will conduct a pilot study to assess the coaches' effect (versus traditional health education using an educational brochure) on overcoming the participants' barriers to discussing cancer screening with their primary care providers and, if needed, to getting screened for breast, cervical, and/or colorectal cancers.

Aim 3: Implementation of full randomized COACH trial among 550 total participants and 550 total coaches: Using convenience sampling and other sampling methods, we will recruit and enroll African American residents of Baltimore City and Prince George's County who are aged 50-74 years. We will utilize our study's IRB-approved flyer to recruit potential study participants in medical centers, senior housing, neighborhood development centers, markets, and community centers in various neighborhoods in our study's catchment areas. Eligible and interested participants will complete an in-person baseline interview administered by a trained interviewer. The participant will then be randomized, stratifying by county and gender, to one of the following two interventions: (1) printed educational materials only (PEM) or (2) printed educational material plus specialized training for his/her health coach to help the participant overcome his/her barriers to cancer screening (COACH). The coach will then complete a short interviewer-administered questionnaire. If the participant is randomized to COACH, then the coach will be invited to participate in a 40-minute in-person training. Participants and coaches will then be queried at 6-months and one year to assess their cancer screening status and other outcomes of interest.

The primary outcome variable of the COACH intervention will be the change in the proportion of participants completing at least one of the recommended screenings, comparing the COACH group to the PEM group during follow up. Another primary outcome will be the change in the proportion of participants who report talking with their healthcare provider regarding at least one of the recommended cancer screening(s) during follow up. Secondary outcome variables will include between-group changes in the time to completion of screenings, changes in cancer screening barriers, and changes in the reported levels of stress for both the participants and coaches.

Study Type

Interventional

Enrollment (Actual)

1106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Johns Hopkins Center to Reduce Cancer Disparities

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Resident in Baltimore City, MD or Prince George's County, MD
  • African American
  • 50-74 years of age
  • Eligible for breast, cervical and/or colorectal cancer screenings at time of study enrollment
  • Has a support person who is willing to participate in the study

Exclusion Criteria:

  • Diagnosis of colon, cervix or breast cancer within the past 5 years
  • A current diagnosis of another cancer
  • Residence in a chronic care facility, being otherwise institutionalized
  • Inability or unwillingness to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Printed Educational Material (PEM) only
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.
Behavioral: Printed Educational Materials (PEM)
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.
Other Names:
  • PEM Group
Experimental: Coach Training (COACH)
The COACH intervention consists of the Printed Educational Materials (PEM) plus the addition of cancer-related training for participant-designated coaches.
Behavioral: Coach Training (COACH)
Participants and their coaches receive Printed Educational Materials (PEM). Additionally, coaches will receive a 40-minute cancer-related training session led by a 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 video presentations, role plays and exercises. Coaches will be given brochures on cancer screening for the three cancer types, a checklist for the coach and a "Things to Remember" diary checkup list, and resources addressing well-known barriers to cancer screening.
Other Names:
  • COACH Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completing at least one recommended cancer screenings (colorectal, breast, cervical)
Time Frame: At six months and one year
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.
At six months and one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 six months and one year
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.
At six months and one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Adrian S Dobs, MD, MHS, Johns Hopkins School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

June 5, 2012

First Submitted That Met QC Criteria

June 5, 2012

First Posted (Estimate)

June 7, 2012

Study Record Updates

Last Update Posted (Actual)

April 26, 2018

Last Update Submitted That Met QC Criteria

April 24, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U54CA153710 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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