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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
NUTRI-HAB
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring Rehabilitation, Nutrition impact symptoms, Quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NUTRI-HAB

Control group

Arm Description

The intervention group participates in a targeted rehabilitation program 'NUTRI-HAB' with a focus on eating problem after treatment for head and neck cancer. The program comprises: a five day residential stay with patient education a two day follow-up residential stay after 3 months two telephone consultations with clinical dietitian between the two residential stays.

The control group receives no intervention other than usual care in the study period. After 3 months, the control group will be offered participation in the same residential rehabilitation program as the intervention group parcitipated in.

Outcomes

Primary Outcome Measures

Percentage change in body weight from baseline to follow up
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 Outcome Measures

Change in health-related quality of life (EORTC QLQ-C30) from baseline to follow up
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.
Change in health-related quality of life (EORTC QLQ-H&N35) from baseline to follow up
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.
Change in health-related quality of life (EQ-5D-5L) from baseline to follow up
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.
Percentage change in hand grip strength from baseline to follow up
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.
Percentage change in '30 seconds sit-to-stand-test' from baseline to follow up
'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.
Percentage change in '6 minutes walk test' from baseline to follow up
'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.
Percentage change in mouth opening from baseline to follow up
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.
Change in symptoms of anxiety and depression from baseline to follow up
Symptoms of anxiety and depression is measured with the Hospital Anxiety and Depression Scale

Full Information

First Posted
April 5, 2019
Last Updated
December 16, 2019
Sponsor
Odense University Hospital
Collaborators
REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care, University of Southern Denmark, University College Copenhagen, Odense Patient Data Explorative Network, Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT03909256
Brief Title
NUTRI-HAB - Posttreatment Rehabilitation of Nutrition Impact Symptoms in Head and Neck Cancer Survivors
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
December 9, 2019 (Actual)
Study Completion Date
December 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care, University of Southern Denmark, University College Copenhagen, Odense Patient Data Explorative Network, Rigshospitalet, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Rehabilitation, Nutrition impact symptoms, Quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The investigator will be blinded when performing the data analyses. Hence, data will be anonymised before analysis and the investigator will not know whether the group of subjects were allocated to the control or the intervention group. Results from blinded data analyses will be interpreted by project group before unblinding.
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NUTRI-HAB
Arm Type
Experimental
Arm Description
The intervention group participates in a targeted rehabilitation program 'NUTRI-HAB' with a focus on eating problem after treatment for head and neck cancer. The program comprises: a five day residential stay with patient education a two day follow-up residential stay after 3 months two telephone consultations with clinical dietitian between the two residential stays.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group receives no intervention other than usual care in the study period. After 3 months, the control group will be offered participation in the same residential rehabilitation program as the intervention group parcitipated in.
Intervention Type
Other
Intervention Name(s)
NUTRI-HAB
Intervention Description
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 Outcome Measure Information:
Title
Percentage change in body weight from baseline to follow up
Description
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.
Time Frame
Difference between measurements at baseline and at follow-up after 3 and 6 months
Secondary Outcome Measure Information:
Title
Change in health-related quality of life (EORTC QLQ-C30) from baseline to follow up
Description
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.
Time Frame
Difference between measurements at baseline and at follow-up after 3 and 6 months
Title
Change in health-related quality of life (EORTC QLQ-H&N35) from baseline to follow up
Description
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.
Time Frame
Difference between measurements at baseline and at follow-up after 3 and 6 months
Title
Change in health-related quality of life (EQ-5D-5L) from baseline to follow up
Description
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.
Time Frame
Difference between measurements at baseline and at follow-up after 3 and 6 months
Title
Percentage change in hand grip strength from baseline to follow up
Description
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.
Time Frame
Difference between measurements at baseline and at follow-up after 3 and 6 months
Title
Percentage change in '30 seconds sit-to-stand-test' from baseline to follow up
Description
'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.
Time Frame
Difference between measurements at baseline and at follow-up after 3 and 6 months
Title
Percentage change in '6 minutes walk test' from baseline to follow up
Description
'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.
Time Frame
Difference between measurements at baseline and at follow-up after 3 and 6 months
Title
Percentage change in mouth opening from baseline to follow up
Description
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.
Time Frame
Difference between measurements at baseline and at follow-up after 3 and 6 months
Title
Change in symptoms of anxiety and depression from baseline to follow up
Description
Symptoms of anxiety and depression is measured with the Hospital Anxiety and Depression Scale
Time Frame
Difference between measurements at baseline and at follow-up after 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann-Dorthe Zwisler, Professor
Organizational Affiliation
REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
Official's Role
Study Director
Facility Information:
Facility Name
REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
City
Nyborg
ZIP/Postal Code
5800
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Within the confines of Danish legislation, anonymised data from the trial will be available for other researchers upon reasonable request when results have been published.
Citations:
PubMed Identifier
32183835
Citation
Kristensen MB, Wessel I, Beck AM, Dieperink KB, Mikkelsen TB, Moller JK, Zwisler AD. 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). Nutr J. 2020 Mar 17;19(1):21. doi: 10.1186/s12937-020-00539-7.
Results Reference
derived

Learn more about this trial

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

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