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

Gladis MM1, Gosch EA, Dishuk NM, Crits-Christoph P.Author informationAbstractClinical 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 author’s 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 Müller ‐ Nordhorn

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 must‐have 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 Trials1. R. Brian Giesler and 2. S. D. Williams

+Author Affiliations1. Indiana University School of Nursing, Indianapolis2. Mary Margaret Walther Program for Cancer Care Research, Indianapolis3. Indiana University Cancer Center, Indianapolis4. Indiana University Cancer Center

1. Correspondence to: Stephen D. Williams, M.D., Indiana University Cancer Center, 535 Barnhill Dr., Rm. 455, Indianapolis, IN 46202Quality-of-life outcomes have become important end points in oncology clinical trials (1–3). 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(4–7). 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-of-life 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 quality-of-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 eight-point 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-of-life 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, quality-of-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 quality-of-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 Trials1. R. Brian Giesler and 2. S. D. Williams

+Author Affiliations1. Indiana University School of Nursing, Indianapolis2. Mary Margaret Walther Program for Cancer Care Research, Indianapolis3. Indiana University Cancer Center, Indianapolis4. Indiana University Cancer Center

1. Correspondence to: Stephen D. Williams, M.D., Indiana University Cancer Center, 535 Barnhill Dr., Rm. 455, Indianapolis, IN 46202Quality-of-life outcomes have become important end points in oncology clinical trials (1–3). 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(4–7). 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-of-life 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 quality-of-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 eight-point 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-of-life 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, quality-of-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 quality-of-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

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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.

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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 fiancé. 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.

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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 2: Depression ...Image Tools

Table 3: Symptoms of...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 self-esteem. 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 patients—all 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 treatment1–4. 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 cancer-specific 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 concerns10–13. 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 persist11–14. The aim of this study was to evaluate the QoL in cancer patients with solid tumors and at the different chemotherapy cycles.

Go to:

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)

Go to:

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 35–40% 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 Rustøen25studies. Further, there were no correlation between extent of the disease and QoL. In contrast, Rustøen25 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 Rustøen25 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