Health Trials

Breast and Cervical Cancer Stigma in Rwanda

ConditionsBreast CancerCervical Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDana-Farber Cancer Institute

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • Behavioral: CHW Educational Intervention

    Behavioral

    Components: Exposure to survivors (video storytelling), educational curriculum (presentation, booklet, video) Target: Community health workers

Treatment groups

1,116 Participants
are divided into 2 treatment groups
Group A: Patient and Caregiver Intervention (RISE)Experimental treatment 1 intervention
Group B: Community Health Worker (CHW) InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
Baseline and within 4 weeks following completion of the pilot intervention (approximately 4-5 months)
3

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.

Time frame
Within 4 weeks following completion of the intervention delivery period (approximately Month 13)
4

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.

Time frame
Within 4 weeks following completion of the intervention delivery period (approximately Month 13)

Secondary outcomes

1

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.

Time frame
During the socioecological stigma assessment phase (approximately Month 2 through Month 13).
2

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.

Time frame
During the socioecological stigma assessment phase (approximately Month 2 through Month 13).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dana-Farber Cancer Institute

Lead sponsor

Dana-Farber/Harvard Cancer Center (DF/HCC) Boston, MA

Collaborator

American Association for Cancer Research

Collaborator

Breast Cancer Research Foundation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: