Breast CancerNCT07663006
Breast and Cervical Cancer Stigma in Rwanda
A study testing Behavioral: RISE Intervention and Behavioral: CHW Educational Intervention in people with Breast Cancer and Cervical Cancer, run by Dana-Farber Cancer Institute at 2 sites in Rwanda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Cervical Cancer
- What is being tested?
- Behavioral: RISE Intervention and Behavioral: CHW Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,116 participants
- Where
- 2 sitesRwanda
- Study dates
- 1 Nov 2026to 1 Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
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- Age 18 and over
- Ability to provide informed consent
- Ability to participate in interview or surveys in English or Kinyarwanda
- 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
- 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
- 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
- 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
Who cannot join
- 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:
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- 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.
- 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.
- 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.
- 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:
- 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:
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Rwanda2 sites
Butaro Level 2 Teaching Hospital (BL2TH), Ministry of Health
Butaro
Eulade Rugengamanzi, MD, +250 783 849 767, erugengamanzi@ughe.org
Eulade Rugengamanzi, MD
University of Global Health Equity (UGHE)
Butaro
Eulade Rugengamazi, MD, +250 783 849 767, erugengamanzi@ughe.org
Eulade Rugengamazi, MD
About this study
Official title: Assessing Breast and Cervical Cancer Stigma and Piloting a Mitigating Intervention 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).
Read the 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.
- Conditions
- Breast Cancer, Cervical Cancer
- Being tested
- Behavioral: RISE Intervention, Behavioral: CHW Educational Intervention
- Keywords
- Breast Cancer, Cervical Cancer, Cancer Stigma
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: RISE InterventionBehavioural
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 InterventionBehavioural
Components: Exposure to survivors (video storytelling), educational curriculum (presentation, booklet, video) Target: Community health workers
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Behavioral: CHW Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: During the socioecological stigma assessment phase (approximately Month 2 through Month 13).
Qualitative Themes of Cancer Stigma Across Socioecological Levels- focus groups
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.
Measured: During the socioecological stigma assessment phase (approximately Month 2 through Month 13).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber/Harvard Cancer Center (DF/HCC) Boston, MA, American Association for Cancer Research, Breast Cancer Research Foundation
- Responsible party
- Principal investigator, Temidayo Fadelu, MD, Dana-Farber Cancer Institute
- Investigators
- Temidayo Fadelu, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663006
- Sponsor's protocol ID
- 25-837
- Status last verified
- Jun 2026
- First submitted
- 22 May 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research