DigiPall; a Trial of Digital Patient Reported Outcome and Biomarker Monitoring in Palliative Care

NCT06615349 | Recruiting DMC

• 1 other identifier: digiPall
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 1

Brief 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 and severely ill patients.

Conditions

Terminal Illness; Terminal Cancer

Keywords

Palliative Care; chatbot; wearable; PROMs; rehospitalisation; mobile health

Outcome Measures

Primary Outcomes (1)

• 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

  84 days

Secondary Outcomes (3)

• Quality of Life in palliative cancer care patients (EORTC QLQ-C15-PAL)

  91 days

• Sense of Security in Care - Patient Edition (SEC-P)

  91 days

• survival

  365 days

Study Arms (2)

DigiPall

EXPERIMENTAL

Patients receive standard of care + DigiPall intervention

Behavioral: DigiPall

control

NO INTERVENTION

Patients receive standard of care

Interventions

DigiPall BEHAVIORAL

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.

DigiPall

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients under curative treatment
• Relevant cognitive impairment

Sponsors & Collaborators

• David Blum: lead
• Zurich University of Applied Sciences: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Related Publications (39)

• 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.

  PMID: 17916873 BACKGROUND

• Alsirafy 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 BACKGROUND

• Donze 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 BACKGROUND

• Gerhardt 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 BACKGROUND

• Chang 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 BACKGROUND

• Peters 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 BACKGROUND

• LeBlanc 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.

  PMID: 25791391 BACKGROUND

• Delgado-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.

  PMID: 26590844 BACKGROUND

• Tsai 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.

  PMID: 19350283 BACKGROUND

• Elsayem 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.

  PMID: 27081645 BACKGROUND

• Delgado-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.

  PMID: 25131891 BACKGROUND

• Henson 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.

  PMID: 25534384 BACKGROUND

• Witt 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.

  PMID: 31832566 BACKGROUND

• Urrea 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.

  PMID: 26474892 BACKGROUND

• Mendoza 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.

  PMID: 25662096 BACKGROUND

• Strohrmann C, Labruyere R, Gerber CN, van Hedel HJ, Arnrich B, Troster G. Monitoring motor capacity changes of children during rehabilitation using body-worn sensors. J Neuroeng Rehabil. 2013 Jul 30;10:83. doi: 10.1186/1743-0003-10-83.

  PMID: 23899401 BACKGROUND

• Seiter J, Derungs A, Schuster-Amft C, Amft O, Troster G. Daily life activity routine discovery in hemiparetic rehabilitation patients using topic models. Methods Inf Med. 2015;54(3):248-55. doi: 10.3414/ME14-01-0082. Epub 2015 Feb 6.

  PMID: 25658903 BACKGROUND

• Muaremi A, Arnrich B, Troster G. Towards Measuring Stress with Smartphones and Wearable Devices During Workday and Sleep. Bionanoscience. 2013;3(2):172-183. doi: 10.1007/s12668-013-0089-2.

  PMID: 25530929 BACKGROUND

• Bennett AV, Jensen RE, Basch E. Electronic patient-reported outcome systems in oncology clinical practice. CA Cancer J Clin. 2012 Sep-Oct;62(5):337-47. doi: 10.3322/caac.21150. Epub 2012 Jul 18.

  PMID: 22811342 BACKGROUND

• Brunelli C, Kaasa S, Knudsen AK, Hjermstad MJ, Pigni A, Caraceni A. Comparisons of patient and physician assessment of pain-related domains in cancer pain classification: results from a large international multicenter study. J Pain. 2014 Jan;15(1):59-67. doi: 10.1016/j.jpain.2013.09.011. Epub 2013 Oct 2.

  PMID: 24373570 BACKGROUND

• Lundstrom S. Is it reliable to use cellular phones for symptom assessment in palliative care? Report on a study in patients with advanced cancer. J Palliat Med. 2009 Dec;12(12):1087. doi: 10.1089/jpm.2009.0207. No abstract available.

  PMID: 19995287 BACKGROUND

• Basch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Schrag D. Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA. 2017 Jul 11;318(2):197-198. doi: 10.1001/jama.2017.7156.

  PMID: 28586821 BACKGROUND

• Ferriolli E, Skipworth RJ, Hendry P, Scott A, Stensteth J, Dahele M, Wall L, Greig C, Fallon M, Strasser F, Preston T, Fearon KC. Physical activity monitoring: a responsive and meaningful patient-centered outcome for surgery, chemotherapy, or radiotherapy? J Pain Symptom Manage. 2012 Jun;43(6):1025-35. doi: 10.1016/j.jpainsymman.2011.06.013. Epub 2012 Jan 24.

  PMID: 22269181 BACKGROUND

• Kaasa S, Loge JH, Fayers P, Caraceni A, Strasser F, Hjermstad MJ, Higginson I, Radbruch L, Haugen DF. Symptom assessment in palliative care: a need for international collaboration. J Clin Oncol. 2008 Aug 10;26(23):3867-73. doi: 10.1200/JCO.2007.15.8881.

  PMID: 18688054 BACKGROUND

• Abernethy AP, Currow DC. Patient self-reporting in palliative care using information technology: Yes, there is hope! Palliat Med. 2011 Oct;25(7):673-4. doi: 10.1177/0269216311422760. No abstract available.

  PMID: 21987664 BACKGROUND

• Cox A, Illsley M, Knibb W, Lucas C, O'Driscoll M, Potter C, Flowerday A, Faithfull S. The acceptability of e-technology to monitor and assess patient symptoms following palliative radiotherapy for lung cancer. Palliat Med. 2011 Oct;25(7):675-81. doi: 10.1177/0269216311399489. Epub 2011 Apr 7.

  PMID: 21474620 BACKGROUND

• Skipworth RJ, Stene GB, Dahele M, Hendry PO, Small AC, Blum D, Kaasa S, Trottenberg P, Radbruch L, Strasser F, Preston T, Fearon KC, Helbostad JL; European Palliative Care Research Collaborative (EPCRC). Patient-focused endpoints in advanced cancer: criterion-based validation of accelerometer-based activity monitoring. Clin Nutr. 2011 Dec;30(6):812-21. doi: 10.1016/j.clnu.2011.05.010. Epub 2011 Jul 5.

  PMID: 21733604 BACKGROUND

• Ng A, Gupta E, Bansal S, Fontillas RC, Amos CE Jr, Williams JL, Dibaj S, Bruera E. Cancer Patients' Perception of Usefulness of Wearable Exercise Trackers. PM R. 2021 Aug;13(8):845-851. doi: 10.1002/pmrj.12475. Epub 2020 Oct 20.

  PMID: 32844592 BACKGROUND

• Pavic M, Klaas V, Theile G, Kraft J, Troster G, Blum D, Guckenberger M. Mobile Health Technologies for Continuous Monitoring of Cancer Patients in Palliative Care Aiming to Predict Health Status Deterioration: A Feasibility Study. J Palliat Med. 2020 May;23(5):678-685. doi: 10.1089/jpm.2019.0342. Epub 2019 Dec 23.

  PMID: 31873052 BACKGROUND

• Blum D, Koeberle D, Omlin A, Walker J, Von Moos R, Mingrone W, deWolf-Linder S, Hayoz S, Kaasa S, Strasser F, Ribi K. Feasibility and acceptance of electronic monitoring of symptoms and syndromes using a handheld computer in patients with advanced cancer in daily oncology practice. Support Care Cancer. 2014 Sep;22(9):2425-34. doi: 10.1007/s00520-014-2201-8. Epub 2014 Apr 5.

  PMID: 24705855 BACKGROUND

• Blum D, Koeberle D, Ribi K, Schmitz SF, Utiger U, Klingbiel D, Strasser F. Electronic monitoring of symptoms and syndromes associated with cancer: methods of a randomized controlled trial SAKK 95/06 E-MOSAIC. BMC Palliat Care. 2012 Sep 24;11:19. doi: 10.1186/1472-684X-11-19.

  PMID: 23006802 BACKGROUND

• Strasser F, Blum D, von Moos R, Cathomas R, Ribi K, Aebi S, Betticher D, Hayoz S, Klingbiel D, Brauchli P, Haefner M, Mauri S, Kaasa S, Koeberle D; Swiss Group for Clinical Cancer Research (SAKK). The effect of real-time electronic monitoring of patient-reported symptoms and clinical syndromes in outpatient workflow of medical oncologists: E-MOSAIC, a multicenter cluster-randomized phase III study (SAKK 95/06). Ann Oncol. 2016 Feb;27(2):324-32. doi: 10.1093/annonc/mdv576. Epub 2015 Dec 8.

  PMID: 26646758 BACKGROUND

• Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan AW, King MT; the SPIRIT-PRO Group; Hunn A, Bottomley A, Regnault A, Chan AW, Ells C, O'Connor D, Revicki D, Patrick D, Altman D, Basch E, Velikova G, Price G, Draper H, Blazeby J, Scott J, Coast J, Norquist J, Brown J, Haywood K, Johnson LL, Campbell L, Frank L, von Hildebrand M, Brundage M, Palmer M, Kluetz P, Stephens R, Golub RM, Mitchell S, Groves T. Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension. JAMA. 2018 Feb 6;319(5):483-494. doi: 10.1001/jama.2017.21903.

  PMID: 29411037 BACKGROUND

• Groenvold M, Petersen MA, Aaronson NK, Arraras JI, Blazeby JM, Bottomley A, Fayers PM, de Graeff A, Hammerlid E, Kaasa S, Sprangers MA, Bjorner JB; EORTC Quality of Life Group. The development of the EORTC QLQ-C15-PAL: a shortened questionnaire for cancer patients in palliative care. Eur J Cancer. 2006 Jan;42(1):55-64. doi: 10.1016/j.ejca.2005.06.022. Epub 2005 Sep 12.

  PMID: 16162404 BACKGROUND

• Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. doi: 10.1200/JCO.2015.63.0830. Epub 2015 Dec 7.

  PMID: 26644527 BACKGROUND

• Hamine S, Gerth-Guyette E, Faulx D, Green BB, Ginsburg AS. Impact of mHealth chronic disease management on treatment adherence and patient outcomes: a systematic review. J Med Internet Res. 2015 Feb 24;17(2):e52. doi: 10.2196/jmir.3951.

  PMID: 25803266 BACKGROUND

• Bradley EH, Curry L, Horwitz LI, Sipsma H, Thompson JW, Elma M, Walsh MN, Krumholz HM. Contemporary evidence about hospital strategies for reducing 30-day readmissions: a national study. J Am Coll Cardiol. 2012 Aug 14;60(7):607-14. doi: 10.1016/j.jacc.2012.03.067. Epub 2012 Jul 18.

  PMID: 22818070 BACKGROUND

• Krevers B, Milberg A. The instrument 'sense of security in care--patients' evaluation': its development and presentation. Psychooncology. 2014 Aug;23(8):914-20. doi: 10.1002/pon.3502. Epub 2014 Feb 14.

  PMID: 24677414 BACKGROUND

• Wallace EM, Cooney MC, Walsh J, Conroy M, Twomey F. Why do palliative care patients present to the emergency department? Avoidable or unavoidable? Am J Hosp Palliat Care. 2013 May;30(3):253-6. doi: 10.1177/1049909112447285. Epub 2012 May 23.

  PMID: 22628898 BACKGROUND

Study Officials

• David Blum, MD PhD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Blum, MD PhD

CONTACT

0041432533742; david.blum@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director Palliative Care Center USZ

Model Details: prospective, randomized, controlled

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 26, 2024
• Study Start: June 11, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)