CARE + COACH for Breast Cancer Screening

Overseen By Katie Nelson, PhD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

Disqualifiers: Recent mammogram, Breast cancer history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to increase breast cancer screening among women in the White Mountain Apache community. Participants will receive either a special education module about mammography (CARE) or the same module plus guidance from a health coach (CARE + COACH). The researchers aim to determine which approach results in more women getting mammograms within two months of referral. Women who may be suitable have been referred for a mammogram by a Whiteriver Indian Health Service provider, identify as American Indian or Alaska Native, and live within 60 miles of the Fort Apache Indian Reservation.

As an unphased trial, this study offers participants the chance to contribute to important research that could enhance breast cancer screening in their community.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this intervention is safe for promoting breast cancer screening?

Research has shown that educational programs like the CARE module are generally safe. These programs provide information and raise awareness without involving physical risks. The CARE module aims to teach women about mammography (breast cancer screening) and its benefits. Although specific safety data for this module is unavailable, similar programs have been well-received without reported problems.

The CARE + COACH treatment adds a personal element by including a health coach. This coach, an Apache paraprofessional, helps participants navigate the screening process. While specific safety data for this combined approach is lacking, it focuses on offering support and guidance, which are not linked to physical risks.

Overall, both treatments emphasize education and support, making them very safe options for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CARE and CARE + COACH interventions because they bring a new dimension to breast cancer screening education, especially for culturally diverse populations. Unlike traditional mammography education, which might not be tailored to specific cultural needs, CARE offers a culturally tailored approach that resonates more effectively with diverse groups. The CARE + COACH intervention takes this a step further by adding a personal touch through an Apache paraprofessional women’s health coach, who acts as a patient navigator. This combination aims to improve understanding and accessibility of breast cancer screening, potentially leading to higher screening rates and earlier detection in communities that might otherwise be underserved.

What evidence suggests that this trial's treatments could be effective for promoting breast cancer screening?

Research shows that educational programs can increase mammography screening among low-income women. Studies have found that mammograms can reduce the risk of dying from breast cancer by 20%-30% by detecting cancer early. In this trial, participants in the CARE arm will receive a program designed to educate and encourage women to get mammograms, potentially leading to more screenings.

Participants in the CARE + COACH arm will receive the CARE program plus a health coach. This combined approach is expected to provide extra benefits, as coaching has improved overall well-being and can help women better navigate the healthcare system, potentially increasing screening rates. The trial aims to significantly boost mammography rates in the White Mountain Apache community. ^{2 5 6 7 8}

Who Is on the Research Team?

Allison Barlow, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

This trial is for American Indian or Alaska Native women who need a mammogram and live near the Fort Apache Indian Reservation. They can't have had a mammogram in the last year, a personal history of breast cancer, plans to move soon, or be unwilling to be randomly assigned to a group.

Inclusion Criteria

Live on within 60 miles of the Fort Apache Indian Reservation

Referral for screening mammography from a Whiteriver Indian Health Service provider

Self-identify as American Indian or Alaska Native (AIAN)

Exclusion Criteria

Unable to participate in full intervention or evaluation due to an anticipated event (e.g., planned move)

I am not willing to be assigned to a treatment by chance.

Women who have received a mammogram within the prior 12 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either the CARE education module or CARE+COACH, which includes a patient navigator

2 months

Multiple sessions (in-person or virtual)

Follow-up

Participants are monitored for mammography uptake and effectiveness of the intervention

2 months

What Are the Treatments Tested in This Trial?

Interventions

• CARE
• CARE + COACH

Trial Overview The study compares two ways to encourage breast cancer screening: CARE (a tailored education module) and CARE+COACH (CARE plus help from an Apache health coach). Women will be put into one of these groups by chance.

How Is the Trial Designed?

Group I: CARE - Intervention arm for mammography education Experimental Treatment 1 Intervention

CARE is a culturally tailored mammography education module.

Group II: CARE + COACH - Intervention arm for mammography education + a patient navigator Experimental Treatment 1 Intervention

CARE + COACH is the CARE education module in addition to a COACH, which is access to an Apache paraprofessional women's health coach. The Coach functions like a patient navigator.

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

Native American Research Center for Health

Collaborator

Trials

6

Recruited

1,300+

Native American Research Centers for Health

Collaborator

Trials

5

Recruited

890+

Published Research Related to This Trial

The Health Coaching Program, tested by 20 family doctors over 12 months, successfully engaged 91% of invited patients, demonstrating high acceptance and feasibility among both patients and physicians.

Of the patients who participated, 37% completed all four steps of the program, and about 50% achieved a positive behavior change, indicating the program's effectiveness in promoting health behavior improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Health counseling in primary care doctors' offices: a new wind! The Health Coaching Program of the Swiss College of Primary Care Medicine]. Neuner-Jehle, S., Grüninger, U., Schmid, M.[2015]

The WISEWOMAN program successfully reached underserved women by providing chronic disease risk factor screenings and lifestyle interventions, demonstrating its effectiveness in enhancing women's health services in three states from 1995 to 1998.

Challenges included the integration of clinical and lifestyle interventions, the need for substantial resources, and the complexity of implementing these programs in stretched healthcare environments, highlighting the importance of planning, training, and support for providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The WISEWOMAN projects: lessons learned from three states. Viadro, CI., Farris, RP., Will, JC.[2015]

The nurse-managed screening program provides comprehensive gynecologic examinations, including breast and pelvic exams, and pap tests, emphasizing individualized care and health promotion for female patients.

The program focuses on health teaching and counseling, which supports illness prevention and encourages self-care practices among women, enhancing their overall health management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventive gynecologic nursing in an inpatient setting. Foley, SF.[2019]

A coaching program for 18 community-based primary care clinicians showed high feasibility and acceptability, with 94% of clinicians believing the feedback would enhance their effectiveness in practice.

The program identified key strengths, such as compassion and engagement with patients, while also highlighting areas for improvement, like acknowledging delays and assessing patient understanding, which can guide future training efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coaching Primary Care Clinicians in the Ambulatory Setting: Direct Observation and Deliberate Practice. Crocetti, M., Kumra, T., Fingerhood, M., et al.[2020]

Group health and wellness coaching is emerging as a cost-effective method to enhance patient engagement and improve health outcomes, allowing access to more clients compared to traditional one-on-one coaching.

Various group coaching initiatives across the U.S. utilize both telephonic and in-person formats, facilitated by trained professionals, highlighting the potential benefits of group support while also identifying challenges that need to be addressed for effective implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group health coaching: strengths, challenges, and next steps. Armstrong, C., Wolever, RQ., Manning, L., et al.[2021]

A systematic review of 17 studies involving 3787 patients found that patient coaching interventions significantly improved communication between patients and physicians, with most interventions consisting of one-on-one sessions lasting 20 to 40 minutes before consultations.

The evidence suggests that multiple coaching encounters, where patients prepare questions and reflect on consultations, can enhance communication effectiveness, indicating a need for further research to identify which patients benefit most from these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does patient coaching make a difference in patient-physician communication during specialist consultations? A systematic review. Alders, I., Smits, C., Brand, P., et al.[2022]

Breast and cervical cancers are the leading causes of cancer deaths among women in the U.S., highlighting the critical need for early detection and treatment.

Nurse practitioners play a vital role in cancer prevention by educating women about risk factors, designing early detection programs, and coordinating care to improve health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Detection of breast cancer and cervical cancer. Teaching life habits]. Leslie, NS.[2007]

The National Breast and Cervical Cancer Early Detection Program (NBCCEDP) grantees are effectively implementing an average of 4.1 out of 5 evidence-based interventions (EBIs) for their clients and providers, indicating strong engagement with these strategies.

However, there is a need for increased implementation of EBIs among non-NBCCEDP clients and providers, as well as a significant gap in the evaluation of these interventions, with less than half of the grantees conducting any form of evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Evidence-Based Interventions to Improve Cancer Screening in the National Breast and Cervical Cancer Early Detection Program. DeGroff, A., Carter, A., Kenney, K., et al.[2019]

Breast and cervical cancer are leading causes of cancer-related deaths among women in the U.S., highlighting the critical need for early detection and treatment to save lives.

Nurse practitioners play a vital role in improving women's health by educating them about cancer risks, initiating screening programs, and advocating for better healthcare services, which can enhance early detection and intervention for these cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of the nurse practitioner in breast and cervical cancer prevention. Leslie, NS.[2005]

About two-thirds of family medicine residency programs reported that their residents had some exposure to health coaches, which is important for training in team-based care.

Residents training in patient-centered medical homes (PCMH) were more likely to have exposure to health coaches, highlighting the role of PCMH certification in enhancing collaborative care experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Growing Trend of Health Coaches in Team-Based Primary Care Training A Multicenter Pilot Study. Gastala, NM., Wingrove, PM., Gaglioti, AH., et al.[2023]

The study explored the use of trained Nurse Coaches to implement the Virtual Integrated Practice (VIP) model in small primary care settings, showing high acceptance and consistent delivery of this new patient care approach.

Results indicated that Nurse Coaches could effectively facilitate quality improvements in small practices, although the degree of implementation varied across different sites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A nurse coach quality improvement intervention: feasibility and treatment fidelity. Minnick, A., Catrambone, CD., Halstead, L., et al.[2008]

Coaching, particularly through a combination of in-person and telecoaching sessions, has been shown to effectively reduce body measurements and enhance motivation and satisfaction in patients seeking weight loss, based on a review of 13 studies.

The study suggests that coaching is a cost-effective approach that integrates education and treatment for weight loss, but further randomized studies are necessary to confirm its impact on chronic disease indicators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coaching and barriers to weight loss: an integrative review. Muñoz Obino, KF., Aguiar Pereira, C., Caron-Lienert, RS.[2022]

Decision coaching significantly improved the decisional comfort of a breast cancer survivor considering extending endocrine therapy from 8 to 10 years, with scores increasing from 2 to 3 out of 4 after coaching.

The coaching process, guided by an oncology nurse using the Ottawa Decision Support Framework, was rated highly for quality, indicating that such support can help survivors make informed, values-based decisions regarding their treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision Support for a Woman Considering Continuing Extended Endocrine Therapy for Breast Cancer: A Case Study. Liska, CM., Stacey, D.[2020]

A culturally specific health coaching program for South Asians effectively engages participants in reducing cardiovascular disease risk, with 1,051 individuals completing at least one year of coaching out of 3,132 candidates.

The program shows low attrition rates and utilizes non-medically trained coaches, making it a cost-effective strategy for cardiovascular disease prevention, although further research is needed to assess the long-term effectiveness of cultural adaptations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A culturally specific health coaching program targeting cardiovascular disease risk in South Asians: rationale, design, and baseline data. Sathe, A., Flowers, E., Mathur, A., et al.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1820866/

A Systematic Review of Mammography Educational ... We conducted a systematic review to examine the effectiveness of educational interventions in increasing mammography screening among low-income women.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2589537023002717

Effectiveness of a telehealth patient education intervention ... Use of BC screening was nonexistent: zero of 420 women reported ever seeing a physician in their lifetime for a breast-related concern. Awareness of BC risk ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9846523/

Look how far we have come: BREAST cancer detection ... The development of screening mammography over 30 years has remarkedly reduced breast cancer–associated mortality by 20%-30% through detection of small cancer ...

4. acr.org acr.org/Clinical-Resources/Clinical-Tools-and-Reference/Screening-Resources/Breast-Imaging-Resources

Mammography and Breast Imaging Resources Free customizable materials give you the ability to: Identify and assess reliable breast cancer screening and outcomes data. Discern breast cancer screening ...

5. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7315e1.htm

Vital Signs: Mammography Use and Association with ... In 2022, more than three quarters (76.5%) of women aged 50–74 and more than one half (59.1%) of those aged 40–49 reported having had a mammogram ...

6. acr.org acr.org/Clinical-Resources/Clinical-Tools-and-Reference/Screening-Resources/Breast-Imaging-Resources/Mammography-CME-Toolkit

Mammography CME Toolkit Use this free CME module to: Access and assess reliable screening and outcomes data. Discern actual breast cancer screening risks vs. benefits.

7. mpca.net mpca.net/wp-content/uploads/2025/04/Breast-Cancer-Screening-Playbook_PDF.pdf

Breast Cancer Screening Playbook Overview: This section contains background information to level-set on the importance of breast cancer screening and ensure understanding of the quality ...

8. ajpmonline.org ajpmonline.org/article/S0749-3797(25)00499-4/abstract

Patterns of breast cancer screening and access to care in a ... A retrospective study was performed to identify patients diagnosed with new invasive breast cancer between 2018 and 2019 at Parkland Health.