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Changes in health-related quality of life of oral cancer patients treated with curative intent: experience of a developing country

Changes in health-related quality of life of oral cancer patients treated with curative intent: experience of a developing country



International Journal of Oral & Maxillofacial Surgery, 2017-06-01, Volume 46, Issue 6, Pages 687-698, Copyright © 2017 International Association of Oral and Maxillofacial Surgeons


Abstract

This study aimed to assess changes in oral cancer patients’ health-related quality of life (HRQOL) and the impact of disease stage on HRQOL scores. HRQOL data were collected from seven hospital-based centres using the Functional Assessment of Cancer Therapy–Head and Neck (FACT-H&N) version 4.0 instrument. The independent samples t -test, χ 2 test, and paired samples t -test were used to analyse the data. A total of 300 patients were recruited. The most common oral cancer sub-site was tongue and floor of mouth (42.6%). Surgical intervention (41.1%) was the most common treatment modality. Significant differences in ethnicity and treatment modality were observed between early and late stage patients. Pre-treatment HRQOL scores were significantly lower for late than early stage patients. At 1 month post-treatment, the functional and head and neck domains and the FACT-H&N (TOI) summary scores showed significant deterioration in both early and late stage patients. In contrast, the emotional domain showed a significant improvement for early and late stage patients at 1, 3, and 6 months post-treatment. Although HRQOL deterioration was still observed among early and late stage patients at 6 months post-treatment, this was not statistically significant. In conclusion, advanced disease is associated with poorer HRQOL. Although ethnic differences were observed across different disease stages, the influence of ethnicity on patient HRQOL was not evident in this study.

Oral cancers, which are primarily squamous cell carcinomas, are a major public health problem worldwide. Globally oral cancer is the sixth most common cancer , with an estimated incidence of 400,000–700,000 new cases per year. In the South-East Asian Region, estimates for the year 2008 ranked oral cancer second for men and sixth for women among all cancers, with an age-standardized incidence rate (ASR) of 6.7 per 100,000 population and age-adjusted death rate of 4.5 per 100 000 population, as compared to 3.9 and 1.9 per 100,000 population, respectively, worldwide . In Malaysia, oral cavity cancer is among the top 20 most common types of cancer, with one new case being diagnosed daily according to the National Cancer Registry . The higher oral cancer burden in the South-East Asian Region is mainly due to the practices of tobacco use and habitual betel quid chewing.

Factors that exert a major influence on cancer survival are a delay in diagnosis and less effective treatment at advanced stages of cancer . This is not unexpected, as oral cancer is often associated with late presentation; more than two-thirds of cases present at advanced stages , which inevitably contributes to poor survival. However, the overall survival of cancer patients has improved over the years as a result of advancements in prevention, diagnosis, and treatment . In the USA, more than half of all cancer patients who receive treatment, including those with head and neck cancer, are expected to become long-term survivors .

Oral cancer patients surviving over the long term often carry a profound physical burden in aspects of communication, ability to swallow, and facial disfigurement . There may also be psychosocial sequelae that can adversely affect the patient’s quality of life . In comparison to cancer patients in general, head and neck cancer patients are amongst the most distressed , mainly due to problems related to speech and swallowing .

Hence, in addition to placing emphasis on standard disease outcome parameters such as tumour control, overall survival, and complications, health-related quality of life (HRQOL) data have become an important source of information concerning the impact of the disease and treatment outcomes for head and neck cancer patients . The routine use of HRQOL questionnaires among cancer patients enables health practitioners to identify the aspects of their patients’ lives affected by treatment and its consequences, as well as the extent of these effects. Such information will allow better decision-making by health practitioners regarding treatment options that are best tailored to patient needs.

A systematic review to determine the association between HRQOL and survival in patients with head and neck cancer found a positive association between physical functioning and survival, as well as between the change in global HRQOL from pre-treatment to 6 months after treatment and survival .

One of the main influences on HRQOL for oral cancer patients is the disease stage at presentation. Patients presenting at late stages have been shown to have poorer HRQOL and a worse prognosis as compared to patients presenting early . Although there is evidence linking disease staging with HRQOL, no such data are available for the Malaysian population and in particular for oral cancer patients. Also, there have been no longitudinal studies so far on the HRQOL of head and neck cancer patients in Malaysia. Thus, the aim of this study was to assess changes in HRQOL of Malaysian oral cancer patients from the point of diagnosis (pre-treatment) through the 1-, 3-, and 6-month follow-ups. Differences in characteristics between patients presenting early and late were also explored, and the impact of disease stage on HRQOL scores was assessed.

Materials and methods

Study design

This was a longitudinal study on Malaysian oral cancer patients receiving treatment at seven selected hospital-based centres nationwide. These centres were chosen as they were the main referral centres for the management of oral cancer patients. Inclusion criteria encompassed Malaysian patients aged 18 years and older, who were diagnosed histologically with oral squamous cell carcinoma. Patients who were mentally compromised or terminally ill (based on medical records) were excluded from the study. Patient consent was obtained prior to data collection.

Data collection

Data were collected by research coordinators who were trained on the research instrument prior to data collection. Clinical details such as tumour site, disease staging, and treatment type were obtained from the medical records. The patients’ socio-demographic details and HRQOL data were collected via face-to-face interview with the patients. Proxy assessment via interviews with patient carers was considered in instances where the patient was very frail after surgery or in the presence of language barriers.

Data on oral health-related quality of life were collected using the Functional Assessment of Cancer Therapy–Head and Neck (FACT-H&N) version 4.0 instrument. This instrument has already been translated into Malay, the national language, and cross-culturally adapted and validated for a Malaysian population . The FACT-H&N used in this study comprises 47 items, which are grouped into six sub-scales, namely the physical (GP), social (GS), emotional (GE), functional (GF), and head and neck (H&N) subscales, with a supplementary set of Malaysian added questions (MAQ). The MAQ comprises a set of questions that were found to be important for the assessment of HRQOL in Malaysian patients in an earlier study and has been validated previously .

FACT derivative summary scales were also analysed. These included (1) FACT-G: FACT General (comprising four subscales GP, GS, GE, GF); (2) FACT-H&N: FACT Head and Neck (comprising five subscales GP, GS, GE, GF, H&N); (3) FACT-H&N (TOI): FACT Head and Neck–Trial Outcome Index (comprising three subscales GP, GF, H&N); (4) FACT-H&N-MAQ: FACT Head and Neck–Malaysian Added Questions (comprising six subscales GP, GS, GE, GF, H&N, MAQ; (5) FHNSI: FACT Head and Neck–Symptom Index (comprising four subscales GP, GE, GF, H&N); and (6) FHNSIMAQ: FACT Head and Neck–Symptom Index and Malaysian Added Questions (comprising five subscales GP, GE, GF, H&N, MAQ). Summary mean scores were calculated and missing data were managed based on the FACT scoring manual . Higher HRQOL scores indicate better HRQOL.

Statistical analysis

Descriptive statistics were recorded using the frequency distribution and mean scores with standard deviation. Disease stage was categorized as early (stage I and II) or late (stage III and IV). The association between demographic and clinical characteristics and disease stage at presentation was assessed by χ 2 test, while the independent samples t -test was used to explore differences in HRQOL mean scores by disease stage. Differences in characteristics of attrition were analyzed using the χ 2 test, and differences in HRQOL scores between pre-treatment and post-treatment visits were analyzed using the paired samples t -test. All statistical analyses were conducted using SPSS version 12.0 software (SPSS Inc., Chicago, IL, USA); P < 0.05 was considered to be statistically significant.

Results

A total of 300 patients were included in this study ( Table 1 ). Their mean age was 61.0 ± 13.7 years and most were female (60.7%) and of Indian ethnicity (35.0%). Betel quid chewing was the most common risk habit practiced (48.2%). The most common oral cancer sub-site was tongue and floor of mouth (42.6%) and the most common treatment modality was surgical intervention without radiation (41.1%).

Table 1
Demographic and clinical characteristics of the study population by cancer stage at baseline.
Characteristics Total ( n = 300 Early ( n = 97)
(Stage I and II)
Late ( n = 203)
(Stage III and IV)
P -value
n (%) n (%) n (%)
Age, years 0.343
Mean ± SD, 61.0 ± 13.7
<50 55 (18.3) 14 (25.5) 41 (74.5)
50–64 118 (39.3) 43 (36.4) 75 (63.6)
>64 127 (42.3) 40 (31.5) 87 (68.5)
Sex 0.771
Male 118 (39.3) 37 (31.4) 81 (68.6)
Female 182 (60.7) 60 (33.0) 122 (67.0)
Marital status 0.510
Single 26 (8.7) 11 (42.3) 15 (57.7)
Married 195 (65.0) 62 (31.8) 133 (68.2)
Divorced/widowed 79 (26.3) 24 (30.4) 55 (69.6)
Education level 0.536
None 109 (36.3) 31 (28.4) 78 (71.6)
Primary 158 (52.7) 54 (34.2) 104 (65.8)
Secondary + tertiary 33 (11.0) 12 (36.4) 21 (63.6)
Ethnicity 0.033
Malay 73 (24.3) 20 (27.4) 53 (72.6)
Chinese 42 (14.0) 20 (47.6) 22 (52.4)
Indian 105 (35.5) 38 (36.2) 67 (63.8)
Indigenous 80 (26.7) 19 (23.8) 61 (76.3)
Smoking ( n = 251) a 0.190
Yes 96 (38.2) 27 (28.1) 69 (71.9)
No 155 (61.8) 56 (36.1) 99 (63.9)
Drinking ( n = 249) a 0.067
Yes 80 (32.1) 20 (25.0) 60 (75.0)
No 169 (67.9) 62 (36.7) 107 (63.3)
Betel quid chewing ( n = 247) a 0.498
Yes 119 (48.2) 37 (31.1) 82 (68.9)
No 128 (51.8) 45 (35.2) 83 (64.8)
Tumour site ( n = 296) a 0.085
Tongue + FOM 126 (42.6) 39 (31.0) 87 (69.0)
Gingiva + palate 57 (19.3) 14 (24.6) 43 (75.4)
Buccal mucosa 105 (35.5) 43 (41.0) 62 (59.0)
Other 8 (2.7) 1 (12.5) 7 (87.5)
Treatment ( n = 297) a 0.000
Surgery only 122 (41.1) 59 (48.4) 63 (51.6)
Surgery + CT and/or RT 103 (34.7) 25 (24.3) 78 (75.7)
CT and/or RT 72 (24.2) 13 (18.1) 59 (81.9)
SD, standard deviation; FOM, floor of mouth; CT, chemotherapy; RT, radiotherapy.

a Total does not add up to 300 due to missing responses.

The characteristics of the patients stratified by disease stage are shown in Table 1 . There was a significant difference in ethnicity and treatment modality between early stage and late stage patients. Most patients presented at the late stages, which was seen uniformly across all ethnicities. The ethnic group with the highest prevalence of late stage presentation was the indigenous people (76.3%), whereas the Chinese had the highest proportion of early stage disease (47.6%). Most patients who presented at a late stage of disease were treated with a combination of surgery + chemotherapy and/or radiotherapy (75.7%), or chemotherapy and/or radiotherapy only (81.9%), whereas a higher proportion of patients who presented with early stage disease were treated with surgery only (48.4%).

HRQOL scores of patients were assessed using a total of six domains, namely physical (GP), social (GS), emotional (GE), functional (GF), head and neck (H&N), and the supplementary set MAQ. Table 2 shows the FACT sub-scale and summary scores at baseline, stratified by disease stage. With the exception of the GS domain, all summary and sub-scale scores for late stage patients were significantly lower than those for patients with early stage disease. Although the same pattern was seen for the GS domain (18.26 ± 5.02 and 19.13 ± 4.71 for late and early stage, respectively), the difference was not statistically significant.

Table 2
Oral health-related quality of life (HRQOL) scores at baseline (pre-treatment), by cancer stage. a
Score Early ( n = 97)
(Stage I and II)
Late ( n = 203)
(Stage III and IV)
P -value
Mean ± SD Mean ± SD
Sub-scale scores
GP 22.75 ± 4.99 20.42 ± 6.44 0.001
GS 19.13 ± 4.71 18.26 ± 5.02 0.152
GE 16.46 ± 4.35 14.71 ± 4.99 0.003
GF 16.48 ± 6.01 13.26 ± 6.85 0.000
H&N 22.45 ± 5.10 20.17 ± 5.66 0.001
MAQ 22.61 ± 6.24 19.83 ± 5.29 0.000
Summary scores
FACT-G 74.84 ± 13.77 66.65 ± 16.57 0.000
FACT-H&N 97.29 ± 17.26 86.73 ± 20.56 0.000
FACT-H&N (TOI) 61.69 ± 12.81 53.81 ± 15.70 0.000
FACT-H&N-MAQ 119.90 ± 20.05 106.56 ± 23.52 0.000
FHNSI 26.93 ± 5.97 24.19 ± 6.75 0.000
FHNSIMAQ 45.67 ± 8.80 42.26 ± 10.52 0.004
SD, standard deviation.

a Higher sub-scale and summary scores indicate higher HRQOL.

The demographic and clinical characteristics of patient attrition stratified by disease stage are shown in Tables 3 and 4 . Among early stage patients, a significance difference was observed only in terms of marital status at the 3 month follow-up, whereby patients who failed to attend were mostly of married or divorced/widowed status. Among late stage patients, there was a significant trend towards an increasing attrition rate with increasing age, and also a pattern of a higher proportion of attrition at later follow-ups. In addition, most patients who attended follow-up visits were those treated with a combination of surgery and chemotherapy or radiotherapy, whereas those who were lost to follow-up were mostly patients who only had chemotherapy and/or radiotherapy (without surgery) as their treatment.

Table 3
Patient attrition by demographic and clinical characteristics: early stage patients.
Characteristics Pre-treatment Post-treatment, n (%)
1 month 3 months 6 months
( n = 97) Inc. Exc. P -value Inc. Exc. P -value Inc. Exc. P -value
n (%) ( n = 51) ( n = 46) ( n = 30) ( n = 67) ( n = 8) ( n = 89)
Age, years 0.231 0.240 0.546 a
<50 14 (14.4) 10 (71.4) 4 (28.6) 4 (28.6) 10 (71.4) 0 (0.0) 14 (100.0)
50–64 43 (44.3) 23 (53.5) 20 (46.5) 17 (39.5) 26 (60.5) 7 (16.3) 36 (83.7)
>64 40 (41.2) 18 (45.0) 22 (55.0) 9 (22.5) 31 (77.5) 1 (2.5) 39 (97.5)
Sex 0.819 0.481 0.475 a
Male 37 (38.1) 20 (54.1) 17 (45.9) 13 (35.1) 24 (64.9) 4 (10.8) 33 (89.2)
Female 60 (61.9) 31 (51.7) 29 (48.3) 17 (28.3) 43 (71.7) 4 (6.7) 56 (93.3)
Marital status 0.112 0.032 * 0.058 a
Single 11 (11.3) 9 (81.8) 2 (18.2) 7 (63.6) 4 (36.4) 3 (27.3) 8 (72.7)
Married 62 (63.9) 31 (50.0) 31 (50.0) 15 (24.2) 47 (75.8) 4 (6.5) 58 (93.5)
Divorced/widowed 24 (24.7) 11 (45.8) 13 (54.2) 8 (33.3) 16 (66.7) 1 (4.2) 23 (95.8)
Education level 0.188 0.951 0.167 a
None 31 (32.0) 17 (54.8) 14 (45.2) 10 (32.3) 21 (67.7) 4 (12.9) 27 (87.1)
Primary 54 (55.7) 25 (46.3) 29 (53.7) 16 (29.6) 38 (70.4) 4 (7.4) 50 (92.6)
Secondary + tertiary 12 (12.4) 9 (75.0) 3 (25.0) 4 (33.3) 8 (66.7) 0 (0.0) 12 (100.0)
Ethnicity 0.850 0.518 0.395 a
Malay 20 (20.6) 12 (60.0) 8 (40.0) 4 (20.0) 16 (80.0) 0 (0.0) 20 (100.0)
Chinese 20 (20.6) 11 (55.0) 9 (45.0) 8 (40.0) 12 (60.0) 4 (20.0) 16 (80.0)
Indian 38 (39.2) 19 (50.0) 19 (50.0) 13 (34.2) 25 (65.8) 1 (2.6) 37 (97.4)
Indigenous 19 (19.6) 9 (47.4) 10 (52.6) 5 (26.3) 14 (73.7) 3 (15.8) 16 (84.2)
Tumour site 0.641 a 0.505 a 0.557 a
Tongue + FOM 39 (40.2) 21 (53.8) 18 (46.2) 14 (35.9) 25 (64.1) 3 (7.7) 36 (92.3)
Gingiva + palate 14 (14.4) 9 (64.3) 5 (35.7) 4 (28.6) 10 (71.4) 1 (7.1) 13 (92.9)
Buccal mucosa 43 (44.3) 20 (46.5) 23 (53.5) 11 (25.6) 32 (74.4) 3 (7.0) 40 (93.0)
Other 1 (1.0) 1 (100.0) 0 (0.0) 1 (100.0) 0 (0.0) 1 (100.0) 0 (0.0)
Treatment 0.782 0.506 0.916 a
Surgery only 59 (60.8) 30 (50.8) 29 (49.2) 16 (27.1) 43 (72.9) 5 (8.5) 54 (91.5)
Surgery + CT and/or RT 25 (25.8) 13 (52.0) 12 (48.0) 10 (40.0) 15 (60.0) 2 (8.0) 23 (92.0)
CT and/or RT 13 (13.4) 8 (61.5) 5 (38.5) 4 (30.8) 9 (69.2) 1 (7.7) 12 (92.3)
FOM, floor of mouth; CT, chemotherapy; RT, radiotherapy.

a Analysis was done by simple logistic regression, as assumptions of the χ 2 test were not fulfilled.

* Significant at P < 0.05.

Table 4
Patient attrition by demographic and clinical characteristics: late stage patients.
Characteristics Pre-treatment Post-treatment, n (%)
1 month 3 months 6 months
( n = 203) Inc. Exc. P -value Inc. Exc. P -value Inc. Exc. P -value
n (%) ( n = 119) ( n = 84) ( n = 63) ( n = 140) ( n = 16) ( n = 187)
Age, years 0.006 * 0.040 * 0.028 *
<50 41 (20.2) 29 (70.7) 12 (29.3) 19 (46.3) 22 (53.7) 7 (17.1) 34 (82.9)
50–64 75 (36.9) 50 (66.7) 25 (33.3) 23 (30.7) 52 (69.3) 6 (8.0) 69 (92.0)
>64 87 (42.9) 40 (46.0) 47 (54.0) 21 (24.1) 66 (75.9) 3 (3.4) 84 (96.6)
Sex 0.192 0.331 0.743
Male 81 (39.9) 43 (53.1) 38 (46.9) 22 (27.2) 59 (72.8) 7 (8.6) 74 (91.4)
Female 122 (60.1) 76 (62.3) 46 (37.7) 41 (33.6) 81 (66.4) 9 (7.4) 113 (92.6)
Marital status 0.240 0.480 0.312 a
Single 15 (7.4) 9 (60.0) 6 (40.0) 6 (40.0) 9 (60.0) 0 (0.0) 15 (100.0)
Married 133 (65.5) 83 (62.4) 50 (37.6) 43 (32.3) 90 (67.7) 15 (11.3) 118 (88.7)
Divorced/widowed 55 (27.1) 27 (49.1) 28 (50.9) 14 (25.5) 41 (74.5) 1 (1.8) 54 (98.2)
Education level 0.844 0.922 0.624
None 78 (38.4) 44 (56.4) 34 (43.6) 25 (32.1) 53 (67.9) 5 (6.4) 73 (93.6)
Primary 104 (51.2) 63 (60.6) 41 (39.4) 31 (29.8) 73 (70.2) 10 (9.6) 94 (90.4)
Secondary + tertiary 21 (10.3) 12 (57.1) 9 (42.9) 7 (33.3) 14 (66.7) 1 (4.8) 20 (95.2)
Ethnicity 0.555 0.550 0.542 a
Malay 53 (26.1) 33 (62.3) 20 (37.7) 20 (37.7) 33 (62.3) 5 (9.4) 48 (90.6)
Chinese 22 (10.8) 10 (45.5) 12 (54.5) 5 (22.7) 17 (77.3) 2 (9.1) 20 (90.9)
Indian 67 (33.0) 41 (61.2) 26 (38.8) 21 (31.3) 46 (68.7) 5 (7.5) 62 (92.5)
Indigenous 61 (30.0) 35 (57.4) 26 (42.6) 17 (27.9) 44 (72.1) 4 (6.6) 57 (93.4)
Tumour site 0.255 a 0.798 a 0.758 a
Tongue + FOM 87 (43.7) 56 (64.4) 31 (35.6) 27 (31.0) 60 (69.0) 8 (9.2) 79 (90.8)
Gingiva + palate 43 (21.6) 25 (58.1) 18 (41.9) 15 (34.9) 28 (65.1) 3 (7.0) 40 (93.0)
Buccal mucosa 62 (31.2) 34 (54.8) 28 (45.2) 18 (29.0) 44 (71.0) 4 (6.5) 58 (93.5)
Other 7 (3.5) 4 (57.1) 3 (42.9) 2 (28.6) 5 (71.4) 1 (14.3) 6 (85.7)
Treatment 0.005 * 0.003 * 0.001 *
Surgery only 63 (31.5) 37 (58.7) 26 (41.3) 18 (28.6) 45 (71.4) 2 (3.2) 61 (96.8)
Surgery + CT and/or RT 78 (39.0) 56 (71.8) 22 (28.2) 34 (43.6) 44 (56.4) 13 (16.7) 65 (83.3)
CT and/or RT 59 (29.5) 26 (44.1) 33 (55.9) 10 (16.9) 49 (83.1) 1 (1.7) 58 (98.3)
FOM, floor of mouth; CT, chemotherapy; RT, radiotherapy.

a Analysis was done by simple logistic regression, as assumptions of the χ 2 test were not fulfilled.

* Significant at P < 0.05.

HRQOL score changes between the pre-treatment assessment and subsequent follow-up visits stratified by disease stage are shown in Tables 5 and 6 . It should be noted that the total number of patients for each subsequent visit decreased due to patient attrition. Among early stage patients, the number of domains that showed deterioration reduced with each follow-up visit, whereas no change was noted in the number of domains that deteriorated among late stage patients. At 1 month post-treatment, the largest mean change observed for both early and late stage patients was the FACT-H&N (TOI) summary mean score (mean change of 4.75 ± 13.18 for early stage and 8.93 ± 15.44 for late stage), whereas the smallest mean change was the deterioration in MAQ domain for early stage patients (0.16 ± 4.17) and the improvement in GS domain for late stage patients (0.13 ± 4.72).

Table 5
Oral health-related quality of life (HRQOL) scores pre-treatment and post-treatment: early stage patients.
Pre-treatment After 1 month
( n = 51)
Difference
(1 month vs. pre-treatment)
P -value a Pre-treatment 3 months
( n = 30)
Difference
(3 month vs. pre-treatment)
P -value a Pre-treatment 6 months
( n = 8)
Difference
(6 month vs. pre-treatment)
P -value a
Mean ± SD Mean ± SD Mean ± SD Mean ± SD Mean ± SD Mean ± SD Mean ± SD Mean ± SD Mean ± SD
Sub-score
GP 22.29 ± 5.46 21.37 ± 5.97 −0.92 ± 5.75 0.2580 22.97 ± 5.42 23.52 ± 4.52 0.55 ± 6.12 0.6210 22.56 ± 7.80 26.89 ± 1.90 4.33 ± 6.10 0.0660
GS 19.08 ± 4.71 20.59 ± 4.15 1.51 ± 3.72 0.0060 20.03 ± 4.85 21.77 ± 4.12 1.74 ± 3.65 0.0130 18.33 ± 5.57 20.11 ± 3.82 1.78 ± 3.27 0.1420
GE 16.41 ± 4.29 18.18 ± 3.83 1.77 ± 5.02 0.0150 16.94 ± 4.37 19.74 ± 4.45 2.81 ± 4.56 0.0020 15.89 ± 5.97 20.67 ± 2.69 4.78 ± 4.32 0.0110
GF 16.71 ± 5.87 15.00 ± 6.82 −1.71 ± 5.67 0.0370 17.94 ± 5.97 17.52 ± 7.02 −0.42 ± 6.92 0.7380 15.22 ± 7.76 19.33 ± 4.95 4.11 ± 7.04 0.1180
H&N 22.33 ± 4.61 20.22 ± 5.23 −2.12 ± 6.01 0.0150 22.42 ± 4.86 20.97 ± 5.75 −1.45 ± 6.55 0.2270 23.78 ± 7.73 23.00 ± 5.12 −0.78 ± 7.12 0.7520
MAQ 21.27 ± 5.10 21.12 ± 4.13 −0.16 ± 4.17 0.7890 21.00 ± 6.07 22.23 ± 5.75 1.23 ± 4.80 0.1650 21.89 ± 2.57 22.22 ± 2.49 0.33 ± 2.06 0.6410
Summary scores
FACT-G 74.49 ± 14.24 75.14 ± 15.08 0.65 ± 13.43 0.7320 77.87 ± 14.68 82.55 ± 13.67 4.68 ± 15.15 0.0960 72.00 ± 20.86 87.00 ± 7.70 15.00 ± 17.07 0.0300
FACT-H&N 96.82 ± 16.74 95.35 ± 18.47 −1.47 ± 16.80 0.5350 100.29 ± 17.57 103.52 ± 16.98 3.23 ± 19.45 0.3630 95.78 ± 28.00 110.00 ± 10.67 14.22 ± 22.42 0.0940
FACT-H&N (TOI) 61.33 ± 12.30 56.59 ± 14.19 −4.75 ± 13.18 0.0130 63.32 ± 12.75 62.00 ± 12.95 −1.32 ± 15.96 0.6480 61.56 ± 20.47 69.22 ± 7.69 7.67 ± 18.49 0.2490
FACT-H&N-MAQ 118.10 ± 19.06 116.47 ± 21.25 −1.63 ± 17.68 0.5140 121.29 ± 20.83 125.74 ± 20.38 4.45 ± 20.99 0.2470 117.67 ± 30.03 132.22 ± 10.43 14.56 ± 22.94 0.0930
FHNSI 26.67 ± 5.85 26.94 ± 6.29 0.28 ± 5.48 0.7220 27.42 ± 6.37 29.03 ± 5.39 1.61 ± 7.14 0.2180 27.22 ± 9.20 30.78 ± 3.38 3.56 ± 6.75 0.1530
FHNSIMAQ 45.84 ± 9.05 46.39 ± 9.59 0.55 ± 7.50 0.6040 46.58 ± 9.53 49.42 ± 9.02 2.84 ± 8.87 0.0850 48.56 ± 11.47 52.00 ± 5.96 3.44 ± 7.67 0.2150
SD, standard deviation.

a Paired t -test.

Table 6
Oral health-related quality of life (HRQOL) scores pre-treatment and post-treatment: late stage patients.
Pre-treatment After 1 month
( n = 119)
Difference
(1 month vs. pre-treatment)
P -value a Pre-treatment 3 months
( n = 63)
Difference
(3 month vs. pre-treatment)
P -value a Pre-treatment 6 months
( n = 16)
Difference
(6 month vs. pre-treatment)
P -value a
Mean ± SD Mean ± SD Mean ± SD Mean ± SD Mean ± SD Mean ± SD Mean ± SD Mean ± SD Mean ± SD
Sub-score
GP 20.36 ± 6.73 18.07 ± 6.67 −2.29 ± 7.15 0.0010 21.95 ± 5.66 19.38 ± 6.75 −2.58 ± 7.16 0.0060 24.00 ± 5.87 23.13 ± 5.04 −0.87 ± 6.24 0.5990
GS 18.57 ± 5.10 18.71 ± 4.82 0.13 ± 4.72 0.7570 18.76 ± 4.43 19.13 ± 5.33 0.37 ± 5.14 0.5720 17.33 ± 4.94 19.33 ± 3.20 2.00 ± 3.96 0.0710
GE 14.37 ± 5.13 15.50 ± 5.11 1.13 ± 5.30 0.0220 15.23 ± 4.42 17.19 ± 4.54 1.97 ± 4.51 0.0010 16.80 ± 4.13 18.87 ± 4.41 2.07 ± 4.64 0.1060
GF 13.76 ± 7.38 11.08 ± 6.52 −2.68 ± 6.94 <0.0001 14.34 ± 6.39 13.19 ± 6.58 −1.15 ± 6.70 0.1840 14.80 ± 6.90 16.87 ± 6.33 2.07 ± 6.72 0.2540
H&N 20.46 ± 5.68 16.50 ± 6.02 −3.96 ± 5.84 <0.0001 21.35 ± 5.40 17.84 ± 7.18 −3.52 ± 7.70 0.0010 23.67 ± 4.76 19.80 ± 6.38 −3.87 ± 7.21 0.0570
MAQ 19.51 ± 4.54 18.83 ± 4.38 −0.68 ± 4.97 0.1380 20.05 ± 3.88 19.05 ± 4.16 −1.00 ± 4.72 0.1010 21.73 ± 2.71 20.07 ± 3.67 −1.67 ± 3.11 0.0570
Summary scores
FACT-G 67.07 ± 17.38 63.35 ± 16.44 −3.71 ± 16.06 0.0130 70.27 ± 14.84 68.89 ± 16.87 −1.39 ± 15.65 0.4880 72.93 ± 17.24 78.20 ± 15.63 5.27 ± 14.92 0.1930
FACT-H&N 87.53 ± 21.27 79.86 ± 20.90 −7.67 ± 19.64 <0.0001 91.63 ± 18.61 86.73 ± 22.42 −4.90 ± 20.52 0.0650 96.60 ± 20.55 98.00 ± 20.34 1.40 ± 18.90 0.7780
FACT-H&N (TOI) 54.59 ± 16.25 45.66 ± 15.63 −8.93 ± 15.44 <0.0001 57.65 ± 14.57 50.40 ± 16.79 −7.24 ± 16.87 0.0010 62.47 ± 14.87 59.80 ± 15.35 −2.67 ± 16.01 0.5290
FACT-H&N-MAQ 107.04 ± 23.51 98.69 ± 23.57 −8.35 ± 21.67 <0.0001 111.68 ± 20.44 105.77 ± 24.57 −5.90 ± 22.14 0.0400 118.33 ± 21.53 118.07 ± 21.84 −0.27 ± 20.08 0.9600
FHNSI 24.32 ± 7.00 22.32 ± 6.74 −2.00 ± 6.41 0.0010 25.94 ± 6.18 24.06 ± 7.09 −1.87 ± 22.14 0.0490 28.93 ± 5.66 28.13 ± 6.38 −0.80 ± 5.56 0.5860
FHNSIMAQ 42.39 ± 10.78 39.62 ± 10.55 −2.77 ± 9.79 0.0020 44.92 ± 9.07 41.84 ± 10.56 −3.08 ± 10.26 0.0210 50.13 ± 7.40 47.47 ± 9.35 −2.67 ± 7.89 0.2120
SD, standard deviation.

a Paired t -test.

At 1 month post-treatment, the GE domain showed significant improvement for both early and late stage patients. The FACT-H&N (TOI) summary mean scores and GF and H&N domains showed significant deterioration among both early and late stage patients. Late stage patients experienced significant deterioration in all FACT summary mean scores.

At 3 months post-treatment, the GE domain continued to demonstrate significant improvement for both early and late stage patients. Early stage patients did not show significant HRQOL deterioration for any of the sub-scale scores. However, among those presenting late, there was a significant deterioration in GP, H&N, and all summary scores except FACT-G and FACT-H&N.

At 6 months post-treatment, the GE domain continued to improve significantly among the early stage patients. There was no significant HRQOL deterioration in any of the domains for both the early and late stage patients.

A further analysis was then performed only for the cohort of patients who were successfully followed-up at all visits. Among patients who presented at an early stage, the trend of a significant improvement in HRQOL for the GE domain was again evident, which was seen at the 3- and 6-month follow-up visits ( Table 7 ). In contrast, among late stage patients, a significant deterioration in HRQOL was observed in the H&N domain at both 1 month and 3 months post-treatment; however, at 6 months post-treatment the deterioration was no longer significant ( Table 8 ). Overall HRQOL deterioration was also observed among late stage patients for the FACT-H&N, FACT-H&N (TOI), and FACT-H&N-MAQ summary mean scores, achieving statistical significance at 1 month post-treatment. This effect was, however, not evident at the subsequent follow-up visits.

Table 7
Oral health-related quality of life (HRQOL) scores pre-treatment and post-treatment for the early stage cohort attending all follow-ups ( n = 7).
Pre-treatment After 1 month Difference
(1 month vs. pre-treatment)
P -value a Pre-treatment 3 months Difference
(3 month vs. pre-treatment)
P -value a Pre-treatment 6 months Difference
(6 month vs. pre-treatment)
P -value a
Mean ± SD Mean ± SD Mean ± SD Mean ± SD Mean ± SD Mean ± SD Mean ± SD Mean ± SD Mean ± SD
Sub-score
GP 22.71 ± 8.52 22.57 ± 5.38 −0.14 ± 5.73 0.9500 22.71 ± 8.52 26.00 ± 2.08 3.29 ± 6.78 0.2470 22.71 ± 8.52 26.71 ± 2.14 4.00 ± 6.51 0.1550
GS 17.86 ± 6.09 20.29 ± 3.77 2.43 ± 2.64 0.0510 17.86 ± 6.09 20.00 ± 4.55 2.14 ± 3.76 0.1820 17.86 ± 6.09 20.14 ± 4.06 2.29 ± 3.59 0.1430
GE 15.29 ± 6.10 18.29 ± 4.23 3.00 ± 5.13 0.1730 15.29 ± 6.10 19.71 ± 3.82 4.43 ± 4.61 0.0440 15.29 ± 6.10 20.29 ± 2.93 5.00 ± 4.40 0.0240
GF 16.00 ± 7.28 12.43 ± 7.28 −3.57 ± 5.19 0.1190 16.00 ± 7.28 15.57 ± 5.35 −0.43 ± 3.46 0.7540 16.00 ± 7.28 19.57 ± 5.50 3.57 ± 7.25 0.2400
H&N 23.00 ± 8.51 22.71 ± 6.58 −0.29 ± 6.37 0.9090 23.00 ± 8.51 22.00 ± 6.71 −1.00 ± 8.66 0.7700 23.00 ± 8.51 22.71 ± 5.77 −0.29 ± 8.10 0.9290
MAQ 21.71 ± 2.81 22.29 ± 3.09 0.57 ± 1.62 0.3860 21.71 ± 2.81 20.14 ± 6.04 −1.57 ± 5.91 0.5080 21.71 ± 2.81 22.29 ± 2.81 0.57 ± 2.30 0.5350
Summary scores
FACT-G 71.86 ± 20.64 73.57 ± 16.01 1.71 ± 12.98 0.7390 71.86 ± 20.64 81.29 ± 10.92 9.43 ± 13.84 0.1220 71.86 ± 20.64 86.71 ± 7.89 14.86 ± 17.85 0.0700
FACT-H&N 94.86 ± 28.85 96.29 ± 22.00 1.43 ± 19.10 0.8500 94.86 ± 28.85 103.29 ± 15.78 8.43 ± 21.20 0.3330 94.86 ± 28.85 109.43 ± 11.09 14.57 ± 24.17 0.1620
FACT-H&N (TOI) 61.71 ± 21.50 57.71 ± 18.35 −4.00 ± 14.70 0.4990 61.71 ± 21.50 63.57 ± 10.83 1.86 ± 15.64 0.7640 61.71 ± 21.50 69.00 ± 8.39 7.29 ± 20.17 0.3760
FACT-H&N-MAQ 116.57 ± 31.01 118.57 ± 24.62 2.00 ± 20.31 0.8030 116.57 ± 31.01 123.43 ± 20.08 6.86 ± 24.02 0.4790 116.57 ± 31.01 131.71 ± 10.50 15.14 ± 24.67 0.1560
FHNSI 26.43 ± 9.88 28.57 ± 6.71 2.14 ± 8.21 0.5160 26.43 ± 9.88 31.57 ± 3.78 5.14 ± 8.63 0.1660 26.43 ± 9.88 30.29 ± 3.73 3.86 ± 6.79 0.1840
FHNSIMAQ 47.71 ± 12.15 50.00 ± 10.21 2.29 ± 9.41 0.5440 47.71 ± 12.15 51.29 ± 9.55 3.57 ± 11.65 0.4480 47.71 ± 12.15 51.29 ± 6.68 3.57 ± 7.55 0.2570
SD, standard deviation.

a Paired t -test.

Table 8
Oral health-related quality of life (HRQOL) scores pre-treatment and post-treatment for the late stage cohort attending all follow-ups ( n = 13).
Pre-treatment After 1 month Difference
(1 month vs. pre-treatment)
P -value a Pre-treatment 3 months Difference
(3 month vs. pre-treatment)
P -value a Pre-treatment 6 months Difference
(6 month vs. pre-treatment)
P -value a
Mean ± SD Mean ± SD Mean ± SD Mean ± SD Mean ± SD Mean ± SD Mean ± SD Mean ± SD Mean ± SD
Sub-score
GP 24.92 ± 5.01 22.85 ± 5.29 −2.08 ± 5.92 0.2300 24.92 ± 5.01 22.08 ± 4.65 −2.85 ± 5.31 0.0770 24.92 ± 5.01 23.38 ± 5.36 −1.54 ± 6.06 0.3780
GS 17.31 ± 5.14 17.77 ± 4.66 0.46 ± 3.28 0.6210 17.31 ± 5.14 20.00 ± 2.61 2.69 ± 4.33 0.0450 17.31 ± 5.14 19.00 ± 3.27 1.69 ± 3.66 0.1210
GE 17.62 ± 3.66 18.69 ± 4.17 1.08 ± 4.82 0.4360 17.62 ± 3.66 19.77 ± 4.00 2.15 ± 4.10 0.0830 17.62 ± 3.66 19.38 ± 4.29 1.77 ± 4.29 0.1620
GF 15.77 ± 6.55 12.54 ± 5.25 −3.23 ± 5.53 0.0570 15.77 ± 6.55 16.62 ± 4.72 0.85 ± 6.59 0.6520 15.77 ± 6.55 16.85 ± 6.73 1.08 ± 6.61 0.5680
H&N 24.08 ± 4.57 18.54 ± 3.93 −5.54 ± 4.52 0.0010 24.08 ± 4.57 19.92 ± 6.51 −4.15 ± 6.71 0.0450 24.08 ± 4.57 20.54 ± 6.45 −3.54 ± 7.69 0.1230
MAQ 22.15 ± 2.38 21.54 ± 2.44 −0.62 ± 2.82 0.4460 22.15 ± 2.38 19.77 ± 3.96 −2.39 ± 3.95 0.0500 22.15 ± 2.38 20.38 ± 3.84 −1.77 ± 3.24 0.0730
Summary scores
FACT-G 75.62 ± 16.32 71.85 ± 13.68 −3.77 ± 11.73 0.2690 75.62 ± 16.32 78.46 ± 13.58 2.85 ± 12.26 0.4190 75.62 ± 16.32 78.62 ± 16.81 3.00 ± 14.30 0.4640
FACT-H&N 99.69 ± 19.23 90.38 ± 16.84 −9.31 ± 14.38 0.0380 99.69 ± 19.23 98.38 ± 18.87 −1.31 ± 15.07 0.7600 99.69 ± 19.23 99.15 ± 21.60 −0.54 ± 19.13 0.9210
FACT-H&N (TOI) 64.77 ± 12.80 53.92 ± 12.20 −10.85 ± 12.52 0.0090 64.77 ± 12.80 58.62 ± 14.39 −6.15 ± 12.76 0.1080 64.77 ± 12.80 60.77 ± 16.06 −4.00 ± 16.37 0.3950
FACT-H&N-MAQ 121.85 ± 19.42 111.92 ± 18.92 −9.92 ± 14.87 0.0330 121.85 ± 19.42 118.15 ± 21.69 −3.69 ± 14.16 0.3660 121.85 ± 19.42 119.54 ± 23.06 −2.31 ± 20.21 0.6880
FHNSI 29.62 ± 4.93 26.46 ± 6.37 −3.15 ± 6.34 0.0980 29.62 ± 4.93 28.08 ± 6.68 −1.54 ± 6.20 0.3890 29.62 ± 4.93 29.00 ± 6.40 −0.62 ± 5.46 0.6910
FHNSIMAQ 51.23 ± 5.82 46.92 ± 8.54 −4.31 ± 7.88 0.0720 51.23 ± 5.82 46.92 ± 10.47 −4.31 ± 8.01 0.0770 51.23 ± 5.82 48.54 ± 9.57 −2.69 ± 7.78 0.2360
SD, standard deviation.

a Paired t -test.

Discussion

This longitudinal study assessed changes in quality of life (HRQOL) of Malaysian oral cancer patients at 1, 3, and 6 months post-treatment. Furthermore, the impact of disease stage on the patient’s HRQOL was also assessed. The results of this study indicate that patients presenting with advanced stage disease are at a disadvantage in terms of their overall HRQOL, thus efforts should be made towards the early detection of oral cancers for better survival, and increasing public awareness of this disease is advocated.

A significant ethnic difference in disease presentation was observed in this study. The highest proportion of late stage disease was found for the indigenous people, whereas the Chinese had the highest proportion of early stage disease. Late presentation among the indigenous people could possibly be due to their low level of awareness of oral cancer. In addition, the delay in diagnosis could also be attributed to their poorer access to healthcare due to financial constraints and poor infrastructure in remote areas. Being strongly rooted in their own cultural beliefs and health-seeking behaviour are other possible reasons contributing to this difference. The Chinese, in contrast, have a higher level of health consciousness, as reported in previous studies in Malaysia in which they were found to have better knowledge on breast cancer and tended to present at an earlier disease stage than other ethnic groups. These findings indicate that health education regarding oral cancer is still very much needed, especially among certain target groups. Customizing health education content and its delivery method to the needs of indigenous groups has to be addressed urgently, particularly as a previous nationwide survey identified this disadvantaged group to be at an increased risk of malignant oral lesions . Accessibility to healthcare services for the indigenous people also warrants immediate attention from healthcare planners in Malaysia.

Differences in treatment modality between early and late stage patients were also observed. Most of the late stage patients were managed by a combination of surgery and chemotherapy or radiotherapy, whereas surgical intervention only was the main treatment modality undertaken for early stage patients in concordance with current best clinical practices. However, this renders late stage patients at a disadvantage, as treatment inclusive of chemotherapy/radiotherapy incurs a higher economic burden for their families. Additionally and perhaps more importantly are the pronounced adverse effects of chemotherapy/radiotherapy (dry mouth, sticky saliva, sensory disorders, speech problems, and eating problems), which directly influence patient HRQOL. Earlier studies have shown that patients receiving chemotherapy/radiotherapy have significantly worse HRQOL than patients undergoing surgery only .

When baseline (pre-treatment) HRQOL scores were compared between early and late stage patients, all scores except for the social domain were significantly lower among patients presenting with late stage disease. This finding concurs with those of earlier studies , and provides further evidence that HRQOL is compromised to a greater extent in patients presenting with late stage disease than in patients presenting with early stage disease.

This study found that among early stage patients, the number of HRQOL domains that showed a deterioration reduced over subsequent follow-ups; however for late stage patients, the number of domains showing a deterioration remained unchanged. This could be explained in part by the treatment modality. As most early stage patients were treated with surgery only, negative HRQOL impacts were mostly faced at 1 month post-surgery, especially in terms of the physical, functional, and head and neck impacts. Studies have shown improvements in these impacts to almost pre-treatment levels with subsequent visits, following post-surgical improvement of the patient’s condition . In contrast, for late stage patients receiving chemotherapy and/or radiotherapy, the number of domains impacted remained unchanged at subsequent visits, mainly due to the sustained treatment side effects. This finding is in agreement with those of earlier studies reporting a higher negative impact and lower HRQOL scores among patients receiving a combination of treatment modalities . This emphasizes the greater need for supportive care services for late stage patients specifically with regards to their physical and head and neck concerns.

At 1 month post-treatment, both early and late stage patients experienced a significant deterioration in their functional and head and neck domains, as well as their FACT-H&N (TOI) summary scores. This is not surprising, as oral cancer and its related treatment has been shown to severely affect patient HRQOL, especially in terms of the physical, functional, and head and neck domains . These impacts are reflected by the largest mean change (deterioration) noted in patient FACT-H&N (TOI) summary mean scores, which comprise the aforementioned items. A point of concern is the significant deterioration in all FACT summary scores among the late stage patients, which reflects the overall impact of late stage disease on all basic aspects/activities of these patients’ daily living.

In contrast, a significant improvement in the emotional domain was observed for both early and late stage patients at 1, 3, and 6 months post-treatment. This could be attributed mainly to the patient’s coping strategies, but perhaps a more pertinent factor is the strength of family support, which is strongly embedded in Malaysian culture, across all ethnic groups. However, it cannot be discounted that patients who experience life-threatening diseases have a tendency to change their internal measurement standards and perception of a ‘good HRQOL’ due to emotional and psychological adaptation to their condition, an increasingly recognized phenomenon known as the ‘response shift’. Other studies have corroborated the effect of the ‘response shift’ on patient HRQOL evaluations pre- and post-treatment . Therefore, although there is an apparent improvement in the patient’s emotional well-being post-treatment due to the patient’s own coping strategies, the effect of the ‘response shift’ phenomenon cannot be discounted. The impact of counselling support services could certainly help patients and their carers to embrace this stance and should not be overlooked. The availability of such services in centres managing oral cancer patients would enable emotional and psychosocial support throughout the patient’s journey with cancer.

A significant deterioration in HRQOL continued to be seen among the late stage patients in terms of their physical condition, head and neck concerns, and most of the summary scores, which is a reflection of the impact of disease staging on patient HRQOL. In contrast, the negative impact of the disease and treatment on patient HRQOL was no longer evident among the early stage patients at 3 months post-treatment. This concurs with earlier studies, which found that disease stage is a predictor of HRQOL . The present study found that at 6 months post-treatment, both early and late stage patients no longer experienced a significant deterioration in their HRQOL.

Being a longitudinal study, patient attrition at follow-up was sizeable. Comparisons between patients who attended subsequent visits and those who did not highlighted significant differences with regards to age and treatment modality. Increasing attrition was seen with increasing age, with a larger proportion observed at later follow-ups. This finding is in agreement with other longitudinal studies , and could be attributed mainly to the frail condition of older patients, rendering it more difficult for them to attend follow-up appointments. Their dependence on others to accompany them for hospital visits is also an instrumental factor in the higher proportion of attrition among the elderly. In addition, studies have found that older patients cope remarkably well , and with careful selection and support, their expectations are lower than younger patients and they can adapt remarkably well to their post-cancer deficits. Younger patients can experience more negative impacts related to family, employment, finance, and the gap between the reality of what they have as a consequence of the cancer and the hopes and expectations they have for their lives. This could be the driving factor for the lower attrition among the younger patients. However, it is noted that patients have an incredible ability to adapt and cope with the effects of their disease .

Patients with advanced stage disease who failed to attend subsequent visits were mostly those who had only received chemotherapy and/or radiotherapy, and not surgery as their treatment modality. This again could be due to the fact that chemo/radiotherapy tends to impact the patient’s HRQOL more severely than surgery , especially in terms of symptom burden. As such, more often than not, their weakened physical condition affects their ability and resolve to attend follow-up visits.

Overall, the late stage patients in this cohort had poorer HRQOL as compared to early stage patients. In light of the present study findings and also those of previous studies documenting that only half of the Malaysian public were able to identify the signs and symptoms of oral cancer , the importance of public education and early detection of this disease cannot be overemphasized. In addition, empowering the public on mouth self-examination (MSE) skills should also be advocated, as MSE has been shown to aid in the early detection of diseases .

The more pronounced impact among late stage patients suggests the need for supportive services such as physiotherapy, speech therapy, and occupational therapy to be integrated into patient management. Also, other spiritually mindful complementary therapies such as yoga, reflexology, music therapy, and art therapy could also offer concurrent benefits as adjunctive treatment for these patients; such therapies have been shown to improve the social, emotional, and spiritual well-being, as well as overall HRQOL of patients . The high attrition rate observed in this study further highlights the need for well integrated supportive care services for patients and their carers to help them cope with and manage the spectrum of their disease impacts.

In conclusion, although significant ethnic differences were observed in the presentation of disease stage, the influence of ethnicity on patient HRQOL was not evident in this study. Oral cancer patients with advanced stage disease suffer greater disease and treatment impacts with poorer overall quality of life than those presenting early. The HRQOL domains most commonly affected are the functional, physical, and head and neck concerns. In contrast, significant improvement in emotional well-being is seen as early as 1 month post-treatment and remains consistently so until 6 months post-treatment.

Funding

This work was supported by a Ministry of Higher Education (MOHE) Malaysia High Impact Research (HIR) grant (grant number UM.C/625/1/HIR/MOHE/DENT/24 ).

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