Prognostic Counselling in Palliative Head and Neck Cancer (ProCoPall) (ProCoPall)

November 18, 2024 updated by: Dr. Marinella P. J. Offerman, Erasmus Medical Center

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Cohort 1
Current general counselling on life expectancy
Experimental: Cohort 2
Individualized prognostic counselling on life expectancy
Other: Individualized prognostic counselling
Individualized prognostic counselling on life expectancy using the prognostic model 'OncologIQ Palliative'

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 weeks
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
3-4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment
Time Frame: At the end of the study
The amount and type of treatment(s) the patient receives in the palliative phase
At the end of the study
Survival
Time Frame: Through study completion, up to 2 years
Overall survival from the start of the palliative trajectory
Through study completion, up to 2 years
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.
Baseline and every 6-8 weeks
Palliative sedation and Euthanasia
Time Frame: Through study completion, up to 2 years
The incidence of palliative sedation and euthanasia
Through study completion, up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Collaborators

Dutch Cancer Society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

October 25, 2024

First Submitted That Met QC Criteria

November 18, 2024

First Posted (Estimated)

November 21, 2024

Study Record Updates

Last Update Posted (Estimated)

November 21, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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