Evaluating Coaches of Older Adults for Cancer Care and Health Behaviors
Condition: Colorectal Cancer; Breast Cancer; Cervical Cancer
MeSH terms: Colorectal Neoplasms; Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Coach Training (COACH); Printed Educational Materials (PEM)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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 intervention name(s): COACH Group; PEM Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening