CancerNCT04995848
Telepalliation - Digital Platform for Patients in Palliation and Their Relatives
A study testing Telepalliation in people with Cancer and Heart Failure, run by Aalborg University at 1 site in Denmark.
Trial summary
This project has focus on patients in palliation testing a digital platform TelePal.dk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Heart Failure, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Telepalliation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteDenmark
- Study dates
- 26 May 2021to 1 Aug 2024
- 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
- Over 18 years
- Live in Esbjerg, Varde, Billund, Fanø or Vejen Municipality
- Cancer, heart failure, chronic obstructive pulmonary disease (COPD), and motor neuron disease (neurological diseases) referred to the Palliation Team at Southwest Jutland Hospital
- Basic computer skills or a relative who has basic computer skills
Who cannot join
- Delirium at enrolment based on CAM score
- Active psychiatric history (as noted in the medical record) other than depression or anxiety related to the main diagnosis referred to palliative care
- Lack of ability to cooperate
Trial locations and contacts
1 site in 1 country.
Jarl Voss Andersen Sigaard, MD contact
Denmark1 site, 1 recruiting
- Recruiting
Palliative Team, South West Jutland Hospital
Esbjerg
Jarl Sigaard, jarl.Sigaard@rsyd.dk
About this study
Official title: Elepalliation - Digital Platform for Patienter i Palliation og Deres pårørende
This project has focus on patients in palliation testing a digital platform TelePal.dk.
Read the detailed description
The aim of the RCT study is to:
- Test, implement, and evaluate a telepalliation program for patients receiving palliative care (cancer, heart failure (HF), COPD, and motor neuron disease) from a clinical, psychosocial, inter-organizational, and health economic perspective.
- Being tested
- Telepalliation
- Keywords
- Palliative care, Palliation, Platform, Quality of life
- Medical subject headings
- Neoplasms, Heart Failure, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelepalliationOther
Telepalliation platform Telepal.dk
| Study group | Role | What they receive |
|---|---|---|
| Telepalliation group | Experimental | The intervention group will participate in the telepalliation program. The patients will lent a tablet during the RCT study to access the TelePal.dk platform an video consultations. The patients will participate from the time they are referred to palliative care, and are enrolled in the telepalliation program for up to six months or until:
1. They stop being followed by the Palliative Team due to lack of symptoms
2. They are diagnosed with delirium based upon clinical guidelines and the Confusion Assessment Method (CAM). The assessment of delirium will be done by either:
* The project nurse or the clinical responsible doctor at the patients' home OR
* A district nurse under video supervision by the project nurse or the clinical responsible doctor
3. Death of the patient Receives: Other: Telepalliation |
| Conventional palliation program | No intervention | The control group will follow a conventional palliation program. The patients will participate from the time they are referred to palliative care, and are enrolled in the telepalliation program for up to six months or until: 1. They stop being followed by the Palliative Team due to lack of symptoms 2. They are diagnosed with delirium based upon clinical guidelines and the Confusion Assessment Method (CAM). The assessment of delirium will be done by either: * The project nurse or the clinical responsible doctor at the patients' home OR * A district nurse under video supervision by the project nurse or the clinical responsible doctor 3. Death of the patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Quality of life
Measured by the European Organization for Research and Treatment of Cancer, questionnaire regarding quality of life in palliative cancer care patients (EORTC QLQ-C15-PAL).
Measured: At baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
Secondary outcomes (11)
Changes in medicine
Information on medicine for both groups will be collected at enrolment and every week from the electronic patient record (EPR). Changes in medicine over time will be analyzed.
Measured: At enrolment and week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
Changes in feeling of security
Measured on a likert scale
Measured: At baseline, twice every week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
Experiences of pain
Numerical Rating Scale (NRS)
Measured: At baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
Experience of pain (brief)
Brief Pain Inventory, short form (BPI-sf)
Measured: At baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
Experiences of patients on the actual use of the TelePal.dk platform and their experiences of being a part of a telepalliation program
Qualitative interviews
Measured: Week 4
Experiences of relatives on the actual use of the TelePal.dk platform and their experiences of being a part of a telepalliation program
Qualitative interviews
Measured: Week 4 and 3 months
Experiences of health care professionals on the actual use of the TelePal.dk platform and their experiences of being a part of a telepalliation program
Qualitative interviews
Measured: 6 months and 12 months
Perceptions on usability of a cross-sector communication platform and telerehabilitation program by patients, relatives and health care professionals
Qualitative interviews
Measured: 12 months
Observations on usability of a cross-sector communication platform and telerehabilitation program by patients, relatives and health care professionals
Observations
Measured: 12 months
Health related quality of life
Measured by EQ-5D Health Questionnaire
Measured: week 1 and week 4
Cost of healthcare services
Cost-effectiveness analysis ((number of phone/video calls, equipment, driving, personal use in palliative care (video and home visits), visits to general practitioner and outpatient clinic, hospitalizations, readmissions and length of stay, visits from palliative team))
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start26 May 2021
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (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 CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Mixed method randomised control trial
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Palliative Team,Hospital of South West Jutland, Center for Innovative Medical Technologies (CIMT), Odense University Hospital, Danish Cancer Society, Laboratory of Welfare Technology, Department of Health Science and Technology, Aalborg University
- Responsible party
- Principal investigator, Birthe Dinesen, Aalborg University
- Investigators
- Birthe Dinesen, MSc, PhD, Principal investigator, Aalborg UniversityJarl Voss Andersen Sigaard, MD, Study director, Palliative Team, South West Jutland Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995848
- Sponsor's protocol ID
- N-20200094
- Status last verified
- Jul 2023
- First submitted
- 26 May 2021
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan for sharing protocol as we are applying for patent.
Publications
Sigaard JVA, Joensen EDR, Birgisdottir UR, Spindler H, Dinesen B. Telepalliation creates a sense of security: A qualitative study of patients with cancer receiving palliative care. Palliat Med. 2026 May;40(5):608-616. doi: 10.1177/02692163251364145. Epub 2025 Oct 7.
PubMed 41055129Sigaard JVA, Henneberg NC, Schacksen CS, Kronborg SH, Petrini L, Kidholm K, Birgisdottir UR, Spindler H, Dinesen B. A Digital Platform (Telepalliation) for Patients in Palliative Care and Their Relatives: Protocol for a Multimethod Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 2;13:e49946. doi: 10.2196/49946.
PubMed 38564264
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elepalliation - Digital Platform for Patienter i Palliation og Deres pårørende
- ClinicalTrials.gov ID
- NCT04995848
- Acronym / sponsor ID
- N-20200094
- Keywords
- Palliative care, Palliation, Platform, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Palliative Team,Hospital of South West Jutland, Center for Innovative Medical Technologies (CIMT), Odense University Hospital, Danish Cancer Society, Laboratory of Welfare Technology, Department of Health Science and Technology, Aalborg University
- Study start
- 26 May 2021 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 9 Aug 2021 (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 project has focus on patients in palliation testing a digital platform TelePal.dk.
Detailed description
The aim of the RCT study is to:
- Test, implement, and evaluate a telepalliation program for patients receiving palliative care (cancer, heart failure (HF), COPD, and motor neuron disease) from a clinical, psychosocial, inter-organizational, and health economic perspective.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mixed method randomised control trial
| Arm | Type | Receives |
|---|---|---|
| Telepalliation group | Experimental | Other: TelepalliationThe intervention group will participate in the telepalliation program. The patients will lent a tablet during the RCT study to access the TelePal.dk platform an video consultations. The patients will participate from the time they are referred to palliative care, and are enrolled in the telepalliation program for up to six months or until: 1. They stop being followed by the Palliative Team due to lack of symptoms 2. They are diagnosed with delirium based upon clinical guidelines and the Confusion Assessment Method (CAM). The assessment of delirium will be done by either: * The project nurse or the clinical responsible doctor at the patients' home OR * A district nurse under video supervision by the project nurse or the clinical responsible doctor 3. Death of the patient |
| Conventional palliation program | No intervention | –The control group will follow a conventional palliation program. The patients will participate from the time they are referred to palliative care, and are enrolled in the telepalliation program for up to six months or until: 1. They stop being followed by the Palliative Team due to lack of symptoms 2. They are diagnosed with delirium based upon clinical guidelines and the Confusion Assessment Method (CAM). The assessment of delirium will be done by either: * The project nurse or the clinical responsible doctor at the patients' home OR * A district nurse under video supervision by the project nurse or the clinical responsible doctor 3. Death of the patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years
- Live in Esbjerg, Varde, Billund, Fanø or Vejen Municipality
- Cancer, heart failure, chronic obstructive pulmonary disease (COPD), and motor neuron disease (neurological diseases) referred to the Palliation Team at Southwest Jutland Hospital
- Basic computer skills or a relative who has basic computer skills
Key exclusion criteria (3 listed)
- Delirium at enrolment based on CAM score
- Active psychiatric history (as noted in the medical record) other than depression or anxiety related to the main diagnosis referred to palliative care
- Lack of ability to cooperate
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 |
|---|---|---|
| TelepalliationTelepalliation platform Telepal.dk | Other | Telepalliation group |
Primary outcome
Changes in Quality of life
Time frame: At baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
Measured by the European Organization for Research and Treatment of Cancer, questionnaire regarding quality of life in palliative cancer care patients (EORTC QLQ-C15-PAL).
11 secondary outcomes
Changes in medicine
Time frame: At enrolment and week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
Changes in feeling of security
Time frame: At baseline, twice every week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
Experiences of pain
Time frame: At baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
Experience of pain (brief)
Time frame: At baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
Experiences of patients on the actual use of the TelePal.dk platform and their experiences of being a part of a telepalliation program
Time frame: Week 4
Experiences of relatives on the actual use of the TelePal.dk platform and their experiences of being a part of a telepalliation program
Time frame: Week 4 and 3 months
Experiences of health care professionals on the actual use of the TelePal.dk platform and their experiences of being a part of a telepalliation program
Time frame: 6 months and 12 months
Perceptions on usability of a cross-sector communication platform and telerehabilitation program by patients, relatives and health care professionals
Time frame: 12 months
Observations on usability of a cross-sector communication platform and telerehabilitation program by patients, relatives and health care professionals
Time frame: 12 months
Health related quality of life
Time frame: week 1 and week 4
Cost of healthcare services
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Derived from this study: PubMed 41055129Sigaard JVA, Joensen EDR, Birgisdottir UR, Spindler H, Dinesen B. Telepalliation creates a sense of security: A qualitative study of patients with cancer receiving palliative care. Palliat Med. 2026 May;40(5):608-616. doi: 10.1177/02692163251364145. Epub 2025 Oct 7.
- Derived from this study: PubMed 38564264Sigaard JVA, Henneberg NC, Schacksen CS, Kronborg SH, Petrini L, Kidholm K, Birgisdottir UR, Spindler H, Dinesen B. A Digital Platform (Telepalliation) for Patients in Palliative Care and Their Relatives: Protocol for a Multimethod Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 2;13:e49946. doi: 10.2196/49946.
- Read more about the Laboratory for Welfare Technology - telehealth and telerehabilitation, Aalborg UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: No. No plan for sharing protocol as we are applying for patent.
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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.
Jarl Voss Andersen Sigaard, MD contact
Birthe Dinesen, MSc, PhD principal investigator
Aalborg University
Jarl Voss Andersen Sigaard, MD study director
Palliative Team, South West Jutland Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telepalliation in people with Cancer and Heart Failure, run by Aalborg University at 1 site in Denmark.
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 4 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: status not confirmed, as of the sponsor's last update on 19 Jul 2023. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Birthe Dinesen, MSc, PhD (+4520515944, bid@hst.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Quality of life (time frame: At baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26). 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 NCT04995848, 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 19 Jul 2023; AzTrials last refreshed its copy on 7 Nov 2026.