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Completed

NCT Number: NCT03909256

NUTRI-HAB - Posttreatment Rehabilitation of Nutrition Impact Symptoms in Head and Neck Cancer Survivors

The study is a randomised controlled trial that aims to test the effect of a residential rehabilitation program with a focus on eating problems after treatment in head and neck cancer survivors. The study will furthermore investigate whether selected nutrition screening and assessment tools can be used to identify head and neck cancer survivor who benefit from the program.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care

Nyborg, 5800, Denmark

About this study

This study is a randomised controlled trial with following objectives:

  • To test the effect of a targeted residential rehabilitation program with focus on the physical, psychological and social aspects of eating problems on body weight, health-related quality of life and physical function in curatively treated head and neck cancer survivors 1-5 years after completion of radiation therapy
  • To test whether a potential effect of the program is associated with/dependent of the participants' score in Scores Patient-Generated Subjective Global Assessment Short Form (PG-SGA-SF), Nutrition Risk Screening 2002 (NRS 2002) or M.D. Anderson Dysphagia Inventory (MDADI) at baseline

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cancer of the larynx, pharynx or oral cavity
  • Treatment with radiation therapy completed 1-5 years before inclusion
  • Curatively treated
  • Expression of interest in participating in the rehabilitation program in a preceding survey
  • Self-reliant and no need for assistance with personal hygiene etc.

Exclusion criteria

  • Active cancer disease at the time of recruitment
  • Not being able to speak and understand Danish
  • No permanent residence in Denmark

Treatment and study plan

NUTRI-HAB

Other

The rehabilitation program is a coordinated multidisciplinary effort involving several specialists e.g. clinical dietitians, nurses, physiotherapists, occupational therapists (responsible for dysphagia management in Denmark), psychologists and social workers.

The program includes group sessions with patient education on how to handle the different aspects of living with eating problems and other late effects. Practical kitchen exercises, physical activity sessions and instruction in swallowing training are included. Individual counseling sessions with clinical dietitians and other health professionals (e.g. physicians) are offered depending on participants' needs.

Participants stay at the premises and all meals throughout the day are served in the dining room or in the café. Foods of different textures and flavors are served to inspire participants and to allow them to experiment.

Between the initial stay and follow-up participants are contacted twice by a clinical dietitian.

Primary outcomes

  1. Percentage change in body weight from baseline to follow up

    Time frame: Difference between measurements at baseline and at follow-up after 3 and 6 months

    Body weight will be measured with a calibrated scale at baseline and at follow up. Measurements will be performed by trained health professionals and standardised protocols will be followed. The change in percent will be calculated for each individual participant and be used as the primary outcome.

Secondary outcomes

  1. Change in health-related quality of life (EORTC QLQ-C30) from baseline to follow up

    Time frame: Difference between measurements at baseline and at follow-up after 3 and 6 months

    Health-related quality of life (QOL) is measured using the generic EORTC QLQ-C30 questionnaire for cancer patients. Questionnaires will be scored according to EORTC's scoring manual, and changes from baseline to follow-up in the QOL-subscales will be calculated for each individual participant.

    The questionnaire consist of 30 items that are further divided into 15 subscales/items: a global health status/QOL scale; the functional scales: physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning and the symptom scales/items: fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties.

    All scales and single-item measures range in score from 0 to 100. A high score represents a higher response level. Thus a high score for a functional scale or global QOL represents a high level of functioning/QOL whereas a high score on a symptom scale represents a high level of symptoms.

  2. Change in health-related quality of life (EORTC QLQ-H&N35) from baseline to follow up

    Time frame: Difference between measurements at baseline and at follow-up after 3 and 6 months

    Health-related quality of life (QOL) is measured using the questionnaire EORTC QLQ-H&N35 specific for head and neck cancer. Questionnaires will be scored according to EORTC's scoring manual, and changes from baseline to follow-up in the QOL-subscales will be calculated for each individual participant.

    The EORTC QLQ-H&N35 consists of 35 items that are further divided into the following symptom scales/items: pain, swallowing, sensory problems, speech problems, trouble with social eating, trouble with social contact, less sexuality, teeth, opening mouth, dry mouth, sticky saliva, coughing, felt ill, pain killers, nutritional supplements, feeding tube, weight loss, weight gain.

    All scales and single-item measures range in score from 0 to 100. A high score represents a higher response level. Thus a high score for symptom scale represents a high level of symptoms.

  3. Change in health-related quality of life (EQ-5D-5L) from baseline to follow up

    Time frame: Difference between measurements at baseline and at follow-up after 3 and 6 months

    Health-related quality of life (QOL) is measured using EQ-5D-5L. Questionnaires will be scored according to manual, and changes from baseline to follow-up in the QOL-subscales will be calculated for each individual participant.

  4. Percentage change in hand grip strength from baseline to follow up

    Time frame: Difference between measurements at baseline and at follow-up after 3 and 6 months

    Hand grip strength will be measured with a calibrated hand dynamometer at baseline and at follow up. Measurements will be performed by trained health professionals and standardised protocols will be followed. Three measurements will be performed for each participant and the mean will be calculated. The change in percent will be calculated for each individual participant.

  5. Percentage change in '30 seconds sit-to-stand-test' from baseline to follow up

    Time frame: Difference between measurements at baseline and at follow-up after 3 and 6 months

    '30 seconds sit-to-stand-test' will be performed at baseline and follow-up. Measurements will be performed by trained health professionals and standardised protocols will be followed. The change in percent will be calculated for each individual participant.

  6. Percentage change in '6 minutes walk test' from baseline to follow up

    Time frame: Difference between measurements at baseline and at follow-up after 3 and 6 months

    '6 minutes walk test' will be performed at baseline and follow-up. Measurements will be performed by trained health professionals and standardised protocols will be followed. The change in percent will be calculated for each individual participant.

  7. Percentage change in mouth opening from baseline to follow up

    Time frame: Difference between measurements at baseline and at follow-up after 3 and 6 months

    Mouth opening will be measured at baseline and follow-up with TheraBite® Range-Of-Motion ROM Scale. The Therabite® ROM Scale is a disposable paper scale that measures the distance (in millimeters) between the upper and lower front teeth on maximal mouth opening. Lower values indicates trismus and increase indicates improvement. Measurements will be performed by trained health professionals and standardised protocols will be followed. The change in percent will be calculated for each individual participant.

  8. Change in symptoms of anxiety and depression from baseline to follow up

    Time frame: Difference between measurements at baseline and at follow-up after 3 and 6 months

    Symptoms of anxiety and depression is measured with the Hospital Anxiety and Depression Scale

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Odense Patient Data Explorative Network
  • REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
  • Rigshospitalet, Denmark
  • University College Copenhagen
  • University of Southern Denmark

Registry information

Official study title

NUTRI-HAB - A Randomised Controlled Trial on the Effect of a Targeted Residential Rehabilitation Program With a Focus on Eating Problems After Treatment for Head and Neck Cancer

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 9, 2019
Registry last updated
Dec 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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