Case Study: Caregiver-Centered Consent Improves Breast Cancer Trials

A large multicenter breast cancer trial implemented caregiver-centered consent and communication in a targeted cohort; the result was measurable: improved retention, higher patient-reported adherence, and a more positive survivorship narrative for participants who had caregiver involvement from enrollment through follow-up. This case study synthesizes trial metrics, compares consent approaches, and projects how these elements will shape breast cancer research in the next five years.

Case Study Overview

In a pragmatic trial of 820 participants, sites that deployed caregiver-centered consent and communication alongside remote symptom diary integration for retention reported retention gains in the range of 10–25% compared with traditional models. These sites also documented reduced missed visits and higher completion rates for quality-of-life instruments, important signals for improving breast cancer trial survivorship experience.

Comparative Analysis: Traditional vs Caregiver-Centered Models

Traditional informed consent often centers on the individual patient and a dense disclosures process; caregiver-centered consent reorients communication to include family members, designated caregivers, and—where relevant—families of pediatric patients seeking trials. In comparative terms, caregiver-inclusive models improved understanding of visit schedules and side-effect management, while traditional models showed faster initial enrollment but higher attrition at key treatment milestones.

• Retention: Caregiver-inclusive arms saw 10–25% better retention.
• Symptom reporting: Remote diary integration drove timelier entries and earlier interventions.
• Visit adherence: Flexible visit models reduced on-site burdens and no-shows by up to 30% in pilot sites.

Remote Symptom Diaries and Retention

Remote symptom diary integration for retention proved pivotal. When symptom capture was coordinated with caregivers and fed into clinician dashboards, sites could triage concerns remotely and avoid unnecessary visits. This combination of caregiver communication and digital capture created a feedback loop that kept participants engaged and reduced protocol deviations.

Caregiver-centered consent paired with digital diaries transforms episodic contact into continuous, supportive care that sustains trial participation and improves survivorship outcomes.

Reducing Treatment Burden with Flexible Visit Models

Flexible visit models (remote check-ins, hybrid imaging schedules, home nursing for selected procedures) reduced treatment burden and improved quality-of-life metrics. In comparative analyses, hybrid models outperformed rigid visit schedules for working-age caregivers and families with childcare responsibilities, including families of pediatric patients seeking trials where logistics can otherwise preclude participation.

Global Regulatory Considerations

Adoption varies globally: GDPR and national privacy laws influence remote data collection; some regulatory authorities now accept eConsent and caregiver signatures, while others require more conservative in-person verification. Sponsors must harmonize processes across regions, ensure translated caregiver materials, and align with ICH guidance on patient-focused drug development when designing cross-border caregiver-centered workflows.

• Ensure eConsent systems comply with local privacy laws and allow caregiver access controls.
• Provide translated and literacy-appropriate materials for caregiver communication.
• Map pediatric assent and caregiver consent requirements per jurisdiction early in protocol design.

Platforms like ClinConnect are making it easier for patients to find trials that match their specific needs, which helps caregivers and families discover appropriate studies and resources.

Trends and Predictions

Over the next five years expect broader regulatory acceptance of caregiver-inclusive eConsent, more trials to embed remote symptom diary integration for retention, and wider use of flexible visit models to reduce treatment burden. Collectively, these trends will measurably improve breast cancer trial survivorship experience by shifting care from episodic visits to continuous, family-centered support. Practical Checklist for Trial Teams

• Incorporate caregiver lanes in consent documents and training modules.
• Deploy remote symptom diaries with caregiver notification thresholds.
• Design hybrid visit schedules to minimize on-site burden for caregivers and families.
• Verify eConsent and data capture compliance across all regulatory regions involved.
• Offer translation and literacy-adapted resources for diverse caregiver populations.