May 2008, Volume 35, Number
3
Online
Exclusive
Symptom Concerns and Quality of Life in Hepatobiliary
Cancers
Virginia Sun, RN, MSN, ANP, Betty Ferrell, RN, PhD, FAAN, Gloria Juarez,
RN, PhD, Lawrence D. Wagman, MD, Yun Yen, MD, PhD, and Vincent Chung, MD
Purpose/Objectives:
To describe the symptom concerns of patients with hepatocellular carcinoma (HCC) and pancreatic cancer and
explore the effect of symptoms on patients’ quality of life (QOL).
Design:
Descriptive, longitudinal study.
Setting:
Ambulatory clinics of a comprehensive cancer center.
Sample:
45 patients actively receiving treatment for either
HCC or pancreatic cancer.
Methods:
Patients were followed from baseline for three
months, with outcome measures repeated monthly. Outcome measures included the
Functional Assessment of Cancer Therapy–Hepatobiliary
(FACT-Hep) and the Functional Assessment of Chronic
Illness Therapy–Spirituality Subscale (FACIT-Sp-12). Descriptive analysis of
demographic, treatment, and symptom data was conducted, followed by two-way
repeated measures analysis of variance of FACT-Hep
and FACIT-Sp-12 scale scores by diagnosis and treatment type.
Main
Research Variables: Symptoms, QOL.
Findings:
Overall QOL is poor in patients with hepatobiliary cancer, and this trend continues over time.
Symptoms such as abdominal pain, fatigue, weight loss, and poor appetite
commonly are reported in this population.
Conclusions:
Patients with hepatobiliary
cancer suffer from multiple symptoms that may have a negative affect on overall
QOL. Specific QOL domains, such as physical and functional well-being, are of
particular concern for patients.
Implications
for Nursing: The identification of specific symptom and QOL
concerns in hepatobiliary cancers will enhance
clinical care and aid in the future development of multidisciplinary
interventions for this understudied cancer population.
Key Points . . .
·
Patients with hepatobiliary
cancers experience high levels of symptom burden because of advanced stages of
disease that may affect overall quality of life (QOL).
·
Overall QOL remains poor through treatment, with
pain, fatigue, weight loss, and poor appetite of greatest concern to patients.
·
Future research with this understudied cancer
population is necessary to determine specific individual, disease, and treatment-related
factors that influence overall QOL.
In the United States, an estimated 59,000 new cases
of hepatobiliary cancers will be diagnosed in the
year 2008, and approximately 52,700 people will die from them (Jemal et al., 2008). The most commonly diagnosed
hepatobiliary cancers are hepatocellular
carcinoma (HCC) and pancreatic cancer. Worldwide, HCC is the fifth most common
of all malignancies and causes approximately one million deaths annually
(McCracken et al., 2007). Pancreatic cancer is the 10th leading cause of all
new cancer cases for men and the fourth leading cause of death across genders (Jemal et al.). These dismal statistics reflect the reality
that hepatobiliary cancers often are diagnosed at
advanced stages with poor prognosis and frequently are coupled with severe
symptom occurrence, including pain, anorexia, mood disorders, and fatigue (Zhu,
2003). Multiple symptom occurrences result in a rapid decline in patients’
function and quality of life (QOL) and increases morbidity and mortality.
Treatment modalities often lead to post-treatment morbidity and symptom burden,
with modest or no improvements in survival, particularly for patients with
pancreatic cancer.
Consequently, patients with hepatobiliary
cancers are vulnerable to disease and treatment-related symptoms that may
negatively affect overall QOL. Despite these concerns, only a limited number of
studies in the literature have addressed symptoms and QOL in patients with HCC.
The primary purpose of this study was to describe specific symptom concerns and
their effect on overall QOL in patients with HCC or pancreatic cancer.
Literature
Review
The effect of disease on overall QOL in patients
with HCC has been reported in the literature. Overall QOL has been found to be
poorer in patients with HCC when compared to a general healthy population (Steel,
Chopra, Olek, & Carr, 2007). Perception of QOL in
patients with pancreatic cancer was found to be mediated not by symptom burden
but rather by coping processes. Patients’ perceived threat of symptoms and
effectiveness of chosen coping strategies were more important (Fitzsimmons,
George, Payne, & Johnson, 1999). Incidence of specific symptoms such as
depression is higher in patients diagnosed with HCC (Steel, Geller, Gamblin, Olek, & Carr, 2007)
and pancreatic cancer (Carney, Jones, Woolson, Noyes,
& Doebbeling, 2003;
Kelsen et al., 1995; Passik
& Roth, 1999). In addition, psychological distress is found to be higher in
patients diagnosed with pancreatic cancer when compared with malignancies in
other sites (Zabora, BrintzenhofeSzoc,
Curbow, Hooker, & Piantadosi,
2001). Common symptoms of pancreatic cancer include pain (82%), anorexia (64%),
early satiety (62%), and weight loss (51%) (Krech & Walsh, 1991). Fatigue, loss of appetite,
and impaired sense of overall well-being also have been reported (Labori, Hjermstad, Wester, Buanes, & Loge,
2006). Sexual functioning was found to be poorer in patients with HCC when
compared to a general healthy population (Steel, Hess, Tunke,
Chopra, & Carr, 2005). Reduced QOL in patients with HCC also has been
related to factors such as comorbidities, younger
age, and sleep disorders and specific symptoms such as pain (Bianchi et al.,
2003).
The advancement in technology has yielded new
treatment modalities in hepatobiliary cancers,
particularly for HCC. Patients with HCC treated with 90-Yttrium microspheres
reported better QOL when compared to patients receiving chemotherapy through
hepatic arterial infusions (Steel, Baum, & Carr, 2004). Fatigue is common
among patients with HCC after transcatheter hepatic
arterial chemoembolization (TACE) and stereotactic
radiation (Lai et al., 2007; Shun et al., 2005). Factors such as pretreatment
fatigue, sleep disturbance, depression, and overall symptom distress predicted
fatigue changes after treatment (Lai et al.). Patients who received TACE followed
by radiofrequency ablation had significantly higher QOL with better social and
functional well-being when compared to patients who received only TACE three
months after treatment (Wang et al., 2007). Factors such as liver function,
recurrence, complications, and age predicted QOL post-treatment (Wang et al.).
With surgical interventions, significant improvements in overall QOL have been
reported three months after resection of HCC (Eid et
al., 2006; Poon et al., 2001).
Assessment of patients treated with major hepatic
resection, minor hepatic resection, and hepatic ablation following a diagnosis
of HCC found little difference in overall QOL between treatment groups (Eid et al.). Common issues after pancreaticoduodenectomy
were related to pancreatic exocrine and endocrine insufficiency, and included
weight loss, abdominal pain, fatigue, foul-smelling stools, and diabetes (Huang
et al., 2000).
The effect of QOL on survival in patients with hepatobiliary cancers has been explored; this area is of
interest because current treatment modalities for hepatobiliary
cancers, particularly pancreatic cancer, produce very modest survival benefits.
Specific domains of QOL, such as physical and functional status, predicted
longer survival in patients with unresectable HCC (Yeo
et al., 2006). In the same cohort, lower appetite scores, advanced stages of
disease, and higher liver dysfunction all independently predicted shorter
survival (Yeo et al.). Better global QOL and family functioning were
significantly associated with survival in a cohort of patients with pancreatic
cancer, even after controlling for stage at diagnosis (Lis,
Gupta, & Grutsch, 2006). In pancreatic cancer,
patients who initially had jaundice had shorter intervals between symptom onset
and first medical treatment, thereby leading to a significantly better
prognosis (Watanabe et al., 2004). Conversely, patients who initially had back
pain had a significantly worse prognosis. (Watanabe et al.).
The level of depression, however, did not predict survival among patients with
pancreatic cancer (Sheibani-Rad & Velanovich, 2006).
Finally, two studies addressed the needs of family
caregivers of patients with hepatobiliary cancer.
Coleman et al. (2005) found that family members were more likely than patients
to access a pancreatic, cancer-specific Web site chat room for information and
support. Questions posted on the Web site focused on end-of-life issues and
symptoms, and pain was the most commonly cited symptom. In a separate study,
Nolan et al. (2006) found that a large number of postings by family members on
the same Web site addressed spirituality, and many family members returned to
the site and posted information after the death of their loved ones.
Overall, the current literature clearly has
documented that QOL is an important issue in hepatobiliary
cancer, and individual, disease, and treatment-related factors can mediate or
moderate patients’ perceptions of QOL. Although the importance of QOL to patients
with hepatobiliary cancer has been supported,
additional research is warranted to clarify the specific components of QOL in
this understudied cancer population. The current study attempted to address the
following questions: What are the specific domains (physical, social,
emotional, functional, spiritual) and overall QOL for patients receiving active
treatment for hepatobiliary cancer? What are the
specific symptom concerns for these patients related to their disease and
treatments?
Conceptual Framework
Figure
1 presents the study model. This model is based on QOL research conducted
at a National Cancer Institute–designated comprehensive cancer center since the
mid-1980s (Ersek, Ferrell, Dow, & Melancon, 1997; Ferrell, Grant, Padilla, Vemuri, & Rhiner, 1991;
Ferrell, Dow, Leigh, Ly & Gulasekaram, 1995;
Ferrell et al., 1996; Ferrell, Grant, Funk, Otis-Green, & Garcia, 1997a,
1997b, 1998;). The model demonstrates that subjects (in this case, patients
with HCC and pancreatic cancer) are expected to experience symptoms that are
disease and treatment related. These symptoms may influence QOL across
physical, social, emotional, functional, and spiritual domains. Other
intervening variables that may affect QOL outcomes included patient
characteristics, disease characteristics, treatment modality, and comorbidities. Study aims were listed under the
corresponding sections in the model. Measures used to collect data on pertinent
variables and outcomes were noted within each corresponding section of the
model.
Methods
Procedure
Approval from an institutional review board was
obtained prior to study initiation. Research nurses approached patients who met
eligibility criteria during regularly scheduled clinic visits. Written informed
consent was obtained from patients prior to participation in the study.
Participants provided demographic and disease data at baseline along with other
outcome measures to assess symptoms and overall QOL across the six domains in
the study model. All outcome measures were repeated monthly after baseline for
a total of three months.
Sample
and Setting
Study participants were recruited from the medical
and surgical oncology ambulatory care clinics at an NCI-designated
comprehensive cancer center. Eligibility criteria included a diagnosis of HCC
or pancreatic cancer, at least age 18, and ability to understand English. The
eligibility criteria were intended to maximize study accrual and to allow the
investigators to collect as much information as possible to describe this
understudied cancer population.
Outcome
Measures
Investigators developed a demographic and treatment
data tool to compile information on each participant at baseline. Demographic
information such as age, ethnicity, education level, religious affiliation,
marital status, living situation, employment status, and annual income were
collected using this tool. The tool also was designed to capture key disease
and treatment variables of importance in describing the sample population and
for analysis of influencing variables.
The Functional Assessment of Cancer Therapy—Hepatobiliary (FACT-Hep) is a
cancer-specific version of the Functional Assessment of Chronic Illness Therapy
(FACIT) measurement system (Cella, 2005). The FACT-Hep is developed specifically for use in patients with hepatobiliary cancers. It contains the original
FACT-General (FACT-G) scales that include a 27-item compilation of general
questions divided into four primary QOL domains: physical, social/family,
emotional, and functional well-being. An additional 18 questions that assess
symptom and QOL concerns pertinent to patients with hepatobiliary
cancer were included. All the disease-specific QOL tools in the FACT system
include the original FACT-G as well as a disease-specific subscale. All items
are scored from 0–4, with higher overall and subscale scores indicating better
QOL. Cronbach alpha was 0.94 and test-retest
reliability of 0.90 has been reported (Heffernan et al., 2002). Alpha
coefficients for the subscales ranged from 0.72 for the social/family domain to
0.84 for the functional domain; these alphas improved at retest (Heffernan et
al.).
The FACIT-Spirituality Subscale (FACIT-Sp-12)
(Peterman, Fitchett, Brady, Hernandez, & Cella, 2002) assesses the spiritual well-being of patients
living with a chronic illness. It measures a sense of meaning and peace, and
also assesses the role of faith in illness. The tool contains 12 items scored at
a range of 0–4, with higher overall and subscales socres
indicating better quality of life. Items are divided into two subscales:
meaning/peace and faith. Cronbach alpha for the
FACIT-Sp-12 was 0.87, and subscale coefficients ranged from 0.81 for the meaning/peace
domain to 0.88 for the faith domain (Peterman et al.). A separate tool was
chosen to measure spirituality, primarily because the overall QOL tool for the
study did not contain a measure of this domain.
Data
Analysis
The specific aims of this study were accomplished
primarily through quantitative methods, which included a descriptive,
longitudinal design to describe symptoms and QOL in patients with hepatobiliary cancers. The Power Analysis and Sample Size
software was used to compute power and sample size requirements that called for
testing relationships using Pearson correlations between QOL subscale scores
and symptom scores. This required calculating five Pearson correlations at each
of four time periods, or a total of 20 correlation coefficients. Because of
inflation of alpha created by conducting multiple statistical tests, a
conservative alpha of 0.01 was selected. A sample size of 42 subjects provided
80% power to detect a difference between null correlation of 0.0 and alteration
correlation of 0.5 using a two-sided Fisher’s two-tailed test at 0.01 significance level.
Analysis included tabulation of standard summary
statistics of demographic characteristics, disease/treatment characteristics,
and all scores at each time point. In addition, descriptive statistics for
individual QOL items, domain scores, symptom subscale scores, and total QOL
scores were computed for each evaluation period. Pearson correlation
coefficients between the symptom score and each of the QOL scale scores were computed
for all four evaluation periods. Mean scores for each QOL and the symptom
scores were plotted in a multiple line graph during the four evaluation periods
to detect trends over time. Descriptive analysis of demographic, treatment, and
symptom data was conducted, followed by two-way repeated measures analysis of
variance (ANOVA) of FACT-Hep and FACIT-Sp-12 scale
scores by diagnosis and type of treatment.
Results
A total of 45 participants were accrued to the study
and had complete data that was evaluable. The mean age of these participants
was 59 years, and 64% were male. This is comparable to the general hepatobiliary cancer population, where incidences are
higher in men and older age (Jemal et al., 2008). The
sample included 51% Caucasian, 22% Asian, 18% Hispanic, and 4% African American
participants. More than half of the Hispanic and Asian participants in the
study were diagnosed with HCC, whereas most Caucasian participants were
diagnosed with pancreatic cancer. Seventy percent of participants were married
and reported living with either a spouse or children. The majority of
participants (65%) had a college education or graduate degree, and 36% had an
educational level of high school or less. Participants diagnosed with HCC were
more likely to have an educational level of high school or less, whereas
patients diagnosed with pancreatic cancer were more likely to have a college or
graduate level education. Most participants (42%) were retired, and 27% were
disabled as a result of their cancer diagnosis.
In terms of disease-specific variables, the study
sample included 22 patients with HCC and 23 patients with pancreatic cancer.
The majority of participants had stage III (26%) or IV (61%) disease at the
time of accrual; 82% had been diagnosed recently, and 13% had recurrent
disease. More than half of patients had undergone some type of surgery for
their cancer. Forty-six percent of those who had previous surgery were in the
HCC group. Having a diagnosis of pancreatic cancer was associated significantly
with previous chemotherapy. Almost 30% of participants reported having
diabetes, and 20% reported being diagnosed with hepatitis. Complete demographic
data by diagnosis is provided in Table 1.
Quality
of Life
Descriptive statistics were computed for each of the
five QOL domains (physical, social, emotional, functional, and spiritual) and hepatobiliary subscale. Repeated measures ANOVA by
diagnosis were conducted. Baseline overall QOL scores were low in the HCC and
pancreatic cancer groups. Over time, overall QOL scores continued to decrease,
with an exception in the HCC group at three-month evaluation, where overall
scores increased. The increase, however, was not statistically significant, and
overall QOL score changes were not statistically significant over time with one
exception: Baseline QOL was higher when compared to the other three evaluation
periods (p = 0.048). A plot of overall QOL scores over time can be found in Figure
2.
In terms of subscale scores, results indicate that
baseline QOL for physical well-being was significantly higher than at one, two,
and three months (p < 0.001), whereas baseline emotional well-being was
significantly higher than two and three months (p = 0.033). No significant
differences over time were found in the social and functional well-being
domains. At baseline, across the four subscales of the FACT-Hep,
scores were highest for social well-being (—X = 22.6, SD = 4.3).
Conversely, scores were lowest for functional well-being (—X = 13.7,
SD = 5.9). At the three-month evaluation, social well-being remained highest (—X
= 22.9, SD = 5.3) and physical well-being was lowest (—X= 10.8, SD =
7.1). Overall QOL scores and subscale scores are provided in Table
2.
Pearson’s correlations between the disease-specific
symptom subscale and each of the QOL subscale scores were computed for all four
evaluations, including baseline. Results at baseline suggest that symptoms were
highly correlated with physical well-being (0.72), functional well-being
(0.73), and overall FACT-Hep scores (0.93).
Correlations at baseline among symptoms and emotional well-being (0.51),
spirituality (0.54), and social/family well-being (0.17) were moderate to low.
These correlational trends were found across time for
the physical well-being domain and overall FACT-Hep
scores. Table
3 provides Pearson’s correlations among symptoms and QOL across study time
points.
Spirituality
No significant differences were found over time or
by group in relation to overall spirituality; however, a significant
interaction between group and time was found in the meaning/peace subscale of
the FACIT-Sp-12. Results suggest that spiritual well-being in the pancreatic
cancer group was significantly higher than the HCC group at the three-month
evaluation, and within the HCC group, baseline spiritual well-being was
significantly higher when compared to the other three evaluation time points (p
< 0.05). No significant differences over time or by diagnosis were found in
the faith subscale scores. Table
4 provides overall spirituality and subscale scores for the FACIT-Sp-12.
Disease-Specific
Symptom Subscale
No significant differences were observed in overall
symptom subscale scores over time or by diagnosis. In the HCC group, the
overall symptom subscale score decreased over time from baseline, one-, and
two-month evaluations, but was increased at three months. For the pancreatic
cancer group, overall scores stabilized between one month and two months and
then decreased by the three-month evaluation. These changes were not
statistically significant.
Individual item responses were explored for the
symptom subscale. This was undertaken to obtain symptom-specific data embedded
within the overall QOL assessment. Particular attention was given to specific
symptoms such as pain, fatigue, weight loss, and mood states because these are
common in hepatobiliary cancer. Overall, symptom
scores were high for weight loss, appetite, fatigue, ability to perform usual
activities, and abdominal pain and tended to worsen over time. Individual item
scores for the symptom subscale are provided in Table
5.
Discussion
In this study, we identified a cancer population
with mainly advanced disease, which is typical for a tertiary cancer center.
Study sample was diverse, with 44% of participants being non-Caucasian.
Baseline QOL, as expected, was low across both diagnoses. This trend continued
over time, with the exception of a slight increase in the HCC group at three
months that was not statistically significant. Because 46% of HCC patients were
treated with surgery in this study, this finding is consistent with previous
studies that suggest recovery of QOL in patients with HCC at three-months after
surgery (Eid et al., 2006; Poon
et al., 2001). Another finding was a trend for worsening of physical and
emotional well-being over time that was statistically significant; however, the
decline was not statistically significant for social and functional well-being,
which is interesting given that a parallel decline in function should be
expected with decreasing physical well-being. The finding suggests that other
factors may be involved in overall perceived functional status in patients with
cancer receiving active treatment and further exploration is warranted.
Recent studies have emphasized the importance of
assessing spirituality in patients with advanced disease, and results have
found that spiritual support is associated with better QOL (Balboni
et al., 2007). Overall spirituality scores were high across both groups.
Significant differences were found in the meaning/peace subscale, where the
pancreatic cancer group scored higher at three months compared to the HCC
group. A significant trend of decline also was observed in overall spirituality
in the HCC group. These results warrant further exploration because spirituality
is the least understood domain of QOL in patients with cancer, regardless of
diagnosis.
Previous studies have found that multiple symptom burden in patients with hepatobiliary
cancer is common (Kelsen et al., 1995; Krech & Walsh, 1991; Steel, Geller, et al., 2007).
Predictably, participants in this study had many symptom-related concerns.
Overall, scores for the symptom subscale were low for both diagnoses. Again, a
trend was found in the HCC group, with a slight improvement in overall symptom
concern at three months that was not statistically significant. The finding is
probably related to a similar improvement in overall QOL shown at three months
for this group, which might indicate that decreased symptom burden resulted in
recovery of QOL. Analysis of individual item responses in the symptom subscale
revealed that, as expected, participants reported high levels of concern for
weight loss, appetite, fatigue, and abdominal pain. This finding is consistent
with previous studies and underscores the importance of aggressive symptom
management for patients with hepatobiliary cancer.
Limitations of the present study included the small
sample size. Findings from the study cannot be generalized. Although ethnic
minority participation was fairly high in this study, the small sample size
precluded determination of statistical differences by ethnicity. The present
pilot study originally was not designed to analyze comparisons across
ethnicity. Although important demographic and disease data were collected, analysis
based on factors such as age and type of treatment cannot be conducted because
of the small sample size. Another limitation is the heterogeneity of a sample
population with two different cancer diagnoses. The combining of the two
diagnoses was undertaken to maximize study accrual. This strategy limited the
number of participants accrued into each diagnosis group, which, in turn,
prohibited generalizations of study results because of the small sample size in
each diagnosis group.
Implications for
Nursing Practice and Research
The findings of this study provide preliminary
insight into the QOL of patients with hepatobiliary
cancers. Results suggest that this understudied cancer population is burdened
with low QOL and multiple symptom concerns. Although these findings were
expected and validated results from previous studies conducted in this
population, it is frustrating to find that research with this understudied
cancer population remains minimal. Nurses caring for patients with hepatobiliary cancer must be aware of the QOL and symptom
concerns and advocate for aggressive symptom management for this vulnerable
cancer population.
Nurse researchers are in an ideal position to
advance the scientific knowledge of the symptoms experience and QOL of patients
with hepatobiliary cancers. Several important areas
of interest warrant further exploration. First, future research with this
cancer population should explore the diagnoses separately. The category of hepatobiliary cancers includes several different and, perhaps,
distinct diagnoses. Therefore, a more homogeneous sample allows for the
potential to derive more meaningful findings specific to patient and family
needs based on diagnosis. Second, given that patients with hepatobiliary
cancers are burdened by multiple symptoms, explorations of other
symptom-related factors affecting QOL, such as distress, may assist in
determining effective symptom management for this cancer population. Effective
symptom management is particularly important given that current treatment
modalities for hepatobiliary cancers produce minimal
or no survival benefit. In this situation, aggressive symptom management is
paramount. Third, future research exploring QOL in this population must include
spirituality as a moderator of overall QOL. Finally, factors such as symptom
and illness perceptions must be explored to fully comprehend the meaning of QOL
for patients with hepatobiliary cancer.
In conclusion, the present study suggests that hepatobiliary cancer is associated with multiple symptoms
burden and diminished QOL. The decline in QOL continues through treatment and
disease progression. Through research, further understanding of the symptom
experience of patients with hepatobiliary cancer will
aid in the development of effective nursing interventions to improve the QOL of
this understudied cancer population.
The authors gratefully acknowledge Gwen Uman, RN, PhD, at Vital Research, LLC, for her assistance
in statistical design and analysis, and Michelle Duff, DPT, director of Patient
and Liaison Services and Medical Affairs at the Pancreatic Cancer Network for her
role as external consultant for this study.
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Virginia Sun, RN, MSN, ANP, is a senior research
specialist, Betty Ferrell, RN, PhD, FAAN, is a research scientist, and Gloria
Juarez, RN, PhD, is an assistant research scientist, all in the Department of
Nursing Research and Education at City of Hope in Duarte, CA; Lawrence D. Wagman, MD, is the executive medical director at St.
Joseph’s Hospital Cancer Center in Orange, CA; and Yun
Yen, MD, PhD, is an associate director of translational research and a
professor and staff physician and Vincent Chung, MD, is an assistant professor
and staff physician, both in the Department of Medical Oncology and
Therapeutics Research at City of Hope. This study was supported by the ONS
Foundation 2005 Trish Greene Memorial Grant. (Submitted
August 2007. Accepted for publication October 8,
2007.)
Author
Contact: Virginia Sun, RN, MSN, ANP, can be reached at vsun@coh.org, with copy to editor at ONFEditor@ons.org.
Digital Object Identifier: 10.1188/08.ONF.E45-E52