Introduction

Most cancer treatment produce unwanted toxicities that interfere with the patient's quality of life. In many cancers the benefits of new treatments over existing approaches have been modest. Thus there have been few examples of new treatments for common cancers that afford a dramatic improvement in cure rate; rather, small but incremental improvements in overall survival have been made.

As new cancer treatments are developed, randomized, controlled trials are conducted to evaluate them, and a common problem is the comparison of a novel intensive treatment regimen against a relatively less toxic standard. In such circumstances, if the survival gain from the new treatment is reliably established but of modest magnitude, then it may be questioned whether the gain is worthwhile for individual patients. Does a small improvement in median survival compensate for additional discomfort (and risks) experienced by the patient?

The discomfort referred to here will be a compound of items comprising features of the treatment itself (e.g. surgery, radiotherapy, or chemotherapy). It will include aspects associated with:

♦ Duration of treatment

♦ Length of hospital stay

♦ Number of clinic visits

♦ Short- and long-term toxicities

♦ Less clinical aspects (perhaps less well-appreciated) summarized as quality of life (QoL) Just as treatment-related toxicity must be documented and compared between therapeutic regimens, it is also mandatory to compare QoL in randomized, clinical trials.

Assessing health-related QoL

Several questionnaires for completion by patients have been developed. The EORTC Quality of Life Study Group have developed a core questionnaire, the EORTC QLQ-C30, to which are added disease-specific modules. The core questionnaire contains 30 questions and, for example, the associated lung cancer module, QLQ-LC13, contains 13 further questions. To simplify the analysis of QoL scores, some of the items on these instruments are combined. For the QLQ-C30 there are five function, three symptom, and one global health-status scales. A patient who scores high for global health-status/QoL is deemed to have high QoL.

Frequency of QoL questionnaires

♦ Baseline QoL after consent but before randomization

♦ Not too frequent to burden patient

♦ Frequent during active treatment period

♦ Assess multiple scores for statistical analysis

Difficulties in QoL assessment

♦ Compliance declines as patient becomes terminal

♦ Compliance may also be poor if patient feels well

♦ Surrogate, relative, nurse, physician can fill in form?

'Missing'data

The missing response may result from an oversight by the patient but alternatively may be due to ambiguity in the question or the patient's reluctance to answer the particular item. It is often important to the investigator to collect information on the impact of treatment on psycho-sexual aspects of the patient's QoL, but patients may regard items relating to sexuality as embarrassing or not relevant. In such cases, the fact that such data is 'missing' will need to be reported. However, a trial nurse who is sensitive to the patient's wishes for privacy will often facilitate the collection of complete data.

10 Ways To Fight Off Cancer

10 Ways To Fight Off Cancer

Learning About 10 Ways Fight Off Cancer Can Have Amazing Benefits For Your Life The Best Tips On How To Keep This Killer At Bay Discovering that you or a loved one has cancer can be utterly terrifying. All the same, once you comprehend the causes of cancer and learn how to reverse those causes, you or your loved one may have more than a fighting chance of beating out cancer.

Get My Free Ebook


Post a comment