Clinical trial · Interventional
DigiPall; a Trial of Digital Patient Reported Outcome and Biomarker Monitoring in Palliative Care
DigiPall; a Randomized Controlled Trial of Digital Patient Reported Outcome and Biomarker Monitoring in Palliative Care
NCT06615349CI-TRIAL-00091971recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Terminal Cancer | — | UNRESOLVED | — |
| Terminal Illness | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DigiPall | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DigiPall
- description
- Patients receive standard of care + DigiPall intervention
- interventionNames
- Behavioral: DigiPall
- type
- NO_INTERVENTION
- label
- control
- description
- Patients receive standard of care
Primary outcomes (1)
- measure
- rate of unplanned rehospitalisations and emergency visits
- timeFrame
- 84 days
- description
- measure will be derived from hospital reports as well as statements by the patient on a weekly basis
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Patients under curative treatment * Relevant cognitive impairment
References
Publications (39)
- BACKGROUNDWheatley 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. PMID 17916873
- BACKGROUNDAlsirafy 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. PMID 25877944
- BACKGROUNDDonze 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. PMID 28084884
- BACKGROUNDGerhardt 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. PMID 24753966
- BACKGROUNDChang 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. PMID 10699909
- BACKGROUNDPeters 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. PMID 16499673
- BACKGROUNDLeBlanc 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.