This study will evaluate feasibility in terms of adherence and compliance to, patient satisfaction with, and recruitment and retention of, an exercise intervention during CRT in advanced HNC patients. Secondary objectives are to obtain preliminary…
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is feasibility of the exercise intervention. Adherence and
compliance will be monitored throughout the programme in a CRF
(physiotherapist) and an exercise log/fitness tracker (patient). Recruitment
rate will be registered in study file. Retention rate and number of supervised
sessions will be registered in study file. 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).
Secondary outcome
Secundary study parameters include; health related Quality of life
(questionnaires), physical fitness (6-minute walking test,hand grip strenght,
30 sec chair stand test), muscle strength (Microfet and hand grip strength),
body composition (bio electric impedance analysis), energy expenditure
(indirect calorimetry) and nutritional status (PG-SGA).
Background summary
Treatment of advanced Head and Neck Cancer (HNC) with Chemoradiotherapy (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. Current evidence, mainly from research
with breast cancer patients, shows that exercise interventions offered during
chemotherapy treatment have positive effect on physical functioning, fatigue
and HRQoL. HNC patients may also benefit from exercise during CRT, although
studies in this population are scarce. Based on our clinical experience and
(limited) available evidence, we developed an exercise program tailored to
preferences and abilities of HNC patients during CRT.
Study objective
This study will evaluate feasibility in terms of adherence and compliance to,
patient satisfaction with, and recruitment and retention of, an exercise
intervention during CRT in advanced HNC patients. Secondary objectives are to
obtain preliminary outcome data for (change in) HRQoL, physical performance,
muscle strength,body composition, nutritional status and energy expenditure for
future power calculations.
Study design
Two-centre feasibility study using a mixed methods design, including
quantitative measures to obtain data on feasibility, physical performance,
muscle strength and mass, HRQoL outcomes, and qualitative methods
(semi-structured interviews) to gain insight into the participants*
perspectives on feasibility and satisfaction.
Intervention
The 10-week exercise intervention combines endurance and resistance training,
and starts between one week prior to and two week after the start of 7 weeks of
CRT and continues for 2-4 weeks after completion of CRT. Related to
high-frequent hospital visits and the willingness to do exercises in daily
life, a combined supervised and home-based, moderate-intensity exercise
programme is planned.
Study burden and risks
Visits scheduled for physical assessment and exercise intervention will be
combined with treatment-related visits if possible.
The patient will be asked threetimes to spend, at most, 30 minutes completing
questionnaires, to perform physical tests and to undergo measurements of body
composition and resting energy expenditure. Furthermore, the patient is asked
to wear an activity tracker, to keep an activity diary and (for two times three
days) a food diary. The patient is also asked to participate in semi-structured
interviews (45 minutes). As in any exercise situation, injuries due to exercise
can occur; to minimize the risk the intensity of the exercise program will be
gradually increased during the study and the program will be supervised by a
physiotherapist. The estimated extra risk for the patient while participating
in this study is low.
Benefits: Possible benefits for participants are a reduction in fatigue and an
increase of physical fitness possibly leading to prosperous recovery and better
HRQoL.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
head neck cancer patients who are scheduled for chemoradiotherapy or bioradiotherapy (cetuximab and radiotherapy)
<=> 18 years of age
sufficient Dutch writing and reading skills
no contra indication for physical activity
Exclusion criteria
na
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL61408.041.17 |
OMON | NL-OMON27597 |