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Feasibility trial shows ePRO-led survivorship care may improve symptoms in early-stage cancer patientsDigital symptom tracking shows promise for cancer survivors in early trial

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Key Takeaway
Consider ePRO-led survivorship models feasible; efficacy requires confirmation in a powered trial.

This feasibility randomized controlled trial enrolled 200 women with early-stage breast (84%) or gynecologic (16%) cancer who were less than 12 months post-curative therapy at two Irish cancer centers. The experimental intervention involved bi-monthly electronic Patient-Reported Outcome (ePRO) assessments for 12 months, with triggered responses from a nurse- and dietitian-led multidisciplinary clinic via a digital platform. The comparator was usual care.

The trial's primary feasibility outcomes—participant enrollment, ePRO survey completion, and healthcare professional engagement triggered by ePROs—were successfully met. Secondary outcomes showed statistically significant improvements in the intervention arm for fatigue (p = 0.018), anxiety (p = 0.012), depression (p < 0.001), and health-related quality of life (p = 0.031). Absolute numbers and effect sizes for these improvements were not reported.

Safety and tolerability data, including adverse events and discontinuations, were not reported. The study's key limitation is its design as a feasibility trial, which was not powered to detect efficacy. The authors conclude the approach is feasible and acceptable, warranting a larger, powered efficacy trial. For practice, this provides preliminary evidence supporting the structure of a complex survivorship model but does not yet establish clinical superiority.

Researchers tested whether a digital support program was practical for women who recently finished treatment for early-stage breast or gynecologic cancer. The study involved 200 women in Ireland. Half used a digital platform to report symptoms like fatigue every two months. If their scores were concerning, it triggered a check-in from a nurse and dietitian. The other half received their usual care.

The main goal was to see if running this program was feasible. The trial successfully met targets for enrolling women, getting them to complete the digital surveys, and having healthcare professionals respond. As a secondary finding, the women using the digital program reported statistically significant improvements in their fatigue, anxiety, depression, and overall quality of life scores compared to the usual care group.

It's important to understand this was a feasibility trial. Its main purpose was to test if the program could be run, not to prove it works better than standard care. The study did not report how large the improvements were or if there were any safety issues. The results are encouraging but preliminary. A much larger study is needed to see if this digital approach should become a regular part of cancer survivorship care.

What this means for you:
Early trial finds digital symptom tracking feasible; larger studies needed to confirm benefits for cancer survivors.

Study Details

Study typeRct
Sample sizen = 200
EvidenceLevel 2
Follow-up12.0 mo
PublishedApr 2026
View Original Abstract ↓
PURPOSE: Those living beyond a cancer diagnosis experience unmet supportive care needs due to fragmented post-treatment pathways and limited integration of digital health tools. The Linking You to Support and Advice (LYSA) trial assessed the feasibility of a complex-intervention which incorporated a nurse- and dietitian-led multidisciplinary clinic and a digital platform for capturing and responding to electronic Patient-Reported Outcome (ePRO) data for women with early-stage breast and gynecologic cancer less than 12 months post-primary curative therapy. METHODS: The LYSA trial was an unblinded, randomized, controlled, feasibility trial co-designed with public and patient involvement, conducted across two cancer centers in Ireland. Participants were randomized to the experimental arm, receiving bi-monthly ePRO assessments and trigger-initiated responses to ePROs for 12 months; or the active comparator arm, receiving usual care. Primary feasibility outcomes included participant enrolment, ePRO survey completion, and healthcare professional engagement triggered by ePRO assessments. Secondary outcomes focused on symptom scores, health-related quality of life (HRQOL), and patient satisfaction. A process evaluation explored factors affecting implementation. RESULTS: The trial met its three predefined feasibility outcomes: 200 participants were enrolled (84% breast, 16% gynecologic), >85% of baseline and endpoint surveys were completed, and >70% of participants in the experimental arm engaged in nurse and dietetic consultations following ePRO symptom triggers. The experimental arm demonstrated significant improvements in fatigue (p = 0.018), anxiety (p = 0.012), depression (p < 0.001) and HRQOL (p = 0.031) scores. The process evaluation indicated high levels of satisfaction with the intervention, with positive feedback on the multidisciplinary approach and responsive symptom management. CONCLUSIONS: LYSA demonstrates the feasibility and acceptability of an ePRO-led survivorship approach, with potential HRQOL and symptom benefits, warranting a powered efficacy trial.
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