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Patient-Reported Side Effect Bother: Understanding the Value of the Baseline Report.
Jessica Roydhouse1, Monique Breslin2, Anne Zola3
1Menzies Institute for Medical Research, University of Tasmania, 15-17 Liverpool Street, Hobart, TAS, 7000, Australia. jessica.roydhouse@utas.edu.au.
Assessing patient-reported side effect bother using the FACT-GP5 item is crucial for cancer trial tolerability. High bother at baseline was linked to increased early discontinuation risk, though not statistically significant after adjustments.
Area of Science:
- Oncology
- Clinical Trials
- Patient-Reported Outcomes
Background:
- Patient tolerability significantly impacts adherence to cancer therapies.
- Understanding patient-perceived side effect burden is key to improving treatment adherence.
Purpose of the Study:
- To evaluate completion rates of the Functional Assessment of Cancer Therapy (FACT) GP5 item for side effect bother.
- To assess the association between side effect bother and other patient-reported outcomes (PROs).
- To determine the impact of side effect bother on early discontinuation from cancer treatment.
Main Methods:
- Analysis of data from three commercial solid tumor cancer trials.
- Utilized the FACT GP5 item to measure overall side effect bother.
- Employed descriptive statistics, correlation, and logistic regression to analyze associations between GP5, other PROs, and discontinuation.
Main Results:
- Completion rates for the FACT GP5 item were high (89.8% at baseline).
- Treatment-experienced patients reported higher rates of significant side effect bother (23.9%) compared to treatment-naïve patients (11.8-15.7%).
- High baseline bother showed a trend towards increased early discontinuation, but this did not reach statistical significance after covariate adjustment.
Conclusions:
- Continued collection and interpretation of the FACT GP5 item are vital for assessing cancer trial tolerability.
- Further investigation into reasons for missing data is recommended.
- Understanding patient-reported side effect bother is essential for optimizing cancer treatment strategies.
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