NCT01613430

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,106

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

4.3 years

First QC Date

June 5, 2012

Last Update Submit

April 24, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

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

    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 Outcomes (1)

  • Time to completion of cancer screenings, and the effect of comorbid conditions, health literacy, patient satisfaction,and health care costs on cancer screening

    At six months and one year

Study Arms (2)

Printed Educational Material (PEM) only

ACTIVE COMPARATOR

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)

Coach Training (COACH)

EXPERIMENTAL

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)

Interventions

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.

Also known as: COACH Group
Coach Training (COACH)

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.

Also known as: PEM Group
Printed Educational Material (PEM) only

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Resident in Baltimore City, MD or Prince George's County, MD
  • African American
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Center to Reduce Cancer Disparities

Baltimore, Maryland, 21202, United States

Location

Related Publications (10)

  • Freeman HP, Alshafie TA. Colorectal carcinoma in poor blacks. Cancer. 2002 May 1;94(9):2327-32. doi: 10.1002/cncr.10486.

    PMID: 12015756BACKGROUND
  • Liberman L, Freeman HP, Chandra S, Stein AL, McCord C, Godfrey D, Dershaw DD. Carcinoma detection at the breast examination center of Harlem. Cancer. 2002 Jul 1;95(1):8-14. doi: 10.1002/cncr.10640.

    PMID: 12115310BACKGROUND
  • Oluwole SF, Ali AO, Adu A, Blane BP, Barlow B, Oropeza R, Freeman HP. Impact of a cancer screening program on breast cancer stage at diagnosis in a medically underserved urban community. J Am Coll Surg. 2003 Feb;196(2):180-8. doi: 10.1016/S1072-7515(02)01765-9.

    PMID: 12595043BACKGROUND
  • Calhoun EA, Whitley EM, Esparza A, Ness E, Greene A, Garcia R, Valverde PA. A national patient navigator training program. Health Promot Pract. 2010 Mar;11(2):205-15. doi: 10.1177/1524839908323521. Epub 2008 Dec 30.

    PMID: 19116415BACKGROUND
  • Viswanathan M, Kraschnewski J, Nishikawa B, Morgan LC, Thieda P, Honeycutt A, Lohr KN, Jonas D; RTI International-University of North Carolina Evidence-based Practice Center. Outcomes of community health worker interventions. Evid Rep Technol Assess (Full Rep). 2009 Jun;(181):1-144, A1-2, B1-14, passim.

    PMID: 20804230BACKGROUND
  • Wells KJ, Battaglia TA, Dudley DJ, Garcia R, Greene A, Calhoun E, Mandelblatt JS, Paskett ED, Raich PC; Patient Navigation Research Program. Patient navigation: state of the art or is it science? Cancer. 2008 Oct 15;113(8):1999-2010. doi: 10.1002/cncr.23815.

    PMID: 18780320BACKGROUND
  • Glajchen M. The emerging role and needs of family caregivers in cancer care. J Support Oncol. 2004 Mar-Apr;2(2):145-55.

    PMID: 15328817BACKGROUND
  • Pinquart M, Sorensen S. Ethnic differences in stressors, resources, and psychological outcomes of family caregiving: a meta-analysis. Gerontologist. 2005 Feb;45(1):90-106. doi: 10.1093/geront/45.1.90.

    PMID: 15695420BACKGROUND
  • Given B, Sherwood PR. Family care for the older person with cancer. Semin Oncol Nurs. 2006 Feb;22(1):43-50. doi: 10.1016/j.soncn.2005.10.006.

    PMID: 16458182BACKGROUND
  • Mbah O, Ford JG, Qiu M, Wenzel J, Bone L, Bowie J, Elmi A, Slade JL, Towson M, Dobs AS. Mobilizing social support networks to improve cancer screening: the COACH randomized controlled trial study design. BMC Cancer. 2015 Nov 16;15:907. doi: 10.1186/s12885-015-1920-7.

Related Links

MeSH Terms

Conditions

Colorectal NeoplasmsBreast NeoplasmsUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Adrian S Dobs, MD, MHS

    Johns Hopkins School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2012

First Posted

June 7, 2012

Study Start

June 1, 2012

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

April 26, 2018

Record last verified: 2018-04

Locations