No registrations found.
ID
Source
Brief title
Health condition
physical activity, energy expediture, Head and neck cancer, malnutrition / lichamelijke activiteit, energiebalans, hoofdhalskanker, ondervoeding
Sponsors and support
Hanze university of applied science, Groningen, the Netherlands
Hanze university of applied science, Groningen, the Netherlands
Intervention
Outcome measures
Primary outcome
Daily step count (steps/day)
Measured energy expenditure (in kcal and METs)
Secondary outcome
Types of physical activity
Mass/fat-free mass (kg)
Muscle strength (number of stand ups)
Estimated energy expenditure (kcal)
Study objective
This study primarily aims to explore changes in physical activity pattern and energy expenditure in head and neck cancer patients, during and after treatment with surgery with or without (chemo)radiation.
The following primary null hypotheses will be tested in this study:
Physical activity of head and neck cancer patients treated with surgery, with or without postoperative (chemo)radiation, does not decrease during treatment period.
Total and resting energy expenditure of head and neck cancer patients treated with surgery, with or without postoperative (chemo)radiation, does not change during treatment period.
Measured energy expenditure does not differ from estimated energy expenditure in head and neck cancer patients treated with surgery, with or without postoperative (chemo)radiation.
The secondary aim of this study is to gain insight in perceived exercise barriers and facilitators, and exercise preferences of head and neck cancer patients.
Study design
Head and neck cancer patients will be assessed three times: 1) one week before start of treatment, 2) six weeks after end of treatment, and 3) four months after end of treatment.
Intervention
Not applicable: observational study
Measurements:
Physical measurements during the study:
Body weight
Length
Muscle mass/fat-free mass: mid upper arm muscle circumference (by means of mid upper arm circumference and triceps skinfold), thigh and calf circumference, bio-electrical impedance analysis
Muscle strength: hand grip strength (Jamar hand grip dynamometer), chair to stand test
Resting energy expenditure: indirect calorimetry (Cosmed K4b2)
Questionnaires:
Malnutrition: Patient-Generated Subjective Global Assessment (PG-SGA)
Frailty: Frailty Instrument for Primary Care of the Survey of Health, Ageing and Retirement in Europe (SHARE-FI)
Fatigue: MVI20
Self efficacy: Exercise Self Efficacy Scale
Self regulation: Self regulation Questionnaire Exercise
Motivation: Stage of Change Exercise
Performance status: WHO performance status scale
Tumor- and treatment-related symptoms: EORTC QLQ-HN35
Eyssoniusplein 18
M. Sealy
Groningen 9714 CE
The Netherlands
050-5953604
m.j.sealy@pl.hanze.nl
Eyssoniusplein 18
M. Sealy
Groningen 9714 CE
The Netherlands
050-5953604
m.j.sealy@pl.hanze.nl
Inclusion criteria
- Newly diagnosed T1, T2, T3 or T4 malignancy in the oral cavity, larynx, oro- or hypopharynx, to be treated with surgery with or without (chemo)radiation
- Age: at least 18 years
- Able to understand and speak the Dutch language
Exclusion criteria
- Second primary tumor, outside the head and neck region
- Wheel chair dependency
- Comorbidity with a contra-indication for physical exercise
- Severe cognitive disabilities
- Skin allergy or highly sensitive skin
- Palliative treatment
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4676 |
| NTR-old | NTR4828 |
| Other | METC UMCG : METC 2012/063 |