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.

Effects of a Multidisciplinary Residential Nutritional Rehabilitation Program in Head and Neck Cancer Survivors—Results from the NUTRI-HAB Randomized Controlled Trial

“…In a pilot study testing a 1-week residential psychoeducational program in HNC survivors, high participant satisfaction and improvements in QOL scales were reported [19]. In another pilot study conducted by the researchers behind the present trial, qualitative data showed that HNC survivors benefitted from participating in a multidisciplinary residential nutritional rehabilitation program [4], and significant improvements in body weight and several QOL scales were seen at the 3-month follow-up [24]. With no control group in any of the pilot studies, the effect of residential rehabilitation programs in HNC survivors should be tested in randomized controlled trials.…”

“…The detailed trial protocol [24] was developed in accordance with the standard protocol items for randomized trials (SPIRIT) 2013 [25,26] statement, the consolidated standards of reporting trials (CONSORT) extension for reporting trials of nonpharmacologic treatments [27], and the template for intervention description and replication (TIDieR) [28] checklist and guide. An overview of trial materials and information on how to obtain these have been published with the trial protocol [24]. The CONSORT 2010 statement [29] and the CONSORT extension for reporting trials of nonpharmacologic treatments [27] were used as guidelines for reporting trial results.…”

“…The CONSORT 2010 statement [29] and the CONSORT extension for reporting trials of nonpharmacologic treatments [27] were used as guidelines for reporting trial results. The detailed trial protocol [24] was developed in accordance with the standard protocol items for randomized trials (SPIRIT) 2013 [25,26] statement, the consolidated standards of reporting trials (CONSORT) extension for reporting trials of nonpharmacologic treatments [27], and the template for intervention description and replication (TIDieR) [28] checklist and guide. An overview of trial materials and information on how to obtain these have been published with the trial protocol [24].…”

“…With no control group in any of the pilot studies, the effect of residential rehabilitation programs in HNC survivors should be tested in randomized controlled trials. Thus, we designed the NUTRI-HAB trial [24]. The primary objective of the trial was to test the effect of a multidisciplinary residential nutritional rehabilitation program compared to standard care on the primary outcome body weight and secondary outcomes physical function, health-related QOL, and symptoms of anxiety and depression in HNC survivors.…”

“…Secondary exploratory objectives and analyses were further predefined in the trial protocol [24]. These will be approached in future publications.…”