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World Journal of Psycho-Social Oncology Volume No 6

Original Article Open Access

Reliability of the Malayalam FACT-Colorectal and predictors of QOL in patients with colorectal carcinoma

K. Chandramohan1, Manoj Pandey2, SreeRekha KR1, Paul Sebastian1, Bejoy C. Thomas3

  • 1Department of Surgical Oncology Regional Cancer Centre, Trivandrum, India;
  • 2Department of Surgical Oncology, Institute of Medical Sciences, Banaras Hindu University Varanasi (UP), India
  • 3Department of Psychosocial Resources and Division of Psychosocial Oncology, Tom Baker Cancer Centre and University of Calgary, Calgary, Alberta, Canada

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0 ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Introduction: Colorectal cancer and its treatment have a profound impact of one’s quality of life. With the increasing prevalence of colorectal cancer in Kerala and given its significant psychosocial morbidity, there is a need for understanding the disease’s impact on the patients’ quality of life.

Patients and Methods: The Functional Assessment of Cancer Therapy for Colorectal cancer (FACT-C) was translated to local language (Malayalam) followed by a prospective study in 102 colorectal cancer patients. Internal consistency of the FACT-C was tested using Chronbach’s alpha. .

Results: Of the four primary QOL domains the alpha values ranged from 0.82 to 0.92 indicating satisfactory internal consistency within each domain. Nearly 50% of the patients had ostomy appliances. Of these 75% were embarrassed because of it and found it difficult to care for the appliance. Physical well-being was poorer in the patients with prior treatment (t=-3, p=0.009), number of children (t=-2, p=0.05), and being on active treatment (t=-2, p=0.03). Physical well-being was significantly better in patients whose spouse’s were highly educated and permanently employed (t=2, p=0.07; t=-2, p=0.04, respectively). Patient’s in the high income group had significantly better social well-being (t=2, p=0.03).

Conclusions: FACT-C Malayalam was found to have a high internal consistency suggesting that the tool is good for use in colorectal cancer patients. Prior treatment, poor income, more children, and active treatment contributes to poor quality of life in colorectal cancer patients.

Introduction

Colorectal Cancer is one of the most common cancers in western world. It is estimated that in US, 141,210 men and (71,850 men and 69,360 women) will be diagnosed with and 49,380 men and women will die of cancer of the colon and rectum in 2011 [1]. They also report a 5-year relative survival rate (1999-2006 for all races) ranging from 90% for localized disease to 12% for disease with distant metastasis with an overall rate of 65% [1].

The incidence of colorectal cancer in India is relatively low. Recent data suggest a trend towards increase in incidence of colorectal cancer. In Trivandrum cancer registry the colorectal cancer incidence has increased from 4.1 to 5.4/ 100,000 in males and from 3 to 3.8% in females over last 5 years [2, 3], an increase of nearly 30%. Colorectal cancer carries a significant risk for stage progression and mortality. More importantly in patients with rectal cancer the poor quality of life brought about by disease and also by its treatment is of major concern [4].

The literature suggests that at least three domains of quality of life (physical, social and sexual) are consistently affected by colorectal cancer [4-6]. With the emergence of collaborative and participatory models, patient reported outcomes (PRO) have become an important measure of health service delivery and its effectiveness [7-9].

Despite the fact that health related quality of life (HRQOL) measures are now commonly used along with traditional clinical indicators of health outcomes, its subjectivity of the disease and treatment impact is still viewed with skepticism [10].

Subjective, as opposed to objective, is not to imply that HRQOL measures are unreliable and poorly defined as health-related QOL can be measured with reliability and validity [11]. Rather, this term is being used in reference to the sense of importance to the subject, and that patients should be the primary source of information regarding their HRQOL [12, 13].

An additional complexity is that in today’s global context, the measure’s relevance to the population in question goes beyond biomedical relevance and also account for cultural or cross cultural relevance [14, 15]. In a study done in UK, it seen that stoma produced more significant drop in quality of life scores of Asian patients compared to non Asian patients [16].

Despite all the languages and diverse contexts of cancer care in India, local language measures of QOL in India are scarce [17]. The psychometric complexity of creating a tool specific to one region in India’s diverse population makes the process less rewarding. However, translating well-documented and established questionnaires has an advantage in terms of time saved on tool development. The process also provides a scope for cross-cultural validity studies, and identifying cross-cultural QOL differences.

The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement system's QOL tools for cancer, the Functional Assessment of Cancer Therapy (FACT) [18], have shown substantial scope as a cross-cultural instrument in the Indian setting [19-21]. The FACT tools contain the core general tool (FACT-G) as the generic QOL measure and the inclusion of a "Additional Concerns" subscale makes it a cancer site specific tool. The FACT Colorectal (FACT-C) (version 4) is a 36-item compilation, subdivided into four primary QOL domains and a disease specific domain – additional concerns for colorectal cancer [22].

The five QOL domains are emotional, physical, social, and sexual and cancer /stoma related. The FACT-C questionnaire developed in English is available in many languages, like French, Dutch, Spanish, German, Italian, Norwegian, Swedish and three Indian languages – Guajarati, Marathi and Punjabi. Malayalam is the language spoken by more than 35 million people in the South-western Indian state of Kerala.

We have earlier reported on translation and validated the FACT-G (general tool for cancer patients) [19], FACT-B (tool for QOL in breast cancer) [20], and FACT-HN (tool for QOL in head and neck cancer) [21] in Malayalam. Because of the steep increase in number of Colorectal cancers in Kerala and the peculiar QOL issues arising out of colorectal cancers, a Malayalam translation of FACT-C tool is essential to address the needs of the patient.

Variable Grouping Frequency %
Sex Male 54 52.9
Female 48 47.1
Income Low 40 39.2
Middle 25 24.5
High 37 36.3
Religion Hindu 70 38.6
Muslim 17 .16.7
Marital Status Married 84 82.4
Single/Divorced/widowed 18 17.6
Patients with childdren Nil 5 4.9
< 3 children 56 54.9
+ 3 children 36 35.3
Patient Occupation Housewife 39 38.2
Daily wager 45 44.1
Regular employment 26 25.5
Spouse Occupation Housewife 39 38.2
Daily Wager 30 29.4
Regular Employment 15 14.7
Primary Symptome Fecal Occult blood 71 69.6
Pain 56 54.9
Disease Colon 34 33.3
Rectum 68 66.7
Prior Treatment Yes 45 44.1
Staging      
T T2 13 12.7
T3 79 12.7
T4 10 9.8
N N0 50 49
N positive 52 51
M M0 86 84.3
M1 16 15.7
Composite Stage I 8 7.8
II 38 37.3
III 41 40.2
IV 15 14.7
Treatment status To begin 14 13.7
Discontinued 2 2
Completed 61 59.8
Ostomy appliance Yes 48 48
Table 1. Distribution of demographic, disease, and treatment variables (N = 102)

Patients and Method

A prospective study was carried out amongst the colorectal cancer patients who were undergoing or underwent treatment at the Regional Cancer Centre, Trivandrum, India. The FACT-C, Version 4 was translated into the local language, Malayalam. For the translation process, standard forward-backward-forward technique was followed [20-23] by three independent language experts with a fourth language expert taking on the role of seeking consensus on the three versions. The objective of the consensus process is to construct phrases with contextual meaning rather a word to word translation. The finalized version was administered and scored as per the manual for the Version 4 of the FACIT measurement system [24].

Details of demographic variables were collected from the patients after completing the FACT-C interview. The pre-treatment variables (such as length and duration of symptoms), disease site, staging [25], previous treatment, present treatment plan, actual treatment carried out, etc., were extracted from patient records.

Analysis

Reliability was estimated using Cronbach’s alpha. Linear regression analysis (forward) was used to identify the socio-demographic predictors of the FACT-C scale and subscale scores.

Results

Demographics

Colorectal cancer patients were approached in both the outpatient and inpatient clinics. One hundred and two patients were approached and all consented to participate in the study. All participants responded to more than 80% of the items in the FACT-C and therefore none were excluded from further analysis. Subscale scores were prorated and calculated as per the guidelines in the FACIT manual [24].

Domain (No. of items) Mean Range SD Alpha Mean Range SD Alpha Mean Range SD Alpha
Physical well-being (7) 19.2 5-28 5.9 0.82 19.6 8-28 5.8 0.85 18.7 5-28 6.1 0.79
Social well-being (7) 21.3 4.67-28 6.0 0.88 20.3 5-28 6.2 0.88 22.3 4.7-28 5.7 0.88
Emotional well-being (6) 13.6 0-24 6.9 0.87 14.3 0-24 6.9 0.88 13.0 1-24 6.9 0.86
Functional well-being (7) 14.4 0-28 7.4 0.91 14.1 3-28 6.5 0.89 14.6 0-28 8.1 0.93
FACT-G (27) 68.4 10.67-106 19.3 0.92 68.3 20-104 18.3 0.91 68.6 10.7-106 20.3 0.92
Additional concerns-C (7) 18 5-27 4.7 0.61 17.1 6-26 4.8 0.63 18.8 5-27 4.4 0.59
FACT C Total (34) 86.4 15.67-130 21.5 0.91 85.4 31-130 20.9 0.91 87.4 15.7-129 22.2 0.91 
FACT C: Functional assessment of cancer therapy-colorectal
     OA: Subset analysis of patients with an ostomy bag
     n-OA: Subset analysis of patients without an ostomy bag

The mean age of respondents was 59.9 (range 22-79 years); average age among the male and female was 53.5 and 52.3 respectively. Nearly 40% of the patients were from the low income category, and 36% of the patients were in the high income group. There were however more females in the low income group than males (44% and 35% respectively). Nearly 32% of the patients were Christian or Muslim and the rest Hindu. At the time of assessment, more than 80% of them were married, 5% did not have children, 35% had three or more children. Of those with children (92 patients, 90%), 46% of the patients had very young and/or unmarried children, only 23% had all of their children married. Nearly 10% (5 males - 9%, and 4 females - 8%) of the sample had received college or professional education, and around 25% were employed having a steady income. Of the 48 female patients, nearly 65% were housewives, 23% were daily wage earners and 13% were in steady income jobs; less than 40% of the male patients were in regular employment while the rest were daily wage earners.

At disease presentation, more than 75% of the patients presented with a T3 stage disease (none of the patients had T1 stage disease and the rest were split between T2 or T4 stage disease), 51% had nodal involvement, and 16% had metastatic disease. At the time of the interview, 60% had completed active treatment while 14% were yet to begin treatment, and 2% had discontinued their required treatment. Nearly 50% of the patients had an ostomy appliance (Table 1). Of these patients, only 25% (9 men and 3 women) were not embarrassed of having the ostomy appliance, and a similar proportion (25%, 8 men and 4 women) did not have difficulty in care for the appliance. The total score of the individual respondent ranged from 15.7-130 with the mean score of 86.4 (Table 2). Cronbach’s alpha for the scale and subscales are compared detailed in Table 2.

Multivariate analysis

In the linear regression (Figure 1), it was noted that physical well-being was significantly poorer in the patients who had had some treatment prior (generally some kind of surgery – generally abdominoperineal resection) to the referral to the tertiary cancer hospital (t=-3, p=0.009), every unit increase in the number of children (t=-2, p=0.05), and being on active treatment at the time of the interview (t=-2, p=0.03).

Physical well-being was significantly better in patients whose spouse’s were better educated as well as permanently employed (t=2, p=0.07; t=-2,p=0.04, respectively). Patient’s in the high income group had significantly better social well-being (t=2, p=0.03). Emotional well-being was significantly better in patients with every unit increase in time between the date of first visit to the tertiary cancer centre (registration) and the date of the interview for the study (t=4, p=0.001), as well as having a higher tumor stage at presentation (t=3, p=0.004).

Outcome score Independent predictor B t p-value R2 of model
Physical Wellbeing         Spouse Education 0.3 1.82 0.073 0.317
Number of children -1.08 -2.03 0.047  
Prior treatment -3.3 -2.69 0.009  
On active treatment at interview -3.33 -2.28 0.026  
Spouse is permanently employed 3.56 2.09 0.04  
Social Wellbeing High income group 2.9 2.23 0.028 0.061
Emotional Wellbeing     Number of children -2.1 -3.77 0.000 0.306
Months between registration & interview 0.1 3.6 0.001  
Tumor stage 4.39 3.02 0.004
Functional Wellbeing     Age -0.2 -3.25 0.002 0.285
Patient is a daily wage employee -5.22 -3.54 0.001  
On active treatment at interview -5.8 -3.37 0.001  
FACT-G       Number of children -4.42 -2.8 0.006 0.325
High income group 13.2 3.45 0.001  
On active treatment at interview -12.88 -2.95 0.004  
Prior treatment -9.81 -2.61 0.011  
Additional Subscale – Colorectal     Female patients 2.59 2.65 0.01 0.19
Interview was post treatment 3.09 3.01 0.004  
Tumor stage 2.42 2.23 0.029  
FACT-C         Spouse is a daily wage employee 12.44 2.09 0.04 0.347
Prior treatment -12.45 -2.97 0.004  
On active treatment at interview -14.81 -3.03 0.003  
Number of children -3.89 -2.19 0.032  
High income group 9.99 2.09 0.04  

Emotional well-being was, however, significantly poorer in patients with greater number of children (t=-4, p=<0.001). Functional well-being was poorer with every unit increase in patient’s age (t=-3, p=0.002), the patient being a daily wage earner (t=-4, p=0.001), as well as being on active treatment at the time of the interview (t=-3, p=0.001).

Patient’s in the high income group had significantly better general (FACT-G) well-being (t=4, p=0.001). However, general well-being was significantly poorer in patients with greater number of children (t=-3, p=0.006), being on active treatment at the time of the interview (t=-3, p=0.004), as well as those patients with some treatment prior to them being referred to the tertiary cancer hospital (t=-3, p=0.004) (Table 3).

Scores on the colorectal subscale were significantly better for female patients (t=3, p=0.01), patients who had competed all treatment (t=3, p=0.004; compared to those that had yet to begin or were currently ongoing treatment) and those having a higher tumor stage at presentation (t=2, p=0.004). Overall QOL (FACT-C) was significantly poorer in patients who had had some treatment prior to the referral to the tertiary cancer hospital (t=-3, p=0.004), on active treatment at the time of the interview (t=-3, p=0.003), and for those with greater number of children (t=-2, p=0.03). Overall QOL (FACT-C) was significantly better in patients whose spouse’s were daily wage earners and those who were in the high income group (t=2, p=0.04, respectively).

Figure 1: Predictors of Quality of life in colo-rectal cancers. (Dotted line – predictor of poor QoL, solid line predictors of better QoL.

Figure 1: Predictors of Quality of life in colo-rectal cancers. (Dotted line – predictor of poor QoL, solid line predictors of better QoL.

Discussion

Literature shows that colorectal cancer patients feel the effect of their illness and/or its treatment affects at least three different areas of functioning. Primarily, physical functioning (e.g., urgency to defecate, frequent/irregular bowel movements, gas, fecal leakage, diarrhea, constipation, etc), consequently having an impact on social functioning (e.g., social activities can be hampered by urgency and/or frequency of their bowel movements, fecal leakage or gas) [26-29]. Thirdly, patients' sexual functioning is often impaired [30]. In men, the inability to attain and/or maintain an erection and incapability of orgasm have been documented [31-34]. Dyspareunia, diminished orgasm and less frequent intercourse have been documented as

In our study of 102 colorectal cancer patients validating the local language version on the FACT-C, an internal consistency of 0.91 indicated its sensitivity being comparable to the original scale. It was noted that the four primary QOL domain values ranged from 0.82 to 0.92 indicating satisfactory internal consistency within each domain. However, for the disease specific (colorectal cancer) additional concerns the Cronbach’s alpha was.61. The subscale does capture several relevant aspects pertinent to the colorectal cancer patient, however of the dissimilarity in the cultural setting as well as the environmental factors (humidity, use of non-Western attire, greater internal and external locus of stigma) may not be covered.

One of the primary predictors of poor QOL on the FACT-C scale and subscales was the patient having had treatment (usually some form of resection) prior to being referred to the tertiary cancer centre (physical well-being, FACT-G and FACT-C). This is of great interest because it could potentially open a discussion on role of the general surgeon with an occasional colo-rectal cancer patient as opposed to the onco-surgeon in a high volume colo-rectal cancer surgical environment with the benefit of multidisciplinary aspects of hospital care [40-41].

Another curious factor was that higher tumor staging (T4) at presentation implied significantly better emotional well-being as well as overall FACT-C scores compared to those with lower tumor burden (T2 or T3, as there were no patients with a T1 staging at presentation). We could rationalize this with a couple of reasons. Firstly, with the lack of access or adherence to screening programs, lower health literacy, as well as fear of social stigma, patients may procrastinate on seeking medical help on symptoms. With advanced tumor burden there is undoubtedly substantial physical burden that accompanies it. Post treatment sequel in patients with advanced disease often offset and outweighs the substantial relief in symptoms like obstruction, pain, bleeding per rectum, and cachexia and hence these patients may have a decrease in quality of life. In Patient with early cancer the treatment sequel outweigh the benefit of survival and due to less distressing symptoms before treatment. This implies the need of the physician to better comprehend the expectations of the patient and be a catalyst to improve communication on outcomes. A study from Japan showed significant improvement in quality of life of cancer patients by giving communication skills training for the nurses [42].

Owing to the fact that sexuality or matters concerning sex is not openly discussed in the Indian context, 33% of the sample did not respond to the item “I am satisfied with my sex life”. This is similar to some of our earlier findings in the breast cancer population [43, 44]. An alternative approach that could be explored would be items that are framed to measure change in satisfaction post diagnosis/ treatment. Similarly in functional well being subscale, questions like “I am able to enjoy life” or “I am enjoying the things I usually do for fun” may not be quiet relevant in Indian context. Unlike the Western developed world, enjoying life is not the pressing concern of life in a developing country - particularly in the poorer sections of society. It is not enjoyment but one’s duties and responsibilities, which push life ahead especially for a poor, daily-wage, subsistence based lifestyle of a low-income Indian family; about than 50-60% of the respondents indicated either ‘no’ or a little bit’ on both these items. There are many studies which looks in to QOL of Colorectal Cancer patients , specifically in to issues brought about by stoma.

According to study by Manderson et al, (2005) an ostomy negatively impacts self-image and sexual/social relationships because an ostomy and its function breach normal bodily boundaries by externalizing fecal matter and cultural aversion to feces exist in many societies [45]. In the study by Karen et al the majority of patients cope extremely well with stoma though many experienced some change in lifestyle (80 percent), and many had (> 40 percent) problems with their sex lives [46]. Fazio et al, compared the functional outcomes of coloplasty, colonic J-Pouch (JP), or a straight anastomosis (SA) after the treatment of low rectal cancer. QOL scores at 24 months were similar for each of the 4 groups [47]. According to another study, Mean QoL scores for body image and male sexual problems were better following AR than APR (P<0.01) Patients with a low anastomosis (< or = 3 cm) had more incontinence for gas and solid stools (P<0.05), and had more incontinence (P=0.006) compared with patients with higher anastomosis, but the QOL was same for both.. Subgroup analysis showed that irradiated patients (n=34) had worse rectal function in terms of frequency, urgency, and incontinence (P<0.01) [48]. But in contrast the study by Fischer et al, showed worse QOL in older patients after ultralow anastomosis compared to APR [49]. Even though there is no dearth of studies looking into QOL issues, the consensus are less clear as far as the outcomes are concerned. This brings in the issue of larger well designed studies across various cultural groups, ethnicities and geographical locations.

Conclusions

A Malayalam translation of the FACT-C (version4) was developed and its sensitivity was found satisfactory, thereby indicating the cross-cultural relevance of the FACT-C questionnaire. However, since this was only an initial study, further in depth and long-term protocols are needed to improve on the validity of the tool. The use of popular tools benefits cross-cultural comparison, yet the need for culturally relevant tools are not discounted.

Authors’ contribution

KC: Did the literature review and prepared the draft manuscript
MP: Conceived and designed the study and edited the final manuscript.
KR: collected the data and helped with analysis of results
PS: Interpretation of data and revision of manuscript
BCT: Analysis and interpretation of data and preparation of manuscript

Acknowledgement

The Authors wish to acknowledge Dr. David Cella, for his kind permission to translate and use FACT-C.

Conflict of Interests

The authors declare that there are no conflicts of interest.

Ethical Consideration

The study was approved by the institute ethics committee.

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