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| Name | Class |
|---|---|
| Dana-Farber/Harvard Cancer Center (DF/HCC) Boston, MA | UNKNOWN |
| American Association for Cancer Research | OTHER |
| Breast Cancer Research Foundation | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Within 4 weeks following completion of the intervention delivery period (approximately Month 13) |
| Rate of Feasibility of Intervention Components |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the socioecological stigma assessment phase (approximately Month 2 through Month 13). |
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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
Exclusion Criteria
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
Exclusion Criteria
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
Exclusion Criteria
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
Exclusion Criteria
Aim 2 Inclusion and Exclusion Criteria Aim 2 Intervention pilot (patient, caregivers and community health workers)
Patient and Caregiver Pilot:
Inclusion Criteria
Exclusion Criteria
Community Health Worker Pilot:
Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Temidayo Fadelu, MD | Contact | +1 617-632-3779 | temidayo_fadelu@dfci.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Temidayo Fadelu, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Butaro Level 2 Teaching Hospital (BL2TH), Ministry of Health | Butaro | Rwanda |
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
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Behavioral: CHW Educational Intervention | Behavioral | Components: Exposure to survivors (video storytelling), educational curriculum (presentation, booklet, video) Target: Community health workers |
|
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.
| Within 4 weeks following completion of the intervention delivery period (approximately 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. | During the socioecological stigma assessment phase (approximately Month 2 through Month 13). |
| University of Global Health Equity (UGHE) | Butaro | Rwanda |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |