Squamous Cell Carcinoma of Head and NeckProCoPallNCT06699316
Prognostic Counselling in Palliative Head and Neck Cancer (ProCoPall)
A study testing Individualized prognostic counselling in people with Squamous Cell Carcinoma of Head and Neck, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
The investigators test the effect of providing individualized prognostic information on life-expectancy to head and neck cancer patients in the palliative phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- Individualized prognostic counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2022to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Illiterate patients
- Insufficient knowledge of Dutch language
- Incompetent (due to i.e. mental state) to consider their own treatment choice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Being tested
- Individualized prognostic counselling
- Keywords
- Palliative Care, Life expectancy, Counseling, Quality of life, Prognosis
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized prognostic counsellingOther
Individualized prognostic counselling on life expectancy using the prognostic model 'OncologIQ Palliative'
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | No intervention | Current general counselling on life expectancy |
| Cohort 2 | Experimental | Individualized prognostic counselling on life expectancy Receives: Other: Individualized prognostic counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 3-4 weeks
Secondary outcomes (4)
Treatment
The amount and type of treatment(s) the patient receives in the palliative phase
Measured: At the end of the study
Survival
Overall survival from the start of the palliative trajectory
Measured: 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.
Measured: Baseline and every 6-8 weeks
Palliative sedation and Euthanasia
The incidence of palliative sedation and euthanasia
Measured: Through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Sep 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Principal investigator, Dr. Marinella P. J. Offerman, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699316
- Sponsor's protocol ID
- 9109
- Acronym
- ProCoPall
- Status last verified
- Nov 2024
- First submitted
- 25 Oct 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39794711
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Prognostic Counseling on Life Expectancy of Head and Neck Cancer Patients in the Palliative Phase
- ClinicalTrials.gov ID
- NCT06699316
- Acronym / sponsor ID
- ProCoPall / 9109
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Keywords
- Palliative Care, Life expectancy, Counseling, Quality of life, Prognosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | No intervention | –Current general counselling on life expectancy |
| Cohort 2 | Experimental | Other: Individualized prognostic counsellingIndividualized prognostic counselling on life expectancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Illiterate patients
- Insufficient knowledge of Dutch language
- Incompetent (due to i.e. mental state) to consider their own treatment choice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized prognostic counsellingIndividualized prognostic counselling on life expectancy using the prognostic model 'OncologIQ Palliative' | Other | Cohort 2 |
Primary outcome
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.
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
4 secondary outcomes
Treatment
Time frame: At the end of the study
Survival
Time frame: Through study completion, up to 2 years
Quality of Life Score
Time frame: Baseline and every 6-8 weeks
Palliative sedation and Euthanasia
Time frame: Through study completion, up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Derived from this study: PubMed 39794711van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized prognostic counselling in people with Squamous Cell Carcinoma of Head and Neck, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional conflict (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06699316, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.