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2358 Improving Quality of Life Based on Electronic Patient Reported Outcomes in Patients with CLL and MDS: The Mypal Study

Program: Oral and Poster Abstracts
Session: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster I
Hematology Disease Topics & Pathways:
Research, Lymphoid Leukemias, MDS, CLL, Clinical Research, Chronic Myeloid Malignancies, Patient-reported outcomes, Diseases, Lymphoid Malignancies, Myeloid Malignancies
Saturday, December 7, 2024, 5:30 PM-7:30 PM

Thomas Chatzikonstantinou, MD1*, Maria Vasilopoulou1*, Dimitrios Kyrou1*, Georgios Karakatsoulis1*, Panagiotis Argyropaidas2*, Sotiria Besikli-Dimou1*, Panos Bonotis1*, Maria Chatzimina2*, Jana Didi3*, Christos Demosthenous, MD4*, Tina Garani-Papadatos5*, Stefan Hoffman6*, Christine Kakalou1*, Eleni Kazantzaki7*, Stephan Kiefer8*, Lefteris Koumakis2*, Eva Hellstrom Lindberg, MD, PhD9*, Julie Ling10*, Christos Maramis1*, Marcel Meyerheim11*, Cathy Payne10*, Heather Parker12*, Sheila Payne13*, Charalampos Pontikoglou7*, Riley Reston12*, Harriet Ryblom14*, Annette Sander15*, Fatima Schera16*, Karin Ekstroem Smedby, MD17, George Zacharioudakis2*, Anastasia Chatzidimitriou1*, Michael Doubek, Prof18, Niki Stavrogianni, MD19*, Paolo Ghia, MD, PhD20,21, Eleni Papadaki22*, Richard Rosenquist, MD, PhD23,24, Norbert Graf11*, Pantelis Natsiavas, PhD1*, Kostas Stamatopoulos1*, Christina Karamanidou1* and Lydia Scarfo, MD20,25

1Institute of Applied Biosciences, Centre for Research and Technology Hellas, Thessaloniki, Greece
2Institute of Computer Science, Foundation for Research and Technology-Hellas, Heraklion, Greece
3Center for Molecular Medicine, Central European Institute of Technology, Masaryk University, Brno, Czech Republic
4Hematology Department – BMT Unit, G Papanicolaou Hospital, Thessaloniki, Greece
5Department of Public Health Policy, School of Public Health, University of West Attica, Athens, Greece
6Promotion Software GmbH, Berlin, Germany
7Department of Hematology, University of Crete School of Medicine, Heraklion, Greece
8Fraunhofer Institute For Biomedical Engineering (IBMT), Sulzbach, Germany
9Center for Hematology and Regenerative Medicine (HERM), Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden
10European Association for Palliative Care, Vilvoorde, Belgium
11Department of Pediatric Oncology and Hematology, Faculty of Medicine, Saarland University, Homburg, Germany
12Atlantis Health, London, United Kingdom
13International Observatory on End-of-Life Care, Faculty of Health and Medicine, Lancaster University, Lancaster, Greece
14Hematology Center, Karolinska University Hospital and Institutet, Stockholm, Sweden
15Pediatric Hematology and Oncology, Hannover Medical School, Hannover, Greece
16Institute for Biomedical Engineering, Sulzbach, Germany
17Division of Clinical Epidemiology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden
18Department of Internal Medicine – Hematology and Oncology, University Hospital Brno and Faculty of Medicine, Masaryk University, Brno, Czech Republic
19Hematology Department and HCT Unit, G. Papanicolaou Hospital, Thessaloniki, Greece
20Strategic Research Program on CLL, IRCCS Ospedale San Raffaele, Milano, Italy
21Università Vita-Salute San Raffaele, Milano, Italy
227. Department of Hematology, University of Crete School of Medicine, Heraklion, Greece
23Department of Clinical Genetics and Genomics, Karolinska University Hospital, Stockholm, Sweden
24Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden
25Università Vita-Salute San Raffaele, Milan, Italy

Introduction:

Palliative care is a critical component of care for patients with chronic hematological malignancies. Leveraging eHealth approaches can potentially facilitate the delivery of palliative care, leading to improved quality of life (QoL).

Methods:

The MyPal study (NCT04370457) is a randomized controlled clinical trial assessing an eHealth intervention on QoL of patients. The study was conducted according to the Declaration of Helsinki. The ethical aspects of the study, given the vulnerability of the patients, were addressed with diligence and approvals were obtained from the appropriate Research Ethics Committees.

Patients who were receiving or had previously received treatment for CLL or MDS were randomly assigned (1:1) to access the MyPal platform versus standard of care. The MyPal platform included a smartphone application used to report QoL status (ePRO questionnaires) and symptoms. The primary endpoint was QoL at 12 months, assessed by the European Organization for Research and Treatment of Cancer (EORTC) quality of life QLQ-C30 General Questionnaire and the Euroqol 5-dimension (Euroqol EQ-5D-3L). Secondary endpoints included physical and emotional functioning, measured by the Integrated Palliative Care Outcome Scale (IPOS), satisfaction with care, measured by the EORTC Patient Satisfaction with Cancer Care questionnaire PATSAT-C33 (PATSAT-C33), and overall survival (OS). Additionally, the Edmonton Symptom Assessment System (ESAS), the Brief Pain Inventory (BPI), and the Emotion Thermometers (ET) QoL questionnaires were assessed only in the intervention group.

Results:

A total of 171 patients (97 and 74 in the control and intervention arms, respectively) who answered multiple questionnaires were included in the analysis. The intervention group reported a significant decrease in pain (β2=-0.48 (-0.77, -0.19), p<0.001) compared to the control group (β1=0.3 (0.09, 0.5), p=0.01) as measured by the EORTC QLQ-C30. Communication and pain as measured by IPOS reduced equally in both groups [β2=0 (-0.03, 0.02), p=0.82; β2=-0.01 (-0.02, 0), p=0.1, respectively]. Family involvement significantly increased over time only for the intervention group [β2=0.32 (0.01, 0.64), p=0.042]. The other items of EORTC QLQ-C30, Euroqol EQ-5D-3L, IPOS, and PATSAT-C33 remained unchanged in both groups.

The intervention group displayed a statistically significant improvement in all ESAS, BPI, and ET scales. The estimated absolute improvement between the first and last assessment was 1.68, 2.16, 0.96, 1.44, 1.68, and 0.96 points for pain, tiredness, nausea, drowsiness, appetite loss, and shortness of breath, respectively, and 0.96, 1.2 and 1.2 for depression, anxiety, and well-being, respectively. The estimated absolute improvement between the first and last assessment for both pain severity and the interference items of the BPI was 1.2 points. Finally, distress, anxiety, depression, anger, and need for help showed a statistically significant reduction over time and an absolute improvement between the first and last assessment of 1.68, 1.92, 1.2, 1.2, and 0.72 points, respectively.

After 12 months, in the ITT, 6 (6.2%) patients died in the control arm and 5 (6.3%) in the intervention arm.

Conclusion:

The MyPal tools improved several aspects of QoL for patients with CLL and MDS while also promoting family involvement in palliative care.

Disclosures: Chatzikonstantinou: AbbVie: Honoraria. Parker: Atlantis Health: Current Employment. Reston: Atlantis Health: Current Employment. Ekstroem Smedby: Abbvie: Honoraria; InCyte: Honoraria. Doubek: AstraZeneca: Honoraria, Research Funding; AbbVie: Honoraria, Research Funding; Janssen: Honoraria, Research Funding. Stavrogianni: Lilly: Honoraria; AstraZeneca: Honoraria, Other: support for attendig meetings; Janssen: Honoraria, Other: support for attendig meetings; AbbVie: Honoraria. Ghia: AstraZeneca: Consultancy, Research Funding; BeiGen: Consultancy; Bristol Myers Squibb: Consultancy, Research Funding; Johnson&Johnson: Consultancy, Research Funding; Galapagos: Consultancy; Loxo@Lilly: Consultancy; MSD: Consultancy; Galapagos: Consultancy; AbbvVie: Consultancy, Research Funding; Roche: Consultancy. Papadaki: X4 pharmaceutical: Other: Advisory Board honorarium. Rosenquist: Illumina: Honoraria; AstraZeneca: Honoraria; AbbVie: Honoraria; Janssen: Honoraria; Roche: Honoraria. Stamatopoulos: Bristol Myers Squibb: Honoraria; Roche: Research Funding; Janssen: Honoraria, Research Funding; Novartis: Research Funding; AstraZeneca: Honoraria, Research Funding; AbbVie: Honoraria, Research Funding; Lilly: Honoraria. Scarfo: Janssen: Honoraria; Lilly: Honoraria; BeiGene: Honoraria; AstraZeneca: Honoraria; AbbVie: Honoraria; Octapharma: Honoraria.

*signifies non-member of ASH