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| Name | Class |
|---|---|
| Dutch Cancer Society | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | No Intervention | Current general counselling on life expectancy | |
| Cohort 2 | Experimental | Individualized prognostic counselling on life expectancy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized prognostic counselling | Other | Individualized prognostic counselling on life expectancy using the prognostic model 'OncologIQ Palliative' |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 3-4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment | The amount and type of treatment(s) the patient receives in the palliative phase | At the end of the study |
| Survival | Overall survival from the start of the palliative trajectory |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Rotterdam | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39794711 | Derived | van den Besselaar BN, Sewnaik A, Dorr MC, Hoesseini A, Hardillo JA, Baatenburg de Jong RJ, Offerman MPJ. A study protocol for individualized prognostic counselling in the palliative phase. BMC Palliat Care. 2025 Jan 10;24(1):9. doi: 10.1186/s12904-025-01647-z. |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| 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. | Baseline and every 6-8 weeks |
| Palliative sedation and Euthanasia | The incidence of palliative sedation and euthanasia | Through study completion, up to 2 years |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |