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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Adrian Dobs, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01613430
First received: June 5, 2012
Last updated: August 25, 2015
Last verified: August 2015
  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. 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.


Condition Intervention
Colorectal Cancer
Breast Cancer
Cervical Cancer
Behavioral: Coach Training (COACH)
Behavioral: Printed Educational Materials (PEM)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Evaluating Coaches of Older Adults for Cancer Care and Health Behaviors (COACH)

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 six months and 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 six months 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.


Enrollment: 1106
Study Start Date: June 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: COACH Group

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.

  Eligibility

Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613430

Locations
United States, Maryland
Johns Hopkins Center to Reduce Cancer Disparities
Baltimore, Maryland, United States, 21202
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
Principal Investigator: Adrian S Dobs, MD, MHS Johns Hopkins School of Medicine
  More Information

Additional Information:
Publications:

Responsible Party: Adrian Dobs, Professor of Medicine and Oncology, Johns Hopkins School of Medicine, 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: August 25, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on September 03, 2015