Breast Cancer, Cervical Cancer
Conditions
Keywords
Breast Cancer, Cervical Cancer, Cancer Stigma
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).
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
BEHAVIORALBehavioral: 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
BEHAVIORALBehavioral: CHW Educational Intervention
Components: Exposure to survivors (video storytelling), educational curriculum (presentation, booklet, video) Target: Community health workers
Sponsors
Dana-Farber Cancer Institute
Dana-Farber/Harvard Cancer Center (DF/HCC) Boston, MA
American Association for Cancer Research
Breast Cancer Research Foundation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Cancer Stigma | 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. |
| Change in Cancer-Related Stigma Score | 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. |
| Rate of Acceptability of Intervention Components | 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. |
| Rate of Appropriateness of Intervention Components | 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. |
| Rate of Feasibility of Intervention Components | 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
| Measure | Time frame | Description |
|---|---|---|
| Qualitative Themes of Cancer Stigma Across Socioecological Levels- individual interviews | 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. |
| Qualitative Themes of Cancer Stigma Across Socioecological Levels- focus groups | 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. |
Countries
Rwanda
Contacts
CONTACTTemidayo Fadelu, MD
PRINCIPAL_INVESTIGATORTemidayo Fadelu, MD
Dana-Farber Cancer Institute
Outcome results
None listed