An interventional study of Individualized prognostic counselling in Squamous Cell Carcinoma of Head and Neck, sponsored by Erasmus Medical Center. Active, not recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-21.
Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Other
The investigators test the effect of providing individualized prognostic information on life-expectancy to head and neck cancer patients in the palliative phase.
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's planned enrollment of 160 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
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Exclusion Criteria:
Current general counselling on life expectancy
Individualized prognostic counselling on life expectancy
Other: Individualized prognostic counselling
Individualized prognostic counselling on life expectancy using the prognostic model 'OncologIQ Palliative'
Decisional conflict
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.
Time frame: 2 weeks
Satisfaction with decision making process and proactive care planning
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
Time frame: 3-4 weeks
Treatment
The amount and type of treatment(s) the patient receives in the palliative phase
Time frame: At the end of the study
Survival
Overall survival from the start of the palliative trajectory
Time frame: Through study completion, up to 2 years
Quality of Life Score
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.
Time frame: Baseline and every 6-8 weeks
Palliative sedation and Euthanasia
The incidence of palliative sedation and euthanasia
Time frame: Through study completion, up to 2 years
Plan to share: No
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This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Erasmus Medical Center