Neck Symptom Survey Version Research Articles

Translation and cross-cultural adaption of the Chinese version of the Vanderbilt Head and Neck Symptom Survey version 2.0: a tool for oral symptom assessment in head and neck cancer patients

BackgroundPatients with head and neck cancer (HNC) who are receiving radiotherapy commonly face detrimental complications, including oral issues. However, oral symptoms are not well understood given the lack of available specific assessment instruments. The Vanderbilt Head and Neck Symptom Survey version (VHNSS) 2.0 is an instrument specifically developed to identify oral symptoms in HNC patients receiving radiotherapy in the United States.ObjectiveTo perform the translation and cross-cultural adaptation of the original English version of VHNSS 2.0 into a Chinese version (Mainland China).MethodsThe translation and cultural adaptation process involved translation by independent translators, construction of a consensus version, back translation into the original English version, analysis by the expert committee and a pretest. The pretest was administered to 90 patients with HNC to assess the feasibility and practicality of the tool.ResultsThe final Chinese version approved by the expert committee was well understood by all participants in the study. The instrument had satisfactory content validity, with indexes of 0.83 for semantic and idiomatic equivalence, 0.90 for cultural equivalence, and 0.91 for conceptual equivalence. Furthermore, this version had good internal consistency, with Cronbach's alpha coefficients ranging from 0.74 to 0.95.ConclusionThe Chinese version of VHNSS 2.0 was translated and cross-culturally adapted for use in China. This translation is a feasible instrument to assess oral health-related quality of life in HNC patients undergoing radiotherapy and will be useful for symptom management by clinicians and researchers in China.

Prophylactic gabapentin decreases fatigue and swallowing difficulty in patients undergoing concurrent chemo-radiation (CCR) for head and neck cancer (HNC): Interim results from a randomized controlled trial.

6059 Background: Preliminary data suggest that gabapentin (G) administered during HNC radiation may decrease treatment associated pain. To confirm this, we undertook a prospective, randomized trial in HNC patients undergoing CCR. Primary outcomes: pain severity (scale of 0-10) and opioid use. Exploratory outcomes: local and systemic symptoms measured by the Vanderbilt Head and Neck Symptom Survey version 2 plus the general symptom survey (VHNSSv2/GSS). We report results of the exploratory endpoints from the interim analysis. Methods: Measures: VHNSSv2 - 50 items, demonstrated reliability/validated, captures acute/chronic local HNC specific symptoms; GSS – 11 item checklist, demonstrated content validity, captures acute/chronic systemic symptoms. Population: HNC patients (≥ stage 2) undergoing primary or adjuvant CCR. Procedures: Randomized to standard pain management (SPM) or SPM + G dose escalated to 900mg tid. VHNSSv2/GSS completed weekly during treatment beginning week 1 and ending the last week of radiation therapy. Results were analyzed using a mixed-effects regression analysis adjusting for baseline levels of each symptom. Results: 71 patients completed a mean of 5.5 surveys. Patients on G experienced a reduction in overall systemic symptoms as measured by the GSS (11-items, p = 0.0073), fatigue (two-items, p = 0.013 ) sleep disturbance (five items, p < 0.0001) , neurosensory eating (3 items, p = 0.026), phlegm-related symptoms (4 items, p = 0.004), and trend to better smell (2 items, p = 0.055). No impact on swallow, xerostomia, voice, dental or musculoskeletal symptoms was noted. Conclusions: This exploratory analysis suggests that G may moderate neurological and neuropsychiatric toxicities in HNC patients undergoing CCR. Further studies are warranted.

Assessment of established patient reported outcomes (PROs) instruments measuring toxicities and quality of life (QOL) for patients (pts) with head and neck cancer (HNC) treated on ECOG 1308 and 2399 studies.

6074 Background: HPV HNC pts are younger and have a higher cure rate than smoking-related pts, and therefore carry treatment toxicities longer. Dose deintensification and conformal RT may result in decreased toxicity. We report the impact of these techniques on patient outcomes in E2399 and E1308 as measured through PROs. Methods: Longitudinal data on acute and late toxicities were recorded prospectively at baseline, post-treatment, and at 6, 12, 24 and 30 months in HPV+ pts on E1308 and HIV+/- pts on E2399 using the following measures: E1308: FACT-HN, KATZ Index of Independence (ADL), Brief Fatigue Index (BFI), Instrumental Activities of Daily Living (IADL), and the Vanderbilt Head and Neck Symptom Survey Version 2 (VHNSS V2); on E2399: FACT-HN. We correlated acute and late toxicities with de-escalation of RT dose (69.3Gy to 54Gy) on E1308, and with IMRT (E1308) vs. conformal RT (E2399). Results: 38 pts on E1308 completed 12 mo VHNSS V2; 32 received low dose IMRT and 6 standard dose, and 56 E2399 pts completed 12 mo FACT-HN. Items from the VHNSS V2 showed that difficulty eating solids (40% vs. 89%, p = 0.011) and improved nutrition (10% vs 44%, p = 0.025) were statistically improved at 12 months by lowering IMRT dose from 69.3Gy to 54Gy. The FACT-HN showed an improvement in eating solids at 12 mo when comparing low dose IMRT vs. 3DRT (65% vs. 33% had no or minimal solid food problems, p = 0.057). No other statistically significant reductions in toxicity were noted on any of the other PRO instruments. Conclusions: Both FACT-HN and VHNSS V2 demonstrated an improvement in eating solids by reducing IMRT dose. FACT-HN demonstrated that IMRT is associated with an improvement in eating solids when compared to 3DRT. Analyses are exploratory and need to be validated using randomized data.Future studies should stress accurate and complete PRO data. The KATZ, BFI, and IADL were not sensitive to detecting differences in toxicities from IMRT dose reduction on E1308. The VHNSS V2 and FACT-HN instruments corroborated specific toxicities both by RT technique as well as IMRT dose, and will therefore be utilized in future ECOG-ACRIN HNC studies. Clinical trial information: NCT01084083.

Translation and cross-cultural adaptation into Brazilian Portuguese of the Vanderbilt Head and Neck Symptom Survey version 2.0 (VHNSS 2.0) for the assessment of oral symptoms in head and neck cancer patients submitted to radiotherapy

IntroductionPatients submitted to radiotherapy for the treatment of head and neck cancer have several symptoms, predominantly oral. The Vanderbilt Head and Neck Symptom Survey version 2.0 is an American tool developed to evaluate oral symptoms in head and neck cancer patients submitted to radiotherapy. ObjectiveThe aim of the present study was to translate the Vanderbilt Head and Neck Symptom Survey version 2.0 into Brazilian Portuguese and cross-culturally adapt this tool for subsequent validation and application in Brazil. MethodsA method used for the translation and cultural adaptation of tools, which included independent translations, synthesis of the translations, back-translations, expert committee, and pre-test, was used. The pre-test was performed with 37 head and neck cancer patients, who were divided into four groups, to assess the relevance and understanding of the assessed items. Data were submitted to descriptive statistical analysis. ResultsThe overall mean of the content validity index was 0.79 for semantic and idiomatic equivalence, and it was higher than 0.8 for cultural and conceptual equivalence. The cognitive interview showed that patients were able to paraphrase the items, and considered them relevant and easily understood. ConclusionThe tool was translated and cross-culturally adapted to be used in Brazil. The authors believe this translation is suited for validation.

The eating experience in long-term survivors of head and neck cancer: a mixed-methods study.

This study explored the eating experience in long-term survivors of head and neck cancer (HNC) ≥3years post concurrent chemoradiation. Quality of life (QOL) and the meanings and perceptions survivors had as it related to the eating experience were explored. Purposive sampling was utilized; 10 long-term survivors of HNC participated in the study. A mixed-methods approach was used; exploratory qualitative research using content analysis and summary statistics was used to describe demographic and clinical characteristics and the Vanderbilt Head and Neck Symptom Survey version 2.0 scores (VHNSS 2.0). Four categories (psychological, social impact, functional status, and the current eating experience) containing 15 subthemes and 1 overarching theme (adaptation) emerged. Current health status, QOL, and QOL related to eating were viewed favorably despite the impact of treatment late effects on participants' daily lives. Adaptation and maladaptation in regard to food choice and downplaying of symptoms were recognized. Interviews as well as the VHNSS 2.0 scores indicated that xerostomia, mucosal sensitivity, swallowing difficulty, length of time required to eat, and dysgeusia remained problematic. Psychological, functional, and social losses associated with eating were identified. Participants modify or avoid foods that are challenging yet report enjoyment with eating. Challenges with eating were downplayed. Due to the potential negative nutritional and social implications of avoiding specific food/food groups, standard of care in long-term survivors of HNC should include assessment of the eating experience and functional challenges. Nutrition professional can help patients optimize dietary intake and the eating experience.

A University Head and Neck Symptom Survey Version 2.0: Responsiveness to Change Over Time

A University Head and Neck Symptom Survey Version 2.0: Responsiveness to Change Over Time

Validation of the Vanderbilt Head and Neck Symptom Survey Version 2.0.

6049 Background: We previously reported the development and preliminary testing of the Vanderbilt Head and Neck Symptoms Survey version 2.0 (VHNSS 2.0 ) for assessment of symptom burden in head and neck cancer (HNC) patients who are undergoing or completed primary or adjuvant radiation based therapy (Cooperstein et al., Head and Neck, 2012, 24(6): 797-804). In addition to expanding items on existing domains, version 2.0 includes new domains such as dental health, mucosal sensitivity, and joint range of motion. Herein we report the results of initial validation of the instrument. Methods: 159 unique patients with HNC completed the 50 item VHNSS 2.0 as a part of one of three supportive care studies. Since each of these studies was prospective and longitudinal with repeated application of the VHNSS 2.0, we chose to utilize the first complete questionnaire for each patient for this analysis. Results: Patient characteristics: median age 57 (range 28-81 years), male 74.8%, Caucasian 91.8%, T3 or T4 46.5%, N2 or N3 66%, Site: pharynx 57.9%, oral cavity 15.1%, larynx 11.3%, 15.7%. Analysis identified 10 distinct clusters with 3 single items. The internal consistency of the clusters was good to excellent. Cronbach’s alpha coefficient, a statistical measure of reliability is shown in the Table. Conclusions: The VHNSS 2.0 is a robust, reliable measure of acute and late toxicities in patients undergoing radiation for HNC. These results provide a platform for administering appropriate interventions, which would ultimately provide for effective management of adverse oral health outcomes. [Table: see text]

Long-term symptom burden and orodental health of oropharyngeal cancer (OPC) survivors following treatment with chemoradiotherapy (CRT) or sequential therapy (ST).

9530 Background: OPC treatment is associated with significant long-term toxicity. Very little is known about the long-term symptom burden and orodental health in OPC survivors >2 yrs from treatment. Methods: Survivors treated for OPC with CRT/ST (involving definitive RT) at Dana Farber Cancer Institute between 2002-2011 and >2 yrs from treatment completion, were identified by chart review and asked to complete the Vanderbilt Head and Neck Symptom Survey version 2 (VHNSS v2), National Health And Nutrition Examination Survey for Oral Health Questionnaire, health care availability survey. Results: 200 survivors were contacted, 127 responded (RR: 64%). Median age at diagnosis was 54 yrs; 85% males; 85% stage IVA/B, 13% stage III; 56% CRT, 43% ST. HPV status: 47% (+), 10% (-), 43% unknown. Median time from treatment completion: 50 mths (24-135 mths). Residual moderate to severe toxicities reported in VHNSS v2: 71% dry mouth; 59% difficulty chewing/swallowing food; 53% feeling of food becoming stuck in the throat; 53% prolonged time to eat; 31% thick mucus, 6% had difficulty sleeping secondary to this; 16% trouble speaking, 27% trouble hearing;30% limitation of neck/shoulder movement; altered taste/smell - 45%/23%; sensitivity to spicy food and dryness-57%/62%; 30% decreased desire to eat, 11% had moderate weight loss. Orodental health assessment: 13% thermal sensitivity, 21% teeth cracking and chipping, 20% loose teeth, 33% had treatment for gum disease, 42% had lost bone around teeth. 98% survivors had health insurance; only 66% had dental insurance. No statistically significant difference was noted with respect to symptoms between CRT or ST. ST did not affect long-term toxicity compared to CRT alone. Conclusions: OPC is known to correlate with HPV positivity, early age at diagnosis and high rates of long-term survival after appropriate therapy. Our study documents that the OPC survivors have substantial residual long-term head and neck and orodental symptoms directly related to the treatment that significantly impacts their quality of life. A substantial number of patients lack dental health coverage, which likely further impacts symptom burden and QOL.

Symptom burden in head and neck cancer: impact upon oral energy and protein intake

This study explored relationships between oral symptom burden (xerostomia, thick secretions, and mucosal sensitivity), energy and protein intake, and weight change over time among head and neck cancer (HNC) patients who have completed concurrent chemoradiation (CCR). Symptom burden was assessed utilizing the Vanderbilt Head and Neck Symptom Survey version 2.0. Weight change was measured from diagnosis to treatment completion, and to the early, mid, and late recovery stage. Energy and protein intake were determined utilizing 24-h diet recalls. Forty-three adult patients treated for HNC enrolled in the study. Mean percentage weight loss from diagnosis to treatment completion was 7.91 ± 4.06 %. Within the mid-recovery stage significant inverse relationships were found between oral protein intake and xerostomia and mucosal sensitivity (r = -0.818, p = 0.012; r = -0.726, p = 0.032, respectively). After controlling for weight change, significant inverse relationships were found within the mid-recovery stage between oral energy intake and xerostomia and mucosal sensitivity (r = -0.740, p = 0.046; r = -0.751, p = 0.043, respectively). Significant, inverse relationships were also found between oral protein intake and xerostomia and mucosal sensitivity (r = -0.835, p = 0.019; r = -0.726, p = 0.033, respectively). Xerostomia and mucosal sensitivity were significantly related to oral energy and protein intake post-CCR in mid-recovery. Weight loss was greatest from diagnosis to treatment completion and continued through the mid-recovery stage. Assessment of oral symptom burden (xerostomia and mucosal sensitivity) and its impact on oral intake and weight post-CCR should be conducted routinely in good patient care.

Vanderbilt head and neck symptom survey version 2.0: Report of the development and initial testing of a subscale for assessment of oral health

The prevalence, severity, and functional implications of adverse oral health outcomes attributed to head and neck cancer therapy are largely undefined. We report development of an oral health outcome subscale for the Vanderbilt Head and Neck Symptom Survey (VHNSS). Oral health outcome questions were formulated through literature review and consultation with an expert panel. Questions were incorporated into the VHNSS resulting in a 50-item survey, scored 0 (none) to 10 (severe). The tool was administered to 70 subjects who completed radiation to assess for feasibility. Patient acceptance was high with a completion time <10 minutes. A full range of scores was noted for 46 of 50 questions. Oral health symptom burden was high early and late posttreatment. The VHNSS version 2.0 was feasible and could be completed in a timely manner. Validation studies are ongoing. The high prevalence of adverse oral health outcomes warrants further study.

Vanderbilt Head and Neck Symptom Survey Version 2.0 (VHNSS 2.0): A tool for the study of long-term oral health consequences of therapy for head and neck cancer (HNC).

9055 Background: HNC therapy causes adverse late oral health outcomes (LOHO), the prevalence, severity, and functional implications of which are largely unknown. VHNSS 1.0 was developed to measure treatment-related symptom burden, but common LOHO were not included. We report the development of a LOHO subscale. Methods: Questions were developed by an expert panel and review of oral health measures for the general population. Final tool included 50 items which scored symptoms or functional manifestations from 0 (none) to 10 (severe). It was administered to 70 subjects who completed radiation ± chemotherapy. Results: Completion time <10 minutes. To focus on late effects, we report on 48 participants ≥ 6 months post-treatment. 60% reported moderate/severe (M/S) xerostomia which impacted chewing/swallowing (54%), speaking (39%), and sleeping (30%). 44% reported M/S thick mucous resulting in choking/gagging (22%), difficulty swallowing (22%), and altered sleep (15%). 28% reported M/S voice changes with hoarsene...