Squamous Cell Carcinoma of Head and Neck
Conditions
Keywords
Palliative Care, Life expectancy, Counseling, Quality of life, Prognosis
Brief summary
The investigators test the effect of providing individualized prognostic information on life-expectancy to head and neck cancer patients in the palliative phase.
Detailed description
In this prospective sequential cohort study, the investigators aim to include 160 patients with a palliative diagnosis of head and neck squamous cell carcinoma, divided into two cohorts. In cohort 1, patients will receive general prognostic counselling, while in cohort 2, patients will receive individualized prognostic counselling using the recently developed prognostic model 'OncologIQ Palliative'. Cohort 2 will commence after completion of cohort 1. The primary outcome will be decisional conflict and satisfaction with the decision-making process and proactive care planning. Additionally, we will assess whether patients undergo palliative treatment and, if so, the type of treatment received. We will also evaluate overall survival, the incidence of palliative sedation or euthanasia, and quality of life.
Interventions
OTHERIndividualized prognostic counselling
Individualized prognostic counselling on life expectancy using the prognostic model 'OncologIQ Palliative'
Sponsors
Dutch Cancer Society
Erasmus Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who received a palliative diagnosis of a squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, supraglottic larynx, glottis larynx and unknown primary.
Exclusion criteria
* Illiterate patients * Insufficient knowledge of Dutch language * Incompetent (due to i.e. mental state) to consider their own treatment choice
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decisional conflict | 2 weeks | Decisional conflict (DC) will be assessed using the Decisional Conflict Scale (DCS) questionnaire, reported two weeks after the consultation in which the palliative diagnosis is shared. The overall score can range from 0 (no DC) to 100 (extremely high DC). A score of ≥25 is considered the cutoff for clinically significant decisional conflict. |
| Satisfaction with decision making process and proactive care planning | 3-4 weeks | To measure satisfaction with decision making process and proactive care planning, including end-of-life discussions on preferred place of death and wishes for palliative sedation and euthanasia we will conduct interviews among patients after counselling with OncologIQ Palliative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment | At the end of the study | The amount and type of treatment(s) the patient receives in the palliative phase |
| Survival | Through study completion, up to 2 years | Overall survival from the start of the palliative trajectory |
| Quality of Life Score | Baseline and every 6-8 weeks | Quality of life will be assessed using the validated questionnaire EORTC QLQ-C15-PAL at baseline and at regular intervals throughout the study period. It consists of 15 questions, assessing 10 domains. All questions are scored on a 4-point scale, ranging from 1 (not at all) to 4 (very much). A higher score indicates a better QoL for the domains of emotional functioning, physical functioning, and global health status. In contrast, for the remaining domains, lower scores indicate better QoL. |
| Palliative sedation and Euthanasia | Through study completion, up to 2 years | The incidence of palliative sedation and euthanasia |
Countries
Netherlands
Outcome results
None listed