Psychometric analysis of Marathi version of an updated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-H&N43).

BACKGROUND: The aim of this study was to perform a psychometric analysis of the Marathi version of an updated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-H&N43) in patients of head and neck squamous cell carcinoma (HNSCC). MATERIAL AND METHODS: After an institutional ethics committee approval and linguistic validation, the Marathi version of EORTC QLQ-H&N43 was served to consecutive eligible, Marathi-speaking HNSCC patients of oral cavity, oropharynx, hypopharynx and larynx, registered from August 2019 to March 2021 and who consented to the study. Performance status scale was used for perceptive assessment of organ function. Psychometric analysis was performed using SYSTAT v. 12 (Cranes software, Bengaluru). RESULTS: A total of 129 patients participated in the study with a median age of 67 years and the man-to-woman ratio of 100:29. The commonest sub-site reported was the oral cavity (61.24%) and the majority were in stage IV disease (69.76%). Ninety patients completed the questionnaire before being started on active oncology treatment at our center. 39 patients completed the questionnaire at pre-treatment and first follow-up. The questionnaire was filled on their own (module) by 32.55% of patients while 67.44% of patients required some kind of assistance (schedule). Internal consistency was moderate to high. The criterion and construct validities were acceptable. The questionnaire was sensitive to change with stage and time. No significant difference was observed in module versus schedule subgroup except for 2 out of 19 item-scales. CONCLUSION: Marathi translation of EORTC QLQ-H&N43 is a sensitive, reliable and valid tool when applied to patients of HNSCC. It can be considered as a schedule.

Marathi translation, linguistic validation, and cross-cultural adaptation of M.D. Anderson dysphagia inventory in patients of head and neck squamous cell cancer.

Background: Self-reported treatment outcome is a better way to measure patient's quality of life (QOL). This study was undertaken to translate dysphagia-specific QOL questionnaire M. D. Anderson Dysphagia Inventory (MDADI) in Marathi language, its linguistic validation, and cross-cultural adaptation in patients of head and neck squamous cell cancer (HNSCC). Methods: After Institutional ethics committee approval, MDADI was translated into Marathi with prior permission from the author of original English questionnaire (AOEQ). The translation procedure included - two forward translations (English to Marathi), formation of first intermediate Marathi translation (FIMT), two back translations (BT) (Marathi to English) of FIMT and interim Marathi translation (IMT) formation. Second intermediate Marathi translation (SIMT) was prepared after face validation of IMT by Marathi subject expert. Pretesting of SIMT was done in 10 patients of HNSCC for linguistic validation and cross-cultural adaptation. After incorporating the patients' suggestions, final Marathi translation was formulated and forwarded to primary author for approval. Results: The grammatically acceptable and conceptually equivalent face-validated SIMT was prepared and given to HNSCC patients. The questionnaire was well understood and unobjectionable reflecting its linguistic validity and cross-cultural adaptation. Some of the patients suggested changes in a few words which were then rectified, rechecked with BT, and the final Marathi translated questionnaire was prepared. The credit statement for AOEQ was used as a footnote in the translated questionnaire. Conclusion: Marathi translation of MDADI is well accepted and comprehensible. It can be used for future studies.

Serum 25-hydroxy vitamin-D levels in head and neck cancer chemoradiation therapy: Potential in cancer therapeutics.

Background: To evaluate the relation between serum-25-hydroxy Vitamin-D levels (S25OHVDL) and concurrent chemoradiation therapy (CTRT) toxicities in patients of head and neck squamous cell cancer (HNSCC). Methods: After an institutional ethics committee approval, consecutive HNSCC patients who received radical/adjuvant CTRT were prospectively evaluated. Patients were assessed for CTRT toxicities using Common Terminology Criteria for Adverse Events version 5.0 (CTCAE-v5.0) and the response was evaluated according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST-1.1). S25OHVDL was assessed at the time of the first follow-up. Patients were divided into group A (Optimal) and group B (suboptimal) according to S25OHVDL. The treatment toxicities were correlated with S25OHVDL. Results: Twenty-eight patients were evaluated for the study. S25OHVDL was optimal in eight (28.57%) and suboptimal in 20 patients (71.42%). Mucositis and radiation dermatitis were significantly more in subgroup B (P-value 0.0011 and 0.0505, respectively). Relatively lower but nonsignificant hemoglobin and peripheral white blood cell counts were observed in subgroup B. Conclusion: Suboptimal S25OHVDL was associated with significantly more skin and mucosal toxicities in HNSCC patients treated with CTRT.

Multiple primary head and neck squamous cell cancer: Lessons learnt.

AIM: To analyze the demographic profile, treatment outcome, and factors affecting them in multiple primary head and neck squamous cell cancer (MPHNSCC) patients. MATERIALS AND METHODS: Hospital case records of patients with histopathology proven MPHNSCC registered in the radiation oncology department from January 2008 to December 2020 were retrospectively studied. Modified Warren-Gates criteria were used to define MPHNSCC. Demographic and clinical details were recorded and analyzed. RESULTS: Twenty-seven patients had histopathology proven MPHNSCC. The median age at diagnosis of an index case was 50 years (minimum 26, maximum 70) with a male to female sex ratio of 22:5. Seventeen (62.96%) patients were tobacco users; either smoked or smokeless. The oral cavity was the commonest sub-site for both an index and second primary malignancy (22 patients; 81.48%) and the majority presented in a locally advanced stage of disease (10; 37.03% and 16; 62.95% for an index and second primary, respectively). The presentation was simultaneous, synchronous, and metachronous in 1 (3.7%), 2 (7.4%), and 24 (88.89%) patients, respectively. Two patients had three sites of MPHNSCC. The average duration of chronicity was 54.37 months (min. 8 and max. 156). MPHNSCC were ipsilateral in 10 (37.04%) patients and re-irradiation was planned for 22 (81.48%) patients with 50% treatment compliance. At the time of the last hospital visit, 18 (66.66%) patients were alive with disease, 7 (25.92%) patients were alive without disease, and 2 (7.40%) patients died of disease. CONCLUSION: A higher percentage of MPHNSCC originated from the oral cavity and the majority presented in the locally advanced stage of disease; despite the site being accessible to self-oral examination. Patient education and physician's awareness regarding the MPHNSCC are needed.

Multiple malignant primary tumors (non-head and neck): Contemplation needed.

BACKGROUND: The incidence of multiple malignant primary tumors (MMPT) is increasing which needs attention. Hence, we undertook this study to analyze clinico-demographic details and treatment outcomes in patients with non-head and neck MMPT. MATERIALS AND METHODS: Hospital case records of patients with histopathology proven MMPT registered in the radiation oncology department from January 1, 2008 to December 31, 2020 were retrospectively studied. Modified Warren-Gates criteria were used to define MMPT. Patients with MMPT of the head and neck (both an index and second primary as head-neck) were excluded from the study. Demographic and clinical details were recorded and analyzed. RESULTS: Forty-two eligible cases of non-head and neck MMPT were studied. The median age at diagnosis of an index case was 55 years (minimum 21, maximum 85) with a male to a female sex ratio of 5:37. Twelve patients had synchronous (28.57%) and 30 had metachronous (71.42%) MMPT. The average period between metachronous tumors was 77.77 months (minimum 12, maximum 312). The most common site of an index and second primary tumor was the breast (26; 61.90% and 23; 54.76%, respectively). Seventeen (65.38%) out of 26 index breast cancer were bilateral breast cancer and nine were others. In six cases of MMPT, there was an association between the breast and cervix. CONCLUSION: Breast cancer was the most common site for both an index and second primary malignancy followed by genital cancers. With cautious monitoring and patient education, second primary tumor could be detected earlier and managed better giving a good quality of life to patients.

Association between depressive symptoms and socioeconomic status in head and neck cancer patients attending rural tertiary health care center.

AIM: To study the association between depressive symptoms and socio-economic status (SES) in patients with head and neck cancer (HNC). MATERIALS AND METHODS: Histopathology-proven non-metastatic and non-recurrent HNC patients attending radiation oncology services in February and June 2021 who consented to the study were evaluated with an interview. Hamilton Depression Rating Scale (HDRS) and modified BG Prasad classification were used to assess depressive symptoms and SES, respectively. Statistical analysis was done using SYSTAT version 12 (by Crane's software, Bangalore). RESULTS: The study cohort comprised 100 patients. The median age was 55 years (minimum: 28, maximum: 86) with a male-to-female ratio of 2.57:1. The majority of patients were educated beyond middle-school level (44%), of middle SES (47%), oral cavity subsite (68%), stage IVA (36%) disease, and were on treatment (79%). HDRS scores showed absent, moderate, and severe depressive symptoms in 21, 63, and 16 patients, respectively, that is, the prevalence of depressive symptoms was 79%. Lower socioeconomic strata showed a significantly higher prevalence of severe depressive symptoms (P-value = 0.01). HDRS score was significantly higher in females (P-value = 0.024) and in patients who were illiterate or were educated less than middle-school level (P-value = 0.010). No statistically significant difference was found between HDRS score and age of patient, stage and site of disease, and on treatment or follow-up status. CONCLUSION: Depressive symptoms are common in patients with head and neck cancer. Low socioeconomic status (SES), female gender, and education less than middle school are associated with severe depressive symptoms. Psycho-oncological and psychotherapeutic interventions are the need of the hour.

Concurrent chemotherapy with high-dose rate brachytherapy after treatment with chemoradiotherapy in cases of locally advanced carcinoma cervix: A study from rural area of Maharashtra, India.

Aim: This study aims to evaluate the efficacy, feasibility, tolerability, and toxicity of concurrent chemotherapy and brachytherapy for locally advanced cervical carcinoma. Materials and Methods: Forty patients of cervical carcinoma were included in this study. The study period ranges from October 2016 to September 2019. Patients were evaluated and treated as per the protocol: external beam radiotherapy (50 Gy in 25 fractions) and concurrent weekly chemotherapy with injection (Inj.) cisplatin (30 mg/m2) followed by high-dose rate brachytherapy (3 fractions of 7 Gy each) and concurrent chemotherapy Inj. cisplatin (30 mg/m2). Results: Out of 40 patients enrolled in the study, 36 patients completed the treatment (17 Stage II and 19 Stage III). The incidence of Grade I and II skin toxicities were 78% and 10%, respectively. The incidence of genitourinary toxicities with respect to Grade I and II were 72% and 12%, respectively. There were Grade III hematological toxicities in two patients and the brachytherapy treatment was delayed for 4-6 days. The overall complete response was found in 28 (78%) patients, partial response in six (16.7%) patients, and progressive disease in two (5.6%) patients at 3 months of follow-up. On the last follow-up, 21 (58%) patients were disease-free and there was disease failure in seven patients (5 local recurrence and 2 with distant metastasis). Conclusion: Brachytherapy with the addition of concurrent chemotherapy is effective and feasible with acceptable toxicity for advanced stages of carcinoma cervix. This study upholds an interesting approach that can be regarded as feasible and tolerable for cervical cancer patients.

Marathi translation, linguistic validation, and cross-cultural adaptation of speech handicap index and voice handicap index in patients of head and neck squamous cell cancer.

Background: Patient reported treatment outcomes is a better way to measure the quality of life (QOL). This study was undertaken to translate the speech handicap index (SHI) and voice handicap index (VHI) in Marathi language and its linguistic validation and cross-cultural adaptation in patients of head and neck squamous cell cancer (HNSCC). Methods: SHI and VHI were translated into Marathi with prior permission from the respective authors of original English questionnaire (RAs). The translation procedure for each tool included two forward translations (English to Marathi), the formation of first intermediate Marathi translation (FIT), two back translations (Marathi to English) of FIT, and interim Marathi translation (IT) formation. The second intermediate Marathi translation (SIT) was prepared after face validation of IT by a subject expert. Pretesting of SIT was done in 20 patients of HNSCC to validate linguistic and cross-cultural adaptation. By incorporating the patient's suggestions, the final Marathi translation was prepared and sent to primary authors for approval. Results: The grammatically and conceptually acceptable and face validated SIT was prepared and administered to HNSCC patients. The patients of the oral cavity and larynx were in SHI and VHI group, respectively (ten patients in each group). The questionnaire was well understood reflecting its linguistic and cross-cultural adaptation. Some of the patients suggested changes in a few words which were then corrected, rechecked with back translation, and final Marathi translated questionnaire was prepared. It was approved by RAs. Conclusion: Marathi translation of SHI and VHI are well accepted and comprehensible. It can be used for future studies.

Marathi Translation and Linguistic Validation of an Updated European Organization for Research and Treatment of Cancer Quality of Life Module for Head and Neck.

Aim This study was aimed to translate an updated European Organization for Research and Treatment of Cancer (EORTC) quality of life module for head and neck (EORTC QLQ-H&N43) in grammatically and conceptually acceptable Marathi language and its linguistic validation. Materials and Methods Approval was obtained from the Institutional Ethics Committee. The permission for translation was obtained from the EORTC translation unit (TU). The EORTC guidelines for the translation were followed to form a translation for pilot testing which was administered to 10 Marathi speaking head and neck squamous cell cancer (HNSCC) patients who gave informed written consent for the participation in the study. Patients were interviewed personally. The final Marathi translation was prepared and sent to EORTC TU for approval. Statistical analysis was performed using SYSTAT version 12 by Cranes software, Bengaluru, Karnataka, India. Results After getting permission, the translation files were received from EORTC TU, including Marathi EORTC QLQ-H&N35 for reference. Two forward translations, reconciled translation, back translations, first interim translation, translation for proof editing, and second interim translation (SIT) were prepared. This SIT was pilot tested in 10 Marathi-speaking HNSCC patients. Each patient was interviewed regarding difficulty in answering, confusing or offensive word, and reframing sentence. The questionnaire was well understood by patients reflecting its linguistic validity. After incorporating the changes as per the patient's interview, updated translation was prepared and sent to EORTC TU which was accepted and approved by EORTC. The psychometric analysis of pilot testing showed that the questionnaire is acceptable. Conclusion Marathi translation of EORTC QLQ-H&N43 is well accepted and understandable. It can be used for future studies.

Quality of voice after radiotherapy in early vocal cord cancer.

Early glottic cancer (T1, T2N0M0), a disease of the voice box, mainly affects the voice. It can be effectively treated with both surgery and radiotherapy. Preservation of the voice while treating vocal cord cancer is not simply retaining the ability to vocalize. It is the determinant of choice of treatment and quality of life following curative management. Radiotherapy has resulted in excellent control rates with voice preservation and has been the standard of care for many decades. Several patient- (e.g., smoking, age, amount of talking during treatment), disease- (e.g., extent and site of lesion) and treatment- (e.g., radiation field size and dose, voice therapy) related factors adversely affect the quality of voice after radiotherapy. Several studies have evaluated voice quality either subjectively or objectively. Still, little is known about it. Voice quality after radiotherapy improves but does not reach the standard of the normal controls.

Factors affecting the quality of voice in the early glottic cancer treated with radiotherapy.

AIMS: To prospectively analyze the objective voice quality before and after radiotherapy (RT) for early glottic cancer and to evaluate the role of different factors that may affect it. METHODS: Patients with T1-T2N0M0 glottic cancer underwent voice quality assessment before treatment and after radical RT. Post-RT voice quality was compared to the voice at diagnosis and the voice of healthy individuals used as controls. A comprehensive set of voice parameters were measured. The effects of age, smoking history, T stage, anterior commissure (AC) involvement, radiation dose, fractionation and volumes on pre-treatment and post-treatment voice quality were analyzed. RESULTS: The voice quality data of 50 patients were analyzed. Following treatment, there was a significant improvement in the majority of measured parameters. However, perturbation and HNR remained inferior compared to controls. A history of smoking, AC involvement and larger RT volumes resulted in poorer voice parameters following RT. There was no significant impact of age alone. T2 tumors had an inferior voice quality before treatment, but did not remain inferior following RT. Hypofractionated RT did not show any negative impact. CONCLUSIONS: There is a considerable improvement of voice quality following RT. Several factors may have specific effects on pre-treatment and post-treatment voice.