Validation of the functional assessment of cancer therapy esophageal cancer subscale

Validation of the Functional Assessment of CancerTherapy Esophageal Cancer Subscale

Gail Darling, MD1

David T. Eton, PhD2

Joanne Sulman, MSW3

Alan G. Casson, MB, ChB4

David Cella, PhD2

1 Division of Thoracic Surgery, Toronto GeneralHospital, University of Toronto, Toronto, Ontario,Canada.

2 Center on Outcomes, Research and Education,Evanston Northwestern Healthcare and Northwes-tern University Feinberg School of Medicine,Evanston, Illinois.

3 Department of Social Work, Mount Sinai Hospi-tal, Toronto, Ontario, Canada.

4 Division of Thoracic Surgery, Dalhousie Univer-sity, Halifax, Nova Scotia, Canada.

BACKGROUND. To develop and validate a quality of life subscale for patients with

esophageal cancer to be used with the Functional Assessment of Cancer Ther-

apy—General (FACT-G).

METHODS. Prospective cohort study of patients with esophageal cancer treated

with surgery alone or neoadjuvant chemoradiotherapy and surgery evaluating the

validity, internal consistency, and responsiveness to change of the FACT-Esopha-

geal (FACT-E) when comparing it with the European Organization for the

Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ

30) and esophageal (OES 24) as well as clinical factors.

RESULTS. The FACT-E demonstrated very good convergent and divergent valid-

ity when compared with the EORTC QLQ30 and OES 24 and clinical variables.

Internal consistency was also good with coefficient a >0.70 for all subscales

and individual items. Stability coefficients were >0.80. Changes in clinical status

were reflected in changes in FACT-E scores demonstrating responsiveness to

change, particularly in patients receiving neoadjuvant chemoradiotherapy before

surgery.

CONCLUSIONS. The FACT-E met or exceeded all standards for validity, providing

an option to measure health-related quality of life for different treatment strate-

gies for esophageal cancer. Cancer 2006;107:854–63.

� 2006 American Cancer Society.

KEYWORDS: esophageal neoplasm, quality of life, health-related quality of life,cancer treatment.

E sophageal cancer has the sixth highest mortality rate of all can-

cers.1 Overall survival is <10% although 5-year survival for

resected patients is 20%–40%.2–5 Phase III trials of neoadjuvant che-

moradiotherapy before surgery have been disappointing, but meta-

analyses have shown some survival benefit.6 However, the time

required for such regimens represents 20% of the estimated median

survival of 16.3 months for patients with resected esophageal can-

cer.7 Relief of the dysphagia experienced by patients with esopha-

geal cancer is also a very important outcome not only because

of resulting weight loss but also because of the loss of enjoyment of

eating with friends or family and social isolation. Hence, quality of

life is an important consideration when making treatment decisions.

To evaluate the effect of treatment on quality of life, an esophageal

cancer subscale (ECS) to be used with the Functional Assessment of

Cancer Therapy—General (FACT-G) quality of life measure was

developed. The FACT-Esophageal (FACT-E) is the complete measure

(FACT-G and ECS). The objective of this study was to validate the

FACT-E in patients with esophageal cancer.

Address for reprints: Gail Darling, MD, Division ofThoracic Surgery, University of Toronto, TorontoGeneral Hospital 9N-955, 200 Elizabeth Street,Toronto, Ontario M5G 2C4, Canada; Fax: (416)340-3660; E-mail: [email protected]

We acknowledge the contributions of Lynn Coul-ter, Jennifer Hornby, and Debbie Murnaghan incompleting this research.

Received December 8, 2005; revision receivedMarch 24, 2006; accepted March 31, 2006.

ª 2006 American Cancer SocietyDOI 10.1002/cncr.22055Published online 6 July 2006 in Wiley InterScience (www.interscience.wiley.com).

854

METHODSDevelopment of the FACT Esophageal Cancer SubscaleThe ECS was developed using an iterative process of

item generation, item reduction, scale construction,

and initial psychometric evaluation.

Item generationThe initial items for the esophageal subscale were

adapted from a disease-specific instrument for head

and neck cancer and the initial questionnaire devel-

oped in collaboration with Cella et al.8,9

Item reduction and further item generationThrough qualitative analysis based on feedback from

11 patients, the initial 57-item disease-specific ques-

tionnaire generated several symptom themes: cough-

ing, pain, lack of energy/fatigue, digestion/elimination,

swallowing, eating including social aspects, and voice

quality. Items that did not fall into these themes as

well as redundant items were eliminated.

After field testing, new items were generated: dry

mouth, breathing, communication, sleep disturbance,

and weight loss. The final list of 17 esophageal-speci-

fic items was appended to the FACT-G and then

evaluated by 7 patients. Feedback confirmed the ap-

propriateness of the changes and ease of completion

of the questionnaire.

Scale constructionThe esophageal subscale was revised to be consistent

with the existing FACT subscales and then reviewed

by an expert panel, and field-tested with 38 patients

who reported that the FACT-E questions were easy to

understand and answer.

Initial psychometric evaluationBased on initial results demonstrating good internal

consistency (Cronbach’s a ¼ 0.86; SPSS 10.0), a for-

mal validation study was initiated.

Validation of the FACT-EThe following steps were completed:

1. Determine the convergent and divergent validity

of the FACT-E against an established standard,

European Organization for the Research and Treat-

ment of Cancer Quality of Life Questionnaire(EORTC core QLQ-C30) and OES 24.

2. Determine the internal consistency and stability

of the FACT-E and its subscales in comparison

with an established standard.

3. Determine the concurrent validity of the FACT-E

by comparing scores across clinical risk factors.

4. Determine the responsiveness to change of the

FACT-E over time and with changes in clinicalcondition.

The 2 parts of the study included the initial vali-

dation in a group of surgical patients (Cohort A) and

then further evaluation of responsiveness to change

in patients receiving induction chemoradiotherapy

before surgery (Cohort B). The study was approved

by the institutional research ethics boards and

informed consent was obtained from all patients.

Study MeasuresFACT-EThe FACT-G consists of 27 items divided among

4 subscales: physical well-being (PWB), functional

well-being (FWB), social/family well-being (SWB), and

emotional well-being (EWB). The sum of these sub-

scales forms the total FACT-G score. The FACT-G

has been well studied and previously validated.9 The

ECS addresses concerns specific to patients with

esophageal cancer such as eating, appetite, swallow-

ing, pain, talking/communicating, mouth dryness,

breathing difficulty, coughing, and weight loss. The

total FACT-E score is the sum of the ECS and the

FACT-G scores. A trial outcome index (TOI) score,

useful where the physical domains are of interest,

was computed by adding the PWB and FWB scores

to the ECS score (See Fig. 1).

Swallowing and eating indexesSwallowing and eating indexes were created a priori

from the ECS items. The swallowing index consists of

5 items (items hn7, e1, e2, e3, and e5 in Fig. 1), and

the eating index consists of 3 items (items hn1, hn5,

and e6 in Fig. 1).

All FACT-E items are rated on a 5-point Likert-

type scale ranging from 0 ¼ ‘‘not at all’’ to 4 ¼ ‘‘very

much’’. Negatively-worded items are reverse scored

so that higher scores always represent better quality

of life (QOL) or less severe symptoms. Possible score

ranges are PWB (0–28), FWB (0–28), SWB (0–28),

EWB (0–24), ECS (0–68), TOI (0–124), swallowing

index (0–20), eating index (0–12), FACT-G (0–108),

and FACT-E (0–176).

QLQ-C30 and OES 24The EORTC core QLQ-C3010 can be used across can-

cer types and consists of 5 functional scales (physi-

cal, role, emotional, cognitive, and social), a global

QOL scale, 8 symptom scales, and 5 single items.

QLQ functional and global QOL scores are trans-

formed to a linear 0–100 scale, with higher scores

indicating better function and QOL. Higher scores on

Validation of the FACT-E/Darling et al. 855

the symptom scales indicate greater symptomatology.

The esophageal cancer-specific module (OES 24) is

designed for use with esophageal cancer patients of

any stage or treatment. It consists of 6 scales and 5

single items (mouth dryness, taste sensation, cough-

ing, talking, and hair loss). All scale and single-item

scores are transformed to a 0–100 scale, with higher

scores indicating greater symptomatology.11

PatientsCohort A included 54 surgical patients with histologi-

cally proven resectable squamous or adenocarci-

noma of the esophagus or gastroesophageal junction,

18 years of age or older, competent to provide in-

formed consent, English-speaking, and with an esti-

mated survival of >3 months.

Cohort B included 29 patients scheduled for

neoadjuvant chemoradiation before surgery. Eligibil-

ity criteria were the same as for Cohort A, specifying

clinical stages T1N1M0, T2-3N0-1M0, T1-3N0-1M1a,

performance status Eastern Cooperative Oncology

Group 0–2, and were medically fit for chemora-

diotherapy.

Data CollectionCohort A patients completed the FACT-E and EORTC

QLQ C30 þ OES 24 modules before surgery (base-

line) and 3–4 months after surgery. At baseline

assessment, alcohol use, weight loss, pain, stage,

treatment, and performance status were noted. The

ECS was administered 3–7 days after the baseline

assessment to determine test–retest reliability.

Cohort B patients completed the FACT-E at base-

line (pretreatment), week 7 (near the end of neoadju-

vant therapy), and week 12–14 (4–6 weeks after

neoadjuvant therapy, but before surgery).

Data AnalysesSpearman correlations (r) were used to determine

the convergent and divergent validity of the FACT-E

including the overall scale, subscales, and aggregate

scores. Spearman correlations were also used to

determine test–retest reliability of the ECS. Coeffi-

cient a was used to determine internal reliability of

the FACT-E. Independent sample t tests were used to

determine whether FACT-E scores can discriminate

across clinical risk factors and symptoms (concurrent

FIGURE 1. Esophageal cancer sub-scale to be used with the FACT-G.

856 CANCER August 15, 2006 / Volume 107 / Number 4

validity). Because of the number of analyses, a was

set at 0.01 (2-tailed) for all significance tests. How-

ever, given the modest number of patients available

for each analysis, effect sizes (ESs) associated with

each mean difference were also computed. The ES

for cross-sectional analyses equals the group mean

difference divided by the pooled within group stan-

dard deviation.

Paired sample t test and repeated measures ana-

lyses of variance (ANOVAs) were used to determine

responsiveness to change in the FACT-E over time. awas again set at 0.01 (2-tailed) for all significance tests.

The ES for prospective analyses equals the difference

between means at 2 time points divided by the sample

standard deviation at the earlier time point.

RESULTSValidation Study, Cohort AIn Cohort A, the average age was 62 years (SD ¼ 11)

and 70% were ECOG 0. Locally advanced disease was

present in 58%: 17% Stage I, and 23% M1A. Patients

were treated with surgery alone (Ivor Lewison, 33%),

left thoracoabdominal with a cervical anastomosis

(29%), transhiatal (19%), or McKeown approaches

(19%).

Convergent and divergent validity of the FACT-EThere was good correlation between the PWB, FWB,

EWB subscales of the FACT-E and the corresponding

physical function, role function, and emotional func-

tion scales of the QLQ (Table 1), demonstrating con-

vergent validity. The PWB subscale showed good

correlations with QLQ symptom scales, including fati-

gue, nausea/vomiting, pain, and appetite loss, whereas

the FWB showed good correlations with fatigue, pain,

sleep, and appetite loss.

Demonstrating divergent validity, there was lower

correlation between EWB and the physical and role

function scales of the QLQ as well as many of the phy-

sical symptoms scales of the QLQ (i.e., fatigue, nau-

sea/vomiting, sleep, and constipation). Similarly, there

was lower correlation between the PWB and the QLQ

30 role function scale and between the FWB subscale

and the EORTC QLQ 30 physical function scale.

There was moderate correlation between the

SWB scale and the QLQ social function scale, but

these 2 scales focus on different issues. The former

focuses on sociability and social support, whereas

the latter taps social activity limitations. The SWB

also correlated with the QLQ’s fatigue and physical

function scale.

As expected, the FACT-G total score, an overall

assessment of health status/QOL, correlates highly

with most of the scales of the QLQ.

Esophageal cancer subscaleThe overall ECS score of the FACT-E correlated highly

with all of the multi-item scales of the OES 24 (Table

2). Most importantly, there were especially high cor-

relations between the overall ECS score, the TOI

score, and the eating and swallowing indexes with

the dysphagia and eating items from the OES 24.

These indexes were also highly correlated with the

emotional problems scale of the OES, a scale that

taps perceptions of worry and burden of the illness

and its treatment. There was also good correlation

between overall ECS and TOI with deglutition, gas-

tro-intestinal symptoms, and pain (Table 2). Weak

correlations with the single items, hair loss and dry

mouth, are likely related to the small number of sur-

gical patients who experienced these items.

Reliability of FACT-EInternal consistency of all FACT-E scales was excel-

lent (Table 3). Coefficient a for all FACT-E subscales,

total, and aggregate scores were >0.70 at both base-

TABLE 1Baseline Convergent and Divergent Validity Coefficients (Spearman Correlations)

FACT score

EORTC QLQ C30 scale

PF RF EF CF SF QOL FT NV PN DYS SL AL CO

PWB 0.53 0.47 0.33 0.46 0.55 0.56 �0.58 �0.52 �0.63 �0.13 �0.37 �0.57 �0.34

SWB 0.43 0.37 0.28 0.04 0.47 0.30 �0.60 �0.15 �0.39 �0.02 �0.30 �0.41 �0.23

EWB 0.22 0.17 0.67 0.42 0.36 0.33 �0.22 �0.24 �0.55 �0.04 �0.29 �0.42 0.02

FWB 0.48 0.58 0.58 0.49 0.68 0.63 �0.64 �0.19 �0.54 �0.06 �0.61 �0.39 �0.33

FACT-G 0.50 0.48 0.64 0.47 0.69 0.58 �0.62 �0.28 �0.63 �0.04 �0.49 �0.49 �0.22

EORTC QLQ scales: PF, physical function; RF, role function; EF, emotional function; CF, cognitive function; SF, social function; QOL, global quality of life; FT, fatigue; NV, nausea/vomiting; PN, pain; DYS, dyspnea;

SL, sleep; AL, appetite loss; CO, constipation.

FACT scales: PWB, physical well-being; SWB, social/family well-being; EWB, emotional well-being; FWB, functional well-being; FACT-G, FACT-general.


line and follow-up. Both aggregate indexes derived

from eating and swallowing items from the ECS had

very good to excellent internal consistency (a > 0.80).

Test–retest reliability for the FACT-G has been pre-

viously shown to be quite good,9 and therefore, test–

retest reliability for the ECS alone was determined in

this study (3–7-day interval after baseline). Stability

coefficients were excellent for the ECS (0.89), eating

index (0.80), and swallowing index (0.87).

Correlation of FACT-E scores with clinical factorsBaseline FACT-E scale, subscale, and aggregate index

scores were compared across 3 clinical factors: alco-

hol use, weight loss, and pain (Tables 4–6). Patients

with worse baseline clinical features tended to report

worse QOL and more symptoms.

Responsiveness to change of FACT-E in surgical patientsResponsiveness to change was evaluated in Cohort A

by comparing baseline to 3–4 months FACT-E sub-

scale scores. As Table 7 shows, PWB decreased signif-

icantly over the study time interval, a result

consistent with the expectations after major surgery,

whereas EWB scores significantly improved. The

overall ECS score showed very little change over

time, as many patients had almost regained their

baseline level of well-being by 3–4 months after sur-

gery. However, after surgery, patients did report sig-

nificantly more mouth dryness and significantly less

chest pain. Increases in breathing difficulty and

declines in ability to communicate with others,

though not statistically significant, were moderate in

size (ESs � 0.50).

Changes in esophageal-specific concerns asso-

ciated with overall QOL were explored by creating

change scores for the swallowing index, eating index,

and all other ECS items by subtracting baseline score

from follow-up score (Table 8). These were then cor-

related with the follow-up FACT-G total score, con-

trolling for baseline FACT-G total score. As Table 8

shows, in Cohort A, 3 changes in esophageal con-

cerns were significantly associated with overall QOL.

Improvements in eating behavior, communication

with others, and appetite from baseline to follow-up

were associated with better follow-up QOL. Though

not statistically significant, increased mouth dryness

from baseline to follow-up was moderately asso-

ciated with worse follow-up QOL.

TABLE 3Internal Reliabilities at Baseline and 3–4-Month Follow-Up

a at Baseline a at Follow-up

FACT-E scale or subscale

Physical well-being 0.72 0.79

Social well-being 0.83 0.75

Emotional well-being 0.88 0.82

Functional well-being 0.90 0.89

FACT-G total 0.85 0.91

Esophageal Ca subscale 0.89 0.86

Eating index 0.88 0.84

Swallowing index 0.86 0.82

Trial outcomes index 0.91 0.92

FACT-E total 0.87 0.92

QLQ-C30 scale

Physical function 0.70 0.86

Role function 0.90 0.96

Emotional function 0.91 0.84

Cognitive function 0.59 0.53

Social function 0.75 0.91

General health/QOL 0.89 0.92

Fatigue 0.84 0.84

Nausea/vomiting 0.66 0.70

Pain 0.83 0.86

OES-24 scale

Dysphagia 0.80 0.70

Deglutition 0.78 0.13

Eating 0.88 0.88

GI symptoms 0.50 0.64

Esophageal pain 0.66 0.60

Emotional problems 0.71 0.81

TABLE 2Spearman Correlations of FACT-E Esophageal-Specific Scores and EORTC OES 24 Scales at Baseline

FACT score

EORTC OES 24 scale

DYSP DEG EAT GIsx ESPain Emot DM TS CGH TK HL

ECS �0.87 �0.42 �0.84 �0.46 �0.49 �0.65 �0.14 �0.38 �0.33 �0.22 0.06

TOI �0.80 �0.35 �0.76 �0.48 �0.53 �0.78 �0.13 �0.44 �0.35 �0.29 �0.18

Eating �0.80 �0.33 �0.82 �0.45 �0.40 �0.64 .00 �0.44 �0.35 �0.29 �0.18

Swallowing �0.83 �0.52 �0.72 �0.40 �0.38 �0.47 �0.14 �0.31 �0.33 �0.16 0.50

FACT-E �0.71 �0.28 �0.68 �0.41 �0.52 �0.84 �0.07 �0.44 �0.32 �0.59 �0.42

EORTC OES scales: DYSP, dysphagia; DEG, deglutition; EAT, eating; GIsx, gastro-intestinal symptoms; ESPain, esophageal-specific pain; Emot, emotional problems; DM, dry mouth; TS, taste sensation; CHG,

coughing; TK, talking; HL, hair loss.

FACT scale: ECS, esophageal cancer scale; TOI, trial outcome index; eating, eating index; swallowing, swallowing index; FACT-E, FACT-esophageal.


Responsiveness to change in patients having neoadjuvantchemoradiotherapy, Cohort BCohort B consisted of 29 patients (22 male), average

age 58 years, (SD ¼ 11) with clinically staged locally

advanced disease (18 stage III, 9 with M1A disease

and 2 with stage II), treated with neoadjuvant che-

moradiotherapy before surgery. All patients were

ECOG 0-1. The baseline scores before the start of

therapy were compared with the follow-up FACT-E

subscale scores at 7 weeks and 12–14 weeks.

TABLE 4Baseline FACT-E Comparisons: Alcohol Use

Alcohol (Yes/No) n Mean ± SD T(df ) P Effect size

PWB No 23 24.57 6 3.10 2.82(51) 0.007 0.73

Yes 30 20.93 6 5.55

SWB No 23 25.21 6 3.28 1.91(51) 0.061 0.52

Yes 30 22.91 6 5.00

EWB No 23 16.72 6 6.36 1.47(51) 0.147 0.40

Yes 30 14.38 6 5.22

FWB No 23 20.57 6 7.18 1.83(51) 0.073 0.50

Yes 30 17.00 6 6.91

FACT-G No 23 87.06 6 17.19 2.56(50) 0.013 0.68

Yes 29 74.49 6 17.87

ECS No 23 51.85 6 10.36 2.01(50) 0.050 0.55

Yes 29 44.72 6 14.28

TOI No 23 96.98 6 17.68 2.39(50) 0.021 0.64

Yes 29 82.71 6 23.85

Eat. Index No 23 6.65 6 3.81 1.21(50) 0.232 0.34

Yes 29 5.24 6 4.44

Swal. Index No 23 14.86 6 4.21 1.92(50) 0.061 0.53

Yes 29 12.14 6 5.69

FACT-E No 23 138.91 6 24.45 2.70(49) 0.009 0.72

Yes 28 118.52 6 28.55

For abbreviation used, see footnotes to Tables 1 and 2.

TABLE 5Baseline FACT-E Comparisons: Weight Loss

Weight loss n Mean ± SD T(df ) P Effect size

PWB None 15 24.66 6 3.54 2.35(47) 0.023 0.71

Some 34 21.15 6 5.26

SWB None 15 24.53 6 4.55 0.69(47) 0.491 0.22

Some 34 23.54 6 4.62

EWB None 15 17.60 6 4.75 1.93(47) 0.060 0.58

Some 34 14.15 6 6.16

FWB None 15 21.67 6 6.28 2.20(47) 0.033 0.68

Some 34 16.82 6 7.43

FACT-G None 15 88.46 6 16.25 2.37(46) 0.022 0.73

Some 33 75.04 6 19.02

ECS None 15 53.71 6 13.72 2.41(46) 0.020 0.72

Some 33 44.35 6 11.85

TOI None 15 100.03 6 22.07 2.68(46) 0.010 0.80

Some 33 82.38 6 20.78

Eat. Index None 15 8.13 6 3.81 2.84(46) 0.007 0.83

Some 33 4.64 6 4.01

Swal. Index None 15 14.90 6 5.07 1.74(46) 0.089 0.53

Some 33 12.16 6 5.06

FACT-E None 15 142.16 6 28.46 2.76(45) 0.008 0.83

Some 32 118.80 6 26.48



TABLE 6Baseline FACT-E Comparisons: Pain

Pain (Yes/No) n Mean ± SD t(df) P Effect size

PWB No 13 25.60 6 2.87 2.84(52) 0.007 0.85

Yes 41 21.39 6 5.09

SWB No 13 25.23 6 3.26 1.23(52) 0.226 0.39

Yes 41 23.51 6 4.68

EWB No 13 16.43 6 6.86 0.86(52) 0.396 0.27

Yes 41 14.81 6 5.63

FWB No 13 22.69 6 5.22 2.51(52) 0.015 0.76

Yes 41 17.27 6 7.20

FACT-G No 13 89.95 6 14.27 2.39(51) 0.021 0.73

Yes 40 76.50 6 18.55

ECS No 13 56.63 6 10.63 3.05(51) 0.004 0.91

Yes 40 44.88 6 12.45

TOI No 13 104.92 6 15.44 3.29(51) 0.002 0.96

Yes 40 83.60 6 21.59

Eat. Index No 13 7.69 6 4.42 1.93(51) 0.059 0.60

Yes 40 5.18 6 3.97

Swal. Index No 13 16.71 6 4.15 2.91(51) 0.005 0.87

Yes 40 12.21 6 5.03

FACT-E No 39 146.58 6 21.74 3.05(50) 0.004 0.91

Yes 120.95 6 27.47


TABLE 7FACT-E Scores at Baseline and 3–4-Month Follow-up (Surgery Group—Cohort A)

FACT-E scale, subscale, or item Time point Mean ± SD t(df) P Effect size

Physical well-being Baseline 22.3 6 5.0 t(52) ¼ 2.87 0.006 0.40

3–4 mo 20.3 6 6.0

Functional well-being Baseline 18.5 6 7.2 t(52) ¼ 1.80 0.079 0.29

3–4 mo 16.4 6 7.3

Social well-being Baseline 23.8 6 4.4 t(52) ¼ 1.51 0.136 0.23

3–4 mo 22.8 6 4.9

Emotional well-being Baseline 15.2 6 6.0 t(52) ¼ 3.55 0.001 0.35

3–4 mo 17.3 6 4.8

Esophageal Ca subscale Baseline 47.6 6 13.1 t(51) ¼ 0.07 0.944 0.01

3–4 mo 47.5 6 11.8

Eating index Baseline 5.8 6 4.2 t(51) ¼ 0.46 0.646 0.07

3–4 mo 6.1 6 3.5

Swallowing index Baseline 13.3 6 5.2 t(51) ¼ 1.62 0.111 0.23

3–4 mo 14.5 6 4.5

Dry mouth Baseline 0.6 6 0.9 t(50) ¼ 2.71 0.009 0.56

3–4 mo 1.1 6 1.4

Trouble breathing Baseline 0.3 6 0.6 t(50) ¼ 2.59 0.012 0.67

3–4 mo 0.7 6 1.1

Voice quality Baseline 2.9 6 1.5 t(50) ¼ 0.59 0.556 0.13

3–4 mo 2.7 6 1.4

Communication with others Baseline 3.7 6 0.5 t(51) ¼ 2.30 0.026 0.80

3–4 mo 3.3 6 1.1

Pain in chest Baseline 0.9 6 1.0 t(50) ¼ 4.17 0.000 0.70

3–4 mo 0.2 6 0.6

Good appetite Baseline 2.4 6 1.6 t(51) ¼ 1.50 0.141 0.19

3–4 mo 2.1 6 1.5

Coughing at night Baseline 0.5 6 1.1 t(51) ¼ 1.36 0.180 0.27

3–4 mo 0.8 6 1.1

Pain in stomach Baseline 0.8 6 1.2 t(51) ¼ 2.47 0.017 0.42

3–4 mo 1.3 6 1.4

Weight loss Baseline 1.3 6 1.4 t(49) ¼ 0.97 0.339 0.21

3–4 mo 1.0 6 1.3


As Table 9 shows, PWB and FWB scores declined

significantly from baseline to Week 7, but improved

significantly by Week 12–14. There were no changes

over time in the SWB and EWB scores.

There was a significant improvement in overall

ECS score from Week 7 to Week 12–14 (Table 9).

Swallowing index scores also improved from Week 7

to Week 12–14 after completion of chemoradiother-

apy. Scores for voice quality and appetite substan-

tially declined from baseline to Week 7, but improved

significantly by Week 12–14.

DISCUSSIONThis analysis of the psychometric properties of the

FACT-E supports its use as a patient-reported out-

come measure in esophageal cancer. The FACT-E has

good construct validity (convergence and divergence)

when compared with the EORTC QLQ 30 and OES

24. It has very good to excellent internal consistency

and stability (test–retest) reliability. FACT-E scores

correlated well with several important clinical factors

and were found to be responsive to change in pa-

tients treated with surgery alone and in those treated

with neoadjuvant chemoradiotherapy.

Although health-related quality of life (HRQOL)

has been identified as an important outcome mea-

sure in cancer and other disease states,12 most stu-

dies of esophageal cancer therapy have not evaluated

the effect of treatment on HRQOL. Neoadjuvant che-

moradiotherapy is used frequently, but when the

toxicity, duration, and limited efficacy of neoadjuvant

therapy is considered, its value over esophagectomy

alone has been questioned.11,13–16 The availability of

a valid, self-administered QOL questionnaire for eso-

phageal cancer will allow comparison of the effect of

different treatments on HRQOL as well as survival

and treatment-related toxicities.

The ECS is similar in length (17 items) to the

OES-18, which was developed as a 24-item scale

(OES 24), and subsequently revised to 18 items by

Blazeby.11,17 The ECS is designed to be used with the

FACT-G, which has been validated previously.9 The

FACT-E can generate a summary or individual com-

ponent scores: (e.g., FACT-G total, FACT-E total) and

individual item or subscale scores (e.g., PWB, ECS,

swallowing index). The 4 primary QOL domains of

the FACT-G provide excellent information on the

common elements that comprise QOL, and allows

for domain comparisons across sites.

On the basis of clinical experience and previous

work by Blazeby et al.,18 patients 3–4 months after

esophagectomy have poorer QOL when compared

with baseline. Similarly, Brooks, using the FACT-E,

reported that QOL did not return to baseline until

9 months after esophagectomy. Furthermore, patients

who had preoperative chemoradiotherapy did not

achieve their baseline QOL, even at 9 months.19 In

contrast, our patients in Cohort A, who had surgery

alone had almost fully recovered by 3–4 months

postoperatively, based on both clinical parameters

and overall FACT-E score. Although there was no sig-

nificant change in the overall ECS score, there were

significant changes in individual items, which em-

phasize the importance of considering individual item

data, the eating and swallowing indexes, in addition

to the total ECS score, to maximize the clinical utility

of the FACT-E. If only the overall score is considered,

important information on the individual factors, such

as communication with others, affecting HRQOL will

be missed.

The second phase of the study (Cohort B), which

evaluated the FACT-E in a group of patients having

preoperative chemoradiotherapy wherein data were

collected at more frequent time points, clearly

demonstrates the responsiveness of the FACT-E to

significant clinical changes.

CONCLUSIONSThis prospective, observational cohort study demon-

strates that the FACT-E is a psychometrically sound

instrument. The scale shows good construct validity

when compared with another validated measure of

esophageal cancer. It also has very good to excellent

reliability (internal consistency and stability) and can

differentiate clinically distinct groups of patients. The

FACT-E is responsive to changes in patient status

over the course of standard therapies for esophageal

cancer. These characteristics make the FACT-E an

excellent choice for use in clinical trials of esopha-

geal cancer.

TABLE 8Partial Correlations of ECS Item and Index Change Scores (Baselineto Follow-up) with Follow-up FACT-G Score Controlling forBaseline FACT-G Score (Cohort A)

ECS index or item Correlation P

Swallowing index 0.02 0.901

Eating index 0.42 0.003

Mouth dryness �0.35 0.013

Trouble breathing �0.27 0.060

Strength of voice quality �0.07 0.629

Communication with others 0.53 0.000

Pain in chest on swallowing 0.10 0.476

Good appetite 0.47 0.001

Coughing at night �0.03 0.816

Pain in stomach 0.01 0.926

Weight loss �0.26 0.071


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TABLE 9FACT-E Scores at Baseline, Week 7 and Week 12–14 (Neo-adjuvant Group—Cohort B)

FACT-E scale, subscale, or item Time Point Mean ± SD F(df) P

Effect sizes of

adjacent means

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Swal. index Baseline 11.8 6 4.4 F(2,44) ¼ 11.35y

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7 wk 12.7 6 4.5

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7 wk 1.0 6 1.0

12–14 wk 0.9 6 1.0

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12–14 wk 0.4 6 0.9

Voice quality Baseline 3.4 6 1.0 F(2,44) ¼ 7.61{ 0.001 0.67, 1.10

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12–14 wk 3.1 6 1.1

Communication with others Baseline 3.7 6 0.5 F(2,44) ¼ 3.08 0.056 0.25, 0.60

7 wk 3.4 6 0.8

12–14 wk 3.6 6 0.7

Pain in chest Baseline 1.3 6 1.2 F(2,44) ¼ 2.53 0.091 0.00, 0.50

7 wk 1.3 6 1.0

12–14 wk 0.8 6 1.0

Good appetite Baseline 2.8 6 1.2 F(2,44) ¼ 5.41{ 0.008 0.46, 0.75

7 wk 1.9 6 1.3

12–14 wk 2.5 6 1.2

Coughing at night Baseline 0.2 6 0.6 F(2,44) ¼ 0.78 0.463 0.13, 0.33

7 wk 0.4 6 0.8

12–14 wk 0.3 6 0.6

Pain in stomach Baseline 1.0 6 1.3 F(2,44) ¼ 0.69 0.508 0.08, 0.25

7 wk 1.1 6 1.2

12–14 wk 0.8 6 1.2

Weight loss Baseline 1.2 6 1.2 F(2,42) ¼ 0.30 0.745 0.08, 0.08

7 wk 1.1 6 1.2

12–14 wk 1.0 6 1.3

* Baseline > 12–14 wk > 7 wk.y12–14 wk > Baseline, 7 wk.

{ Baseline, 12–14 wk > 7 wk.


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Validation of the functional assessment of cancer therapy esophageal cancer subscale