Project Snapshot
- Project type
- Clinical trial UX / protocol experience design
- Trial context
- Phase III oncology maintenance trial
- Source material
- Primary audience
- Patients, caregivers, site teams, clinical operations stakeholders
- Core challenge
- Translating a complex oncology protocol into a clearer patient journey while identifying high-burden operational moments
- Key outputs
- Interactive patient journey, protocol burden and operational complexity map, protocol burden summary
- My role
- Clinical content analysis, patient journey mapping, protocol burden analysis, UX structure, visual communication
The Problem
Patients and site teams experience clinical trial protocols from very different perspectives. Patients need to understand what will happen across screening, randomization, treatment, monitoring, and follow-up. Site teams must coordinate eligibility checks, visit windows, labs, scans, treatment schedules, safety monitoring, and documentation requirements.
In this Phase III oncology maintenance trial, the protocol created multiple points of complexity: a compressed screening period, treatment every two weeks, repeated monitoring, and long-term follow-up. Without a clear visual structure, these requirements could be difficult for patients to understand and challenging for sites to explain consistently.
Design Challenge
How might we turn a complex oncology trial protocol into two clear experience tools: one that helps patients understand their journey, and one that helps study teams identify protocol burden and operational complexity?
My Approach
- 1Reviewed the protocol structure, visit schedule, treatment flow, and follow-up requirements.
- 2Identified patient-facing moments of uncertainty, high burden, and decision complexity.
- 3Mapped the clinical journey from chemotherapy completion through long-term follow-up.
- 4Translated protocol requirements into two views: a patient-friendly journey and an operational burden map.
- 5Developed recommendations for clearer communication, caregiver support, and digital reminders.
What I Designed
Patient-Friendly Interactive Journey
A step-by-step experience that explains what happens at each stage of the trial, how the patient might feel, and what guidance may help reduce anxiety.
Protocol Burden & Operational Complexity Map
A clinical operations view showing where protocol requirements create high patient, caregiver, and site burden.
Protocol Burden Summary
A concise summary of the highest-friction points, including screening compression, active treatment intensity, and transition complexity.
To show both sides of the trial experience, I created two complementary views: one focused on the patient's understanding of the journey, and one focused on protocol burden, operational complexity, and high-friction execution points.
Deliverable 1: Interactive Patient Journey
Your Clinical Trial Journey
Click each step to learn more about what to expect
Journey Progress
Step 1 of 7
📝What Happens
- 1Complete chemotherapy cycles
- 2Doctor checks response (complete response, partial response, stable disease)
💭How You Might Feel
Hopeful but physically tired
💡Helpful Tip
Ask your doctor what scan results mean before moving forward
You're not alone on this journey
Your care team is with you every step of the way
Deliverable 2: Protocol Burden & Operational Complexity Map
Oncology maintenance trial feasibility and protocol-burden analysis
Journey Progress
Step 1 of 7
High-Burden Points
- •Patient is entering the trial immediately after an intensive chemotherapy period, when fatigue, cytopenias, renal function changes, and residual toxicity may still affect readiness.
- •Eligibility depends on completion of 4-6 cycles of gemcitabine plus cisplatin or gemcitabine plus carboplatin.
- •Disease status must be confirmed as complete response, partial response, or stable disease before randomization.
Complex Transitions
- •Transition from standard chemotherapy care into maintenance trial screening must occur within a defined post-chemotherapy window.
- •The protocol requires randomization no less than 4 weeks and no more than 10 weeks after the last chemotherapy dose.
- •Patients must shift from chemotherapy-focused monitoring to maintenance-treatment eligibility, imaging confirmation, and protocol-specific assessments.
Potential Operational Challenges
- •Risk of missing the 4-10 week randomization window if scan scheduling, lab recovery, tissue availability, or consent timing is delayed.
- •Coordination is required between oncology treatment records, imaging review, eligibility confirmation, and study start.
- •Patients recovering from chemotherapy may have abnormal labs or unresolved toxicities that complicate eligibility review.
Protocol Burden Summary
This oncology maintenance trial creates the greatest operational burden at three points:
Screening compression
Eligibility, imaging, labs, tissue, consent, and randomization must align within narrow windows.
Early active treatment
Q2W infusion visits, premedication, safety labs, PK/ADA sampling, and immune-toxicity monitoring create high visit intensity.
Disease monitoring and transition points
Frequent imaging, progression decisions, crossover rules, end-of-treatment procedures, biopsy expectations, and long-term survival follow-up require careful coordination.
Key Insights
Patients need a visual timeline, not only written protocol instructions.
The highest burden occurs during screening, treatment initiation, active treatment, and disease monitoring.
Caregiver involvement should be planned early, especially around visits, scans, and side effect monitoring.
Digital reminders may reduce confusion around appointments, labs, imaging, and follow-up expectations.
Side effect guidance should clearly separate expected symptoms from urgent warning signs.
Design Decisions
- Used a step-by-step journey structure to reduce cognitive overload.
- Separated patient-facing guidance from operational complexity to support two audiences.
- Used burden labels to make high-friction protocol moments easier to identify.
- Included emotional context, such as uncertainty and fatigue, to reflect the patient experience.
- Highlighted caregiver and site-team implications because trial participation extends beyond the patient alone.
Implications for Clinical Trial Design & Communication
- Patient-facing trial materials should include visual timelines in addition to written consent and protocol summaries.
- Screening and randomization windows should be explained clearly because they create early confusion and logistical pressure.
- Caregiver education should be integrated into trial communication, especially for oncology maintenance studies.
- Side effect guidance should be proactive, visual, and easy to reference between visits.
- Digital tools can support reminders, visit preparation, symptom reporting, and follow-up expectations.
Outcome
This case study demonstrates how a complex oncology protocol can be transformed into a clearer patient and operational experience. The final deliverables help patients understand what to expect, help caregivers anticipate support needs, and help clinical teams identify high-burden moments that may require additional communication or workflow planning.