NUTRI-HAB - Posttreatment Rehabilitation of Nutrition Impact Symptoms in Head and Neck Cancer Survivors
NCT ID: NCT03909256
Last Updated: 2019-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
71 participants
INTERVENTIONAL
2019-04-15
2019-12-09
Brief Summary
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Detailed Description
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1. 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
2. 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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Results from blinded data analyses will be interpreted by project group before unblinding.
Study Groups
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NUTRI-HAB
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.
NUTRI-HAB
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.
Control group
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.
No interventions assigned to this group
Interventions
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NUTRI-HAB
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Not being able to speak and understand Danish
* No permanent residence in Denmark
18 Years
ALL
No
Sponsors
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REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
OTHER
University of Southern Denmark
OTHER
University College Copenhagen
OTHER
Odense Patient Data Explorative Network
OTHER
Rigshospitalet, Denmark
OTHER
Odense University Hospital
OTHER
Responsible Party
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Marianne Boll Kristensen
PhD student, Clinical dietitian
Principal Investigators
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Ann-Dorthe Zwisler, Professor
Role: STUDY_DIRECTOR
REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
Locations
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REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
Nyborg, , Denmark
Countries
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References
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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.
Other Identifiers
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18/14847
Identifier Type: -
Identifier Source: org_study_id