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Rationale and design of a randomised controlled trial investigating the effect of multidisciplinary nutritional rehabilitation for patients treated for head and neck cancer (the NUTRI-HAB trial).

ABSTRACT: BACKGROUND:Eating problems frequently affect quality of life and physical, psychological and social function in patients treated for head and neck cancer (HNC). Residential rehabilitation programmes may ameliorate these adverse effects but are not indicated for all individuals. Systematic assessment of rehabilitation needs may optimise the use of resources while ensuring referral to rehabilitation for those in need. Yet, evidence lacks on which nutrition screening and assessment tools to use. The trial objectives are: 1) To test the effect of a multidisciplinary residential nutritional rehabilitation programme compared to standard care on the primary outcome body weight and secondary outcomes health-related quality of life, physical function and symptoms of anxiety and depression in patients curatively treated for HNC and 2) To test for correlations between participants' development in outcome scores during their participation in the programme and their baseline scores in Nutritional Risk Screening 2002 (NRS 2002), the Scored Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF), and M. D. Anderson Dysphagia Inventory (MDADI) and to assess sensitivity, specificity and predictive values of the three tools in relation to a clinically relevant improvement in outcome scores. METHODS:In a randomised controlled trial, 72 patients treated for HNC recruited through a nationwide survey will be randomised to a multidisciplinary residential nutritional rehabilitation programme or to a wait-list control group. Data are collected at baseline, three and six months. Primary outcome is change in body weight, and secondary outcomes include changes in quality of life, physical function and symptoms of anxiety and depression. Potential correlations between intervention effect and baseline scores in NRS 2002, PG-SGA-SF and MDADI will be tested, and sensitivity, specificity and predictive values of the three tools in relation to a clinically relevant improvement in outcome scores will be assessed. DISCUSSION:This is the first randomised controlled trial to test the effect of a multidisciplinary residential nutritional rehabilitation programme in patients treated for HNC. Recruitment through a nationwide survey gives a unique possibility to describe the trial population and to identify potential selection bias. As the trial will explore the potential of different nutrition screening and assessment tools in the assessment of rehabilitation needs in patients treated for HNC, the trial will create knowledge about how selection and prioritisation of nutritional rehabilitation aimed at patients treated for HNC should be offered. The results may contribute to a better organisation and use of existing resources in benefit of patients treated for HNC. TRIAL REGISTRATION:The trial is registered by The Danish Data Protection Agency (registration 2012-58-0018, approval number 18/14847) and the Regional Committees on Health Research Ethics for Southern Denmark (journal number 20182000-165). ClinicalTrials.gov Identifier: NCT03909256. Registered April 9, 2019.

SUBMITTER: Kristensen MB

PROVIDER: S-EPMC7079410 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Rationale and design of a randomised controlled trial investigating the effect of multidisciplinary nutritional rehabilitation for patients treated for head and neck cancer (the NUTRI-HAB trial).

Kristensen Marianne Boll MB Wessel Irene I Beck Anne Marie AM Dieperink Karin B KB Mikkelsen Tina Broby TB Møller Jens-Jakob Kjer JK Zwisler Ann-Dorthe AD

Nutrition journal 20200317 1

<h4>Background</h4>Eating problems frequently affect quality of life and physical, psychological and social function in patients treated for head and neck cancer (HNC). Residential rehabilitation programmes may ameliorate these adverse effects but are not indicated for all individuals. Systematic assessment of rehabilitation needs may optimise the use of resources while ensuring referral to rehabilitation for those in need. Yet, evidence lacks on which nutrition screening and assessment tools to ...[more]

PMID: 32183835

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Project description:Background: Locally advanced head and neck cancer is managed either by combined surgery and (chemo) radiotherapy or definitive (chemo) radiotherapy, which may deteriorate nutritional status. Previous data have shown that intensive nutritional intervention by a dietician reduces radiation-induced adverse events including weight loss. Objective: To determine if on-demand nutritional counseling (ODC, control group) would be as efficacious as intensive nutritional counseling (INC, experimental group) in patients undergoing (chemo) radiotherapy. Methods: Fifty-eight patients were randomly assigned to receive INC (n = 26) or ODC (n = 32). Outcome measures were nutritional status (PG-SGA), weight loss, handgrip strength (HGS), body composition, and survival. Results: Weight loss and impaired nutritional parameters during oncological treatment were seen equally in both groups (NS). Leaner patients at baseline maintained their weight, while overweight patients lost both weight and handgrip strength during treatment. Disease-free survival (DFS) (median = 43 months) was not affected by weight loss during treatment. Lower baseline HGS and malnutrition were associated with worse DFS (low vs. normal HGS: 15 vs. 42 months; p = 0.05 and malnutrition vs. good nutrition status: 17 vs. 42 months; p = 0.014, respectively). Survival according to low vs. normal HGS in the INC group was 4 vs. 44 months (p = 0.007) and in the ODC group 28 vs. 40 months (p = 0.944). According to malnutrition vs. good nutritional status in the INC group, DFS was 21 vs. 43 months (p = 0.025) and in the ODC group 15 vs. 41 months (p = 0.03). Conclusions: As for our primary endpoint, individualized on-demand nutritional counseling was as efficacious as intensive counseling in preventing deterioration of nutritional status and incidence of malnutrition during (chemo) radiotherapy. This should be verified with larger number of patients. Additional findings were that overweight patients had more severe weight loss, but not poorer survival. Low HGS and malnutrition at baseline were associated with poor survival. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT02159508.

Project description:BackgroundReflexive responses to head-neck perturbations affect the injury risk in many different situations ranging from sports-related impact to car accident scenarios. Although several experiments have been conducted to investigate these head-neck responses to various perturbations, it is still unclear why and how individuals react differently and what the implications of these different responses across subjects on the potential injuries might be. Therefore, we see a need for both experimental data and biophysically valid computational Human Body Models with bio-inspired muscle control strategies to understand individual reflex responses better.MethodsTo address this issue, we conducted perturbation experiments of the head-neck complex and used this data to examine control strategies in a simulation model. In the experiments, which we call 'falling heads' experiments, volunteers were placed in a supine and a prone position on a table with an additional trapdoor supporting the head. This trapdoor was suddenly released, leading to a free-fall movement of the head until reflexive responses of muscles stopped the downwards movement.ResultsWe analysed the kinematic, neuronal and dynamic responses for all individuals and show their differences for separate age and sex groups. We show that these results can be used to validate two simple reflex controllers which are able to predict human biophysical movement and modulate the response necessary to represent a large variability of participants.ConclusionsWe present characteristic parameters such as joint stiffness, peak accelerations and latency times. Based on this data, we show that there is a large difference in the individual reflexive responses between participants. Furthermore, we show that the perturbation direction (supine vs. prone) significantly influences the measured kinematic quantities. Finally, 'falling heads' experiments data are provided open-source to be used as a benchmark test to compare different muscle control strategies and to validate existing active Human Body Models directly.

Project description:ImportanceMultidisciplinary care (MDC) yields proven benefits for patients with cancer, although it may be underused in the complex management of head and neck squamous cell carcinoma (HNSCC).ObjectiveTo characterize the patterns of MDC in the treatment of HNSCC among elderly patients in the US.Design, setting, and participantsThis nationwide, population-based, retrospective cohort study used Surveillance, Epidemiology, and End Results (SEER)-Medicare linked data from January 1, 1991, to December 31, 2011, to identify patients 66 years or older diagnosed with head and neck cancer and determine the dates of diagnosis, oncology consultations, treatment initiation, and speech therapy evaluation in addition to MDC completion. Multidisciplinary care was defined in a stage-dependent manner: localized disease necessitated consultations with radiation and surgical oncologists, and advanced-stage disease also included a medical oncology consultation, all before definitive treatment. Data were analyzed between December 2016 and September 2020.Main outcomes and measuresRates of MDC across all subsites of head and neck cancer as measured by the presence of an evaluation for each oncologist on the MDC team and its effect on treatment initiation.ResultsThis cohort study assessed 28 293 patients with HNSCC (mean [SD] age, 75.1 [6.6] years; 67% male; 87% White) from the SEER-Medicare linked database. The HNSCC subsites included larynx (40%), oral cavity (30%), oropharynx (21%), hypopharynx (7%), and nasopharynx (2%). Overall, the practice of MDC significantly increased over time, from 24% in 1991 to 52% in 2011 (P < .001). For patients with localized (stage 0-II) tumors, 60% received care in the multidisciplinary setting, whereas 28% of those with advanced-stage disease did. A total of 18 181 patients (64%) were treated with initial definitive nonsurgical therapy across all stages. Regardless of stage and subsite, few patients (2%) underwent evaluation by a speech-language pathologist before definitive therapy. Multidisciplinary care prolonged the time to initiation of definitive treatment by 11 days for localized disease and 10 days for advanced disease.Conclusions and relevanceThis cohort study found that most elderly patients with localized HNSCC received MDC, whereas few patients with advanced-stage disease received such care, although a significant proportion received adjuvant therapy. Multidisciplinary care may prolong time to initiation of definitive treatment with an uncertain impact. Consultation with a speech-language pathologist before definitive therapy was rare.

Project description:PurposeHealth literacy is a current Public Health priority in Portugal. The participation of well-informed patients in their care and shared decision making are essential, especially in chronic aggressive and debilitating pathologies such as recurrent or metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC).AimsThis study aimed to characterize R/M HNSCC patients' and caregivers' information needs identified by healthcare professionals (HCPs).MethodsTwo online Focus Groups, one with only medical doctors and the other with other HCPs involved in the treatment of R/M HNSCC patients, were conducted, using a modified Metaplan, Lean or adapted PDCA methodology. The discussions were audio recorded in full and content analysis was performed using ATLAS.ti qualitative data analysis software.ResultsTopics addressed were diagnosis, treatment, quality of life, and global evaluation. In general, all experts agreed that only essential information should be cautiously given, according to patients' and caregivers' wishes. It was consensual that patients are given the necessary information to adhere to treatment. Two main barriers were identified: one barrier was associated with verbal communication due to the lack of health literacy of these patients, and the other barrier regarded healthcare access. It was also considered important to remind patients of the daily and social activities that they could and should maintain, as well as providing sufficient social resources and problem-solving training to caregivers.ConclusionsThis qualitative study highlights the complexity of R/M HNSCC patients' care. Immediate availability of psychologists and psychiatrists should be implemented in all centers that treat HNSCC patients. The differences found between the physicians' Focus Group and other HCPs' Focus Group in some of the addressed topics emphasize the importance of a multidisciplinary and holistic approach, in a biomedical model integrated with a biopsychosocial model.

Dataset Information

Rationale and design of a randomised controlled trial investigating the effect of multidisciplinary nutritional rehabilitation for patients treated for head and neck cancer (the NUTRI-HAB trial).

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Rationale and design of a randomised controlled trial investigating the effect of multidisciplinary nutritional rehabilitation for patients treated for head and neck cancer (the NUTRI-HAB trial).

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