A prospective clinical trial with sequential cohorts on the effect of individualized prognostic counselling on treatment decisions and quality of life in patients with head and neck cancer.

A prospective clinical trial with sequential cohorts on the effect of individualized prognostic counselling on treatment decisions and quality of life in patients with head and neck cancer. - Prognostic counselling in head and neck cancer

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47696

Enrollment

400

Registered

2013-05-28

Start date

2014-01-13

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

plaveiselcelcarcinoom van het hoofd-hals gebied head and neck squamous cell carcinoma

Interventions

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 loca

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
* A significant reduction of decisional conflict in the intervention group.	—

Secondary

Measure	Time frame
* 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	—

Measure

Time frame

* 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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)