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Quality of Life Clinical Trials

Help explore ways to improve comfort and quality of life for individuals with cancer

Health related quality of life is increasingly used as an end point in clinical trials. Particularly, in diseases with a poor prognosis such as metastatic cancer, quality of life may be of major concern. However, clinicians are still reluctant to accept quality of life as an end point equivalent to more “objective” end points such as size of the tumor as assessed by imaging or disease free survival in patients with cancer. Having to deal with practical and time consuming issues such as randomization, informed consent, and the organization of study medication when enrolling patients into clinical trials, clinicians may consider the assessment of quality of life as an additional burden to themselves and their patients.

The past four decades have seen the development of a new technology in medicine that is based entirely on data obtained from patients’ self-reports of their symptoms and functional status. The assessments in clinical trials have been particularly useful for elucidating the effects of various cancers and their treatments on patients’ lives and have provided additional information that enhances the usual clinical endpoints used for determining the benefits and toxicity of treatment.

In recent years, there has been a growing acceptance of the view that the goals of cancer treatment should include concerns about quality of life (QOL) as well as length of life. Patients with cancer experience a variety of symptoms due to their disease and its treatment, such as pain, fatigue, and nausea, that can have a significant negative impact on their well-being and functioning. The development of multidimensional self-report QOL instruments has allowed investigators to measure the adverse impact of disease and its treatment on well-being and functioning and evaluate the efficacy of interventions designed to prevent or treat these adverse effects. Findings from QOL research suggest that routine use of QOL instruments as part of clinical practice has the potential to improve the quality of care that patients receive as well as their health status. However, in addition to its many benefits, there are also many challenges to assessing quality of life in research and clinical practice.

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Learn more about supportive care at the U-M Comprehensive Cancer Center

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