Life-limiting IllnessNCT06549075
Therapeutic Support to Strengthen Dignity, Mental Well-being and Quality of Life in Acute Palliative Care Patients.
A study testing Therapeutic support and Standard Specialized Palliative Consultation Service in people with Life-limiting Illness and Breast Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The goal of this clinical trial is to test the benefit of a newly designed personalized therapeutic intervention compared to the standard specialized palliative care service at the swiss acute palliative hospital care.The main questions it aims to answer are: Does an additional therapeutic support that fits the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Life-limiting Illness, Breast Cancer, Glioblastoma
- What is being tested?
- Therapeutic support and Standard Specialized Palliative Consultation Service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Sep 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Informed Consent
- Patients seen by the palliative consultation-liaison service at the University Hospital Basel as an in- or outpatient
- Suffering from a life-limiting serious illness (≤ 18 months)
- ≥ 18 years of age
- Willingness and capacity to commit to three study visits
Who cannot join
- Delirious (ICD-10: F05.9)
- Inability to give consent (lack of decisional capacity to consent)
- Inability to follow the procedures of the study due to psychological disorders, dementia, or other cognitively impairment of the participant,
- Too ill to complete the requirements of the protocol
- Unable to understand, speak and read German
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Personalized Modular Intervention to Promote Dignity, Meaningfulness and Mindfulness by a Palliative Care Consultation-Liaison Service in Swiss Acute Hospital Care. A Randomized Controlled Trial
The goal of this clinical trial is to test the benefit of a newly designed personalized therapeutic intervention compared to the standard specialized palliative care service at the swiss acute palliative hospital care.The main questions it aims to answer are:
Does an additional therapeutic support that fits the individual needs of a palliative care patient increases dignity and mental well-being as measures by a questionnaire (Patient Dignity Inventory) to a larger extent than standard palliative care alone? Is the additional therapeutic support perceived as helpful? Researchers will compare the additional therapeutic support with standard palliative care to standard palliative care alone.
Read more
Participants will:
Receive additional therapeutic support in two structured sessions a 60 minutes and/or standard palliative care Fill out questionnaires before and after therapeutic interventions and standard palliative care Provide a semi-structured interview following the therapeutic support
Read the detailed description
Patient with a life-limiting serious illness commonly experience substantial emotional and spiritual distress, death anxieties, depressive symptoms and loss of dignity and purpose in life. Fostering dignity and meaning and relieving psychological distress have been identified as a core objective for end-of-life care. However, individual's needs for dignity and psychological support at the end of life may vary. Therefore, a personalized approach is needed. On the basis of theoretical frameworks and existing dignityfostering and meaning based interventions, and a workshop with international experts in the field of palliative care, the investigators have developed a personalized modular intervention, consisting of three modules, including CALM Therapy, Dignity Therapy, and a mindfulness-based intervention.
The overall purpose of this study is to test the efficacy of the designed personalized modular intervention compared to the specialized palliative care service at the swiss acute palliative hospital care.
Patients are randomized to either receiving standard specialized palliative consultation (SSPC) and the modular intervention or standard palliative consultation services alone. Within the intervention group, participants can choose one of the three modules based on personal preference and the recommendation of the palliative care team (based on assessment). All three interventions consist of two structured sessions.
The control group will receive SSPC alone. According to needs standard specialized palliative care will include support of symptom control, shared decision making/ advance care planning, network planning and support of relatives.
SSPC is performed by specialized inter-professional palliative care service, including doctors and advanced nurse practitioners, certified by national standards for specialist palliative care. Other professions are involved depending on needs. Patients are seen as required at least twice a week.
Patients will be asked to fill in a set of questionnaires at baseline (T0), after the completion of the intervention (T1) and at 1-month follow-up (T2). A brief semi-structured qualitative interview will be conducted with the patients following completion of the intervention to assess perceived benefits and challenges of the intervention.
The primary objective is to evaluate if mental well-being tend to improve over the pre- versus post study design as measured by the Patient Dignity Inventory and if this effect is significantly larger in the modular intervention group as compared to the standard specialized palliative consultation (SSPC) group.
- Conditions
- Life-limiting Illness, Breast Cancer, Glioblastoma, Prostate Cancer
- Being tested
- Therapeutic support, Standard Specialized Palliative Consultation Service
- Keywords
- dignity, palliative care, short-term intervention, end-of-life care
- Medical subject headings
- Breast Neoplasms, Glioblastoma, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic supportOther
Also called personnalized modular therapeutic support
The modular intervention consists of three modules, including Dignity Therapy, CALM Therapy and Mindfulness-based training. According to the patient's preferences, the patient will be allocated to one of the three interventions, which will be conducted by trained therapists within two sessions.
Standard Specialized Palliative Consultation ServiceOther
According to needs standard specialized palliative care will include support of symptom control, shared decision making/ advance care planning, network planning and support of relatives.
| Study group | Role | What they receive |
|---|---|---|
| Personnalized modular therapeutic support | Experimental | Not described Receives: Other: Therapeutic support; Other: Standard Specialized Palliative Consultation Service |
| Standard Specialized Palliative Consultation Service | Active comparator | Not described Receives: Other: Standard Specialized Palliative Consultation Service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Dignity Inventory
Questionnaire (Self-reported outcome), higher score means worse outcome
Measured: Baseline, after intervention, 4 week follow-up
Secondary outcomes (2)
Patient Health Questionnaire PHQ-9
higher score means worse outcome
Measured: Baseline, after intervention, 4 week follow-up
Integrated Palliative Outcome Scale (IPOS)
Higher score means worse outcome
Measured: Baseline, after intervention, 4 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start10 Sep 2024
- Primary completion28 May 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Life-limiting IllnessStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549075
- Sponsor's protocol ID
- 2024-01301
- Other IDs
- 2024-01301
- Status last verified
- Oct 2026
- First submitted
- 8 Aug 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Personalized Modular Intervention to Promote Dignity, Meaningfulness and Mindfulness by a Palliative Care Consultation-Liaison Service in Swiss Acute Hospital Care. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06549075
- Acronym / sponsor ID
- 2024-01301
- Conditions
- Life-limiting Illness, Breast Cancer, Glioblastoma, Prostate Cancer
- Keywords
- dignity, palliative care, short-term intervention, end-of-life care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 28 May 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 12 Aug 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 goal of this clinical trial is to test the benefit of a newly designed personalized therapeutic intervention compared to the standard specialized palliative care service at the swiss acute palliative hospital care.The main questions it aims to answer are:
Does an additional therapeutic support that fits the individual needs of a palliative care patient increases dignity and mental well-being as measures by a questionnaire (Patient Dignity Inventory) to a larger extent than standard palliative care alone? Is the additional therapeutic support perceived as helpful? Researchers will compare the additional therapeutic support with standard palliative care to standard palliative care alone.
Participants will:
Receive additional therapeutic support in two structured sessions a 60 minutes and/or standard palliative care Fill out questionnaires before and after therapeutic interventions and standard palliative care Provide a semi-structured interview following the therapeutic support
Detailed description
Patient with a life-limiting serious illness commonly experience substantial emotional and spiritual distress, death anxieties, depressive symptoms and loss of dignity and purpose in life. Fostering dignity and meaning and relieving psychological distress have been identified as a core objective for end-of-life care. However, individual's needs for dignity and psychological support at the end of life may vary. Therefore, a personalized approach is needed. On the basis of theoretical frameworks and existing dignityfostering and meaning based interventions, and a workshop with international experts in the field of palliative care, the investigators have developed a personalized modular intervention, consisting of three modules, including CALM Therapy, Dignity Therapy, and a mindfulness-based intervention.
The overall purpose of this study is to test the efficacy of the designed personalized modular intervention compared to the specialized palliative care service at the swiss acute palliative hospital care.
Patients are randomized to either receiving standard specialized palliative consultation (SSPC) and the modular intervention or standard palliative consultation services alone. Within the intervention group, participants can choose one of the three modules based on personal preference and the recommendation of the palliative care team (based on assessment). All three interventions consist of two structured sessions.
The control group will receive SSPC alone. According to needs standard specialized palliative care will include support of symptom control, shared decision making/ advance care planning, network planning and support of relatives.
SSPC is performed by specialized inter-professional palliative care service, including doctors and advanced nurse practitioners, certified by national standards for specialist palliative care. Other professions are involved depending on needs. Patients are seen as required at least twice a week.
Patients will be asked to fill in a set of questionnaires at baseline (T0), after the completion of the intervention (T1) and at 1-month follow-up (T2). A brief semi-structured qualitative interview will be conducted with the patients following completion of the intervention to assess perceived benefits and challenges of the intervention.
The primary objective is to evaluate if mental well-being tend to improve over the pre- versus post study design as measured by the Patient Dignity Inventory and if this effect is significantly larger in the modular intervention group as compared to the standard specialized palliative consultation (SSPC) group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personnalized modular therapeutic support | Experimental | Other: Therapeutic support, Other: Standard Specialized Palliative Consultation Service |
| Standard Specialized Palliative Consultation Service | Active comparator | Other: Standard Specialized Palliative Consultation Service |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed Consent
- Patients seen by the palliative consultation-liaison service at the University Hospital Basel as an in- or outpatient
- Suffering from a life-limiting serious illness (≤ 18 months)
- ≥ 18 years of age
- Willingness and capacity to commit to three study visits
Key exclusion criteria (5 listed)
- Delirious (ICD-10: F05.9)
- Inability to give consent (lack of decisional capacity to consent)
- Inability to follow the procedures of the study due to psychological disorders, dementia, or other cognitively impairment of the participant,
- Too ill to complete the requirements of the protocol
- Unable to understand, speak and read German
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 |
|---|---|---|
| Therapeutic supportAlso: personnalized modular therapeutic supportThe modular intervention consists of three modules, including Dignity Therapy, CALM Therapy and Mindfulness-based training. According to the patient's preferences, the patient will be allocated to one of the three interventions, which will be conducted by trained therapists within two sessions. | Other | Personnalized modular therapeutic support |
| Standard Specialized Palliative Consultation ServiceAccording to needs standard specialized palliative care will include support of symptom control, shared decision making/ advance care planning, network planning and support of relatives. | Other | Personnalized modular therapeutic support, Standard Specialized Palliative Consultation Service |
Primary outcome
Patient Dignity Inventory
Time frame: Baseline, after intervention, 4 week follow-up
Questionnaire (Self-reported outcome), higher score means worse outcome
2 secondary outcomes
Patient Health Questionnaire PHQ-9
Time frame: Baseline, after intervention, 4 week follow-up
Integrated Palliative Outcome Scale (IPOS)
Time frame: Baseline, after intervention, 4 week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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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 Therapeutic support and Standard Specialized Palliative Consultation Service in people with Life-limiting Illness and Breast Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 20 Oct 2026. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient Dignity Inventory (time frame: Baseline, after intervention, 4 week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2026.