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NCT Number: NCT07663006

Breast and Cervical Cancer Stigma in Rwanda

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral: CHW Educational Intervention

Behavioral

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

Primary outcomes

  1. Prevalence of Cancer Stigma

    Time frame: Baseline

    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.

  2. Change in Cancer-Related Stigma Score

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

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

  3. Rate of Acceptability of Intervention Components

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

    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.

  4. Rate of Appropriateness of Intervention Components

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

    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.

  5. Rate of Feasibility of Intervention Components

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

    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.

Secondary outcomes

  1. Qualitative Themes of Cancer Stigma Across Socioecological Levels- individual interviews

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

    Cancer stigma will be qualitatively assessed from the joint qualitative analysis of individual interviews. The outcome consists of identified themes related to stigma, which will be categorized and mapped to domains of the Health Stigma and Discrimination (HSD) framework.

  2. Qualitative Themes of Cancer Stigma Across Socioecological Levels- focus groups

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

    Cancer stigma will be qualitatively assessed from the joint qualitative analysis of focus groups. The outcome consists of identified themes related to stigma, which will be categorized and mapped to domains of the Health Stigma and Discrimination (HSD) framework.

Study contacts

Contact information is provided by the study sponsor or research team.

Temidayo Fadelu, MD

CONTACT

[email protected]

+1 617-632-3779

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Jun 23, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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