Measuring health-related quality of life impacts among head and neck cancer patients of a developing country.
by
Sobia BilalBDS, MSc, PhDSchool of DentistryInternational Medical UniversityKuala Lumpur, Malaysia.Email: [email protected]
Associate Prof. Dr. Jennifer G DossBDS, MDS, PhDFaculty of DentistryUniversity of Malaya, ,Malaysia.
?2
Survival….
of Life
of Life3
4
Pakistan
PUNJAB
SINDH
KHYBER PAKHTUNKHWA
BALUCHISTAN
PAKISTAN
22.6%
13.4%
8.6%
11.4%
Prevalence of
14.5% (Chaudary, 2008)
Prevalence of Head & Neck cancer
Chaudhry S, Khan AA, Mirza KM, Iqbal HA, Masood Y, Khan NR, Izhar F (2008)Estimating the burden of head and neck cancers in the public health sector of Pakistan, Asian Pac J Cancer Prev 9:529-532 5
Paan
Supari Naswar
Guthka
Smokeless tobacco in Pakistan
6
Tobacco - Risk factor
EVIDENCEHigh % - chewable tobacco
(Shah, 2002; Alam,1998; Merchant, 1998)
Chewable tobacco associated with oral cancer
(Bile, 2010; Ariyaratne, 2000; Balaram, 2002; Dhar, 2000; Bhattacharjee et al., 2006).
Impact of Head and neck cancer....
7
Late presentation Aggressive Treatment modalities
Poor HRQoL
Delayed cancer
treatment
Low SES
Low Literacy
rate
Lack of health
facilities
Lack of awarenes
s
Lack of screening programs
High rate of morbidity
Poor HRQoL
RationalNeed of HRQoL measure in
Pakistan
8
9
Keeping all these considerations in mind
This study was formulated…
Earlier phases of this study…Selection of the most suitable HRQoL questionnaire for Pakistani population? Cross-cultural adaptation of FACT-H&N.
FACIT-H&N-v4(List, 1996)
Appropriate for Pakistani culture
1.Translation
2.Pre-test
3.Pilot test
Same language adaptation method was incorporated!
Decision Tree ISPOR’ 2009
• Face & content validity• Identified a set of
nine Pakistani Cultural Questions
Reliability:• Internal consistencyConstruct validity:•Known group•Convergent / discriminate•Dimensionality – factor analysis(Guillemin, 1993)
FACT-H&N (v4)-Urdu
• Cross-culturally adapted• Identified Pakistani set of nine
questions• Demonstrated good cross-sectional
• Construct validity• Reliability (Bilal, 2014)
Objective of study phase being presented today….
11
To assess the impact of head and neck cancer and its treatment on the HRQoL of Pakistani head and neck cancer patients.
Ethical approval – 3 levels
12
Medical Ethics Approval – University of Malaya• DF CO1114/0078(P) Faculty of Dentistry Medical
Ethics Committee, University of Malaya
Official permission – Study settings• Directors • Head of the departments
Patients Informed consent & Confidentiality• Patient information sheet• Patient consent form• Assurance of confidentiality• Audio recording - discarded after study
completion
Patient Information Sheet
Patient Consent Form
Methodology
13
• Cross-sectional questionnaire survey• Quantitative component
Study design
• Jinnah Post Graduate Medical Centre• Civil Hospital Karachi• Lyari General Hospital
Study setting
• Cross-culturally adapted FACT-H&N (v4)-Urdu• Patients socio demographic form• Patients clinical information form
Study instrument
Jinnah Post Graduate Medical Centre•Federal Government
Civil Hospital Karachi•Sindh Government
Lyari General Hospital•City District Government
Methodology
Inclusion criteria• 18 years and above• New, on-going and follow up patients• Dental, ENT and oncology
departments• Cancer stages TNM – I-IV*• All treatment stages• ICD-10 C00-C14 (lip, oral cavity,
pharynx), C32 (larynx)
Exclusion criteria• < 18 years of age• Terminally ill patients (too frail)• Mentally compromised patients
(based on medical records)• Cancer other than head and
neck region
14
*Sobin LH, Wittekind Ch, eds. International Union Against Cancer TNM Classification of Malignant Tumours. 5th ed. New York: John Wiley & Sons, 1997: 33-37.
MethodologyStudy sampling
15
• Consecutive Clinical Convenience sampling
• Includes all eligible cases for the identified study period. This reduces the chance of systematic bias related to convenience sampling.
Study samplin
g
Kelsey JL, Whittemore AS, Evans AS et al. (1996) Methods in observational epidemiology. 2nd Ed. New York: Oxford University Press. 311-326.
MethodologyStudy sample size
• Epi info software to estimate sample size• The maximum sample size was calculated by using the
following information extracted from previous studies.• Treatment status of cancer: ongoing, pre-treatment, follow-up
• Ratio of QoL scores 1 : 1.14 : 1.28• Diff. in QoL scores = 5.4• SD = 14.3• Alpha level = 0.05• Power = 80%• Sample size = 361
16
Methodology
Training of data collectorsWHO-STEPS manual
17
• 6 data collectors• Post-graduate students of Masters of
Dental Surgery• Training & Standardization
• FACIT-H&N understanding (each item meant)
• Uniformity in the interview technique
• Organization of collected data
• Data collection protocol
MethodologyData collection procedure
18Patients were thanked and given a token of appreciation. (gift hamper of oral
care products)
The cross-culturally adapted HRQoL questionnaire was administered to the patient through face-to-face interviews and filled by the data collector.
The questionnaire regarding socio demographic details and clinical information was filled by the data collector
Patients were provided ‘ Patient Information Sheet’ and consent was sought on the ‘Consent Form’.
Patients were briefed about the face to face interview session
MethodologyData analysis
19
Inferential statistics
Association between patients clinical information and HRQoL scores (ANOVA)Association between patients socio demographic details and HRQoL scores (ANOVA)
Descriptive statistics Patients socio demographic
detailsClinical
information HRQoL scores
The FACT summary scales
FACT-G: FACT-General (PWB, SWB, EWB, FWB) - 27 items
FACT-H&N: FACT-Head and Neck (PWB, SWB, EWB, FWB, H&N) - 37 items
FACT-H&N-PCQ: FACT- Head and neck-Pakistani Culture Questions (PWB, SWB, EWB, FWB, H&N,PCQ - 45 items
FACT-H&N-TOI: FACT-Head and neck –Trail Outcome Index (PWB, FWB, H&N - 24 items
FHNSI: FACT Head and Neck Symptom Index - 10 items
ResultsPatient characteristic
Socio-demographic characteristics
20
Number of patients 361 (n) 100 (%)
Age group: 18 – 45 46 – 60 61 – 85 Gender: Male FemaleMarital Status: Married Single Widowed DivorcedEmployment status Employed UnemployedEducation Level: None Primary Secondary TertiaryEthnicity: Muhajir Punjabi Sindhi Baloch Pathan
10117585
244117
267473710
113248
1821183526
14942906415
28.048.523.5
67.632.4
74.013.010.22.8
31.368.7
50.432.79.77.2
41.311.624.917.74.2
Predominantly
• Of the total 361 (100% response)• Aged 46-60 years – Mean age 52.6 years (SD:11.65)• Males – 68%• Married – 74%• Unemployed – 69%• No formal education – 50%• Muhajir ethnic group – 41%
Correlates with previous studies
Alicikus et al. (2009) Chang et al. (2008) Conroy et al. (2004) Cella et al. (1998)Ratio 2:1
Correlates with previous studies
Thomas et al. (2009), Hammerlid et al. (2001), Chang et al. (2008), List et al. (1996)
Schoen et al. (2007) Population literacy rate is only 54.9%.
(CIA, 2013)
Results Patient characteristic Clinical characteristics
21
Number of patients 361 (n) 100 (%) Site of Tumor: Oral cavity Pharynx / LarynxType of Tumor: Squamous cell carcinoma Others NASize of Tumor: 0 – 2 cm >2 – 4 cm >4 – 6cm >6 cm NAStage of Tumor: I II III IVTreatment Status: Pre-treatment Ongoing- treatment Follow-upTreatment Type: Surgery Radiotherapy Chemotherapy Combination Palliative NA
230131
287
569
4067
2053712
3572
17282
13516561
142384
1253913
63.736.3
79.51.4a
19.1b
11.118.656.810.23.3
9.7
19.947.622.7
37.445.716.9
39.310.51.1
34.6c
10.83.6
a Oth
er tu
mor
type
s in
clud
e ad
enoc
arci
nom
a, m
elan
oma
and
acin
ar c
ell c
arci
nom
a.b P
atien
ts w
aitin
g fo
r pat
holo
gica
l rep
ort o
r mis
sing
info
rmati
on in
the
reco
rd.
c Com
bina
tion
of tr
eatm
ent i
nclu
ded
Surg
ery
+ ra
diot
hera
py, s
urge
ry +
che
mot
hera
py Predominantly
• Of the total 361 (100% response)• Oral cavity tumors – 64%• >4-6cms Tumor size – 57% • Late stage tumor (III & IV) – 70%• Surgery & combination treatment – 39% & 35%
Correlates with previous studies
Funk et al (2012), Bhurguri et al (2000)
Lifestyle risk factors
mutage.oxfordjournal.org, 2013
Correlates with previous findings
85% List et al (1996) 67% Doss et al (2011)
Inverse care law
Hart JD, (1971)
Late case presentation
‘Pragmatic experimentation’
Lack of access to healthcare services
Seek Complimentary & alternative medicine (CAM)
Biomedical services
Early stage (I & II)Late stage (III & IV)
Correlates with previous findings
Funk et al (2012),Doss et al (2011),Nasar et al (2010),
Hassanein et al (2005),Vatanian et al (2004),
List et al (1996)
Non-biomedical therapeutic options
• Spiritual healers• Unani Hakeems• Bonesetters• Herbalists• Quacks
FACT summary & subscale scores
22
Categories of FACT scores
Severe Moderate Mild
Lower score
Higher scoreFisch et al (2003)
3 quartile of 108 (actual score)Severe = 0-36
Moderate = 37-72Mild = 101-148
Moderate
Mild
Moderate
Moderate
Moderate
Moderate
Moderate
Moderate
Moderate
Severe Severe
Uncertainty of life & death Financial worries Family well-being Limited knowledge of
disease & treatment
Low SES Inability to work
Advance disease Aggressive treatment Malnourishment
Enjoying life & content with QoL not an option
FACT summary scores by socio-demographic characteristics
23
Mean (sd) FACT-G FACT-H&N FACT-H&N-PCQ
FACT-H&N-TOI
FHNSI
Age group 18 – 45 46 – 60 61 – 85 Gender Male FemaleMarital Status Married Single Widowed DivorcedEmployment Employed UnemployedEducation None Primary Secondary TertiaryEthnicity Muhajir Punjabi Sindhi Balochi Pathan
48.19 (3.92)a
53.70 (3.32)44.39 (3.50) 45.261 (3.48)a
52.265 (3.47) 53.802 (3.16)a
59.583 (3.68)48.763 (4.20)32.903 (5.58) 53.991 (3.49)a
43.535 (3.54) 53.809 (3.42)a
53.141 (3.51)48.776 (4.03)39.325 (4.34) 45.182 (4.97)a
78.287 (4.20)67.350 (5.20)70.008 (5.04)64.176 (6.42)
66.577 (5.19)a
74.818 (4.40)65.288 (4.63) 45.261 (3.48)a
52.265 (3.47) 75.430 (4.18)a
83.995 (4.87)66.138 (5.56)50.014 (7.38) 53.991 (3.49)a
43.535 (3.54) 75.371 (4.53)a
73.644 (4.65)67.847 (5.33)58.714 (5.74) 64.651 (4.97)a
78.287 (4.20)67.350 (5.20)70.008 (5.04)64.176 (6.42)
81.394 (6.05)a
90.597 (5.12)81.196 (5.40) 80.310 (5.37)a
88.482 (5.35) 92.280 (4.87)a
101.471 (5.67)80.897 (6.48)62.936 (8.60) 91.232 (5.39)a
77.560 (5.47) 92.156 (5.28)a
89.538 (5.41)83.073 (6.21)72.817 (6.69) 79.562 (5.79)a
95.075 (4.89)83.542 (6.06)85.631 (5.87)78.170 (7.47)
37.015 (3.84)a
43.696 (3.25)39.584 (3.43) 38.856 (3.41)41.341 (3.40) 44.402 (3.09)a
48.076 (3.60)37.956 (4.12)29.960 (5.46) 44.247 (3.42)a
35.950 (3.47) 44.169 (3.35)42.028 (3.44)37.697 (3.94)36.500 (4.25) 36.788 (3.68)a
45.078 (3.11)40.506 (3.85)41.848 (3.73)36.272 (4.75)
18.767 (1.44)a
21.207 (1.22)20.185 (1.29) 20.062 (1.28)20.044 (1.28) 21.501 (1.16)a
23.150 (1.35)18.524 (1.55)17.038 (2.05) 20.888 (1.29)a
19.218 (1.30) 21.143 (1.26)20.436 (1.29)19.380 (1.48)19.253 (1.60) 18.909 (1.38)a
22.655 (1.17)20.112 (1.45)19.972 (1.40)18.619 (1.79)
Tend to experience more social isolation due to cultural practices and misery and are predisposed to easily
lose hope on life.
In this study41.3% H&N cancer
92.0% oral cavity cancer
Differed from previous findings
Jesus et al (2010) Yeole et al (2003)
Poorer scores o Younger & older age groupo Maleso Divorcedo Unemployedo Tertiary educationo Muhajir ethnic group
FACT summary scores by clinical characteristic
24
Mean (sd) FACT-G FACT-H&N FACT-H&N-PCQ
FACT-H&N-TOI
FHNSI
Site of Tumor: Oral cavity Pharynx / LarynxType of Tumor: SCC OthersSize of Tumor: 0 – 2 cm >2 – 4 cm >4 – 6cm >6 cmStage of Tumor: I II III IVTreatment Status: Pre-treatment Ongoing Follow-upTreatment Type: Surgery Radiotherapy Combination Palliative
53125 (3.63)a
44.400 (3.44) 53.341 (2.01)44.184 (6.31) 68.75 (22.6)a
68.59 (21.4)57.94 (24.2)30.64 (15.2) 70.371 (3.99)a
67.819 (2.78)57.494 (1.80)44.012 (2.60) 60.857 (3.63)a
24.435 (3.61)60.996 (3.41) 54.983 (3.62)a
51.747 (4.32)49.638 (3.54)38.684 (4.24
77.212 (4.80)a
60.576 (4.55)
70.036 (2.67)67.752 (8.36) 90.20 (32.9)a
92.38 (29.7)76.76 (32.9)43.18 (18.6) 92.486 (5.41)a
91.125 (3.77)76.099 (2.44)59.098 (3.53) 87.630 (4.81)a
36.231 (4.78)82.821 (4.51) 76.377 (4.80)a
72.387 (5.73)69.794 (4.69)57.019 (5.61)
93.634 (5.59)a
75.158 (5.30) 86.646 (3.11)82.146 (9.73) 111.15 (38.5)a
112.94 (34.8)94.00 (38.2)55.54 (20.9) 113.829 (6.28)a
111.514 (4.38)93.424 (2.83)73.817 (4.10) 107.384 (5.60)a
45.880 (5.57)99.924 (5.25) 93.226 (5.59)a
88.842 (6.67)85.446 (5.46)70.069 (6.54)
47.241 (3.55)a
32.955 (3.37) 38.401 (1.97)41.795 (6.18) 51.07 (26.8)a
53.83 (23.5)42.58 (24.5)23.16 (11.5) 52.971 (4.07)52.722 (2.84)41.593 (1.83)33.134 (2.66) 56.291 (3.56)a
14.702 (3.54)49.302 (3.34) 45.941 (3.55)a
40.793 (4.24)41.480 (3.47)32.180 (4.15)
24.097 (1.34)a
16.009 (1.27) 17.209 (0.74)a
22.897 (2.33) 22.15 (10.9)a
23.22 (8.6)18.89 (9.5)11.13 (5.4) 22.943 (1.59)22.764 (1.11)18.390 (0.72)14.976 (1.04) 24.911 (1.34)a
10.318 (1.33)24.930 (1.25) 22.490 (1.33)a
19.922 (1.59)20.823 (1.30)16.977 (1.56)
aP<0.05
bOther tumor types include adenocarcinoma, melanoma and acinar cell carcinoma
Poorer scores o Pharynx/Larynxo Large tumor sizeo Late stage tumoro On-going treatment statuso Combination & palliative treatment
modalities
Significant negative impact on all the domains of life
Hammerlid et al (1997;1998)
Correlates with previous findings
Funk et al (1997)Hammerlid et al (1999) de Graeff et al,
1999a,b
Lowest scores – Palliative
• Inadequate pain control• Only at private institutional level
Hospice-palliative care services and indicative ratios of hospice-palliative care services to populations in selected Muslim-majority countries with comparison to the United Kingdom and the United States (Wright et al., 2008).
Conclusion
25
RQ What impact does head and neck cancer and its treatment have on HRQoL for Pakistani patients?
The impact of H&N cancer and its treatment was assessed using cross-culturally adapted FACT-H&N on a consecutive clinical convenience sample of 361 patients.
Overall poor to moderate HRQoL was noted among the sample group. Highest negative impact noted for Emotional-well-being domain whereas least impact was noticed for Social-well-being.
References• Wild D et al. (2009)Multinational Trials—Recommendations on the Translations Required,Approaches to Using the Same
Language in Different Countries, and the Approaches to Support Pooling the Data: The ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good Research Practices Task Force Report. Value in health 12 (4) : 430-440.
• List MA, D'Antonio LL, Cella DF, Siston A, Mumby P, Haraf D, Vokes E (1996) The Performance Status Scale for Head and Neck Cancer Patients and the Functional Assessment of Cancer Therapy-Head and Neck Scale. A study of utility and validity, Cancer 77:2294-2301
• Chaudhry S, Khan AA, Mirza KM, Iqbal HA, Masood Y, Khan NR, Izhar F (2008)Estimating the burden of head and neck cancers in the public health sector of Pakistan, Asian Pac J Cancer Prev 9:529-532
• Bhurgri Y, Bhurguri A, Hasan SH, Zaidi ZA, Rahim A, Sankaranarayanan R, Parkins M (2003) Cancer incidence in Karachi, Pakistan : First results from Karachi Cancer Registry. Int. J. Cancer: 85, 325–329
• Bhurgri Y, Bhurguri A, Usman A, Pervez A, Kayani A, Bashir I, Ahmed R, Hasan SH (2006) Epidemeological review of head and neck cancer in KarachiCancer of the oral cavity - trends in Karachi South. Asian Pac J Cancer Prev 7:195-200
• Bhurgri Y, Bhurguri A, Hussainy AS, Usman A, Faridi N, Malik J, Zaidi ZA, Muzaffar S, Kayani N, Pervez S, Hasan SH (2003) Cancer of the oral cavity and pharynx in Karachi – Identification of potential risk factors. Asian Pac J Cancer Prev 4:125-130
• Guillemin F, Bombardier C, Beaton D. (1993) Cross- cultural adaptation of health-realted quality of lifemeasures: Literature review and proposed guidelines. Journal Clinical Epidemiology,2: 1417-1432.
• Bilal S, Doss JG, Rogers SN. (2014) The use of the FACT-H&N (v4) in clinical settings within a developing country: a mixed method study. J Cran Maxillofacial Surg. DOI: 10.1016/j.jcms.2014.04.015
• Fisch MJ, Titzer ML, Kristeller JL et al (2003) Assessment of Quality of Life in Outpatients With Advanced Cancer: The Accuracy of Clinician Estimations and the Relevance of Spiritual Well-Being—A Hoosier Oncology Group Study. Journal of Clinical Oncol 21(14):2754-2759 DOI: 10.1200/JCO.2003.06.093)
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“Wish not so much to live long… As to live well’
Benjamin Franklin