To investigate decisional conflict, treatment choices, and quality of life in patients with HNSCC after individualized prognostic counselling, in comparison with the current prognostic counselling. Secondary objectives are to investigate (disease-…
ID
Source
Brief title
Condition
- Other condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Health condition
plaveiselcelcarcinoom van het hoofd-hals gebied
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* A significant reduction of decisional conflict in the intervention group.
Secondary outcome
* Fraction of patients who choose not to follow RWHHT advice and therefore
receive a non-protocol based treatment in the intervention group.
* Quality of life: level of quality of life, specified on head and neck cancer,
anxiety and/or distress.
* (Disease-free) survival rates: recurrence of the tumor, death and cause of
death
* Socio-economic status: highest level of education, current profession and
postal code of the home address
Background summary
In the Netherlands, about 2700 new patients with head and neck squamous cell
carcinoma (HNSCC) are diagnosed annually. In majority of cases, treatment
consists of surgery, radiotherapy, chemotherapy and combinations of these
modalities. All types of treatment are associated with high morbidity,
sometimes compromising vital functions. Accurate counselling for treatment
options, survival rates and quality of life is important. Dedicated software
packages incorporating prognostic models have proven to aid physicians in
making accurate predictions of prognosis for the individual patient with HNSCC.
Our hypothesis is that individualized prognostic counselling leads to less
decisional conflict. In patients with a poor prognosis individualized
prognostic counselling may lead less extensive treatment and an improved
quality of life.
Study objective
To investigate decisional conflict, treatment choices, and quality of life in
patients with HNSCC after individualized prognostic counselling, in comparison
with the current prognostic counselling. Secondary objectives are to
investigate (disease-free) survival rates in patients after individualized
prognostic counselling, in comparison with the current prognostic counselling
and to investigate the influence of socio-economic status on treatment choices,
decisional conflict, quality of life and (disease-free) survival.
Study design
Prospective clinical trial with sequential cohorts.
Intervention
The individual prognosis is calculated by OncologIQ, software on the computer,
which is able to calculate survival rates in each individual, by using tumor-
and patient characteristics. Besides localization and TNM-classification of the
tumor, also age, gender, past diseases and comorbidity (ACE-27) of the patient
are taken into account. The calculation shows a patient-specific survival rate,
expressed in time-bound percentages for 1, 2 and 5 years of survival.
Study burden and risks
The extra burden of a patient is restricted to answering 4 questionnaires
(total of 27 questions).
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
Primary squamous cell carcinoma of lip, nasopharynx, oral cavity, oropharynx, larynx or hypopharynx
Second primary squamous cell carcinoma of lip, nasopharynx, oral cavity, oropharynx, larynx or hypopharynx
Curative intent
Follow-up takes place in the Erasmus MC
Written informed consent from the patient
Exclusion criteria
No curative intent based on tumor site and tumor characteristics
Recurrent tumor
Simultaneous or synchronic multiple primary HNSCC
Illiterate patient
Insufficient knowledge of Dutch language
Incompetent (due to a.o. mental state) to consider their own treatment choice
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 | NL42154.078.13 |
| OMON | NL-OMON27751 |