Fear of Cancer Recurrence 7 Scale Tamil Translation and Validation among Breast Cancer Survivors in India

INTRODUCTION

Fear of cancer recurrence (FCR) is a common concern and applies to patients with cancer irrespective of their cancer site. It is a normal reaction to a life-changing event.^[1]

One of the most relevant definitions of FCR is ‘the fear or worry that cancer could return or progress in the same place or another part of the body.^[2] The most prevalent and top concerned unmet need reported was FCR, but the level of FCR stated by the survivors varied between low and moderate. Few psychosocial factors associated with higher FCR were younger age, comorbid physical symptoms and their severity, mental distress and poorer quality of life. The aftermath of FCR affected patients’ behavioural, emotional and functional aspects.^[3]

The assessment of FCR is crucial for understanding the psychological state of a patient’s diagnosis and treatment. There are various measures available for assessing FCR, a few of the most popularly used are listed as Cancer Worry Scale,^[4,5] FCR Inventory (FCRI),^[6] Concerns about Recurrence Questionnaire-4,^[7] fears of cancer recurrence scale (FCR7) and short-form (FCR4).^[8]

FCR7 is one of the most widely used, comprehensive and simple tools. This scale was translated and validated into Chinese among early-stage lung cancer patients. Findings indicated that FCR7 C was a brief and psychometrically valid tool that was strongly recommended for screening among Chinese-speaking cancer patients for baseline assessment and management.^[9]

While analysing the literature on FCR, shows that the majority of FCR-related studies have taken place in developed countries. The primary reason for this contrast is that FCR being a relatively new phenomenon under study is slowly gaining significance and popularity within the medical fraternity. The lack of standardised tools in the regional languages may have contributed to less research on FCR from lower- and middle-income countries.

A screening tool to assess the FCR in any regional Indian language was unavailable; hence, there was a need to translate and validate the FCR7. Therefore, the present study aims to translate and validate the FCR7 scale into the regional language Tamil.

MATERIAL AND METHODS

Translation procedure

The FCR7 author was contacted and permission for the translation was sought. The translation and cross-cultural adaptation and validation were carried out using the forward and backward protocol by adopting the international guidelines.^[10]

Two independent experts who were native speakers of the target language and proficient in English translated FCR 7 from the original language English to the target language Tamil (Forward translation Tamil I and II). Reconciliation processes were carried out for both the forward translated Tamil versions. The most meaningful and culturally appropriate words were chosen to decide on the final reconciliation version FCR 7 Tamil I. This reconciliation version was back-translated by two independent experts to source language (back translation I and II) to confirm any ambiguous statements and discrepancies. Thus, framing the back-translated report constitutes two forward translations, one reconciliation report and two backward translations. Proofreading of the FCR 7 Tamil version was carried out to rectify any mistakes in the language or any other faults. A field study was conducted and concluded by finalising the FCR 7 Tamil scale (FCR7-T) [Figure 1].

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Figure 1:

The process followed for FCR7 translation.

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The content validity of the study could be established when the FCR7 scale was provided to the subject matter experts and were asked to provide their feedback on how accurately each of the questions depicted the construct in question. The feedback received from them was matching with the responses of the original FCR7 scale. The first four questions reflected anxiety related to the FCR, questions 5 and 7 represented impaired cognitive process subsequent to anxiety and 6^th question depicted behavioural responses. These factors were considered effective in the FCR7 questionnaire. The translated version of the FCR7-T scale was face validated by administering to 10 BCSv. The BCSv was asked whether all the questions were understandable and sounded natural and whether the sentence construction was relevant to the context. BCSv were also enquired about any words they felt were irrelevant or out of context concerning FCR, and their suggestions were recorded. Subsequently, test and retest analysis was carried out on 38 BCSv from the same setting with the inclusion criteria stated earlier, out of which 32 responded for a retest with a time interval of 15 days. After the test-retest reliability, internal consistency reliability (Cronbach’s alpha) was established with 106 BCSv following the same recruitment criteria. To better understand the item – quality of FCR7-T, we did item to total (scale) correlation.

RESULTS

Participants reported their FCR during face validity and expressed that the items were easy to comprehend and respond to. Hence, FCR7-T was well supported by the BCSv. Subsequently, a field study was carried out on a sample of 32 BCSv [Supplementary Table 1] with a mean age of 50.25 (SD7.94). The interclass correlation coefficient (ICC) for test and retest was 0.910 with a range of 0.816–0.956 which shows excellent internal consistency and a Cronbach’s alpha of 0.962 value indicating high reliability for FCR7-T. Given that Cronbach’s alpha is 0.96 and ICC value of 0.910, test-retest reliability was established for FCR 7 Tamil.

Following the establishment of test-retest reliability, the FCR7-T was validated with a sample of 106 consecutive BCSv.

All BCSv were females, with the exclusion of three cases as they did not meet the inclusion criteria. Hence, a total of 106 BCSv were considered for final analysis [Table 1]. The mean age of 106 samples was 46.58 (SD 8.9) years. The majority of the survivors received a school education and 40.6% of BCSv were between 40 and 50 years.

An equal representation was reported on the place of stay of the BCSv; however, most of them stayed in metropolitan cities (40.6%). More than two-thirds of the samples were Hindus (90.6%), and the majority of them were married (83 %), with 75.5% belonging to the nuclear family and 87.7% comprised homemakers. On the duration of survivorship, a larger portion of BCSv (38.7%) belonged to <2 years after the completion of treatment. More than half of BCSv was diagnosed with Stage II breast cancer (67.9%) [Table 1].

In all invasive breast cancer survivors, a large portion of BCSv was treated with mastectomy (88.7%) and chemotherapy recipients were 93.4%. Two-thirds of the BCSv were treated with radiotherapy (67%) and hormonal therapy (75.5%). The majority of the samples were identified to be positive with the tumour markers oestrogen (79.2%). Around half of the BCSv did not have any comorbidity [Table 1].

A few missing items were found in hormone receptors and Human Epidermal Growth Factor Receptor 2 (HER2) where the details were unknown.

The internal consistency of FCR7-T using Cronbach’s alpha was found to be 0.864 for 106 BCSv indicating high internal consistency for the tool.

An item to total score (scale) correlation of FCR7 T was conducted to better understand item quality. In the present study, item to total correlation ranged between 0.568 and 0.940, which comes under the acceptable level of alpha; hence, we kept all the original items of FCR7. While comparing the internal consistency (Cronbach’s alpha value of 0.864) (n = 106) of FCR7-T with each item-total correlation comparatively, the weakest relation was found with Item 6 (0.568) followed by Item 5 (0.761), which was preceded with Item 4 (0.839), Item 2 (0.826) and Item 3 (0.818). The most robust relationship with the Cronbach’s value of 0.96 was found with Item 7 (0.940) and Item 1 (0.873) [Table 2].

The results of correlation indicated that all items had a significantly strong correlation between them at a 0.01 level except Item F6 (0.616) [Table 3].

[Table 4] shows that a relationship could be established with FCR7 and both scales FACT-B and IES-R. On FACT-B (r = –0.259 and P = 0.01), the survivors with high FCR reported poorer quality of life and with IES-R (r = 0.270 and P = 0.01)), the correlation value was found significant at P = 0.01 level. While considering the critical value for Spearman’s table (according to the method by Kendall and Smith, 1939), the value is 0.197 at a 0.05 level for the sample size of 106. The results are greater than the critical value of 0.197, establishing criteria validity for the FCR7 scale.

A Chi-square analysis was conducted to assess the association of FCR7 with the demographic and clinical characteristics, but no significant association was found.

To measure the severity of the FCR, the median was calculated as 17 and 51.9% of breast cancer survivors reported less FCR than the median value, and a balance of 48.1% was observed to have higher FCR than the median [Figure 2].

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Figure 2:

FCR median and percentage of BCSv falling below and above the median.

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DISCUSSION

As far as the available literature is considered, this is the first study to explore and establish reliability and validity on FCR7 scale in any regional language in India. The present study was exclusively carried out among a homogeneous group of breast cancer survivors. This scale was originally validated in English.^[8] In the present study, a few participants who were emotionally affected during the administration of the tool were provided with professional support by the researcher who is a trained clinical psychologist.

From the study results, the FCR7-T version was found to be highly reliable with strong internal consistency, reliability and satisfactory criterion validity.

A strong correlation was found between each item-total correlation and internal consistency value. The present study found the lowest correlation with FCR Item 6 and the highest correlation with FCR Item 7. These results exactly replicated the lowest and highest scores and supported the psychometrics exploratory factor analysis in the original study.^[8] The item-total correlation is in line with the French-Canadian version item-total correlation of the FCRI study.^[6]

In the results item-total scores with each item scores and between items, the lowest agreement was found with Item F6, ‘I examine myself to see if I have physical signs of cancer’. This may be because this particular question focuses on self-examination, which comes under the routine screening practises and is mostly advised by the physicians to patients. Hence, it stands independent from the rest of the questions in FCR7 that is irrespective of whether the patients experiencing FCR or not they follow the self-examination process.

FCR7 – 6^th question alone has a physical assessment which is not a direct question on FCR, which is stated in the study conducted on lung cancer patients FCR and hence may be one of the factors justifying the Item 6^th of FCR having a weak correlation with the total item.^[9]

Results depicted a monotonic relationship of FCR 7 with FACT-B and IES-R. An inverse correlation between FCR and quality of life (FACT-B) states that breast cancer survivors with high FCR experienced a poorer overall quality of life. Our results replicated studies done by Shin et al.^[13] who also concluded an inverse correlation between FCR and European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life questionnaire (QLQ-C30) on QoL indicated that cancer patients with high FCR might have a poor quality of life.

FCR7 T had a positive correlation with IES-R stating that survivors with higher FCR had symptoms such as intrusive thoughts about cancer coming back and anxiety features, which may be included in the hyperarousal subscale combinedly reflecting post-traumatic stress symptoms in the participants. These observations were similar to the findings of Mehnert’s study on fear of cancer progression (FoP) and cancer-related intrusive cognitions in breast cancer survivors. Significant correlations were noted between FoP and post-traumatic stress disorder diagnosis.^[14]

While considering the median of FCR, it was found that around half of the BCSv experienced more FCR during their survivorship period, which is similar to the studies by Schapira et al.^[15] where it was reported that the majority of the population had reported moderate to high FCR, however, which was fluctuating over a while.

CONCLUSION

The Tamil version of the FCR7 tool is highly sensitive for measuring FCR.

The results of FCR7 T reveal that it is a brief, valid and reliable tool for assessing cancer recurrence. FCR is primarily applicable to the survivor group, and FCR7 T emerged as a sensitive tool. Their worry about cancer recurrence could be measured appropriately.