Breast and Cervical Cancer Stigma in Rwanda

Official title

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

Overview

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.

Interventions

• Behavioral Behavioral: RISE Intervention
  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 Behavioral: CHW Educational Intervention
  Components: Exposure to survivors (video storytelling), educational curriculum (presentation, booklet, video) Target: Community health workers

Primary outcome measures

• Prevalence of Cancer Stigma [Time frame: Baseline]
• Change in Cancer-Related Stigma Score [Time frame: Baseline and within 4 weeks following completion of the pilot intervention (approximately 4-5 months)]
• Rate of Acceptability of Intervention Components [Time frame: Within 4 weeks following completion of the intervention delivery period (approximately Month 13)]
• Rate of Appropriateness of Intervention Components [Time frame: Within 4 weeks following completion of the intervention delivery period (approximately Month 13)]
• Rate of Feasibility of Intervention Components [Time frame: Within 4 weeks following completion of the intervention delivery period (approximately Month 13)]

Secondary outcome measures (2)

• Qualitative Themes of Cancer Stigma Across Socioecological Levels- individual interviews [Time frame: During the socioecological stigma assessment phase (approximately Month 2 through Month 13).]
• Qualitative Themes of Cancer Stigma Across Socioecological Levels- focus groups [Time frame: During the socioecological stigma assessment phase (approximately Month 2 through Month 13).]

Eligibility 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Rwanda · 2 centers

• Butaro Level 2 Teaching Hospital (BL2TH), Ministry of Health — Butaro
• University of Global Health Equity (UGHE) — Butaro

Identifiers

NCT: NCT07663006 · 25-837

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗