Prognostic Counselling in Palliative Head and Neck Cancer (ProCoPall)

NCT06699316 | Active Not Recruiting

• 1 other identifier: 9109
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Squamous Cell Carcinoma of Head and Neck

Keywords

Palliative Care; Life expectancy; Counseling; Quality of life; Prognosis

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Treatment

  At the end of the study

• Survival

  Through study completion, up to 2 years

• Quality of Life Score

  Baseline and every 6-8 weeks

• Palliative sedation and Euthanasia

  Through study completion, up to 2 years

Study Arms (2)

Cohort 1

NO INTERVENTION

Current general counselling on life expectancy

Cohort 2

EXPERIMENTAL

Individualized prognostic counselling on life expectancy

Other: Individualized prognostic counselling

Interventions

Individualized prognostic counselling OTHER

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

Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Illiterate patients
• Insufficient knowledge of Dutch language
• Incompetent (due to i.e. mental state) to consider their own treatment choice

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Dutch Cancer Society: collaborator

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 39794711 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: November 21, 2024
• Study Start: September 1, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)