Linguistic Validation of the Functional Assessment of Chronic Illness Therapy-Spiritual-Well-being-Expanded Version 4 Tool into Malayalam Language and its Feasibility in Advanced Cancer Patients Receiving Palliative Care

Objective: The objective of this study was to validate the ‘Functional Assessment of Chronic Illness Therapy-Spiritual-Well-being-Expanded(FACIT-SpEx) Version 4’ tool in Malayalam and assess its feasibility among advanced cancer patients receiving palliative care. Materials and Methods: The study was carried out at the outpatient Department of Cancer Palliative Medicine of Malabar Cancer Centre between November 2022 and June 2023. Initially, the FACIT-Sp-Ex version 4 tool with 23 items was translated into the Malayalam language with a forward-backward translation procedure. This was followed by pilot testing in 10 advanced adult cancer patients receiving palliative care who could read and comprehend the Malayalam language. After answering the draft version of the validated tool, patients responded to questions from a Malayalam-translated cognitive debriefing script. Results: The process of translation and cross-cultural adaptation went on smoothly with very few hurdles. The Malayalam terms used in three items Sp7, Sp9 and Sp23 when back translated were found to be different from the source. These issues were resolved with the use of the most suitable translations and closest equivalents available in Malayalam. In the pilot testing, the majority (70%) of the patients were female. The mean age of patients was 45.90 (standard deviation [SD] = 7.62) years. Carcinoma breast (50%) was the most common type of cancer. All the patients knew their diagnosis, while only 80% knew the prognosis. Almost 90% of the patients were receiving some form of palliative anticancer treatment. All patients completed the draft version of the validated tool. The mean spiritual well-being score measured using this validated tool was 71.20 (SD = 15.10). Analysis of the debriefing interviews revealed that the Malayalam version was easy to complete, relevant, and appropriate. Conclusion: Linguistic validation and cognitive debriefing produced the Malayalam translated FACIT-Sp-Ex version 4 tool conceptually equivalent to the original FACIT-Sp-Ex version 4 tool, and it is feasible for its use.