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: sobiabilal@imu.edu.my

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.

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“Wish not so much to live long… As to live well’

Benjamin Franklin