Colorectal CancerCOACHNCT01613430
Evaluating Coaches of Older Adults for Cancer Care and Health Behaviors
A study testing Coach Training (COACH) and Printed Educational Materials (PEM) in people with Colorectal Cancer and Breast Cancer, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Breast Cancer, Cervical Cancer
- What is being tested?
- Coach Training (COACH) and Printed Educational Materials (PEM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,106 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Center to Reduce Cancer Disparities
Baltimore, Maryland, 21202
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer, Breast Cancer, Cervical Cancer
- Being tested
- Coach Training (COACH), Printed Educational Materials (PEM)
- Medical subject headings
- Colorectal Neoplasms, Breast Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coach Training (COACH)Behavioural
Also called COACH Group
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.
Printed Educational Materials (PEM)Behavioural
Also called PEM Group
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Coach Training (COACH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: At six months and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Adrian S Dobs, MD, MHS, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613430
- Sponsor's protocol ID
- U54CA153710
- Other IDs
- U54CA153710
- Acronym
- COACH
- Status last verified
- Apr 2018
- First submitted
- 5 Jun 2012
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Freeman HP, Alshafie TA. Colorectal carcinoma in poor blacks. Cancer. 2002 May 1;94(9):2327-32. doi: 10.1002/cncr.10486.
PubMed 12015756Liberman 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.
PubMed 12115310Oluwole 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.
PubMed 12595043Calhoun 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.
PubMed 19116415Viswanathan 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.
PubMed 20804230Wells 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.
PubMed 18780320Glajchen M. The emerging role and needs of family caregivers in cancer care. J Support Oncol. 2004 Mar-Apr;2(2):145-55.
PubMed 15328817Pinquart 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.
PubMed 15695420Given 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.
PubMed 16458182Mbah 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.
PubMed 26573809
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Coaches of Older Adults for Cancer Care and Health Behaviors (COACH)
- ClinicalTrials.gov ID
- NCT01613430
- Acronym / sponsor ID
- COACH / U54CA153710
- Conditions
- Colorectal Cancer, Breast Cancer, Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,106 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Printed Educational Material (PEM) only | Active comparator | 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. |
| Coach Training (COACH) | Experimental | Behavioral: Coach Training (COACH)The COACH intervention consists of the Printed Educational Materials (PEM) plus the addition of cancer-related training for participant-designated coaches. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coach Training (COACH)Also: COACH GroupParticipants 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. | Behavioural | Coach Training (COACH) |
| Printed Educational Materials (PEM)Also: PEM GroupParticipants 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. | Behavioural | Printed Educational Material (PEM) only |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Background: PubMed 12015756Freeman HP, Alshafie TA. Colorectal carcinoma in poor blacks. Cancer. 2002 May 1;94(9):2327-32. doi: 10.1002/cncr.10486.
- Background: PubMed 12115310Liberman 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.
- Background: PubMed 12595043Oluwole 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.
- Background: PubMed 19116415Calhoun 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.
- Background: PubMed 20804230Viswanathan 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.
- Background: PubMed 18780320Wells 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.
- Background: PubMed 15328817Glajchen M. The emerging role and needs of family caregivers in cancer care. J Support Oncol. 2004 Mar-Apr;2(2):145-55.
- Background: PubMed 15695420Pinquart 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.
- Background: PubMed 16458182Given 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.
- Derived from this study: PubMed 26573809Mbah 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.
- The Johns Hopkins Center to Reduce Cancer DisparitiesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian S Dobs, MD, MHS principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coach Training (COACH) and Printed Educational Materials (PEM) in people with Colorectal Cancer and Breast Cancer, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completing at least one recommended cancer screenings (colorectal, breast, cervical) (time frame: At six months and one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01613430, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2018.