Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Breast Neoplasms

Breast Diseases

Fibrocystic Breast Disease

Uterine Cervical Neoplasms

Skin Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Lydia Pace, MD, MPH

Vincent Cubaka, MD

Breast cancer incidence is increasing in low- and middle-income countries (LMICs) and breast cancer mortality is high in these regions largely due to late stage diagnoses. This is true in the low-income East African country of Rwanda, where there are no national protocols in place to guide evaluation and referral of breast symptoms at primary health facilities.

This study will use quantitative and qualitative methods to examine implementation of the Women's Cancer Early Detection Program (WCEDP) in order to understand optimal strategies to scale and sustain breast cancer early diagnosis in Rwanda and other limited-resource settings. The WCEDP is an adaptation of a prior intervention in Burera District, which focused on building community awareness of breast symptoms, improving clinicians' clinical breast assessment (CBA) skills, and implementing weekly breast clinics at the primary health care center and hospital levels. The Burera intervention was associated with improvements in health care workers' knowledge and skills, increases in care-seeking and receipt of care by women with breast symptoms, and an increase in early-stage breast cancer diagnoses.

Despite the Burera trial's promising results it was clear adaptations would be needed for real-world scaleup. The Burera intervention focused on breast health in isolation, hindering scalability in a limited-resource health system. In addition, it benefited from intensive patient tracking, feasible with the study's resources and implementation in a single district. Rwanda Biomedical Centre (RBC) is now scaling up breast cancer early diagnosis using the Burera training program with two key adaptations. First, in an effort to expand reach and increase efficiency, breast cancer early diagnosis services are offered together with cervical cancer screening in a combined initiative, the Women's Cancer Early Detection Program. The WCEDP combines these services through: 1)Combined provider trainings; 2)Community awareness-raising about both cancers; and 3)Weekly district hospital (DH) and HC clinics for women eligible for cervical cancer screening and CBA. RBC's second adaptation, an effort to facilitate patient tracking and linkage to care at scale, is a tablet-based EMR that allows clinicians to share information across facilities, identify missed visits, and document patient phone calls. These adaptations address priorities of the WHO's Global Breast Cancer Initiative: integrating early diagnosis into primary care services and building systems to facilitate referrals. By examining these adaptations in a real-world setting, this research will contribute to global efforts to identify evidence-based implementation strategies to address breast cancer in LMICs.

This study will leverage a longstanding partnership between RBC, Partners In Health (PIH), and Brigham and Women's Hospital (BWH) to pursue the following Specific Aims:

Aim 1. Use the RE-AIM framework to examine implementation and impact of Rwanda's adaptation and scale-up of breast cancer early diagnosis within the WCEDP, in 3 districts with 52 HCs.

1a. Evaluate the WCEDP's reach using interrupted time series analysis to examine its impact on the number of patients receiving CBA at HCs, and engagement of older women and those with breast symptoms.

1b. Examine program effectiveness, adoption and implementation by assessing timely linkage to care, loss-to-follow-up, service delivery, and EMR use.

Aim 2. Use patient and provider interviews, guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework, to elicit contextual factors related to successes and challenges of scaleup, including the WCEDP's fit and acceptability for communities, clinicians, and facilities.

Evaluating Scaleup of an Adapted Breast Cancer Early Diagnosis Program in Rwanda

The primary analysis will be interrupted time series (ITS) Poisson regression to compare the number of patients presenting for CBA to health centers each week in the months before and after initiation of the WCEDP

The investigators will examine the median age of individuals presenting before and after WCEDP

Investigators will examine the proportion of patients evaluated at health centers with CBA who had symptoms

Proportion of patients evaluated with CBA at health centers who also had cervical cancer screening (Reach)

Number and percentage of women seen at health centers for CBA who are referred to district hospitals (and seen within 1 month of DH visit)

Number and percentage of women seen at district hospitals for CBA who are referred to referral facilities (and seen within 1 month of DH visit)

Number and percentage of community health workers (CHWs) trained

Number and percentage of clinicians trained in the program and in electronic medical record

Number and percentage of weeks that clinics are held at each health center and district hospital (and the average percentage per district)

Number of days/ month that CHWs hold community awareness events or do home visits (and average percentage per district)

Proportion of weeks in which electronic medical record missed-visit reports are run in each district hospital

Of patients who have missed district hospital visits, percentage with phone call documented in the electronic medical record

Partners in Health

Rwanda Biomedical Centre

Johns Hopkins University

Brigham and Women's Hospital

Assistant Professor of Medicine

Community health workers and nurses affiliated with 7 health centers received the breast cancer early detection trainings in April-May 2015

Community health workers and nurses affiliated with 7 health centers received the breast cancer early detection trainings in November-December 2015

6 health centers served as controls and did not receive training during the study period

Weeklong training in signs, symptoms and treatability of breast cancer, performance of clinical breast exam, and structured algorithms for management of breast complaints followed by regular mentorship for health center nurses. CHWs received a one-day training in breast awareness and how to educate communities about breast health.

Experimental: Training, Phase 1

Experimental: Training, Phase 2

This project proposes a pilot intervention in Burera District to train rural Rwandan community health workers (CHWs) in breast awareness, and to train primary care nurses at rural health centers in the assessment and management of breast complaints, with a focus on when patients must be urgently referred for more advanced evaluation. The project will randomize health centers to receive the intervention and will evaluate the impact of these trainings on nurse and CHW knowledge and skills. In order to help Rwanda prepare for national early detection efforts, the investigators will also assess the impact of these trainings on patient volume at the health center level, and visits and further diagnostic testing at the district hospital level. The investigators will also examine the impact on the length of diagnostic delays experienced by patients with a breast problem. Among those patients diagnosed with breast cancer, the investigators will also assess their stage at diagnosis.

Promoting Early Detection of Breast Cancer in Rural Rwanda: Impact of Community Health Worker and Nurse Training

Promoting Early Detection of Breast Cancer in Rural Rwanda: Impact of a Community Health Worker and Health Center Nurse Training Program

Nurses' knowledge will be assessed through written tests administered immediately before and immediately after trainings, and delayed post-tests administered 3 to 6 months after training. The investigators will use an adapted instrument that incorporates the Breast Cancer Knowledge Test and other surveys to assess clinician knowledge about breast cancer risk, signs and symptoms, and treatability. Questions were developed through review of existing instruments used in the United States, Mexico, the United Kingdom, and Nigeria, and expert input, feedback from clinical colleagues in Rwanda, and pilot testing with Rwandan hospital-based nurses. We will assess each nurse's overall test score as the total percentage of questions correct and assess scores within specific knowledge domains. The more questions answered correctly and the higher the score, the better the outcome (the score represents the percent of questions answered correctly).

CHWs' knowledge will be assessed through written tests administered immediately before and immediately after trainings, and delayed post-tests administered 3 to 6 months after training. The investigators will use an adapted instrument that incorporates the Breast Cancer Knowledge Test and other surveys to assess clinician knowledge about breast cancer risk, signs and symptoms, and treatability. Questions were developed through review of existing instruments used in the United States, Mexico, the United Kingdom, and Nigeria, and expert input, feedback from clinical colleagues in Rwanda, and pilot testing with Rwandan hospital-based nurses. We will assess each CHW's overall test score as the total percentage of questions correct and assess scores within specific knowledge domains. The more questions answered correctly and the higher the score, the better the outcome (the score represents the percent of questions answered correctly).

Nurses' performance scores on clinical breast exam checklists that assess completion of the steps required for high-quality clinical breast exam and are based on other published checklists adapted to the rural Rwandan setting. CBE materials were based on CBE guidelines and published and unpublished curricula adapted to our setting. During her regular health center visits, the breast health mentor will assess nurses' clinical skills in their clinics by using a checklist that includes the same questions as the pre- and post-test assessment form. When possible, the mentor will assess individual nurses by using the same checklist two or more times during a given clinical session, including one at the beginning of a session. We will analyze checklists completed between May 2015 and September 2016. The more actions performed correctly and the higher the score, the better the outcome (the score represents the percent of actions performed correctly).

Number of patients per month with breast concerns presenting at health centers before versus after the intervention, and compared with control health centers.

Number of patients from intervention health centers requiring referral to the district hospital before versus after the intervention, and compared with patients from control health centers.

Number of patients from intervention health centers requiring ultrasound before versus after the intervention, and compared with patients from control health centers

Number of patients from intervention health centers requiring breast biopsy before versus after the intervention, and compared with patients from control health centers.

Among patients referred from intervention versus control health centers to the hospital for breast concerns, length of time experienced between onset of symptoms and first presentation to a health center.

Among patients referred from intervention versus control health centers to the hospital for breast concerns, length of time experienced between first presentation at a health center and first presentation at the hospital.

Among patients referred to the hospital from intervention health centers, proportion diagnosed with breast cancer compared to the proportion among those referred from control health centers, and the proportion from intervention health centers before the trainings.

Among patients diagnosed with breast cancer from intervention health centers, the AJCC versus 7 clinical breast cancer stage documented in hospital medical records. The investigators will compare the proportion of patients presenting with Stage I or II stage disease to the proportion with stage I or II disease among those referred from control health centers, and those from intervention health centers before the trainings.

Breast Cancer Research Foundation

University of Pennsylvania

Ministry of Health, Rwanda

Individuals in this group are those residing in districts where health facilities have implemented a breast cancer screening program integrated with cervical cancer screening, the Women's Cancer Early Detection Program (WCEDP).

Implementation of early diagnosis approach targeting symptomatic women, combined with use of electronic medical record to facilitate documentation, patient tracking across levels of the health care system, and patient contact

Early diagnosis program combined with electronic medical record

Lydia Pace

This observational study evaluates scale-up of a breast cancer early detection program in Rwanda that was initially piloted in a single district. Specifically investigators will examine patient volume, service delivery, loss-to-follow-up rates, and cancer detection rates noted following implementation of scale-up to 3 additional districts. For scaleup, breast cancer screening with CBE was added to a cervical cancer screening initiative, in a combined Women's Cancer Early Detection Program (WCEDP).

Investigators previously conducted a cluster randomized controlled trial of a clinician training program to facilitate prompt evaluation of women with breast symptoms in one rural district of Rwanda. Subsequently, Rwanda Biomedical Centre (RBC) has scaled up the curriculum in 3 districts, adapting the program to integrate CBE screening into a cervical cancer screening initiative. In this study, we will evaluate implementation of this combined screening initiative. Investigators will assess patient volume, services, diagnoses, and loss to follow up.

Promoting Earlier Detection of Breast Cancer in Rwanda: Scaleup in the National Health Care System

Proportion of patients presenting to health centers who are ultimately diagnosed with cancer; proportion of patients who receive biopsy who are ultimately diagnosed with cancer; proportion of individuals diagnosed with cancer who initially presented with versus without breast symptoms

Rates of loss-to-follow up before and after implementation of electronic medical record in districts utilizing breast cancer screening approach; and loss to follow up in districts implementing early diagnosis approach and EMR

Number of patients presenting at the health centers, district hospital and referral hospitals

Among women diagnosed with breast cancer, distribution of cancer stage among women who participated in the WCEDP.

out-of-pocket costs borne by patients while undergoing evaluation for an abnormal clinical breast exam

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluating Scaleup of an Adapted Breast Cancer Early Diagnosis Program in Rwanda	NCT05364138	Breast Cancer Benign Breast D... Cervix Cancer		-	Brigham and Women's Hospital
Evaluating Scaleup of an Adapted Breast Cancer Early Diagnosis Program in Rwanda	NCT05364138	Breast Cancer Benign Breast D... Cervix Cancer		-	Brigham and Women's Hospital
Evaluating Scaleup of an Adapted Breast Cancer Early Diagnosis Program in Rwanda	NCT05364138	Breast Cancer Benign Breast D... Cervix Cancer		-	Brigham and Women's Hospital
Promoting Early Detection of Breast Cancer in Rural Rwanda: Impact of Community Health Worker and Nurse Training	NCT03919682	Breast Cancer	Experimental: T... Experimental: T...	-	Brigham and Women's Hospital
Promoting Earlier Detection of Breast Cancer in Rwanda: Scaleup in the National Health Care System	NCT04258085	Breast Cancer Benign Breast D...	Early diagnosis...	-	Brigham and Women's Hospital

Spots Global Cancer Trial Database for rwanda

Every month we try and update this database with for rwanda cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for rwanda

Every month we try and update this database with for rwanda cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rwanda cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.