Mitigation Intervention to Reduce Breast and Cervical Cancer Stigma for Patients, Caregivers, and Healthcare Workers in Rwanda
This clinical trial develops and tests a mitigation intervention, consisting of psychoeducation, support groups, education and exposure to experiential storytelling, to reduce breast and cervical cancer stigma for patients, caregivers and healthcare workers in Rwanda. Breast and cervical cancers are the most common female cancers in women in sub-Saharan Africa. Stigma is a primary reason why some women in sub-Saharan Africa are unwilling to pursue curative cancer treatments. In fact, stigma can occur across the care continuum from prevention to survivorship. The mitigation intervention addresses stigma in multiple ways across patients, their caregivers and healthcare workers. The intervention may be a feasible way to reduce breast and cervical cancer stigma for patients, their caregivers and healthcare workers in Rwanda.
Inclusion Criteria
- INDIVIDUAL INTERVIEWS AND SURVEYS: Patients with pathologically confirmed breast or cervical cancer
- INDIVIDUAL INTERVIEWS AND SURVEYS: Patients receiving treatment at Butaro Cancer Center of Excellence (BCCOE) during the study period
- INDIVIDUAL INTERVIEWS AND SURVEYS: Age 18 and over
- INDIVIDUAL INTERVIEWS AND SURVEYS: Ability to provide informed consent
- INDIVIDUAL INTERVIEWS AND SURVEYS: Ability to participate in interview or surveys in English or Kinyarwanda
- INTERPERSONAL INTERVIEWS AND SURVEYS: 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
- INTERPERSONAL INTERVIEWS AND SURVEYS: Age 18 and over
- INTERPERSONAL INTERVIEWS AND SURVEYS: Ability to provide informed consent
- INTERPERSONAL INTERVIEWS AND SURVEYS: Ability to participate in interview or surveys in English or Kinyarwanda
- INSTITUTIONAL FOCUS GROUP: Healthcare Worker
- INSTITUTIONAL FOCUS GROUP: Working in a preselected health center, district hospital, provincial hospital in the Northern Province
- INSTITUTIONAL FOCUS GROUP: Age 18 or older
- INSTITUTIONAL FOCUS GROUP: Ability to provide informed consent
- INSTITUTIONAL FOCUS GROUP: Ability to participate in interview or surveys in English or Kinyarwanda
- INSTITUTIONAL SURVEYS: Healthcare worker
- INSTITUTIONAL SURVEYS: Registered with relevant professional organization in Rwanda
- INSTITUTIONAL SURVEYS: Age 18 or older
- INSTITUTIONAL SURVEYS: Ability to provide informed consent
- INSTITUTIONAL SURVEYS: Ability to participate in surveys in English or Kinyarwanda
- PATIENT AND CAREGIVER PILOT: Patients with pathologically confirmed breast cancer who are actively receiving curative-intent treatment at BCCOE during the study period and a designated caregiver
- PATIENT AND CAREGIVER PILOT: Patients getting systemic neoadjuvant chemotherapy who are expected in the clinic on a 3-week cycle
- PATIENT AND CAREGIVER PILOT: Patients who have at least 4 cycles of therapy remaining
- PATIENT AND CAREGIVER PILOT: Age 18 and over
- PATIENT AND CAREGIVER PILOT: Ability to provide informed consent
- PATIENT AND CAREGIVER PILOT: Ability to participate in pilot, interview, and surveys in English or Kinyarwanda
- COMMUNITY HEALTH WORKER PILOT: Community Health Worker registered with relevant healthcare facilities in Northern Rwanda
- COMMUNITY HEALTH WORKER PILOT: Age 18 or older
- COMMUNITY HEALTH WORKER PILOT: Willing to engage in activities related to breast and cervical cancer and to support survivors
- COMMUNITY HEALTH WORKER PILOT: Ability to provide informed consent
- COMMUNITY HEALTH WORKER PILOT: Ability to participate in pilot, interview, and surveys in English or Kinyarwanda
Exclusion Criteria
- INDIVIDUAL INTERVIEWS AND SURVEYS: Unwilling or unable to consent to participation
- INDIVIDUAL INTERVIEWS AND SURVEYS: Unable to comprehend study language (Kinyarwanda or English)
- INDIVIDUAL INTERVIEWS AND SURVEYS: Individuals who are not yet adults (infants, children, teenagers)
- INDIVIDUAL INTERVIEWS AND SURVEYS: Prisoners
- INDIVIDUAL INTERVIEWS AND SURVEYS: Pregnant women
- INTERPERSONAL INTERVIEWS AND SURVEYS: Unwilling or unable to consent to participation
- INTERPERSONAL INTERVIEWS AND SURVEYS: Unable to comprehend study language (Kinyarwanda or English)
- INTERPERSONAL INTERVIEWS AND SURVEYS: Individuals who are not yet adults (infants, children, teenagers)
- INTERPERSONAL INTERVIEWS AND SURVEYS: Prisoners
- INTERPERSONAL INTERVIEWS AND SURVEYS: Pregnant women
- INSTITUTIONAL FOCUS GROUP: Unwilling or unable to consent to participation
- INSTITUTIONAL FOCUS GROUP: Unable to comprehend study language (Kinyarwanda or English)
- INSTITUTIONAL FOCUS GROUP: Individuals who are not yet adults (infants, children, teenagers)
- INSTITUTIONAL FOCUS GROUP: Prisoners
- INSTITUTIONAL FOCUS GROUP: Pregnant women
- INSTITUTIONAL SURVEYS: Unwilling or unable to consent to participation
- INSTITUTIONAL SURVEYS: Unable to comprehend study language (Kinyarwanda or English)
- INSTITUTIONAL SURVEYS: Individuals who are not yet adults (infants, children, teenagers)
- INSTITUTIONAL SURVEYS: Prisoners
- INSTITUTIONAL SURVEYS: Pregnant women
- PATIENT AND CAREGIVER PILOT: Unwilling or unable to consent to participation
- PATIENT AND CAREGIVER PILOT: Unable to comprehend study language (Kinyarwanda or English)
- PATIENT AND CAREGIVER PILOT: Individuals who are not yet adults (infants, children, teenagers)
- PATIENT AND CAREGIVER PILOT: Prisoners
- PATIENT AND CAREGIVER PILOT: Pregnant women
- COMMUNITY HEALTH WORKER PILOT: Unwilling or unable to consent to participation
- COMMUNITY HEALTH WORKER PILOT: Unable to comprehend study language (Kinyarwanda or English)
- COMMUNITY HEALTH WORKER PILOT: Individuals who are not yet adults (infants, children, teenagers)
- COMMUNITY HEALTH WORKER PILOT: Prisoners
- COMMUNITY HEALTH WORKER PILOT: Pregnant women
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07663006.
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PRIMARY OBJECTIVES:
I. To complete a socioecological assessment of breast and cervical cancer stigma in Rwanda.
II. To utilize community participatory research methods to synthesize stigma assessment results into developing components of multi-modal interventions to mitigate breast and cervical cancer stigma.
OUTLINE: Participants are assigned to 1 of 2 aims.
AIM 1: Patients and their caregivers are assigned to group 1 or 2, healthcare workers are assigned to group 2 or 3.
GROUP 1: Patients and their caregivers participate in an interview regarding the causes, contexts, consequences, and responses to cancer stigma.
GROUP 2: Patients, their caregivers, and healthcare workers complete a survey about cancer stigma, patients and caregivers may participate in an interview.
GROUP 3: Healthcare workers attend a focus group regarding the causes, contexts, consequences, and responses to cancer stigma.
AIM 2: Patients are assigned to group 4, their caregivers are assigned to group 5, and healthcare workers are assigned to group 6.
GROUP 4: Patients complete resilience training every 3 weeks for 4 sessions. Session topics include active coping and stress management, self-esteem and body image, family and community support and communication, and gratitude. Patients receive a check-in phone call between sessions. Patients also view the storytelling videos during the last 1-2 sessions.
GROUP 5: Caregivers attend support groups every 3 weeks, for 90 minutes, for up to 4 sessions. Patients may attend during the last 1 or 2 sessions. Caregivers also view the storytelling videos during the last 1-2 sessions.
GROUP 6: Healthcare workers attend education training over 1-2 days related to breast and cervical cancer, particularly its common signs and symptoms, importance of early detection, screening and prevention, diagnosis and treatment process, as well as myths and facts related to both cancers. It will also include information about stigma related to both cancers, survivors’ self-care tips, role of healthcare workers in supporting survivors, and what survivors, families, and healthcare workers can do to reduce stigma. They also receive a booklet and access to a recording of the training. Healthcare workers also view the storytelling videos during the training.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorTemidayo Fadelu
- Primary ID25-837
- Secondary IDsNCI-2026-05190
- ClinicalTrials.gov IDNCT07663006