Prognostic Counselling in Palliative Head and Neck Cancer (ProCoPall)

Not Applicable

Active, not recruiting

• Conditions: Squamous Cell Carcinoma of Head and Neck

• Registration Number: NCT06699316
• Lead Sponsor: Erasmus Medical Center

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.

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2024-10-25
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-18
• Last Update Submitted: 2024-11-18
• Study First Posted: 2024-11-21
• Last Update Posted: 2024-11-21
• Primary Completion: 2025-12-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Erasmus MC; 🇳🇱 Rotterdam, Netherlands