Clinical trial · Interventional
Breast and Cervical Cancer Stigma in Rwanda
Assessing Breast and Cervical Cancer Stigma and Piloting a Mitigating Intervention in Rwanda
NCT07663006CI-TRIAL-00115553not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral: CHW Educational Intervention | Behavioral | — | UNRESOLVED |
| Behavioral: RISE Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patient and Caregiver Intervention (RISE)
- description
- Patients with breast cancer and their caregivers will receive the RISE intervention, which includes resilience skills building (patients), peer-to-peer support groups (caregivers), and exposure to survivors through video storytelling (both).
- interventionNames
- Behavioral: Behavioral: RISE Intervention
- type
- EXPERIMENTAL
- label
- Community Health Worker (CHW) Intervention
- description
- Community health workers will receive exposure to survivors' components and an educational curriculum delivered via presentation, booklet, and video.
- interventionNames
- Behavioral: Behavioral: CHW Educational Intervention
Primary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.