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De haalbaarheid van een beweegprogramma tijdens behandeling van hoofd-halskanker

Recruiting
Conditions
Treatment of advanced Head and Neck Cancer with CRT has a negative impact on physical functioning, body composition, fatigue and health related quality of life (HRQoL). Unintentional weight loss, of which a large percentage is lean body mass, often occurs despite intensive nutritional support. Besides dietary interventions, physical exercise is a prerequisite for maintaining and rebuilding muscle mass.
Registration Number
NL-OMON27597
Lead Sponsor
niversity Medical Center Utrecht and Netherlands Cancer Institute
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
37
Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

- HNSCC Patients who are scheduled for CRT

Exclusion Criteria

There are no exclusion criteria.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Feasibility:&#61623; Main outcome: Adherence to supervised and home-based sessions will be monitored throughout the programme (maximum: 6 sessions per week x 10 weeks) in a CRF (physiotherapist;one supervised session per week) and an exercise log/fitness tracker (patient; five home-based sessions per week).<br /><br>&#61623; Compliance with the exercise protocol (intensity and duration) will be registered in a CRF (physiotherapist) and an exercise log (patient).<br /><br>&#61623; Recruitment rate; registered in study file<br /><br>&#61623; Retention rate; registered in study file. Reasons of patients who drop-out during the intervention will be registered.<br>
Secondary Outcome Measures
NameTimeMethod
Secondary study outcomes: include physical fitness, nutritional status and energy needs that will be assessed by objective physical and nutritional performance indicators and questionnaires. Patient satisfaction will be explored by semi-structured interviews focusing on the beliefs, thoughts, perceptions and engagement with the exercise intervention before (week 0) and after (week 12).
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