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Active, Not Recruiting

NCT Number: NCT06699316

Prognostic Counselling in Palliative Head and Neck Cancer (ProCoPall)

The investigators test the effect of providing individualized prognostic information on life-expectancy to head and neck cancer patients in the palliative phase.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Squamous Cell Carcinoma of Head and Neck Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus MC

Rotterdam, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individualized prognostic counselling

Other

Individualized prognostic counselling on life expectancy using the prognostic model 'OncologIQ Palliative'

Primary outcomes

  1. Decisional conflict

    Time frame: 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.

  2. Satisfaction with decision making process and proactive care planning

    Time frame: 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 outcomes

  1. Treatment

    Time frame: At the end of the study

    The amount and type of treatment(s) the patient receives in the palliative phase

  2. Survival

    Time frame: Through study completion, up to 2 years

    Overall survival from the start of the palliative trajectory

  3. Quality of Life Score

    Time frame: 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.

  4. Palliative sedation and Euthanasia

    Time frame: Through study completion, up to 2 years

    The incidence of palliative sedation and euthanasia

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Dutch Cancer Society

Registry information

Official study title

Individualized Prognostic Counseling on Life Expectancy of Head and Neck Cancer Patients in the Palliative Phase

Acronym: ProCoPall

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Nov 21, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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