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

Odense University Hospital

Status: Completed

Conditions: Head and Neck Cancer

Treatments: Other: NUTRI-HAB

Study type: Interventional

Funder types: Other

Identifiers

NCT03909256

18/14847

Details and patient eligibility

About

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.

Full description

This study is a randomised controlled trial with following objectives:

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

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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71 participants in 2 patient groups

NUTRI-HAB

Experimental group

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.

Treatment:

Other: NUTRI-HAB

Control group

No Intervention group

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.