Survival has been the customary research outcome measured in calculating
the effectiveness of cancer treatment. Acute and chronic complications
also have been recognized and, to some degree, quantified in order
to objectively compare the morbidity and mortality of different
treatment modalities, including surgery, chemotherapy, and radiation
therapy. With the recent attention to cost-containment in the
evaluation process, treatment outcomes have expanded to include
the subjective impact of treatments on quality of life (QOL) of
the individual with cancer. This has accelerated research aimed
at defining and measuring QOL in individuals diagnosed with cancer
(and their families). From this research, the theoretical framework
of QOL continues to evolve as we consider what should be measured,
by whom, and in what time frame, as well as the validity and reliability
of measurement tools.
Despite the lack of a specific definition, the literature supports
the idea that QOL is a complex construct encompassing multiple
domains. The most common domains include socioeconomic status,
physical health, relationships with friends and family, and satisfaction
with self.[1,2] Included within these domains are measurable parameters,
such as symptom distress, functional status, rehabilitation, social
dependence, life satisfaction, return to a perceived "normal
life," and individual attitudes toward the disease "cancer."
Chronic physiologic effects and late complications that may result
from cancer and its treatment may range from those minimally affecting
an individual's activities of daily living to major complications
that significantly impair organ system health and function. Research
has demonstrated that, of all the identified domains, a negative
change in physical health has the greatest impact on overall QOL.[3,4]
In addition, the overlap between health and functional status
is seen whenever individuals define their state of health by what
they can or cannot do. This is important in the setting of
head and neck cancer, where an individual's ability to perform
appropriately in areas of eating and speaking significantly influences
a wide range of behaviors, from social and family interactions
to more internalized feelings of self-esteem and competence.
Quality-of-life research in the head and neck cancer population
has focused primarily on functional status, symptom distress,
and rehabilitation. The assessment of QOL as part of clinical
practice was initiated over 40 years ago, and began with narrative
and cross-sectional studies. These were followed by simple quantitative
measures of various treatment-related parameters, and later by
longitudinal studies of greater complexity.
Most of the early research concentrated on identifying psychosocial
problems experienced by individuals with head and neck cancer.
In a 1986 systematic analysis of the literature on psychosocial
issues in individuals with head and neck cancer, Pruyn et al identified
both the physical problems (swallowing, chewing, speech, and physical
appearance) and psychosocial problems (anxiety, depression, loss
of self-esteem, and uncertainty about the future) that have an
impact on overall QOL. They concluded that these problems might
precipitate an individual's isolation from friends, difficulties
with reemployment, and social and sexual tensions within families.
In a more recent (1992) review of the literature, Gotay and Moore
analyzed the methodology employed in current research on QOL after
treatment for head and neck cancer in order to facilitate future
studies. This analysis suggested that most studies did not
assess QOL in a comprehensive or uniform fashion, with large variations
among studies in the inclusion of particular domains and parameters.
An individual's physical status, both directly and as it influenced
functioning, was the most frequent domain assessed, whereas only
a minority of studies included psychological status, spirituality,
sexuality, social status, and occupational functioning. In addition,
site-specific domains received the most emphasis. Most studies
assessed concerns particularly important in head and neck cancer,
including speech, communication, eating, and swallowing. Measurement
within a specific domain was also found to differ from study to
study. Some researchers selected a single tool or method to measure
or evaluate a parameter, whereas others chose multiple data-collection
methods. Finally, the impact of surgical treatment was given much
more consideration than was the effect of radiation or chemotherapy.
Quality-of-life studies in individuals treated with radiation
therapy for head and neck cancer were developed in response to
the comparison of complications associated with radiation and
surgery. These studies attempted to further define which QOL domains
were most affected by radiation to the head and neck, as well
as to validate new measurement tools.
In 1991, Rathmell et al published the results of a pilot study
undertaken to determine which QOL measures would be most useful
in the follow-up of patients participating in clinical trials
of treatments for head and neck cancer. They found that questions
relating to quality of speech, ability to eat, levels of energy
and activity, and aspects of psychological well-being detected
the largest effects on QOL. In addition, the level of impairment
in QOL was consistently higher in patients treated with surgery
plus radiotherapy than in those treated with radiotherapy alone.
QOL Assessment Instruments
During this same time period, the European Organization for Research
and Treatment of Cancer (EORTC) adopted a modular approach to
QOL assessment in cancer clinical trials. A core instrument, the
QLQ-C30, was designed to cover a range of QOL issues relevant
to a broad spectrum of cancer patients. This core instrument was
designed to be supplemented by more specific subscales or modules
to assess aspects of QOL of particular importance to specific
subgroups of patients.
In 1992, Bjordal and Kaasa published the psychometric validation
of the EORTC Core Quality of Life Questionnaire with a diagnosis-specific
module for head and neck cancer patients. This was a self-reporting
questionnaire (multi-item scale) designed to assess physical,
cognitive, emotional, social, and role functioning. The questionnaire
discriminated among patient subgroups and among acute, subacute,
and late toxicities of treatment. Other disease- and treatment-related
symptoms, including pain, fatigue, and emesis, were measured by
means of single-item scales.
Another QOL measurement tool, the Head and Neck Radiotherapy Questionnaire
(HNRQ), emerged to specifically measure acute radiation-related
morbidity and QOL from the perspective of patients with head and
neck cancer treated with radiotherapy. This instrument was
developed by a panel of health-care workers to measure outcomes
of acute radiation-induced symptoms for clinical trials of radical
radiation therapy in patients with American Joint Committee on
Cancer (AJCC) stage III and IV cancers of the oral cavity, oropharynx,
hypopharynx, or larynx. The questionnaire was validated in a randomized
double-blind trial of concomitant fluorouracil infusional therapy
or saline placebo administered intermittently during a course
of radiation therapy. Three a priori constructs were identified.
The HNRQ and its domain scores all showed a change from baseline
to reflect a decline in QOL with an increase in morbidity during
radiotherapy and in the recovery period after treatment. In addition,
the HNRQ correlated with existing toxicity indices, including
the World Health Organization (WHO) stomatitis scale, Byfield
stomatitis scale, and WHO skin toxicity index, as well as the
Eastern Cooperative Oncology Group (ECOG) and Karnofsky (KPS)
performance status scales. Finally, there was a significant difference
in HNRQ scores during radiotherapy between the group that received
fluorouracil and the placebo group (P = .0007).
The HNRQ differed from other existing site- and symptom-specific
toxicity indices in that it provided a comprehensive assessment
of several symptomatic domains to produce a summary score. In
addition, it touched on issues related to psychosocial function,
such as social and family interactions, outlook on the future,
From this literature review, it is apparent that valid methods
of measuring certain aspects of QOL in the head and neck cancer
population exist and continue to evolve. It is widely accepted
that QOL research remains in its infancy in terms of definition
of the domains, as well as measurement. However, for this research
to influence clinical care, these tools must be used appropriately
when comparing morbidity, mortality, and cost-effectiveness of
different treatment options. This cannot be accomplished if the
focus is strictly on developing new tools used in a few studies.
Despite the limitations of many of the present tools, repetitive
use and growth of these tools will provide more convincing and
sound data for validating clinical practice. An example of this
process is evident in a series of recently published studies addressing
the issue of functional outcome as a domain of QOL in a specific
population: patients with cancer of the base of tongue treated
with different modalities.
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