1Quality of life: expanding the scope of clinical significance.

Gladis MM1, Gosch EA, Dishuk NM, Crits-Christoph P.

Author information
Abstract
Clinical researchers have turned their attention to quality of life assessment as a means of
broadening the evaluation of treatment outcomes. This article examines conceptual and
methodological issues related to the use of quality of life measures in mental health. These
include the lack of a good operational definition of the construct, the use of subjective versus
objective quality of life indicators, and the nature of the relationship between symptoms and
quality of life judgments. Of special concern is the ability of quality of life measures to detect
treatment-related changes. The authors review the application of quality of life assessment across
diverse patient groups and therapies and provide recommendations for developing
comprehensive, psychometrically sophisticated quality of life measures.
PMID:
10369052
[PubMed - indexed for MEDLINE]

2More and more frequently, clinical trials include the evaluation of Health-Related Quality of
Life (HRQoL), yet many investigators remain unaware of the unique measurement and analysis
issues associated with the assessment of HRQoL. At the end of a study, clinicians and
statisticians often face challenging and sometimes insurmountable analytic problems. Design and
Analysis of Quality of Life Studies in Clinical Trials details these issues and presents a range of
solutions. Written from the authors extensive experience in the field, it focuses on the very
specific features of QoL data: its longitudinal nature, multidimensionality, and the problem of
missing data.The author uses three real clinical trials throughout her discussions to illustrate
practical implementation of the strategies and analytic methods presented. As Quality of Life
becomes an increasingly important aspect of clinical trials, it becomes essential for clinicians,
statisticians, and designers of these studies to understand and meet the challenges this kind of
data present. In this book, SAS and S-PLUS programs, checklists, numerous figures, and a clear,
concise presentation combine to provide readers with the tools and skills they need to
successfully design, conduct, analyze, and report their own studies.
*Diane L. Fairclough University of Colorado Health Sciences Center, Denver, USA A volume in
the Interdisciplinary Statistics series Series edited by Byron Morgan, Peter van den Heijden, Tery
Speed, and Niels Keiding

3J Epidemiol Community Health. 2006 Sep; 60(9): 822.

PMCID: PMC2566037
Assessing quality of life in clinical trials, 2nd ed
Reviewed by Jacqueline MllerNordhorn
P Fayers, R Hays. Oxford University Press, 2005.
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 tumour as assessed by imaging or disease free survival
in patients with cancer. Having to deal with practical and time consuming issues such as
randomisation, informed consent, and the organisation 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.
Barriers to the acceptance of the notion of quality of life may include difficulties in both the
understanding of the underlying concepts as well as in the interpretation of the results. This is not
surprising as quality of life is not routinely included in the medical curriculum and clinicians are,
therefore, not trained in analysing and interpreting quality of life data, in contrast with other
professions such as psychologists or sociologists.Assessing quality of life in clinical trials by
Fayers and Hays should play an important part in making quality of life concepts accessible to
both clinicians and researchers. The book provides an excellent overview on the state of the art
and current issues in quality of life assessment and research. It describes how health status
instruments are best developed and validated, how they are translated into different languages,
how quality of life data may be analysed in an appropriate way, and how the results may be
interpreted adequately. Important issues such as the clinical relevance of the observed differences
in quality of life between groups or of change over time are discussed. Advice on how to deal, in
scientific analysis, with the common problem of missing data is provided. In addition, emerging
concepts are introduced, such as preference based measures reflecting the value that patients or
the community, or both, place on different health states. The book is generally written in a
concise and clear style including a sufficient number of examples as well as a summary at the
end of each chapter. However, whereas most chapters are intuitively understandable even for
readers without a profound knowledge of statistics and methodological issues, some may require
more detailed experience in the analysis of quality of life data.

The book Assessing quality of life in clinical trials is certainly a musthave for everyone
involved in quality of life assessment. To increase the acceptance of quality of life as an
important outcome in clinical research, it is certainly an important goal to impart knowledge
about quality of life concepts to all those involved in medical care. However, in the long term, it
will be crucial to evaluate how the assessment of quality of life actually improves medical care
and how quality of life may be integrated in the decision making process with regard to the care
of individual patients.
4Opportunities and Challenges: Assessing Quality of Life in Clinical Trials
1.
2.

R. Brian Giesler and

S. D. Williams
+Author Affiliations

1. Indiana University School of Nursing, Indianapolis

2. Mary Margaret Walther Program for Cancer Care Research, Indianapolis
3. Indiana University Cancer Center, Indianapolis
4. Indiana University Cancer Center
1.
Correspondence to: Stephen D. Williams, M.D., Indiana University Cancer Center, 535
Barnhill Dr., Rm. 455, Indianapolis, IN 46202
Quality-of-life outcomes have become important end points in oncology clinical trials (13).
Their popularity can be attributed to several factors, including the growing recognition that the
so-called soft nature of most quality-of-life variables does not preclude valid and reliable
measurement(47). Perhaps the most important factor is the proliferation of therapies that has
occurred over the past few decades. Physicians possess a larger therapeutic arsenal for cancer
than ever before. However, most available therapies are accompanied by frequent and sometimes
debilitating side effects. A given treatment modality may convey greater (or equivalent) life
expectancy relative to another yet lower a patient's quality of life to such an extent that the
patient would have been better off had he or she undergone a different therapy. Incorporating
quality-of-life assessments into clinical trials provides the opportunity to acquire a more
comprehensive picture of the benefits and detriments that accrue from a given therapy, thereby
increasing the likelihood of making optimal treatment decisions. However, with increased
opportunities come new challenges. In this issue of the Journal, Moinpour et al. (8) present the
results of a study that illustrates both the opportunities and the challenges of assessing quality-oflife outcomes in clinical trials.
Moinpour et al. (8) report results from a prospective, quality-of-life study designed to
complement a Southwest Oncology Group (SWOG) randomized trial (INT-0105) that compares
orchiectomy plus placebo with orchiectomy plus flutamide in patients with metastatic prostate
cancer (9). This study was conducted before disease-specific measures for patients with

advanced prostate cancer (10), (11) were generally available. To assess their primary outcome
variables, Moinpour et al. (8) used the Mental Health Index and Physical Functioning Scale from
the SF-36 [36-Item Short Form Health Survey in the Medical Outcomes Study) (5), which are
considered generic measures of health-related quality of life, and single-item measures of
diarrhea, gas pain, and body image.
All quality-of-life instruments were self-administered to a subsample (n = 739) of trial
participants at baseline and at 1 month, 3 months, and 6 months. Additional measures were also
administered [e.g., the Symptom Distress Scale (12)], although data from these measures were
not or only partially reported. By use of a conservative analytic approach, Moinpour et
al. (8) found that patients randomly assigned to the placebo arm generally enjoyed better mental
health and less diarrhea than patients assigned to the flutamide arm. Differences on other qualityof-life variables did not achieve statistical significance but usually fell in the same direction. Of
note, no survival differences were found across the two arms.
Two points, in particular, deserve comment. The first point is that, as illustrated by the findings
of Moinpour et al. (8), quality-of-life assessments provide important information in clinical
trials. When neither arm conveys a survival benefit, as occurred in SWOG trial INT-0105 (9), the
effect on quality of life will provide the best means to determine which treatment is most likely
to benefit patients. The findings of Moinpour et al.(8) permit a straightforward conclusion in this
regard. What is less clear is how great a quality-of-life benefit the patients in the placebo arm
experienced relative to the patients in the flutamide arm. How big a difference on a mental health
index, for example, is necessary to infer that one therapy provides meaningfully better life
quality than another?
In the current study, Moinpour et al. (8) indicate that the statistically significant eight-point
difference found between the treatment arms at 6 months was equivalent to the difference found
between patients with hypertension and patients with congestive heart failure on the same
measure. Although this approach is helpful, it lacks precision. Statistical significance is all that is
required when the goal is to determine whether one therapy is better than another, but problems
arise when one needs to know how much better one therapy is over another. Would an eightpoint difference, for example, justify foregoing a toxic therapeutic regimen for a less-toxic
alternative that would provide a shorter life expectancy? The answer depends, in part, on what an
eight-point difference means. These issues challenge all investigators currently working with
quality-of-life outcomes. Various attempts have been made to clarify the meaning of quality-oflife scores (13) and to quantify the length of life versus quality-of-life tradeoffs that treatment
decisions often involve (14), but clearly this area requires further study.
The second point is that quality-of-life assessments in clinical trials are feasible. Moinpour et
al. (8) were able to obtain response rates that never dropped below 80% and were able to
determine that missing data were not systematically related to health status. The reasons for the

success of this study are probably due to a variety of factors, including adherence to a strict
protocol and the fact that patients with advanced stage prostate cancer are often healthier than
patients with other forms of advanced stage cancer, which would tend to make data collection
less burdensome and more likely to succeed. However, even when burden is a concern, qualityof-life data can often successfully be collected. Although multi-item scales are more likely to
provide reliable data (15), single-item measures, which are quickly and easily administered, can
be sufficient if one's goal is to compare groups cross-sectionally (16).
In summary, the study of Moinpour et al. (8) illustrates the importance and feasibility of qualityof-life assessment in clinical trials. This investigation also provides compelling evidence that
flutamide, when coupled with bilateral orchiectomy, provides less benefit than orchiectomy
alone for patients with prostate cancer who have metastatic disease. However, some caution is
warranted when generalizing from quality-of-life data collected during clinical trials. The mere
knowledge of participating in a clinical trial, regardless of the arm to which a patient has been
randomly assigned, is likely to affect the patient's quality of life (e.g., by raising the patient's
hopes). Moreover, some research suggests that asking quality-of-life questions constitutes an
intervention in and of itself, since it may sensitize patients and their health-care providers to
problems that otherwise would have been ignored (17). These issues are not necessarily
problematic, depending on the goals of the investigation, but do warrant careful consideration
whenever investigators decide to use quality-of-life outcomes as end points in clinical trials.

Oxford University Press

Opportunities and Challenges: Assessing Quality of Life in Clinical Trials

1.
2.

R. Brian Giesler and

S. D. Williams
+Author Affiliations

1. Indiana University School of Nursing, Indianapolis

2. Mary Margaret Walther Program for Cancer Care Research, Indianapolis
3. Indiana University Cancer Center, Indianapolis
4. Indiana University Cancer Center
1.
Correspondence to: Stephen D. Williams, M.D., Indiana University Cancer Center, 535
Barnhill Dr., Rm. 455, Indianapolis, IN 46202
Quality-of-life outcomes have become important end points in oncology clinical trials (13).
Their popularity can be attributed to several factors, including the growing recognition that the
so-called soft nature of most quality-of-life variables does not preclude valid and reliable
measurement(47). Perhaps the most important factor is the proliferation of therapies that has
occurred over the past few decades (1). Physicians possess a larger therapeutic arsenal for cancer

than ever before. However, most available therapies are accompanied by frequent and sometimes
debilitating side effects. A given treatment modality may convey greater (or equivalent) life
expectancy relative to another yet lower a patient's quality of life to such an extent that the
patient would have been better off had he or she undergone a different therapy. Incorporating
quality-of-life assessments into clinical trials provides the opportunity to acquire a more
comprehensive picture of the benefits and detriments that accrue from a given therapy, thereby
increasing the likelihood of making optimal treatment decisions. However, with increased
opportunities come new challenges. In this issue of the Journal, Moinpour et al. (8) present the
results of a study that illustrates both the opportunities and the challenges of assessing quality-oflife outcomes in clinical trials.
Moinpour et al. (8) report results from a prospective, quality-of-life study designed to
complement a Southwest Oncology Group (SWOG) randomized trial (INT-0105) that compares
orchiectomy plus placebo with orchiectomy plus flutamide in patients with metastatic prostate
cancer (9). This study was conducted before disease-specific measures for patients with
advanced prostate cancer (10), (11) were generally available. To assess their primary outcome
variables, Moinpour et al. (8) used the Mental Health Index and Physical Functioning Scale from
the SF-36 [36-Item Short Form Health Survey in the Medical Outcomes Study) (5), which are
considered generic measures of health-related quality of life, and single-item measures of
diarrhea, gas pain, and body image.
All quality-of-life instruments were self-administered to a subsample (n = 739) of trial
participants at baseline and at 1 month, 3 months, and 6 months. Additional measures were also
administered [e.g., the Symptom Distress Scale (12)], although data from these measures were
not or only partially reported. By use of a conservative analytic approach, Moinpour et
al. (8) found that patients randomly assigned to the placebo arm generally enjoyed better mental
health and less diarrhea than patients assigned to the flutamide arm. Differences on other qualityof-life variables did not achieve statistical significance but usually fell in the same direction. Of
note, no survival differences were found across the two arms.
Two points, in particular, deserve comment. The first point is that, as illustrated by the findings
of Moinpour et al. (8), quality-of-life assessments provide important information in clinical
trials. When neither arm conveys a survival benefit, as occurred in SWOG trial INT-0105 (9), the
effect on quality of life will provide the best means to determine which treatment is most likely
to benefit patients. The findings of Moinpour et al.(8) permit a straightforward conclusion in this
regard. What is less clear is how great a quality-of-life benefit the patients in the placebo arm
experienced relative to the patients in the flutamide arm. How big a difference on a mental health
index, for example, is necessary to infer that one therapy provides meaningfully better life
quality than another?

In the current study, Moinpour et al. (8) indicate that the statistically significant eight-point
difference found between the treatment arms at 6 months was equivalent to the difference found
between patients with hypertension and patients with congestive heart failure on the same
measure. Although this approach is helpful, it lacks precision. Statistical significance is all that is
required when the goal is to determine whether one therapy is better than another, but problems
arise when one needs to know how much better one therapy is over another. Would an eightpoint difference, for example, justify foregoing a toxic therapeutic regimen for a less-toxic
alternative that would provide a shorter life expectancy? The answer depends, in part, on what an
eight-point difference means. These issues challenge all investigators currently working with
quality-of-life outcomes. Various attempts have been made to clarify the meaning of quality-oflife scores (13) and to quantify the length of life versus quality-of-life tradeoffs that treatment
decisions often involve (14), but clearly this area requires further study.
The second point is that quality-of-life assessments in clinical trials are feasible. Moinpour et
al. (8) were able to obtain response rates that never dropped below 80% and were able to
determine that missing data were not systematically related to health status. The reasons for the
success of this study are probably due to a variety of factors, including adherence to a strict
protocol and the fact that patients with advanced stage prostate cancer are often healthier than
patients with other forms of advanced stage cancer, which would tend to make data collection
less burdensome and more likely to succeed. However, even when burden is a concern, qualityof-life data can often successfully be collected. Although multi-item scales are more likely to
provide reliable data (15), single-item measures, which are quickly and easily administered, can
be sufficient if one's goal is to compare groups cross-sectionally (16).
In summary, the study of Moinpour et al. (8) illustrates the importance and feasibility of qualityof-life assessment in clinical trials. This investigation also provides compelling evidence that
flutamide, when coupled with bilateral orchiectomy, provides less benefit than orchiectomy
alone for patients with prostate cancer who have metastatic disease. However, some caution is
warranted when generalizing from quality-of-life data collected during clinical trials. The mere
knowledge of participating in a clinical trial, regardless of the arm to which a patient has been
randomly assigned, is likely to affect the patient's quality of life (e.g., by raising the patient's
hopes). Moreover, some research suggests that asking quality-of-life questions constitutes an
intervention in and of itself, since it may sensitize patients and their health-care providers to
problems that otherwise would have been ignored (17). These issues are not necessarily
problematic, depending on the goals of the investigation, but do warrant careful consideration
whenever investigators decide to use quality-of-life outcomes as end points in clinical trials.

Oxford University Press

Defining quality of life

QOL is a multidimensional concept that can be difficult to define due to the subjective nature of
both positive and negative aspects of life.1According to UNdata, a division of the United
Nations, QOL is defined as a notion of human welfare (well-being) measured by social
indicators rather than by 'quantitative' measures of income and production.2 For many, QOL
refers to the ability to enjoy normal life activities, such as shopping, driving, working, and
entertaining. In nursing, we need to remember that some treatments can impair this ability to
enjoy a normal life without providing substantial benefit. One author stated, The term 'quality
of life' extends not only to the impact of treatment and side effects, but to the recognition of the
patient as an individual, and as a whole person; body, mind, and spirit.3
Back to Top | Article Outline
Adaptation Model
The Adaptation Model is an applicable theory for addressing oncology patients and their
QOL.4 In this model, the human being is described as a biopsychosocial being. There's also the
philosophic assumption that humans have faith/spirituality. Adaptation is defined as the process
and outcome whereby thinking and feeling persons use conscious awareness and choice to create
human and environmental integration.5 The patient is in constant interaction with the
environment in which there are three types of stimuli that provoke a response: focal stimuli,
contextual stimuli, and residual stimuli.
Focal stimuli are internal or external stimuli immediately confronting the person, such as
chemotherapy, radiation, and biopsies. Contextual stimuli are stimuli that affect the situation,
such as the patient has a history of smoking or the cost of treatment. The person's beliefs or
attitudes are residual stimuli that may influence the situation. For example, the patient thinks that
after the initial diagnosis, death is soon to follow.
According to this model, the patient adapts in four modes based on basic needs to maintain
integrity: the physiologic-physical mode, the self-concept mode, the role function mode, and the
interdependence mode. All the modes impact one another.
The physiologic-physical mode entails the needs of oxygenation, elimination, nutrition, activity
and rest, protection, senses, endocrine function, neurologic function, and fluid and electrolyte
balances. There are many attacks on the physiologic being during the disease and treatment
processes of cancer.

The self-concept mode relates to the physical self and personal self. Physical self includes body
sensations and body image.6 Many body image issues exist among cancer patients; for example,
when a woman has a mastectomy, a man has a colostomy, or a 20-year-old loses her hair.
Personal self includes matters such as self-ideal, self-consistency, and the spiritual self.
Oncology patients may experience anxiety related to uncertainty, loss of hope, and even guilt.
The impact on the personal self can vary a great deal based on the patient's residual stimuli.
The role function mode emphasizes the need for a person to know who he or she is in relation to
others. Social integrity is included in the interdependence mode, balancing independence and
dependence of a person in relationships. This mode focuses on love, respect, and value.
Utilizing the nursing process, the goal of the nurse is to promote adaptation in the four modes,
contributing to health and increasing QOL. Figure 1 demonstrates the multidimensional process
of the Adaptation Model.

Figure 1:. Adaptatio...

Image Tools
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Mode 1: Physiologic-physical
Initially, changes in the cancer patient's QOL occur in the physiologic-physical mode. Pain is
common in cancer patients and can be related to the disease process and/or treatment modalities.
Pain is defined as what the patient says it is.7 Let's take Ms. S, who asked if she would be in pain.
After having a bone marrow aspiration, her perceived level of pain was an 8 out of 10. Ms. S
responded to this stimulus with a period of inactivity and lack of sleep. After the nurse's
intervention of providing a pharmacologic agent, Ms. S was able to return to her previous level
of activity.
Ms. S's treatment regimen included chemotherapy. As an adverse reaction of the regimen, she
had a change in the way food tasted, which affected her nutrition status. Previous to this
alteration in taste, Ms. S enjoyed Mexican cuisine, but the spices in the food became too much
for her to tolerate. Her diet while in the hospital was changed to a bland diet, which she didn't
like. She was able to reach a compromise by returning to her favorite Mexican foods that were
cooked without excess spice.
Another effect of the chemotherapy that altered Ms. S's QOL was alopecia. Although the loss of
hair is temporary, there are many potential sequelae. Ms. S didn't understand why the nurses

were preparing her for hair loss. They were telling her to be aware that her natural resistance to
infection would be decreased, with loss of her eyelashes and nasal hair. Did they not understand
she was losing the hair on her head? Of course they did, the education included possible
temperature regulation issues with the loss of scalp hair and the need for wearing protective
coverings in the cold and the use of sunscreen. But Ms. S was more concerned with her outward
appearance and what she would look like without hair.
Back to Top | Article Outline
Mode 2: Self-concept
Ms. S's concern with hair loss impacted her body image. Nursing interventions dealing with
alopecia, as it relates self-concept, include resources for wigs and support groups. Sexuality is
also a physical domain of the self-concept that affects QOL. This is a difficult concept to address
because most people are embarrassed or uncomfortable talking about sexuality. Ms. S was
hesitant to discuss the challenges and concerns she had about sexual relations with her fianc.
The nurses caring for Ms. S addressed these issues with sexuality using the PLISSIT model.8
The PLISSIT model is a four-level intervention for dealing with sexuality issues, allowing for the
nurse to intervene at the patient's comfort level. The first intervention is permission (P), giving
the patient the go-ahead to talk about the topic. The second level is limited information (LI),
which allows the nurse to address concerns, myths, or misconceptions and answer questions. The
next level of intervention offers specific suggestions (SS). Seasoned nurses and advanced
practice nurses are able to intervene in this phase of the model. At this level, suggestions need to
take into account the values of all involved. Newer nurses may choose to refer the patient at this
level to a seasoned caregiver. The final intervention in the model is intensive therapy (IT). This
requires in-depth knowledge and usually involves outpatient treatment, such as a professional
counselor, due to the longer-term nature than the nurse-patient interaction allows.
Additional opportunities for nursing to intervene with the patient in the self-concept mode deal
with the personal self. Ms. S experienced several challenges in this area. She expressed some
uneasiness and fear related to the possibility of a bone marrow transplant. She felt very
powerless when it came to her lymphoma. The nurses intervened by listening to her concerns and
educating her about options and the transplant procedure.
Ms. S. voiced feelings of guilt because her family and friends had to change their plans to
accommodate her illness. The cost of treatment was a burden to her and her family. She didn't
feel that she was who she wanted to be. Ms. S coped with these feelings by relying on her
spiritual beliefs; while in the hospital, her clergy came to visit regularly. Ms. S's reliance on her
spiritual beliefs assisted her in coping and adapting to her cancer diagnosis. Patients who don't

have this support will need nurses to listen to them and provide empathy. Providing the patient
with a list of local support options is also helpful (Table 1).

Table 1: Online reso...

Image Tools
Guilt isn't only an emotion affecting the QOL for patients currently fighting cancer, but also for
those who've survived and now have a history of cancer. The number of cancer survivors has
increased to 11.7 million as reported in 2007.9 These patients may continue to have feelings of
guilt, but now the guilt relates to why they survived and others didn't.
Back to Top | Article Outline
Mode 3: Role function
Everyone has a primary and secondary. The primary role, based on age, gender, and
developmental stage, determines much of our behavior. The secondary role is achieved and based
on developmental stage. Primary and secondary roles are fairly stable roles. The tertiary role can
be temporary and freely chosen. We know that Ms. S is a 20-year-old woman who graduated
high school and is attending college. She went from feeling good about herself and studying in
school to sadness about being a patient. She's newly engaged and went from planning on caring
for her future family to being the one cared for. Patients who place a great deal of emphasis on
their role will experience greater disturbances in QOL, which can lead to depression.
According to the National Cancer Institute (NCI), 15% to 25% of all cancer patient experience
depression.10 The NCI noted that some patients are at higher risk for depression than others. Risk
factors may be cancer related or noncancer related (Table 2). It's important for nurses to assess
for symptoms of depression in their oncology patients (Table 3). The earlier depression is
identified, the earlier it can be treated. Also included in the nurse's assessment is medication
reconciliation, including herbal treatments. Herbals, such as the popular St. John's wort, can
interact with some chemotherapy agents, lessening their efficacy.11

Table 3:
Symptoms
Table 2:
of...
Depression ... Image Tools

Image Tools
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Mode 4: Interdependence
Finding the balance between dependence and independence in relationships can be a struggle for
oncology patients. The equilibrium is offset when patients feel they're taking more than they're
giving to the relationship. The support system of the family and significant others can make a
difference. If patients feel secure in their relationships, they adjust and adapt better to the cancer
experience. If not, they may experience loneliness, increased emotional distress, and
hopelessness.
Ms. S had friends that she used to hang out with, but they had a difficult time with her
diagnosis and treatments. However, Ms. S had other support systems that allowed her to adapt
and cope. Again, referring patients to support groups in which to share and listen to others who
have experienced the same disease processes may help decrease the patient's loneliness and
increase QOL. Interdependence, role function, and self-concept all contribute to a patient's selfesteem. The inability to cope or adapt in one of these modes inhibits the oncology patient's
ability to adapt in the other modes.
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Palliative care
Palliative care is a specialized approach in healthcare for serious, chronic, life-limiting illnesses.
The focus is on relieving and preventing suffering of patients, which improves QOL. Palliative
care teams have a multidisciplinary approach, addressing the physical, emotional, social, and
spiritual needs of the patientsall of the aspects in the four modes of the Adaptation Model.
Palliative care starts at the time the patient is diagnosed and continues until the end of life.
Although Ms. S. didn't have the benefit of a palliative care team, she never complained that she
had a poor QOL, even at age 21 when her life ended.
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Your impact
The nurse manager greatly impacts a patient's QOL not only through direct contact with the
patient, but also indirectly through his or her activities and interactions with the staff. A strong
supportive structure for nursing staff is essential. The nurse manager can provide the following
supportive roles: approachable, caring, walks the talk, motivates development of self confidence,

gives genuine feedback, provides competent staffing, promotes a cohesive team, and
constructively resolves conflict.12 Providing nurses with educational opportunities related to
cancer symptom management and end-of-life care contributes to this structure.
Although end-of-life education is beneficial, nurses need the opportunity to cope with their
emotions related to the loss of a patient. An example of this is establishing a memorial service in
collaboration with chaplain services so staff members may bereave the loss of their patients. An
invitation to such a service can be extended to family members to assist in the coping of their
loss, which will also contribute to the families' QOL.
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Quality of life along the continuum
QOL is different for everyone. Nurses have the ability to impact a patient's life with every
interaction and intervention. During the time we're assessing our patients for symptoms and
intervening, we strive to increase the patient's QOL. Through a holistic approach, nursing
provides an empathetic ear, educational information, medication administration and education,
and spiritual support to improve QOL for all patients, not just those with cancer.
5Factors affecting quality of life in cancer patients undergoing chemotherapy
MS Heydarnejad,1 Dehkordi A Hassanpour,1 and Dehkordi K Solati2
Author information Copyright and License information
This article has been cited by other articles in PMC.
Abstract
Go to:
Introduction
The term quality of life (QoL) is used to evaluate the general well-being of individuals and
societies. According to the World Health Organization (WHO), quality of life (QoL) defined as
individual perception of life, values, objectives, standards, and interests in the framework of
culture. A number of illness-related factors exist that can affect QoL. The amount of symptoms
distressed experienced by an individual has been related to QoL in a number of people with
cancer. QoL is increasingly being used as a primary outcome measure in studies to evaluate the
effectiveness of treatment14. Patients generally instead of measuring lipoprotein level, blood

pressure, and the electrocardiogram, make decisions about their health care by means of QoL
which estimates the effects on outcomes important to themselves5.
An increasingly important issue in oncology is to evaluate QoL in cancer patients6. The cancerspecific QoL is related to all stages of this disease7,8. In fact, for all types of cancer patients
general QoL instruments can be used to assess the overall impact of patients' health status on
their QoL; however hand cancer-specific instruments assess the impact of a specific cancer on
QoL6. In some cancer diseases (glioma for instance), QoL has become an important endpoint for
treatments comparison in randomized controlled trials so that in these patients clinical studies
increasingly incorporate QoL as endpoint9.
Cancer can produce many different symptoms, some subtle and some not at all subtle. Some
symptoms of cancer affecting QoL in patients would be cancer type and stage, as some types of
cancer do not present any symptoms until they are in advanced stages, time since diagnosis,
patient acceptance, intensity of the disease and the level of psychological distress experienced by
caregivers.
The main problems of long-term cancer survivors are in the areas of social/emotional support,
health habits, spiritual/ philosophical view of life, and body image concerns1013. Many studies
show good or adequate overall QoL in these patients. However, among long-term survivors,
psychosocial issues and physical symptoms such as pain and lymphedema, particularly the
adverse effects of systemic adjuvant therapy (chemotherapy) on QoL still persist1114. The aim of
this study was to evaluate the QoL in cancer patients with solid tumors and at the different
chemotherapy cycles.
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Methods
This study was a cross-sectional. A total of 200 cancer patients were included in the present
analysis. The study was conducted in Tehran hospital. Before being asked the subjects to
participate and fill out QoL questionnaire, a formal consent was obtained from all of them. If the
following criteria met by the patients15, then they were invited to participate:
1. diagnosed with solid tumors,
2. planning to receive chemotherapy,
3. no history of other chronic disease such as diabetic or heart disease, and

4. aged 18 years or older.

With some modification, the European Organization for Research and Treatment of Cancer QoL
Questionnaire (EORTC QLQ-C30) was used to measure QoL in the patients. The test consisted
of 56 questions and had arranged into 5 domains (Table 1): (a) physical, role, cognitive,
emotional, and social functioning demographic data as well as cancer/treatment information (b)
patient's general conditions (c) patient's physical activities (d) social status and occupational
function and (e) sleep pattern. With the aid of a nurse and/or a medical student, the
questionnaires were filled out during interview. Each question had an equal value and the QoL
was quantified as the sum of the scores for all domains. The scores were classified into three
categories, namely favorable, fairly favorable, and favorable. The higher scores on this scale
represent a better QoL. The chi square test was used to find the correlation of the clinical
variables and QoL scores using the SPSS software (version 14). The level of significance was set
at p < 0.05 for all tests.

Table 1
Frequency of the pain intensity with QoL in cancer patients undergoing CT (N=200)
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Results
The quality of life was lower in the patients with pain compared to those had no pain (Table 1).
In addition, statistical analyses indicated that there was a significant relationship between the
pain intensity with reducing or losing body performance and QoL (P <0.05). The majority of
patients (54.5%) were male, aged 18-75 years, with a mean age of 46.2 (650%), unmarried
(44%), primary school graduates (65%), and had not sufficient income (79.5%). The relationship
between cancer type and QoL is depicted in Table 2.

Table 2
Frequency of type of cancer with QoL in cancer patients undergoing CT (N=200)
GI (gastrointestinal) cancer at the stage III was the most common cancer, accounting for 3540%
of all the patients. Most of the patients (85%) were aware of their disease. Findings about QoL in
the rest of four domains depicts that the most common problems in regard to this category were:
fear about future (29%), thinking about the disease and its consequences (26.5%), impatient
(24%), and depression (17.5%). The QoL was fairly favorable in majority (66%) of the patients.
There was no correlation between the QoL and variables such as age, sex, marital status, duration
of disease, economic conditions, and occupational function. Furthermore, no correlation was
found between QoL and the patients' educational level (literate or illiterate).
Table 3 shows relationship between fatigue and QoL in cancer patients undergoing
chemotherapy. Patients with low fatigue had better QoL than the others and in fact chi square test
showed a significant relationship between the fatigue and QoL in cancer patients undergoing
chemotherapy.

Table 3
Frequency of the fatigue with QoL in cancer patients undergoing CT (N=200)
The relationship between QoL and the number of CT cycles shows that majority (66%) of the
patients had fairly favorable QoL. A strong correlation was found between QoL and number of
CT cycles. Nevertheless, significant difference was found between the level of QoL in patients
with 2 CT cycles and/or with 3-5 cycles (p< 0.001). This was the case also for the level of QoL
in patients with e 6 cycles (p< 0.001).
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Discussion
An important issue in cancer care and research is QoL. The QoL refers to global well-being,
including physical, emotional, mental, social, and behavioral components. In the last few years, a
number of informative and valid QoL tools have become available to measure health-related
QoL6. The most widely applicable instrument to measure the QoL in cancer patients is the

EORTC QLQ-C30. Using this method, the current study assessed the QoL in cancer patients
undergoing CT. Several studies support our findings on the influence of CT on good or adequate
QoL among the cancer patients undergoing CT1,2. For instance Nematollahi showed in patients
suffering from lymphatic tumors that there was a positive correlation between CT and QoL1.
Likewise, the QoL of African American women with breast cancer was found to be relatively
high; cancer recurrence and metastasis to the lymphatic glands had significant effect on the
QoL17. It has also been shown that CT had a measurable adverse effect on QoL in women with
node-positive operable breast cancer18. The results of our study indicate that CT may improve the
QoL in cancer patients.
Nowadays QoL has been introduced as an endpoint for treatment comparisons in many cancer
types, particularly in advanced stages19. QoL also, as an early indicator of disease progression
could help the physician in daily practice to closely monitor the patients20. QoL may be
considered to be the effect of an illness and its treatment as perceived by patients3 and is
modified by factors such as impairments, functional stress, perceptions and social opportunities4.
As reducing mortality and ensuring optimal health-related QoL are perhaps the main objectives
of medical care10, this study shows that improvement of QoL in cancer patient can be carried out
by means of CT. In fact, improving QoL is as important as the survival benefit that a
pharmacological treatment may provide. However, this is not always the case. For example,
Nemati et al21 reported that the level of QoL in the patients with leukemia was 87.5% lower than
that in the control group. The differences might be due to different patients' population (sample
size or patient age), or cancer types. The current study selected patients (aged 18 years) with
various solid tumors while Nemati et al21 sampled 40 adolescence patients (aged < 18 years) with
leukemia.
In this study, the majority of the patients (68%) who had completed 3 or more cycles of CT
reported a fairly favorable or favorable level of QoL. This may show that QoL is directly related
to cancer treatment procedure, i.e. CT. Likewise, except for a small group (13.3%) of the patients
that their sleep pattern was not favorable, the others had good QoL. This implies that CT can lead
to the better sleep pattern in cancer patients. Our results are consistent with other studies. For
instance Chen et al15 found that QoL in lung cancer patients during the fourth cycles of CT
improved slightly over the baseline values; the patients perceived more sleep disturbances during
the early cycles of CT. Similar results have been found in patients suffering from advanced
cancer by Mystakidou22 and from breast cancer by Fortner21.
The findings of the present study show that there is no correlation between QoL and age, gender,
social status, marriage, and job. Similar results have reported by Nematollahi16, Vedat et al.24, and
Rusten25studies. Further, there were no correlation between extent of the disease and QoL. In

contrast, Rusten25 and Holzner26 in two separate studies found that the extent to which QoL of
cancer patients depends on the time elapsed since initial treatment; with an increase in the extent
of the disease, a decrease in the QoL was observed. The difference might be due to the duration
of disease; the extent of the disease in 87% of the patients of the current study was less than two
years whilst it was more than 2 years in Rusten25 and Holzner26 studies.
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Conclusion
Cancer is an important health issue influencing QoL. An appropriate treatment which may
provide care to the cancer patients is CT. The obtained results here indicate a strong correlation
between QoL and number of CT cycles in cancer patients. Since CT is socially stigmatized in
some countries e.g. Iran, encouraging patients to complete a CT course might play an important
role in the treatment outcome and the QoL in cancer patients.
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Acknowledgement