Breast and Cervical Cancer Stigma in Rwanda

NCT07663006 | Not Yet Recruiting

• 1 other identifier: 25-837
• Study Type: interventional
• Target: 1,116
• Locations: 1 country
• Sites: 2

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).

Conditions

Breast Cancer; Cervical Cancer

Keywords

Breast Cancer; Cervical Cancer; Cancer Stigma

Outcome Measures

Primary Outcomes (5)

• Prevalence of Cancer Stigma

  Cancer-related stigma will be assessed using validated and adapted survey instruments among patients, caregivers, and healthcare workers. The primary outcome is the prevalence of stigma based on the adapted scale. The investigators will also assess stigma in different subgroups based on demographic, and clinical characteristics.

  Baseline

• Change in Cancer-Related Stigma Score

  The outcome is defined as the change in stigma score from baseline to post-intervention among participants, with higher reductions indicating improvement in stigma.

  Baseline and within 4 weeks following completion of the pilot intervention (approximately 4-5 months)

• Rate of Acceptability of Intervention Components

  Acceptability of the intervention components will be evaluated using the Acceptability of Intervention Measure (AIM). The outcome is defined as the proportion (percentage) of participants with a total AIM score ≥16 (range of scores 4 - 20), based on 4 items rated on a 5-point Likert scale (1 = completely disagree to 5 = completely agree), with higher percentages indicating greater acceptability.

  Within 4 weeks following completion of the intervention delivery period (approximately Month 13)

• Rate of Appropriateness of Intervention Components

  Appropriateness of the intervention components will be evaluated using the Intervention Appropriateness Measure (IAM). The outcome is defined as the proportion (percentage) of participants with a total IAM score ≥16 (range of scores 4 - 20), based on 4 items rated on a 5-point Likert scale, with higher percentages indicating greater perceived appropriateness.

  Within 4 weeks following completion of the intervention delivery period (approximately Month 13)

• Rate of Feasibility of Intervention Components

  Feasibility of the intervention components will be evaluated using the Feasibility of Intervention Measure (FIM). The outcome is defined as the proportion (percentage) of participants with a total FIM score ≥16 (range of scores 4 - 20), based on 4 items rated on a 5-point Likert scale, with higher percentages indicating greater feasibility.

  Within 4 weeks following completion of the intervention delivery period (approximately Month 13)

Secondary Outcomes (2)

• Qualitative Themes of Cancer Stigma Across Socioecological Levels- individual interviews

  During the socioecological stigma assessment phase (approximately Month 2 through Month 13).

• Qualitative Themes of Cancer Stigma Across Socioecological Levels- focus groups

  During the socioecological stigma assessment phase (approximately Month 2 through Month 13).

Study Arms (2)

Patient and Caregiver Intervention (RISE)

EXPERIMENTAL

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).

Behavioral: Behavioral: RISE Intervention

Community Health Worker (CHW) Intervention

EXPERIMENTAL

Community health workers will receive exposure to survivors' components and an educational curriculum delivered via presentation, booklet, and video.

Behavioral: Behavioral: CHW Educational Intervention

Interventions

Behavioral: RISE Intervention BEHAVIORAL

Components: Resilience skills building (psychoeducation), peer-to-peer support groups, exposure to survivors via video storytelling Target: Patients with breast cancer and their caregivers

Patient and Caregiver Intervention (RISE)

Behavioral: CHW Educational Intervention BEHAVIORAL

Components: Exposure to survivors (video storytelling), educational curriculum (presentation, booklet, video) Target: Community health workers

Community Health Worker (CHW) Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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
• 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.
• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Dana-Farber/Harvard Cancer Center (DF/HCC) Boston, MA: collaborator
• American Association for Cancer Research: collaborator
• Breast Cancer Research Foundation: collaborator

Study Sites (2)

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

Butaro, Rwanda

Location

University of Global Health Equity (UGHE)

Butaro, Rwanda

Location

MeSH Terms

Conditions

Breast Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Temidayo Fadelu, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Temidayo Fadelu, MD

CONTACT

+1 617-632-3779; temidayo_fadelu@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 23, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu

Locations

RW (2)