Terminal IllnessNCT06615349
DigiPall; a Trial of Digital Patient Reported Outcome and Biomarker Monitoring in Palliative Care
A study testing DigiPall in people with Terminal Illness and Terminal Cancer, run by David Blum at 1 site in Switzerland.
Trial summary
The aim of this study is to test if a system consisting of a wearable device measuring heartbeats and steps, together with daily communication with a chatbot on the smartphone asking the patients about their symptoms and giving tips, can reduce unplanned hospital readmissions and improve well-being in advanced cancer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Terminal Illness, Terminal Cancer
- What is being tested?
- DigiPall
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Jun 2025to Sep 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
- Patients with established diagnosis of a metastatic cancer/severe illness with limited life expectancy receiving palliative care services
- Estimated life expectancy <24 months (physician's guess)/ >3 months
- Karnofsky Index ≥ 50% / ECOG≤ 2
- Aged >18 years
- Owns and uses a smartphone
- Give written informed consent
Who cannot join
- Patients under curative treatment
- Relevant cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, Canton of Zurich, 8091
David Blum, MD PhD, 0041442553742, david.blum@usz.ch
Manuel Amann, MS
About this study
Official title: DigiPall; a Randomized Controlled Trial of Digital Patient Reported Outcome and Biomarker Monitoring in Palliative Care
The aim of this study is to test if a system consisting of a wearable device measuring heartbeats and steps, together with daily communication with a chatbot on the smartphone asking the patients about their symptoms and giving tips, can reduce unplanned hospital readmissions and improve well-being in advanced cancer and severely ill patients.
Read the detailed description
The aim of this study is to test the effect of a remote symptom and digital biomarker monitoring system on unplanned hospital readmissions, quality of life and sense of security in advanced cancer patients and patients with severe illnesses in palliative care.
Patients with cancer or other life-threatening illnesses are often burdened with pain and other distressing symptoms. Palliative care is an approach to prevent and relief suffering by means of early identification, assessment and treatment of these symptoms with the overall aim to improve quality of life of patients.
Palliative care wards are established in larger hospitals in Switzerland and provide short-term acute treatment of patients with incurable diseases. More than half of the patients are discharged home. However, unplanned rehospitalisations and emergency visits unfortunately occur frequently. Unplanned rehospitalisations are burdensome for the patient and caregiver and they are associated with higher costs. Up to 50% of unplanned rehospitalisations or hospital readmissions are deemed avoidable.
An unplanned hospital readmission within a specified time frame is an often applied quality benchmark in health care. When patients are discharged from specific palliative care wards, a good interprofessional outpatient or home care service has been most effective. However, close monitoring through home care teams is time consuming, costly, hindered by long distances and home care teams are not available everywhere. Furthermore, in many European countries primary care practices are rarified and reimbursement of home visits are insufficient. Therefore, new and innovative approaches for monitoring of this patient group are needed, especially in view of a growing number of patients and a decreasing number of care givers.
In the digital era self tracking is becoming more fashionable and daily screen-time is increasing. Concerning symptoms and well-being, patients monitoring themselves is the best option, because only they can adequately determine how they feel. Performance status and its deterioration can be remotely assessed by wearables. Mobile health technology is an easy and feasible way to monitor activity and health status.
This randomized controlled study aims to compare two groups of palliative patients, both receiving standard treatment with the intervention group additionally receiving the monitoring system. In the DigiPall intervention group, biomarker data is continuously gathered by a wearable device and questions about their subjective health status will be answered by the patients through chat. Based on their answers, automated feedback is provided. This feedback will not include any new prescriptions or suggest anything that was not already discussed with the treating physician, rather it will be reminding the patient of options in accordance to the existing treatment plan. There is strong evidence pointing to patients failing to implement the suggested treatment plan after discharge being a key factor in avoidable rehospitalisations. Therefore, the goal of the intervention is to strengthen the patient's self-management ability and sense of security, resulting in a better outcome in addition to reducing health care cost.
This approach has been well received in the feasibility study and the current study design has been developed with input by the patients themselves. During the study a patient group for advice will be consulted periodically.
- Conditions
- Terminal Illness, Terminal Cancer
- Being tested
- DigiPall
- Keywords
- Palliative Care, chatbot, wearable, PROMs, rehospitalisation, mobile health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DigiPallBehavioural
DigiPall is an intervention combining a sensor-equipped wearable with a chatbot communicating via WhatsApp on the patient's smartphone. Patients will be asked two questions daily for their subjective rating through WhatsApp on their smartphone, worded slightly differently depending on the measured values for steps, heart rate and compliance as well as the patient's answer the day before.
| Study group | Role | What they receive |
|---|---|---|
| DigiPall | Experimental | Patients receive standard of care + DigiPall intervention Receives: Behavioral: DigiPall |
| control | No intervention | Patients receive standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of unplanned rehospitalisations and emergency visits
measure will be derived from hospital reports as well as statements by the patient on a weekly basis
Measured: 84 days
Secondary outcomes (3)
Quality of Life in palliative cancer care patients (EORTC QLQ-C15-PAL)
14 items scored from 1-4, higher score indicates worse outcome
1 item scored from 1-7, higher score indicates better outcome
Measured: 91 days
Sense of Security in Care - Patient Edition (SEC-P)
16 items scored from 1-6, higher score indicates better outcome
Measured: 91 days
survival
overall survival
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start11 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Terminal IllnessStudies 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
- prospective, randomized, controlled
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Blum
- Sponsor type
- University, hospital or other
- Collaborators
- Zurich University of Applied Sciences
- Responsible party
- Sponsor-investigator, David Blum, University of Zurich
- Investigators
- David Blum, MD PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615349
- Sponsor's protocol ID
- digiPall
- Status last verified
- Jul 2025
- First submitted
- 23 Sep 2024
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wheatley VJ, Baker JI. "Please, I want to go home": ethical issues raised when considering choice of place of care in palliative care. Postgrad Med J. 2007 Oct;83(984):643-8. doi: 10.1136/pgmj.2007.058487.
PubMed 17916873Alsirafy SA, Raheem AA, Al-Zahrani AS, Mohammed AA, Sherisher MA, El-Kashif AT, Ghanem HM. Emergency Department Visits at the End of Life of Patients With Terminal Cancer: Pattern, Causes, and Avoidability. Am J Hosp Palliat Care. 2016 Aug;33(7):658-62. doi: 10.1177/1049909115581819. Epub 2015 Apr 15.
PubMed 25877944Donze JD, Lipsitz S, Schnipper JL. Risk Factors and Patterns of Potentially Avoidable Readmission in Patients With Cancer. J Oncol Pract. 2017 Jan;13(1):e68-e76. doi: 10.1200/JOP.2016.011445. Epub 2016 Oct 23.
PubMed 28084884Gerhardt G, Yemane A, Hickman P, Oelschlaeger A, Rollins E, Brennan N. Medicare readmission rates showed meaningful decline in 2012. Medicare Medicaid Res Rev. 2013 May 28;3(2):mmrr.003.02.b01. doi: 10.5600/mmrr.003.02.b01. eCollection 2013.
PubMed 24753966Chang VT, Hwang SS, Feuerman M, Kasimis BS. Symptom and quality of life survey of medical oncology patients at a veterans affairs medical center: a role for symptom assessment. Cancer. 2000 Mar 1;88(5):1175-83. doi: 10.1002/(sici)1097-0142(20000301)88:53.0.co;2-n.
PubMed 10699909Peters L, Sellick K. Quality of life of cancer patients receiving inpatient and home-based palliative care. J Adv Nurs. 2006 Mar;53(5):524-33. doi: 10.1111/j.1365-2648.2006.03754.x.
PubMed 16499673LeBlanc TW, Nickolich M, Rushing CN, Samsa GP, Locke SC, Abernethy AP. What bothers lung cancer patients the most? A prospective, longitudinal electronic patient-reported outcomes study in advanced non-small cell lung cancer. Support Care Cancer. 2015 Dec;23(12):3455-63. doi: 10.1007/s00520-015-2699-4. Epub 2015 Mar 21.
PubMed 25791391Delgado-Guay MO, Rodriguez-Nunez A, Shin SH, Chisholm G, Williams J, Frisbee-Hume S, Bruera E. Characteristics and outcomes of patients with advanced cancer evaluated by a palliative care team at an emergency center. A retrospective study. Support Care Cancer. 2016 May;24(5):2287-2295. doi: 10.1007/s00520-015-3034-9. Epub 2015 Nov 21.
PubMed 26590844Tsai SC, Liu LN, Tang ST, Chen JC, Chen ML. Cancer pain as the presenting problem in emergency departments: incidence and related factors. Support Care Cancer. 2010 Jan;18(1):57-65. doi: 10.1007/s00520-009-0630-6. Epub 2009 Apr 7.
PubMed 19350283Elsayem AF, Elzubeir HE, Brock PA, Todd KH. Integrating palliative care in oncologic emergency departments: Challenges and opportunities. World J Clin Oncol. 2016 Apr 10;7(2):227-33. doi: 10.5306/wjco.v7.i2.227.
PubMed 27081645Delgado-Guay MO, Kim YJ, Shin SH, Chisholm G, Williams J, Allo J, Bruera E. Avoidable and unavoidable visits to the emergency department among patients with advanced cancer receiving outpatient palliative care. J Pain Symptom Manage. 2015 Mar;49(3):497-504. doi: 10.1016/j.jpainsymman.2014.07.007. Epub 2014 Aug 15.
PubMed 25131891Henson LA, Gao W, Higginson IJ, Smith M, Davies JM, Ellis-Smith C, Daveson BA. Emergency department attendance by patients with cancer in their last month of life: a systematic review and meta-analysis. J Clin Oncol. 2015 Feb 1;33(4):370-6. doi: 10.1200/JCO.2014.57.3568. Epub 2014 Dec 22.
PubMed 25534384Witt D, Kellogg R, Snyder M, Dunn J. Windows Into Human Health Through Wearables Data Analytics. Curr Opin Biomed Eng. 2019 Mar;9:28-46. doi: 10.1016/j.cobme.2019.01.001. Epub 2019 Jan 28.
PubMed 31832566Urrea B, Misra S, Plante TB, Kelli HM, Misra S, Blaha MJ, Martin SS. Mobile Health Initiatives to Improve Outcomes in Primary Prevention of Cardiovascular Disease. Curr Treat Options Cardiovasc Med. 2015 Dec;17(12):59. doi: 10.1007/s11936-015-0417-7.
PubMed 26474892Mendoza M, Han M, Meyring-Wosten A, Wilund K, Kotanko P. It's a non-dialysis day... Do you know how your patient is doing? A case for research into interdialytic activity. Blood Purif. 2015;39(1-3):74-83. doi: 10.1159/000369430. Epub 2015 Jan 20.
PubMed 25662096
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DigiPall; a Randomized Controlled Trial of Digital Patient Reported Outcome and Biomarker Monitoring in Palliative Care
- ClinicalTrials.gov ID
- NCT06615349
- Acronym / sponsor ID
- digiPall
- Conditions
- Terminal Illness, Terminal Cancer
- Keywords
- Palliative Care, chatbot, wearable, PROMs, rehospitalisation, mobile health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- David BlumUniversity, hospital or other
- Collaborators
- Zurich University of Applied Sciences
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 26 Sep 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 aim of this study is to test if a system consisting of a wearable device measuring heartbeats and steps, together with daily communication with a chatbot on the smartphone asking the patients about their symptoms and giving tips, can reduce unplanned hospital readmissions and improve well-being in advanced cancer and severely ill patients.
Detailed description
The aim of this study is to test the effect of a remote symptom and digital biomarker monitoring system on unplanned hospital readmissions, quality of life and sense of security in advanced cancer patients and patients with severe illnesses in palliative care.
Patients with cancer or other life-threatening illnesses are often burdened with pain and other distressing symptoms. Palliative care is an approach to prevent and relief suffering by means of early identification, assessment and treatment of these symptoms with the overall aim to improve quality of life of patients.
Palliative care wards are established in larger hospitals in Switzerland and provide short-term acute treatment of patients with incurable diseases. More than half of the patients are discharged home. However, unplanned rehospitalisations and emergency visits unfortunately occur frequently. Unplanned rehospitalisations are burdensome for the patient and caregiver and they are associated with higher costs. Up to 50% of unplanned rehospitalisations or hospital readmissions are deemed avoidable.
An unplanned hospital readmission within a specified time frame is an often applied quality benchmark in health care. When patients are discharged from specific palliative care wards, a good interprofessional outpatient or home care service has been most effective. However, close monitoring through home care teams is time consuming, costly, hindered by long distances and home care teams are not available everywhere. Furthermore, in many European countries primary care practices are rarified and reimbursement of home visits are insufficient. Therefore, new and innovative approaches for monitoring of this patient group are needed, especially in view of a growing number of patients and a decreasing number of care givers.
In the digital era self tracking is becoming more fashionable and daily screen-time is increasing. Concerning symptoms and well-being, patients monitoring themselves is the best option, because only they can adequately determine how they feel. Performance status and its deterioration can be remotely assessed by wearables. Mobile health technology is an easy and feasible way to monitor activity and health status.
This randomized controlled study aims to compare two groups of palliative patients, both receiving standard treatment with the intervention group additionally receiving the monitoring system. In the DigiPall intervention group, biomarker data is continuously gathered by a wearable device and questions about their subjective health status will be answered by the patients through chat. Based on their answers, automated feedback is provided. This feedback will not include any new prescriptions or suggest anything that was not already discussed with the treating physician, rather it will be reminding the patient of options in accordance to the existing treatment plan. There is strong evidence pointing to patients failing to implement the suggested treatment plan after discharge being a key factor in avoidable rehospitalisations. Therefore, the goal of the intervention is to strengthen the patient's self-management ability and sense of security, resulting in a better outcome in addition to reducing health care cost.
This approach has been well received in the feasibility study and the current study design has been developed with input by the patients themselves. During the study a patient group for advice will be consulted periodically.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, randomized, controlled
| Arm | Type | Receives |
|---|---|---|
| DigiPall | Experimental | Behavioral: DigiPallPatients receive standard of care + DigiPall intervention |
| control | No intervention | –Patients receive standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with established diagnosis of a metastatic cancer/severe illness with limited life expectancy receiving palliative care services
- Estimated life expectancy <24 months (physician's guess)/ >3 months
- Karnofsky Index ≥ 50% / ECOG≤ 2
- Aged >18 years
- Owns and uses a smartphone
Key exclusion criteria (2 listed)
- Patients under curative treatment
- Relevant cognitive impairment
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 |
|---|---|---|
| DigiPallDigiPall is an intervention combining a sensor-equipped wearable with a chatbot communicating via WhatsApp on the patient's smartphone. Patients will be asked two questions daily for their subjective rating through WhatsApp on their smartphone, worded slightly differently depending on the measured values for steps, heart rate and compliance as well as the patient's answer the day before. | Behavioural | DigiPall |
Primary outcome
rate of unplanned rehospitalisations and emergency visits
Time frame: 84 days
measure will be derived from hospital reports as well as statements by the patient on a weekly basis
3 secondary outcomes
Quality of Life in palliative cancer care patients (EORTC QLQ-C15-PAL)
Time frame: 91 days
Sense of Security in Care - Patient Edition (SEC-P)
Time frame: 91 days
survival
Time frame: 365 days
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 10 Jul 2025.
- Background: PubMed 17916873Wheatley VJ, Baker JI. "Please, I want to go home": ethical issues raised when considering choice of place of care in palliative care. Postgrad Med J. 2007 Oct;83(984):643-8. doi: 10.1136/pgmj.2007.058487.
- Background: PubMed 25877944Alsirafy SA, Raheem AA, Al-Zahrani AS, Mohammed AA, Sherisher MA, El-Kashif AT, Ghanem HM. Emergency Department Visits at the End of Life of Patients With Terminal Cancer: Pattern, Causes, and Avoidability. Am J Hosp Palliat Care. 2016 Aug;33(7):658-62. doi: 10.1177/1049909115581819. Epub 2015 Apr 15.
- Background: PubMed 28084884Donze JD, Lipsitz S, Schnipper JL. Risk Factors and Patterns of Potentially Avoidable Readmission in Patients With Cancer. J Oncol Pract. 2017 Jan;13(1):e68-e76. doi: 10.1200/JOP.2016.011445. Epub 2016 Oct 23.
- Background: PubMed 24753966Gerhardt G, Yemane A, Hickman P, Oelschlaeger A, Rollins E, Brennan N. Medicare readmission rates showed meaningful decline in 2012. Medicare Medicaid Res Rev. 2013 May 28;3(2):mmrr.003.02.b01. doi: 10.5600/mmrr.003.02.b01. eCollection 2013.
- Background: PubMed 10699909Chang VT, Hwang SS, Feuerman M, Kasimis BS. Symptom and quality of life survey of medical oncology patients at a veterans affairs medical center: a role for symptom assessment. Cancer. 2000 Mar 1;88(5):1175-83. doi: 10.1002/(sici)1097-0142(20000301)88:53.0.co;2-n.
- Background: PubMed 16499673Peters L, Sellick K. Quality of life of cancer patients receiving inpatient and home-based palliative care. J Adv Nurs. 2006 Mar;53(5):524-33. doi: 10.1111/j.1365-2648.2006.03754.x.
- Background: PubMed 25791391LeBlanc TW, Nickolich M, Rushing CN, Samsa GP, Locke SC, Abernethy AP. What bothers lung cancer patients the most? A prospective, longitudinal electronic patient-reported outcomes study in advanced non-small cell lung cancer. Support Care Cancer. 2015 Dec;23(12):3455-63. doi: 10.1007/s00520-015-2699-4. Epub 2015 Mar 21.
- Background: PubMed 26590844Delgado-Guay MO, Rodriguez-Nunez A, Shin SH, Chisholm G, Williams J, Frisbee-Hume S, Bruera E. Characteristics and outcomes of patients with advanced cancer evaluated by a palliative care team at an emergency center. A retrospective study. Support Care Cancer. 2016 May;24(5):2287-2295. doi: 10.1007/s00520-015-3034-9. Epub 2015 Nov 21.
- Background: PubMed 19350283Tsai SC, Liu LN, Tang ST, Chen JC, Chen ML. Cancer pain as the presenting problem in emergency departments: incidence and related factors. Support Care Cancer. 2010 Jan;18(1):57-65. doi: 10.1007/s00520-009-0630-6. Epub 2009 Apr 7.
- Background: PubMed 27081645Elsayem AF, Elzubeir HE, Brock PA, Todd KH. Integrating palliative care in oncologic emergency departments: Challenges and opportunities. World J Clin Oncol. 2016 Apr 10;7(2):227-33. doi: 10.5306/wjco.v7.i2.227.
- Background: PubMed 25131891Delgado-Guay MO, Kim YJ, Shin SH, Chisholm G, Williams J, Allo J, Bruera E. Avoidable and unavoidable visits to the emergency department among patients with advanced cancer receiving outpatient palliative care. J Pain Symptom Manage. 2015 Mar;49(3):497-504. doi: 10.1016/j.jpainsymman.2014.07.007. Epub 2014 Aug 15.
- Background: PubMed 25534384Henson LA, Gao W, Higginson IJ, Smith M, Davies JM, Ellis-Smith C, Daveson BA. Emergency department attendance by patients with cancer in their last month of life: a systematic review and meta-analysis. J Clin Oncol. 2015 Feb 1;33(4):370-6. doi: 10.1200/JCO.2014.57.3568. Epub 2014 Dec 22.
- 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.
David Blum, MD PhD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DigiPall in people with Terminal Illness and Terminal Cancer, run by David Blum 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 6 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: looking for participants now, as of the sponsor's last update on 10 Jul 2025. 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?
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 David Blum, MD PhD (0041432533742, david.blum@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of unplanned rehospitalisations and emergency visits (time frame: 84 days). 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 NCT06615349, which also lists 39 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 10 Jul 2025.