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North Carolina.
32
This previous cross-sectional study
found that at approximately 3 months postdiagnosis,
African Americans reported higher physical well-being
than non-Hispanic whites. The current study includes
the median 3-month survey (baseline) and two addi-
tional assessment points at approximately 2 and 3 years
postdiagnosis. The strengths of this study relative to
other published studies are the long-term HRQOL
follow-up assessments, the large population-based study
group, and inclusion of a large African American cohort.
The overall goal of this study is to identify the sociode-
mographic, behavioral, and clinical characteristics asso-
ciated with HRQOL over time.
MATERIALS AND METHODS
Participants and Study Design
A detailed description of the parent study, the Carolina
Head and Neck Cancer Study (CHANCE), can be found in Diva-
ris et al.
33
Briefly, the CHANCE study—a population-based
case-control study of risk factors for HNC—included patients
aged 20 to 80 years who were residents of a 46-county region in
North Carolina, and who had a newly diagnosed, first primary
invasive squamous cell carcinoma between January 1, 2002,
and February 28, 2006. Patients were excluded if they had can-
cer of the lip, salivary glands, nasopharynx, nasal cavity, and
nasal sinuses. In addition, individuals with carcinomas of other
histologies, carcinomas at other head and neck sites, or a his-
tory of recurrent or second primary tumors were also not eligi-
ble. Cases were identified by means of a rapid case
ascertainment process in conjunction with the North Carolina
Central Cancer Registry in which newly diagnosed cancer cases
were identified and reported to the study office every month.
This case information was sent to the study office, and initial
eligibility was confirmed. With physician’s permission, patients
were approached and invited to participate. After consent at a
baseline in-person interview, information was obtained on dem-
ographics, risk factors, medical history, diet, and other factors.
At the baseline interview, permission to obtain medical records
was requested. The medical records were collected and
abstracted in order to obtain information on each patient’s first
course of treatment and pertinent comorbid conditions. All pro-
cedures were performed in accordance with the ethical stand-
ards of the University of North Carolina at Chapel Hill (Chapel
Hill, NC) Institutional Review Board and in accordance with
the Helsinki Declaration of 1975, as revised in 1983.
A subcohort of CHANCE cases was targeted for a multi-
phase prospective assessment of HRQOL. These phases
included data collection at up to three time points postdiagno-
sis. The first phase of HRQOL data collection (baseline) was
conducted in 2005 as part of the overall study baseline in-
person interview that collected HRQOL data on cases with a
diagnosis of HNC between 2002 and 2005. The median time
between diagnosis and the baseline HRQOL data collection was
3 months. Phase 2 (follow-up 1 [FU1]) was conducted using a
mailed questionnaire between 2005 and 2008. The median time
between diagnosis and the FU1 data collection was 22 months.
The third HRQOL data collection phase (follow-up 2 [FU2])
using a mailed questionnaire was conducted between 2007 and
2009. The median time between diagnosis and the FU2 data col-
lection was 42 months. A total of 587 patients were included in
this longitudinal analysis, of which 133 patients had HRQOL
data from all three phases (baseline, FU1, FU2); 37 had base-
line and FU1 data; 236 had FU1 and FU2 data; 52 had only
baseline data; 127 had only FU1 data; and two had only FU2
data. The response rate was 86% for baseline, 91% for FU1, and
95% for FU2.
Measures
The baseline in-person interview collected data on individ-
uals’ sociodemographic characteristics, including age, sex, race,
education, marital status, and insurance status. Participants
reported their health behaviors, including tobacco and alcohol
use. Individuals also reported their height and weight (for cal-
culating body mass index) and comorbid conditions, including
anemia, liver disease, hepatitis, cardiovascular disease, pulmo-
nary disease, renal disease, diabetes, and cancers other than
head and neck. The comorbid conditions variable was catego-
rized as none versus one or more chronic conditions. Patients
also self-reported the type of treatment that they received (e.g.,
surgery, radiation, chemotherapy) and if they were currently
using a feeding tube.
Health-related quality of life was measured by the Func-
tional Assessment of Cancer Therapy–Head and Neck (FACT-
H&N) questionnaire.
34,35
The FACT-H&N includes the FACT-
General scales of Physical Well-Being (7 questions; score range 0–
28; minimally important difference, [MID]
5
2–3 points), Social
Well-Being (7 questions; range 0–28; MID not available), Emo-
tional Well-Being (6 questions; range 0–24; MID
5
2 points), and
Functional Well-Being (7 questions; range 0–28; MID
5
2–3
points).
36,37
The FACT-H&N includes 12 additional questions on
symptoms and issues specific to HNCs, including ability to eat;
dry mouth; difficulty breathing; difficulty swallowing; voice qual-
ity; ability to communicate; body image; pain in the mouth,
throat, or neck; and alcohol and tobacco use. Following the FACT-
H&N scoring guidelines, we summed across nine of the 12 ques-
tions in the FACT-H&N (excluding alcohol and tobacco use and
pain) to create the Head and Neck Cancer Subscale score (score
range 0–36; MID
5
3–4 points). All FACT-H&N questions have
five response options: “not at all,” “a little bit,” “somewhat,” “quite
a bit,” and “very much.” Higher summed scale scores represent
better HRQOL.
37
Minimally important differences are defined as
the smallest difference in scores between groups that patients
perceive as important or personally meaningful, either beneficial
or harmful.
37,38
The MIDs were determined in a separate study
conducted by the FACT developers using anchor- and
distribution-based methods.
37
Statistical Analyses
Demographic and clinical characteristics were summarized
using proportions. Linear mixed effect models were used on
each of the FACT scale scores to account for the longitudinal
nature of the data. Time since diagnosis (in months) was used
to track time. Each participant may have up to three measure-
ments of HRQOL scores, at baseline and follow-up visits 1 and
2. The correlation between any two HRQOL measurements of a
participant was specified as exp
f
2
d
ij
=
h
g
, where
d
ij
was the
time between the two measurements. This specification
reflected stronger correlation between two HRQOL scores when
they were measured closer in time and weaker correlation
when they were measured farther apart in time.
To identify factors associated with the FACT scales, back-
ward variable selection procedures were used with stay-in
P
value
set to 0.05. The initial model included time of measurement (lin-
ear and quadratic) and all the main effects of the demographic
and clinical characteristics listed in Table I, plus their interac-
tions with time (linear and quadratic), to allow for the effect of
these covariates to vary over time. Among the covariates, feeding
tube usage and tobacco/alcohol usage were time-dependent. Once
Reeve et al.: Factors Associated With Quality of Life
130