Assessing Breast and Cervical Cancer Stigma and Piloting a Mitigating Intervention in Rwanda
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,116
- 试验地点
- 2
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aim 1 Inclusion and
排除标准
- •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
- 另有 34 项未显示
研究者
Temidayo Fadelu, MD
Principal Investigator
Dana-Farber Cancer Institute