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

Trial Summary

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 data supports the effectiveness of the CARE + COACH treatment for breast cancer screening?

Research shows that health coaching can help patients make positive health changes by improving communication and motivation. In one study, health coaching led to positive behavior changes in half of the patients, suggesting it could be effective in encouraging regular breast cancer screening. ^{1 2 3 4 5}

Is the CARE + COACH intervention safe for humans?

The available research on health coaching, including group and culturally specific programs, suggests that these interventions are generally well-accepted and feasible, with no significant safety concerns reported. However, specific safety data for the CARE + COACH intervention in breast cancer screening is not provided in the available studies. ^{2 6 7 8 9}

How does the CARE + COACH treatment for breast cancer screening differ from other treatments?

The CARE + COACH treatment is unique because it combines an educational module with personalized support from a women's health coach, focusing on improving adherence to breast cancer screening guidelines. This approach emphasizes education and personalized coaching, which is different from standard treatments that may not include such individualized support. ^{10 11 12 13 14}

What is the purpose of this trial?

The goal of this study is to evaluate the relative benefits of an intervention to promote breast cancer screening among women in the White Mountain Apache (WMA) community. Women will be randomized to receive CARE, a culturally tailored mammography education module, or CARE+COACH, which is the CARE education module plus access to an Apache paraprofessional women's health coach (i.e., patient navigator). The CARE intervention was developed through a community-based participatory research process. The primary outcome is mammography uptake within 2 months of a referral.

Research Team

Allison Barlow, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria

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.

I have had breast cancer before.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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 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 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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Coaching and barriers to weight loss: an integrative review. [2022]

2. Switzerland 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]. [2015]

3. Ireland pubmed.ncbi.nlm.nih.gov

Does patient coaching make a difference in patient-physician communication during specialist consultations? A systematic review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Coaching Primary Care Clinicians in the Ambulatory Setting: Direct Observation and Deliberate Practice. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

The Growing Trend of Health Coaches in Team-Based Primary Care Training A Multicenter Pilot Study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Group health coaching: strengths, challenges, and next steps. [2021]

7. Canada pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

A nurse coach quality improvement intervention: feasibility and treatment fidelity. [2008]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. Canada pubmed.ncbi.nlm.nih.gov

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

11. United States pubmed.ncbi.nlm.nih.gov

The WISEWOMAN projects: lessons learned from three states. [2015]

12. United States pubmed.ncbi.nlm.nih.gov

Using Evidence-Based Interventions to Improve Cancer Screening in the National Breast and Cervical Cancer Early Detection Program. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Preventive gynecologic nursing in an inpatient setting. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

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