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

NCT03919682 | Completed

• 1 other identifier: 2014P002688
• Study Type: interventional
• Target: 1,203
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breast Cancer

Keywords

early detection; Rwanda

Outcome Measures

Primary Outcomes (3)

• Health center nurse knowledge

  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).

  up to 6 months

• Community health worker knowledge

  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).

  up to 6 months

• Health center nurse clinical skills

  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).

  up to 16 months

Secondary Outcomes (8)

• Health center volume

  30 months

• District hospital referrals

  30 months

• Breast ultrasounds

  30 months

• Breast biopsy

  30 months

• Patient delays

  24 months

Study Arms (3)

Training, Phase 1

EXPERIMENTAL

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

Other: Experimental: Training, Phase 1

Training, Phase 2

EXPERIMENTAL

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

Other: Experimental: Training, Phase 2

Control

NO INTERVENTION

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

Interventions

Experimental: Training, Phase 1 OTHER

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.

Training, Phase 1

Experimental: Training, Phase 2 OTHER

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.

Training, Phase 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Community health workers or health center nurses affiliated with a designated intervention health center
• Interested in participating

You may not qualify if:

• Not interested in participating
• Not available for training

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Breast Cancer Research Foundation: collaborator
• University of Pennsylvania: collaborator
• Partners in Health: collaborator
• Ministry of Health, Rwanda: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 18, 2019
• Study Start: April 18, 2015
• Primary Completion: April 17, 2017
• Study Completion: April 17, 2017
• Last Updated: August 26, 2021

Record last verified: 2021-08