Determine arm and shoulder function and quality of life scores before and after treatment of SST. The untreated extremity can serve as a control.Determine riskfactors for a poor functionale outcome and quality of life after treatment for SST (e.g.…
ID
Source
Brief title
Condition
- Respiratory tract neoplasms
- Respiratory tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Questionnaire DASH (Disability of Arm, Shoulder and Hand)
Questionnaire Quality of life (SF-36)
Objective measurement of arm- and shoulderfunction (treated and untreated
extremity)
A.R.A.-test: Action research arm-test
9-hole peg-test
R.O.M.-test: Range Of Motion-test
FAT-test: Frenchay Arm Test
Secondary outcome
Age
Symptomatic period before start treatment
Radiotherapy dose
chemotherapy scheme
clinical tumour stage (cTNM)
pathological tumour stage (pTNM)
Time interval between induction and surgery
Time interval between surgery and study date
Right or left handedness
Background summary
Superior sulcus tumours are rare lung carcinoma's classified as stage 2B or 3.
With trimodality treatment (induction chemoradiotherapy, followed by surgery)
patients have a relatively favouorable prognosis, especially compared to other
stage 3 patients. However, the function of shoulder and arm and quality of life
may be impaired due to the intensive local treatment. In the literature
virtually no data are available on this topic. Since VUmc is a referral centre
for patients with SST and since 2002 all patients have been treated with the
same protocol, an ideal situation exists to evaluate the long term disabilities
and quality of life after treatment.
Study objective
Determine arm and shoulder function and quality of life scores before and after
treatment of SST. The untreated extremity can serve as a control.
Determine riskfactors for a poor functionale outcome and quality of life after
treatment for SST (e.g. radiotherapydose, interval between induction and
surgery, etc
To inform patients in the future before surgery on the expected function and
quality of life after resection
If avoidable risk factors can be identified, e.g. through perioperative measures
Initiate new studies on safety of new treatment protocols (eg. higher
radiotherapy doses)
Study design
Longitudinal cohort study in patients operated in VUmc aftter induction with
chemoradiation for SST since 01-01-2002
Study burden and risks
Study will be scheduled on the same day as a outpatient clinic visit has been
booked (if any). For patients who do not have a visit booked at VUmc, they will
be asked to make a seperate appointment for this study. These participants will
get a reimbursement of travel expenses.
De Boelelaan 1117, Postbus 7057
1007 MB, Amsterdam
Nederland
De Boelelaan 1117, Postbus 7057
1007 MB, Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Surgical resection of sulcus superior tumour in VUmc after induction treatment with chemoradiatiotherapy
Treated after 01-01-2002
Age at treatment between 18 and 80 years
Exclusion criteria
Current functional status ECOG >2 (confined to bed or chair >50% of waking hours)
Armfunction not assessable due to causes unrelated to locoregional treatment for SST (e.g. CVA, trauma, brain metastasis)
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 |
---|---|
CCMO | NL30761.029.09 |