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Evaluating Coaches for Older Adults Cancer Care and Health


N/A
65 Years
74 Years
Open (Enrolling)
Both
Colorectal Cancer, Breast Cancer, Cervical Cancer

Thank you

Trial Information

Evaluating Coaches for Older Adults Cancer Care and Health


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.

1. Aims/objectives/research question/hypotheses: 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. 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.

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 25 coaches; and (Aim
3) a full-size randomized trial involving recruitment of total 550 study participants and
275 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
25 participant-designated coaches: Using convenience sampling, we will recruit and enroll
African American residents (1:1 men to women) of Baltimore City and Prince George's County
who are aged 65-74 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, we will recruit and enroll African American
residents (1:1 men to women) of Baltimore City and Prince George's County who are aged 65-74
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 one-hour in-person,
small group 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Completing at least one recommended cancer screenings (colorectal, breast, cervical)

Outcome Description:

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.

Outcome Time Frame:

At baseline, mid-year, one year

Safety Issue:

No

Principal Investigator

Jean G Ford, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins Center to Reduce Cancer Disparities

Authority:

United States: Institutional Review Board

Study ID:

U54CA153710

NCT ID:

NCT01613430

Start Date:

June 2012

Completion Date:

August 2015

Related Keywords:

  • Colorectal Cancer
  • Breast Cancer
  • Cervical Cancer
  • Breast Neoplasms
  • Uterine Cervical Neoplasms
  • Colorectal Neoplasms

Name

Location

Johns Hopkins Center to Reduce Cancer DisparitiesBaltimore, Maryland  21202