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Clinical Trials/NCT07663006
NCT07663006Not yet recruitingNot Applicable

Assessing Breast and Cervical Cancer Stigma and Piloting a Mitigating Intervention in Rwanda

Dana-Farber Cancer Institute2 sites in 1 country1,116 target enrollmentStarted: November 1, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
1,116
Locations
2

Study Overview

Brief 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).

Detailed Description

The aim of this research study is to pilot components of an intervention to reduce the impact breast and cervical cancer stigma on patients and caregivers to improve the patient care experience and patient outcomes. The study seeks to achieve two goals. The first, to understand how stigma (negative attitudes, shame, or discrimination) related to breast and cervical cancer shows up in Rwanda-for patients, within families and caregiving relationships, and across the healthcare system. To do this, the team will use a combination of surveys and in-depth conversations to capture both numbers and lived experiences.

The second study aim is to co-develop culturally appropriate, community-informed interventions that translate research findings into practical supportive care strategies for cancer patients and caregivers. A Community Advisory Board comprising survivors, caregivers, community health workers, nurses, social workers, mental health professionals, and an oncologist will guide intervention development and implementation. Using a community-based participatory approach and intervention mapping, the team will design the RISE program, which includes: (1) resilience skills training for patients delivered in four group sessions aligned with chemotherapy cycles; (2) peer support groups for caregivers addressing caregiving burden, emotional well-being, stigma, communication, and community resources; and (3) survivor-informed videos presenting lived experiences and coping strategies.

Approximately 1,086 participants will be enrolled.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion 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
  • +34 more not shown

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Temidayo Fadelu, MD

Principal Investigator

Dana-Farber Cancer Institute

Study Sites (2)

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