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Not Yet Recruiting NCT07663006

Breast and Cervical Cancer Stigma in Rwanda

Conditions: Breast Cancer, Cervical Cancer

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 1116
Sponsor: Dana-Farber Cancer Institute

Location: Butaro Level 2 Teaching Hospital (BL2TH), Ministry of Health Butaro

Summary

This study aims to assess breast and cervical cancer stigma and pilot a multi-modal intervention to mitigate stigma among patients, caregivers, and community health workers in Rwanda. The elements include resilience training (patient), support group (caregivers), or exposure to survivors by video and in-person (patient, caregivers, and community health workers), and educational curriculum (community health workers).

Eligibility Criteria

Aim 1 Inclusion and Exclusion Criteria Aim 1 Interviews and Surveys Individual interviews and surveys: Potential patients will be identified by the clinical team from physical and electronic registries of patients. Potential participants will be screened for eligibility by the study research assistant. Inclusion Criteria * Patients with pathologically confirmed breast or cervical cancer * Patients receiving treatment at BCCOE during the study period * Age 18 and over * Ability to provide informed consent * Ability to participate in interview or surveys in English or Kinyarwanda Exclusion Criteria * Unwilling or Unable to consent to participation. * Unable to comprehend study language (Kinyarwanda or English) * Individuals who are not yet adults (infants, children, teenagers) * Prisoners * Pregnant women Note: Determination of ability to consent will be made by trained study staff prior to enrollment Interpersonal interviews and surveys: Caregivers of the potential patients will be identified from the potential patients. Potential patients will be identified by the clinical team from physical and electronic registries of patients. Potential participants will be screened for eligibility by the study research assistant. Inclusion Criteria * Caregiver (including spouses, children, family members or other individuals as designated by patients) of patients with pathologically confirmed breast or cervical cancer who are actively receiving treatment at BCCOE during the study period * Age 18 and over * Ability to provide informed consent * Ability to participate in interview or surveys in English or Kinyarwanda Exclusion Criteria * Unwilling or Unable to consent to participation. * Unable to comprehend study language (Kinyarwanda or English) * Individuals who are not yet adults (infants, children, teenagers) * Prisoners * Pregnant women Note: Determination of ability to consent will be made by trained study staff prior to enrollment Institutional Focus group: An official participation letter will be sent from BL2TH to leaders of the preselected facilities. Interested participants will be encouraged to contact the study team. Potential participants will be invited by their hospital/center leadership and screened for eligibility by the study research assistant. Inclusion Criteria * Healthcare Worker * Working in a preselected health center, district hospital, provincial hospital in the Northern Province * Age 18 or older * Ability to provide informed consent * Ability to participate in interview or surveys in English or Kinyarwanda Exclusion Criteria * Unwilling or Unable to consent to participation. * Unable to comprehend study language (Kinyarwanda or English) * Individuals who are not yet adults (infants, children, teenagers) * Prisoners * Pregnant women Note: Determination of ability to consent will be made by trained study staff prior to enrollment Institutional surveys: Formal participation invitation will be sent to the Rwanda Medical and Dental Council, National Council of Nurses and Midwives, and the Rwanda Allied Health Professions Council. Potential participants will be screened for eligibility electronically and informed consent obtained electronically. Inclusion Criteria * Healthcare Worker * Registered with relevant professional organization in Rwanda * Age 18 or older * Ability to provide informed consent * Ability to participate in surveys in English or Kinyarwanda Exclusion Criteria * Unwilling or Unable to consent to participation. * Unable to comprehend study language (Kinyarwanda or English) * Individuals who are not yet adults (infants, children, teenagers) * Prisoners * Pregnant women Note: Determination of ability to consent will be made by trained study staff prior to enrollment Aim 2 Inclusion and Exclusion Criteria Aim 2 Intervention pilot (patient, caregivers and community health workers) Patient and Caregiver Pilot: Inclusion Criteria * Patients with pathologically confirmed breast cancer who are actively receiving curative-intent treatment at BCCOE during the study period and a designated caregiver * Patients getting systemic neoadjuvant chemotherapy who are expected in the clinic on a 3-week cycle * Patients who have at least 4 cycles of therapy remaining * Age 18 and over * Ability to provide informed consent * Ability to participate in pilot, interview, and surveys in English or Kinyarwanda Exclusion Criteria * Unwilling or Unable to consent to participation. * Unable to comprehend study language (Kinyarwanda or English) * Individuals who are not yet adults (infants, children, teenagers) * Prisoners * Pregnant women Note: Determination of ability to consent will be made by trained study staff prior to enrollment Community Health Worker Pilot: Inclusion Criteria * Community Health Worker registered with relevant healthcare facilities in Northern Rwanda * Age 18 or older * Willing to engage in activities related to breast and cervical cancer and to support survivors * Ability to provide informed consent * Ability to participate in pilot, interview, and surveys in English or Kinyarwanda Exclusion Criteria * Unwilling or Unable to consent to participation * Unable to comprehend study language (Kinyarwanda or English) * Individuals who are not yet adults (infants, children, teenagers) * Prisoners * Pregnant women

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07663006). StuddyBuddy aggregates publicly available trial information.