Palliative CarePrimPalNCT07737899
Primary Palliative Care - a Feasibility Cluster Trial
A study testing Primary Palliative Care Complex Intervention (PrimPal) in people with Palliative Care and Primary Palliative Care, run by University of Coimbra at 2 sites in Portugal.
Trial summary
This feasibility cluster-controlled randomized trial (RCT) evaluates a complex intervention for the delivery of primary palliative care in Family Health Units (FHUs). The intervention consists of training General Practitioners (GPs) in palliative care through a 30 hour e-learning program and implementing a structured… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Primary Palliative Care, Advanced Cancer
- What is being tested?
- Primary Palliative Care Complex Intervention (PrimPal)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesPortugal
- Study dates
- 1 Oct 2026to 31 Aug 2027
- 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
- Aged 18 years or older.
- Enrolled as a patient on the list of a recruited General Practitioner in one of the participating Family Health Units.
- Diagnosed with one or more of the following advanced chronic conditions:
- Advanced-stage neoplasm (metastatic/stage IV cancer);
- Chronic Obstructive Pulmonary Disease (COPD) - GOLD classification III or IV;
- Congestive Heart Failure (CHF) - New York Heart Association (NYHA) functional classification III or IV;
- Chronic Kidney Disease (CKD) - stage IV or V.
Who cannot join
- Refusal to provide informed consent or to participate in the study at any point.
- Disease severity requiring urgent medical intervention (acute crisis/emergency care need at time of recruitment).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal2 sites
Family Health Unit 1 - ULS Coimbra (Intervention)
Coimbra
Family Health Unit 2 - ULS Coimbra (Control)
Coimbra
About this study
This feasibility cluster-controlled randomized trial (RCT) evaluates a complex intervention for the delivery of primary palliative care in Family Health Units (FHUs). The intervention consists of training General Practitioners (GPs) in palliative care through a 30 hour e-learning program and implementing a structured consultation model (4 consultations over 12 weeks) for adult patients with advanced chronic illness. One FHU will receive the intervention and one FHU will follow usual care. The primary goal is to assess feasibility metrics (GP adherence, patient recruitment rate, and patient retention rate), which will inform the design of a subsequent full-scale cluster RCT.
Read the detailed description
Background: Demographic ageing and the rising burden of chronic disease have dramatically increased the need for palliative care. Most patients with palliative care needs are cared for in primary health care (PHC) settings, yet GPs often lack training and systematic tools to identify and manage these patients. The Principal Investigator developed a complex intervention combining GP training and a new consultation model during doctoral research, demonstrating promising results (reduction in physical and psychological symptoms) in a before-after study (published in Palliative Medicine, DOI: 10.1177/02692163231219682). The present feasibility trial is the next methodological step before undertaking a full-scale cluster RCT.
Design: Feasibility cluster-controlled RCT with an embedded qualitative component (mixed-methods). Randomisation occurs at the cluster (FHU) level. Two FHUs from ULS Coimbra (central Portugal) will be recruited: one allocated to the intervention arm and one to the control (usual care) arm.
Intervention: GPs in the intervention FHU will complete a 30hour e-learning training programme covering palliative care communication, symptom management, and patient assessment/control. After training, each GP will apply the new structured consultation model to recruited patients over 12 weeks (4 consultations). The model is grounded in the 4th edition of the National Consensus Project's Clinical Practice Guidelines for Quality Palliative Care and WONCA's core competencies for GPs in palliative care.
Control: GPs in the control FHU will follow usual care without any specific palliative care training or structured consultation model.
Participants: Adult patients (≥18 years) on the list of recruited GPs with a diagnosis of: advanced-stage neoplasm (metastatic cancer), COPD GOLD III/IV, Congestive Heart Failure NYHA III/IV, or Chronic Kidney Disease stage IV/V.
Feasibility outcomes: GP implementation rate (primary), patient recruitment rate, and patient retention rate will be assessed at baseline (T0), week 6 (T1), and week 12 (T2). Qualitative data will be collected through interviews with GPs and patients to explore perceived barriers and benefits of the intervention.
Significance: Results will be used to refine the intervention and study procedures, and to power a future definitive cluster RCT.
- Conditions
- Palliative Care, Primary Palliative Care, Advanced Cancer, Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure Chronic, Chronic Kidney Disease (Stages 4 and 5)
- Being tested
- Primary Palliative Care Complex Intervention (PrimPal)
- Keywords
- Palliative care, Primary Palliative Care, General practice, Family medicine, Feasibility study, Cluster randomized controlled trial, Complex intervention, Chronic disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Renal Insufficiency, Chronic, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Palliative Care Complex Intervention (PrimPal)Other
- GPs will receive an e-learning palliative care training programme with a 30-h load, including topics such as the role of communication, the main problems and symptoms of patients with palliative care needs and how to assess and control them. Additionally, the programme covered how to apply the newly developed medical consultation model and how to use the Integrated Palliative Care Outcome Scale (IPOS) patient version
- Primary palliative care consultation model divided into five areas (1) summarizing clinical information, (2) objective symptoms' management, (3) assessment and coding of chronic diseases and symptoms, (4) planning clinical approach and (5) addressing other problems/concerns - 4 consultations over 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Primary Palliative Care Consultation | Experimental | General Practitioners in the intervention FHU complete a 30hour e-learning training programme in palliative care and apply a new structured consultation model over 12 weeks (4 consultations) with recruited patients. Receives: Other: Primary Palliative Care Complex Intervention (PrimPal) |
| Control (Usual Care) | No intervention | GPs in the control FHU deliver usual palliative care without specific training or structured consultation model. |
What is being measured
The primary outcome is the main question the study is designed to answer.
GP Feasibility Rate (Implementation Rate)
Percentage of GPs in the intervention arm who successfully implement the new consultation model with their recruited patients (excluding failures due to reasons unrelated to the physician, e.g., patient death or withdrawal). Feasibility is considered demonstrated if ≥70% of GPs complete the model with at least 80% of their recruited patients.
Measured: 12 weeks (from start of intervention to end of consultation cycle - Week 12 / T2)
Secondary outcomes (4)
Patient Recruitment Rate
Percentage of contacted eligible patients who agree to participate in the study.
Measured: Baseline (T0) - during recruitment period
Patient Retention Rate
Percentage of enrolled patients who complete all 4 consultations and remain in the study until week 12.
Measured: Week 12 (T2)
Perceived Barriers to Implementation
Qualitative exploration of obstacles experienced by GPs and patients in the implementation of the intervention, assessed via semi-structured interviews
Measured: Week 12 (T2) - end of intervention
Perceived Benefits of the Intervention
Qualitative exploration of the benefits perceived by GPs and patients from the intervention, assessed via semi-structured interviews.
Measured: Week 12 (T2) - end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- Unidade Local de Saúde de Coimbra, EPE
- Responsible party
- Principal investigator, Carlos Seiça Cardoso, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737899
- Sponsor's protocol ID
- IN1590 | PrimPal Trial
- Other IDs
- 2024.18252.PEX
- Acronym
- PrimPal
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seica Cardoso C, Prazeres F, Oliveiros B, Nunes C, Simoes P, Aires C, Rita P, Penetra J, Lopes P, Alcobia S, Baptista S, Venancio C, Gomes B. Feasibility and effectiveness of a two-tiered intervention involving training and a new consultation model for patients with palliative care needs in primary care: A before-after study. Palliat Med. 2024 Sep;38(8):842-852. doi: 10.1177/02692163231219682. Epub 2024 Jan 16.
PubMed 38226491Seica Cardoso C, Prazeres F, Nunes C, Simoes P, Aires C, Rita P, Penetra J, Lopes P, Alcobia S, Gomes B. Impact of a complex intervention in primary care for patients with palliative care needs in their healthcare utilization: a before-after study. Prim Health Care Res Dev. 2026 Jan 30;27:e15. doi: 10.1017/S1463423625100777.
PubMed 41612825
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Palliative Care - a Feasibility Cluster Trial
- ClinicalTrials.gov ID
- NCT07737899
- Acronym / sponsor ID
- PrimPal / IN1590 | PrimPal Trial
- Conditions
- Palliative Care, Primary Palliative Care, Advanced Cancer, Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure Chronic, Chronic Kidney Disease (Stages 4 and 5)
- Keywords
- Palliative care, Primary Palliative Care, General practice, Family medicine, Feasibility study, Cluster randomized controlled trial, Complex intervention, Chronic disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Collaborators
- Unidade Local de Saúde de Coimbra, EPE
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 30 Jul 2026 (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.
This feasibility cluster-controlled randomized trial (RCT) evaluates a complex intervention for the delivery of primary palliative care in Family Health Units (FHUs). The intervention consists of training General Practitioners (GPs) in palliative care through a 30 hour e-learning program and implementing a structured consultation model (4 consultations over 12 weeks) for adult patients with advanced chronic illness. One FHU will receive the intervention and one FHU will follow usual care. The primary goal is to assess feasibility metrics (GP adherence, patient recruitment rate, and patient retention rate), which will inform the design of a subsequent full-scale cluster RCT.
Detailed description
Background: Demographic ageing and the rising burden of chronic disease have dramatically increased the need for palliative care. Most patients with palliative care needs are cared for in primary health care (PHC) settings, yet GPs often lack training and systematic tools to identify and manage these patients. The Principal Investigator developed a complex intervention combining GP training and a new consultation model during doctoral research, demonstrating promising results (reduction in physical and psychological symptoms) in a before-after study (published in Palliative Medicine, DOI: 10.1177/02692163231219682). The present feasibility trial is the next methodological step before undertaking a full-scale cluster RCT.
Design: Feasibility cluster-controlled RCT with an embedded qualitative component (mixed-methods). Randomisation occurs at the cluster (FHU) level. Two FHUs from ULS Coimbra (central Portugal) will be recruited: one allocated to the intervention arm and one to the control (usual care) arm.
Intervention: GPs in the intervention FHU will complete a 30hour e-learning training programme covering palliative care communication, symptom management, and patient assessment/control. After training, each GP will apply the new structured consultation model to recruited patients over 12 weeks (4 consultations). The model is grounded in the 4th edition of the National Consensus Project's Clinical Practice Guidelines for Quality Palliative Care and WONCA's core competencies for GPs in palliative care.
Control: GPs in the control FHU will follow usual care without any specific palliative care training or structured consultation model.
Participants: Adult patients (≥18 years) on the list of recruited GPs with a diagnosis of: advanced-stage neoplasm (metastatic cancer), COPD GOLD III/IV, Congestive Heart Failure NYHA III/IV, or Chronic Kidney Disease stage IV/V.
Feasibility outcomes: GP implementation rate (primary), patient recruitment rate, and patient retention rate will be assessed at baseline (T0), week 6 (T1), and week 12 (T2). Qualitative data will be collected through interviews with GPs and patients to explore perceived barriers and benefits of the intervention.
Significance: Results will be used to refine the intervention and study procedures, and to power a future definitive cluster RCT.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Palliative Care Consultation | Experimental | Other: Primary Palliative Care Complex Intervention (PrimPal)General Practitioners in the intervention FHU complete a 30hour e-learning training programme in palliative care and apply a new structured consultation model over 12 weeks (4 consultations) with recruited patients. |
| Control (Usual Care) | No intervention | –GPs in the control FHU deliver usual palliative care without specific training or structured consultation model. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 years or older.
- Enrolled as a patient on the list of a recruited General Practitioner in one of the participating Family Health Units.
- Diagnosed with one or more of the following advanced chronic conditions:
- Advanced-stage neoplasm (metastatic/stage IV cancer);
- Chronic Obstructive Pulmonary Disease (COPD) - GOLD classification III or IV;
Key exclusion criteria (2 listed)
- Refusal to provide informed consent or to participate in the study at any point.
- Disease severity requiring urgent medical intervention (acute crisis/emergency care need at time of recruitment).
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 |
|---|---|---|
| Primary Palliative Care Complex Intervention (PrimPal)1. GPs will receive an e-learning palliative care training programme with a 30-h load, including topics such as the role of communication, the main problems and symptoms of patients with palliative care needs and how to assess and control them. Additionally, the programme covered how to apply the newly developed medical consultation model and how to use the Integrated Palliative Care Outcome Scale (IPOS) patient version 2. Primary palliative care consultation model divided into five areas (1) summarizing clinical information, (2) objective symptoms' management, (3) assessment and coding of chronic diseases and symptoms, (4) planning clinical approach and (5) addressing other problems/concerns - 4 consultations over 12 weeks. | Other | Primary Palliative Care Consultation |
Primary outcome
GP Feasibility Rate (Implementation Rate)
Time frame: 12 weeks (from start of intervention to end of consultation cycle - Week 12 / T2)
Percentage of GPs in the intervention arm who successfully implement the new consultation model with their recruited patients (excluding failures due to reasons unrelated to the physician, e.g., patient death or withdrawal). Feasibility is considered demonstrated if ≥70% of GPs complete the model with at least 80% of their recruited patients.
4 secondary outcomes
Patient Recruitment Rate
Time frame: Baseline (T0) - during recruitment period
Patient Retention Rate
Time frame: Week 12 (T2)
Perceived Barriers to Implementation
Time frame: Week 12 (T2) - end of intervention
Perceived Benefits of the Intervention
Time frame: Week 12 (T2) - end of intervention
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 3 Aug 2026.
- Background: PubMed 38226491Seica Cardoso C, Prazeres F, Oliveiros B, Nunes C, Simoes P, Aires C, Rita P, Penetra J, Lopes P, Alcobia S, Baptista S, Venancio C, Gomes B. Feasibility and effectiveness of a two-tiered intervention involving training and a new consultation model for patients with palliative care needs in primary care: A before-after study. Palliat Med. 2024 Sep;38(8):842-852. doi: 10.1177/02692163231219682. Epub 2024 Jan 16.
- Background: PubMed 41612825Seica Cardoso C, Prazeres F, Nunes C, Simoes P, Aires C, Rita P, Penetra J, Lopes P, Alcobia S, Gomes B. Impact of a complex intervention in primary care for patients with palliative care needs in their healthcare utilization: a before-after study. Prim Health Care Res Dev. 2026 Jan 30;27:e15. doi: 10.1017/S1463423625100777.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Palliative Care Complex Intervention (PrimPal) in people with Palliative Care and Primary Palliative Care, run by University of Coimbra at 2 sites in Portugal.
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 7 inclusion and 2 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: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. 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?
Contact Carlos S Cardoso, PhD (00351 239 857 700, carlosseicacardoso@uc.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GP Feasibility Rate (Implementation Rate) (time frame: 12 weeks (from start of intervention to end of consultation cycle - Week 12 / T2)). 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 NCT07737899, which also lists 2 linked publications.
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 3 Aug 2026.