Policy review demands better quality of life data in cancer clinical trials

A new policy review from Common Sense Oncology (CSO) and the European Organisation for Research and Treatment of Cancer (EORTC) calls for quality of life data to play a more central role in clinical trials evaluating adjuvant cancer treatments. The recommendations aim to help patients and clinicians better understand the real-world impact of treatment when making care decisions.

Published in The Lancet Oncology, the review led by Ian Tannock, Michael Brundage and Madeline Pe focuses on adjuvant therapies, where treatment decisions often involve balancing the potential benefits of reducing cancer recurrence against treatment-related side effects and their impact on daily functioning and overall quality of life.

Putting quality of life alongside survival

The authors recommend that clinical trial reports include not only average quality of life scores, but also the proportion of patients who experience a clinically meaningful deterioration in quality of life and how long that deterioration lasts. According to the review, this information is easier for patients and clinicians to interpret and is more useful for informed decision-making.

"Patients considering adjuvant therapy deserve clear information not only about the potential benefits of treatment, but also about the likelihood, severity and duration of any negative effects on their quality of life," said Prof. Ian Tannock, co-lead author of the review.

The recommendations also call for the use of validated patient-reported outcome measures, regular assessment throughout treatment and follow-up, better handling of missing data, and inclusion of quality of life findings in the primary publication of clinical trials.

Making patient-reported outcomes more meaningful

The review highlights that clinician-reported toxicity data alone do not fully capture the patient experience and stresses the importance of assessing symptoms, functioning and overall quality of life directly from patients.

"Quality of life results become useful when they can be used to discuss questions that matter to patients," said Dr Madeline Pe, Head of the EORTC Quality of Life Department and co-lead author. "These recommendations support reporting approaches that facilitate meaningful discussions between patients and clinicians about quality of life. By showing how many patients experience a clinically meaningful deterioration in quality of life, and how long that deterioration persists, patient-reported outcomes provide information that is directly relevant to treatment decisions. This helps patients and clinicians better understand the likely impact of different treatment options on daily functioning and well-being, supporting more informed and shared decision-making."

A continuing EORTC-CSO collaboration

This publication is the latest collaboration between CSO and EORTC to improve how patient-reported outcomes are analysed, interpreted and reported in cancer research. The shared goal is to ensure that treatment decisions are informed not only by survival outcomes, but also by their impact on patients' lives.

By improving the way quality of life outcomes are reported, we can ensure that patient-reported data play a more meaningful role in treatment decisions and future cancer care."

Dr. Michael Brundage, co-lead author of the review