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

NCT03909256 | Completed DMC

• 1 other identifier: 18/14847
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

Rehabilitation; Nutrition impact symptoms; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (8)

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

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

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

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

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

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

• Percentage change in hand grip strength from baseline to follow up

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

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

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

Study Arms (2)

NUTRI-HAB

EXPERIMENTAL

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.

Other: NUTRI-HAB

Control group

NO INTERVENTION

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.

Interventions

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.

NUTRI-HAB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cancer of the larynx, pharynx or oral cavity
• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care

Nyborg, 5800, Denmark

Location

Related Publications (1)

• 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.

  PMID: 32183835 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Ann-Dorthe Zwisler, Professor

  REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student, Clinical dietitian

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 9, 2019
• Study Start: April 15, 2019
• Primary Completion: December 9, 2019
• Study Completion: December 9, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)