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Prospective Pilot Study of Telehealth as Domiciliary Follow-up after Hematopoietic Cell Transplantation during the COVID19 Pandemic (Preprint)



Background: Patients who have recently received hematopoietic cell transplant (HCT) are at higher risk of acute complications in the first weeks after discharge, especially during the COVID19 pandemic. Objective: The aim of this study was to test the use of a telehealth platform for the follow-up of transplanted patients during the first 2 weeks from discharge. Methods: 21 patients who received autologous or allogeneic HCT for hematological malignancies were screened from the 30th April 2020 to 15th July 2020. The telehealth platform consisted in the daily collection of vital signs and physical or psychological symptoms for 2 weeks after hospital discharge. Required medical devices (oximeter, blood pressure monitor)were given to patients and a dedicated smartphone application was developed to collect this data. Daily medical revision of the data was performed form a hematologist specialized in HCT through a web-based software. Results: Only 12 out of 21 patients were able to enter or complete the study. Technological barriers were the most frequent limiting factor of the study. In the 12 patients who completed the study, adherence in reporting data was high. Patients' experience in using such a system was considered generally good. In 2 cases, the system allowed the early recognition of acute complications. Conclusions: This pilot study showed that application of telehealth systems can be applied in the early post-transplant setting with evident advantage for the physicians and patients in terms of both medical and psychological perspectives. Technological issues still represent a problem in the applicability of such a system, especially for elderly patients. Easier to use technologies could help in the future in expanding the use of telehealth systems in this setting. Clinicaltrial: None.
Original Paper
Use of Telehealth for Domiciliary Follow-up After Hematopoietic
Cell Transplantation During the COVID-19 Pandemic:Prospective
Pilot Study
Alberto Mussetti1,2, MD; Maria Queralt Salas1,2, MD; Maria Condom1,2, MD; Maite Antonio2,3, MD; Cristian Ochoa2,4,5,
DPhil; Iulia Ivan1,2, MD; David Jimenez Ruiz-De la Torre1,2, MD; Gabriela Sanz Linares1,2, MD; Belen Ansoleaga1,2,
MD; Beatriz Patiño-Gutierrez1, RN; Laura Jimenez-Prat1, RN; Rocio Parody1,2, MD; Ana Sureda-Balari1,2, MD
1Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet, L'Hospitalet de Llobregat, Barcelona, Spain
2Institut d'Investigació Biomèdica de Bellvitge, Barcelona, Spain
3Oncohematogeriatrics Unit, Institut Català d'Oncologia-Hospitalet, Barcelona, Spain
4Psycho-Oncology Unit, Institut Català d’Oncologia, ICOnnecta’t Health Program, Hospital Duran i Reynals, L’Hospitalet de Llobregat, Barcelona,
5Clinical Psychology and Psychobiology Department, Faculty of Psychology, University of Barcelona, Barcelona, Spain
Corresponding Author:
Alberto Mussetti, MD
Clinical Hematology Department
Institut Català d'Oncologia-Hospitalet
Hospital Duran i Reynals
Avinguda de la Gran Via de l'Hospitalet, 199-203
L'Hospitalet de Llobregat, Barcelona, 08908
Phone: 34 622188475
Background: Patients who have recently received a hematopoietic cell transplant (HCT) are at higher risk of acute complications
in the first weeks after discharge, especially during the COVID-19 pandemic.
Objective: The aim of this study was to test the use of a telehealth platform for the follow-up of HCT patients during the first
two weeks after discharge.
Methods: In total, 21 patients who received autologous or allogeneic HCT for hematological malignancies were screened from
April 30, 2020, to July 15, 2020. The telehealth platform assisted in the daily collection of vital signs as well as physical and
psychological symptoms for two weeks after hospital discharge. The required medical devices (oximeter and blood pressure
monitor) were given to patients and a dedicated smartphone app was developed to collect this data. The data were reviewed daily
through web-based software by a hematologist specializing in HCT.
Results: Only 12 of 21 patients were able to join and complete the study. Technological barriers were the most frequent limiting
factor in this study. Among the 12 patients who completed the study, adherence to data reporting was high. The patients’experience
of using such a system was considered good. In two cases, the system enabled the early recognition of acute complications.
Conclusions: This pilot study showed that telehealth systems can be applied in the early posttransplant setting, with evident
advantages for physicians and patients for both medical and psychological aspects. Technological issues still represent a challenge
for the applicability of such a system, especially for older adult patients. Easier-to-use technologies could help to expand the use
of telehealth systems in this setting in the future.
(JMIR Form Res 2021;5(3):e26121) doi: 10.2196/26121
SARS-CoV-2; COVID-19; hematology; hematopoietic cell transplantation; telemedicine; mortality; surveillance; monitoring;
stem cell; transplant; app; medical device
JMIR Form Res 2021 | vol. 5 | iss. 3 | e26121 | p. 1 (page number not for citation purposes)
Patients receiving a hematopoietic cell transplant (HCT) have
a high risk of developing severe acute toxicities in the early
posttransplant period. An increased mortality risk has been
observed in HCT patients who go on to develop COVID-19,
with an estimated mortality rate between 20%-40% [1,2].
Although other hematological procedures can be postponed in
case of emergency, there is an international agreement to not
defer transplant procedures, especially for rapidly progressing
diseases such as acute leukemias and aggressive lymphomas.
Due to this, it is necessary to improve the domiciliary clinical
monitoring of patients who received transplants to rapidly detect
clinical deterioration. In addition, unnecessary in-person visits
that might increase the risk of intrahospital contagion should
be reduced. During the last few years, smart devices for
assessing vital signs or physical activity have emerged as
breakthrough innovations in the oncological setting [3-5]. Digital
technologies allow clinicians to perform real-time monitoring
of a patient’s clinical status. In patients with COVID-19, the
use of devices such as digital oximeters allow for early detection
of clinical deterioration and a safer domiciliary follow-up. This
is of paramount importance for patients who have received
transplants, who have higher COVID-19–related mortality than
the general population.
The aim of this study (SMARTCOVID19 study) is to report the
feasibility of a real-time patient monitoring system through the
use of a smartphone app and mobile health care devices. The
institutional review board of Institut Catalá d'Oncologia -
Hospitalet approved the study. Inclusion criteria were the
following: those aged >18 years who had received autologous
or allogeneic HCT while hospitalized and have a smartphone
with an operating system able to run the SMARTCOVID19
app. Those who did not have adequate social support were
excluded from the study.
Patient education regarding the use of the platform was provided
by a hematologist at the time of enrollment, which was 1-2 days
before hospital discharge.
Vital signs (heart rate, oxygen saturation, and arterial blood
pressure) were collected daily using clinically validated
oximeters (Onyx II, Nonin Inc) and a blood pressure monitor
(iHealth Track, iHealth Labs), while temperature was measured
using domiciliary thermometers. Patients were educated on how
to measure their respiratory frequency. A checklist of clinical
symptoms was completed daily (presence of cough, myalgia,
headache, fatigue, dyspnea, emesis, odynophagia, rhinitis,
conjunctivitis, and chest pain). An analog visual scale
“thermometer” (0-10) used to detect potential cases of anxiety
or depressive disorders was completed by patients daily. Scores
of >6 resulted in an automatic referral to a psycho-oncologist
through the platform, who would contact the patient and evaluate
whether psychological support was needed via videoconference.
A chat service was available for nonurgent communications.
All data were reported to an online platform through a
smartphone app (“Saludencasa,” Fundación Trilema) compatible
with Apple (iOS Version 9 or higher) and Android systems
(Version 6 or higher). A hematologist with experience with
HCTs reviewed all patient data daily. Programmed alarms were
set in the event of any of the following situations: fever >38 C,
oxygen saturation <92%, tachycardia >125 beats per minute,
hypotension (systolic blood pressure <90 mm Hg, diastolic
blood pressure <60 mm Hg), altered mental status, and persistent
emesis or diarrhea (lasting more than 48 hours). In case of alarm
activation, the hematologist contacted the patient by phone to
evaluate the need for an in-person visit and determine the
clinical management steps that were considered most
appropriate. Outpatient monitoring started from the day of
hospital discharge 2 days and continued for 14 days. The study
accrual period was April 30, 2020, to July 15, 2020. Data were
collected prospectively and all patients signed informed consent
forms. Finally, two weeks after the end of the recruitment period,
patients were contacted by phone and asked to answer a
satisfaction questionnaire.
During the study period, 16 of 21 patients who received
transplants were successfully recruited into the study (76%
feasibility). Reasons for patients not being enrolled were the
following: language incompatibility (1 patient), no consent (1
patient), and no compatible smartphone (3 patients). Of the 16
enrolled patients, the median age was 50 years (range 22-70
years), 38% (n=6) were female, and 94% (n=15) had lymphatic
diseases. In addition, 38% (n=6) of HCTs were autologous and
62% (n=19) were allogeneic.
Of the 16 enrolled patients, 4 were not able to use the app due
to an inability to use smartphone apps in general. Of the
remaining 12 patients, average adherence to reporting study
data (median number of days reported across all patients during
the planned 14-day study period) was as follows: 89% for
temperature, 90% for oxygen saturation, 70% for respiratory
frequency, 85% for cardiac frequency, 89% for blood pressure,
65% for symptoms reporting, and 71% for emotional distress.
Automatic alarms were activated only 3 times: twice for the
presence of clinical symptoms and once for emotional distress.
Only one patient spoke with the psycho-oncologist via
videoconference. In total, 4 patients used the chat service to
communicate with hospital personnel.
Despite the feasibility nature of the study, data collected with
the digital system helped the clinician to recognize calcineurin
inhibitor–induced arterial hypertension in one patient and acute
cutaneous graft-versus-host disease (grade I) in another patient.
Only two patients in this cohort were readmitted within 14 days
of discharge, both due to grade 4 odynophagia related to herpes
simplex virus 1/2 reactivation.
The patients’ responses to the survey questions about their
experience with the telehealth system are reported in Table 1.
JMIR Form Res 2021 | vol. 5 | iss. 3 | e26121 | p. 2 (page number not for citation purposes)
Table 1. Patients’ responses to survey questions about their experience with the telehealth system (n=12).
Mean score (scored from 1-5, where 1=disagree
and 5=agree)
4.67Overall satisfaction with the telehealth system
4.67Did you feel safer at home with the use of the telehealth system?
4.67Do you think that using such a device has improved your domiciliary follow-up?
4.50Was the app easy to use?
3.50When you feel well, would you be comfortable substituting in-person visits with telemedicine?
Our prospective study showed that the use of mobile health care
devices and smartphone apps for self-reported outcomes is
feasible in the post-HCT setting. In a study conducted by Nawas
et al [6], it was found that telehealth evaluations could be useful
in the early peritransplant period, with a high satisfaction rate
among patients. In our study, we found that patients felt safer
when using the telehealth system. However, only a few patients
would completely substitute an in-person visit with telehealth
monitoring. This suggests that an in-person visit with a medical
doctor is still the preferred follow-up modality for patients who
have received transplants. Apart from vital signs monitoring
and blood test results, which could be evaluated without the
patient present, other aspects of medical care cannot be replaced
by telehealth. Human contact and empathy are still largely
needed during a visit. With respect to feasibility and adherence,
two observations emerged from our study. The first is that only
57% of the potential patients used the telehealth system in the
end. Technological barriers such as incompatible smartphones
or inexperience in using smartphone apps were the main causes
for study failure. This problem was more frequently observed
in older adult patients living alone or without caregivers able
to help them use the devices. A solution to this could be to
automate data collection through the use of devices that
automatically monitor and report this data. Newer wearable
devices could allow for real-time monitoring of patients’ heart
rate, oxygen saturation, and physical activity in an automated
manner. A second technological issue became apparent when
evaluating the reporting adherence of the people who succeeded
in using the platform. In this case, adherence to reporting clinical
parameters such as respiratory frequency or symptoms was low.
The use of currently available wearable devices could also
resolve this adherence issue. In addition to technical issues, it
is possible that psychological barriers could have contributed
to reducing study adherence. Better patient education on how
to use this system could also improve adherence, and should
always be considered when applying digital medicine. Finally,
the quality of telehealth monitoring should be complemented
and improved by the collection of other clinically relevant
parameters. For example, a virtual physical examination could
be carried out through the use of high-quality video calls, digital
stethoscopes, and weight scales [6,7]. In our study, the system
worked well for detecting acute complications such as infections
and dehydration. It is useful for monitoring the early
posttransplant period, when acute complications are more
frequent. For long-term follow-up, this system should be
implemented with other technologies (eg, ones that allow visual
communication between physicians and patients).
A study limitation was the small number of patients that
completed the study. However, the study population was
considered sufficient for a pilot study. In fact, the results
obtained should be used to improve the design of the next study,
which will recruit a larger number of patients. In addition, the
uptake and use of newer technologies could be influenced by
country or hospital resources. Such a system would not be
feasible to implement within hospitals or health care systems
that cannot afford such expenses. This applicability issue is
common to the majority of studies using newer technologies.
In conclusion, telehealth monitoring could potentially improve
patient follow-up in terms of both physical and psychological
outcomes. This is especially true whenever an external cause
(such as the COVID-19 pandemic) impedes in-person visits.
Technological issues still represent a barrier to the wider
application of telehealth monitoring systems in a medical setting
and these issues should be considered for future studies.
We acknowledge all patients and their families, as well as all health care workers and scientists helping in the fight against the
SARS-CoV-2 outbreak. We thank CERCA Programme/Generalitat de Catalunya for institutional support. In addition, we thank
Tarsila Ferro Garcia for her help in finding the resources required to develop the study. We also thank Fundación Trilema for
their free support in creating the platform for the study.
Authors' Contributions
AM contributed to conception and design and data analysis, and prepared the first draft of the manuscript. All authors contributed
to collection and assembly of data, interpretation, and manuscript revision. All authors approved the final manuscript.
Conflicts of Interest
None declared.
JMIR Form Res 2021 | vol. 5 | iss. 3 | e26121 | p. 3 (page number not for citation purposes)
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HCT: hematopoietic cell transplant
Edited by G Eysenbach; submitted 28.11.20; peer-reviewed by J Mariotti, H Mehdizadeh, P Tripathi; comments to author 30.12.20;
revised version received 31.12.20; accepted 16.01.21; published 12.03.21
Please cite as:
Mussetti A, Salas MQ, Condom M, Antonio M, Ochoa C, Ivan I, Jimenez Ruiz-De la Torre D, Sanz Linares G, Ansoleaga B,
Patiño-Gutierrez B, Jimenez-Prat L, Parody R, Sureda-Balari A
Use of Telehealth for Domiciliary Follow-up After Hematopoietic Cell Transplantation During the COVID-19 Pandemic: Prospective
Pilot Study
JMIR Form Res 2021;5(3):e26121
doi: 10.2196/26121
PMID: 33600351
©Alberto Mussetti, Maria Queralt Salas, Maria Condom, Maite Antonio, Cristian Ochoa, Iulia Ivan, David Jimenez Ruiz-De la
Torre, Gabriela Sanz Linares, Belen Ansoleaga, Beatriz Patiño-Gutierrez, Laura Jimenez-Prat, Rocio Parody, Ana Sureda-Balari.
Originally published in JMIR Formative Research (, 12.03.2021. This is an open-access article distributed
under the terms of the Creative Commons Attribution License (, which permits
unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Formative
Research, is properly cited. The complete bibliographic information, a link to the original publication on,
as well as this copyright and license information must be included.
JMIR Form Res 2021 | vol. 5 | iss. 3 | e26121 | p. 4 (page number not for citation purposes)
... It also represents an opportunity to reduce caregiver burden since this method can provide direct access to patient data for the care team's evaluation. In a Spanish study called the SMARTCOVID19 study, allo/autoHCT patients (n = 16) and their caregivers participated in an outpatient monitoring plan for 14 days [13]. A smartphone application was used to collect data on vital signs and symptoms for 14 days after hospital discharge. ...
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Simple Summary Patients with high-risk acute leukemias and lymphomas undergo stem cell transplantation or cellular therapies to achieve a cure. These are complex treatments that are typically offered by specialty medical centers. Patients are treated and monitored in the hospital for 3–4 weeks due to the potential for life-threatening complications. While it is still in its infancy, the use of telemedicine is changing this treatment paradigm by allowing patients to be in the comfort of their own home. We review data on how telemedicine is being incorporated for patients who receive stem cell transplantation or cellular therapy. Abstract Telemedicine has played an important role in delivering healthcare for primary care, chronic disease patients, and those with solid organ malignancies. However, its application in subspecialties such as hematologic malignancies, hematopoietic cell transplantation (HCT), or chimeric antigen receptor-T cell (CAR-T) therapy is not widespread since physical examination is a vital component in delivering care. During the COVID-19 pandemic, we widely used telemedicine, since protecting our immunocompromised patients became our top priority. The employment of HCT and CAR-T therapies continues to grow for high-risk hematologic malignancies, particularly in older and frail patients who must visit specialty centers for treatment access. Generally, HCT and CAR-T therapy care is highly complex, necessitating commitment from patients, caregivers, and a multidisciplinary team at specialty academic centers. All healthcare systems adapted to the crisis and implemented rapid changes during the COVID-19 public health emergency (PHE). Telemedicine, a vital modality for delivering healthcare in underserved areas, experienced rapid expansion, regardless of the geographic region, during the COVID-19 PHE. The data emerging from practices implemented during the PHE are propelling the field of telemedicine forward, particularly for specialties with complex medical treatments such as HCT and CAR-T therapy. In this review, we examine the current data on telemedicine in HCT and cellular therapy care models for the acute and long-term care of our patients.
... Only 12 of 21 patients eligible for the trial were able to enroll and complete this study, with technological barriers being the most frequent limiting factor in the study. However, among the 12 patients who enrolled, high adherence rates and reasonable patient satisfaction with the system were observed field 54 . Similarly, pilot studies to monitor cardiovascular risk factors among adult transplant recipients had also been tested, which showed good compliance among participating patients 55 . ...
Full-text available
Background : The Coronavirus Disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has significantly impacted global health and healthcare delivery systems. Objective : Describe secondary effects of the COVID-19 pandemic and mitigation strategies used in the delivery of hematopoietic stem cell transplantation care. Study Design : We performed a comprehensive literature search encompassing changes in specific donor collection, processing practices, patient outcomes, and patient-related concerns specific to transplant and transplant-related healthcare delivery. Results : We summarize the available literature on the secondary impacts the COVID-19 pandemic had on the fields of hematopoietic stem cell transplant and cellular therapy. Conclusions: The COVID-19 pandemic has had numerous secondary impacts on patients undergoing transplant and the healthcare delivery systems involved in providing complex care to transplant patients. Institutions must identify these influences on outcomes and adjust accordingly to maintain and improve outcomes for the transplant and cellular therapy community.
Purpose of review: To describe the state-of-the-art of telemedicine in hematology through the description of most relevant studies published in the pre-COVID19 and during the COVID19 era. Recent findings: Telemedicine has recently gained momentum in hematology due to the COVID19 pandemic. Due to a necessary improvement of domiciliary follow-up of patients during the pandemic and an increase in technologies able to offer telemedicine, the number of studies has increased in the last 2 years. Telemedicine showed the potential to improve the monitoring of both benign and malignant hematological diseases. Patients affected by thalassemias, hemophilias and/or myeloproliferative diseases were monitored successfully with telemedicine platform. For higher-risk patients such as high-dose chemotherapy or stem cell transplantation, better platforms are needed (e.g. use of wearable devices systems). Also, telemedicine showed to be useful for the follow-up of hematological patients with COVID19. Summary: Despite the clear potential advantages of telemedicine for the follow-up of hematological patients, more evidence is required before adopting this approach in larger cohorts of patients. Larger- and higher-quality studies are highly needed in this setting.
Hematopoietic stem cell transplantation (HCT) has the potential to cure malignant and nonmalignant diseases but remains associated with a wide range of complications, necessitating dedicated lifelong follow-up. While patients are monitored closely during the peri-HCT period, leaving the hospital setting after HCT introduces new challenges. This scoping review explores the current use of patient-generated eHealth data in the outpatient setting. PubMed, Scopus, CINAHL, APA PsycINFO, and the International HTA Database were systematically searched in July 2021, leading to 22 studies (13 full text articles and 9 abstracts) included in this review. The large majority were small to medium-sized (n=15, 68.2%) pilot or feasibility studies (n=18, 81.8%), and were published between 2016 and 2021 (n=16, 72.7%). Collection of patient-reported outcomes were the most popular reported eHealth intervention (n=14, 63.6%), followed by vital sign monitoring (n=5, 22.7%), and home-based spirometry (n=3, 13.6%), mostly in the early post-transplantation setting. eHealth interventions had favorable feasibility and acceptability profiles. However, we identified little evidence regarding the evaluation of the efficacy, long-term monitoring, data security and cost-effectiveness of eHealth interventions. Larger randomized studies are warranted to draw formal conclusion about eHealth impact on HCT outcomes and best ways to incorporate eHealth in clinical practice.
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Na abordagem a este tema, importa destacar os recursos tecnológicos eHealth e mHealth, apps e jogos. Salienta-se a importância da promoção da capacitação do outro para o seu autocuidado, através destes diversos recursos, que potenciem a motivação, facilitem a participação ativa do sujeito, fornecendo materiais educacionais. Ao recorrer ou prescrever estas intervenções, os enfermeiros precisam de adequar a sua adequabilidade destas intervenções ao contexto do indivíduo. Estes recursos têm e terão implicações na transformação dos cuidados de enfermagem, que devem ser estudados e equacionados num cuidado que poderá ser denominado de “Cuidado híbrido”. Estas ferramentas são projetadas para melhorar a vigilância da saúde, gestão do sistema de saúde, educação em saúde, tomada de decisão clínica e para apoiar mudanças comportamentais relacionadas às prioridades de saúde pública e gestão de doenças (WHO, 2016). Além disso, são promotores da transformação digital potenciando a qualidade na prestação de cuidados com foco nas necessidades das pessoas. Em suma, a adoção destes recursos tecnológicos possibilita que as organizações de saúde possam tomar decisões mais eficientes, perante um desafio ou oportunidade. Por outro lado, a implementação destas soluções digitais permite que os profissionais apostem na melhoria contínua, acrescentando valor aos cuidados de enfermagem. E por fim, permitem que os utentes se tornem mais ativos na autogestão da sua doença, promovendo o autocuidado em diferentes contextos de doenças crónicas.
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Allogeneic hematopoietic cell transplantation (allo-HCT) is a highly complex, costly procedure for patients with oncologic, hematologic, genetic, and immunologic diseases. Demographics and socioeconomic status as well as donor availability and type of health care system are important factors that influence access to and outcomes following allo-HCT. The last decade has seen an increase in the numbers of allo-HCTs and teams all over the world, with no signs of saturation. More than 80 000 procedures are being performed annually, with 1 million allo-HCTs estimated to take place by the end of 2024. Many factors have contributed to this, including increased numbers of eligible patients (older adults with or without comorbidities) and available donors (unrelated and haploidentical), improved supportive care, and decreased early and late post-HCT mortalities. This increase is also directly linked to macro- and microeconomic indicators that affect health care both regionally and globally. Despite this global increase in the number of allo-HCTs and transplant centers, there is an enormous need for increased access to and improved outcomes following allo-HCT in resource-constrained countries. The reduction of poverty, global economic changes, greater access to information, exchange of technologies, and use of artificial intelligence, mobile health, and telehealth are certainly creating unprecedented opportunities to establish collaborations and share experiences and thus increase patient access to allo-HCT. A specific research agenda to address issues of allo-HCT in resource-constrained settings is urgently warranted.
Purpose of review: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) impacted every facet of hematopoietic cell transplantation. This article reviews the adjustments to recipient and donor care that occurred in response to this unprecedented event. Recent findings: Transplant centers modified algorithms, patient flow, education, and how we provided care. Our donor center partners reworked how donors were evaluated and products delivered to the transplant center. Our professional societies provided guidelines for patient and donor care and rapidly modified these based upon the never-ending stream of new data learned about SARS-CoV-2. Our research organizations provided rapid analyses to ensure the care modifications necessitated did not have a profound negative impact on our patients or donors. Summary: The efforts of transplant providers and donor centers worldwide allowed patients to receive the transplant needed with assurances that they were receiving the best care available despite the worldwide challenge.
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Background: Telehealth involves the use of telecommunication and information technology for the delivery of clinical care and may be a mechanism to alleviate the burden of visits faced by patients undergoing hematopoietic cell transplantation (HCT). Few studies have evaluated the feasibility and acceptability of telehealth visits in the care of HCT patients. Methods: We conducted 27 telehealth visits with 25 patients undergoing HCT using a videoconferencing system that allows for real-time, two-way interactions and administered satisfaction surveys to patients and providers. Results: Of the 25 patients included in the study, 20 (80%) and five (20%) were undergoing autologous and allogeneic HCT, respectively. The telehealth visits were distributed as follows: 3 inpatient visits upon admission for HCT; 11 inpatient visits between 2-14 days post-HCT; 4 inpatient visits prior to discharge after HCT; 8 outpatient, post-HCT follow-up visits; and 1 handoff to a community oncologist. Out of a total of 54 provider assessments, 7 providers (13%) were unable to complete some part of the physical examination, but no provider reported being unable to manage patients' symptoms through telehealth. 81% of patients were either satisfied or very satisfied with the telemedicine session. Overall satisfaction was higher among patients than providers (mean scores 4.12 vs. 2.64; scale 1-5, 1: very poor; 5: excellent). Technological barriers resulting in delays and suboptimal physical examination were largely responsible for provider dissatisfaction. Conclusions: The use of telehealth to deliver comprehensive follow-up care to HCT patients is feasible across different HCT types but is dependent upon quality of data streaming and videoconferencing technologies.
Background: Understanding outcomes and immunologic characteristics of cellular therapy recipients with SARS-CoV-2 is critical to performing these potentially life-saving therapies in the COVID-19 era. In this study of recipients of allogeneic (Allo) and autologous (Auto) hematopoietic cell transplant and CD19-directed chimeric antigen receptor T cell therapy (CAR-T) at Memorial Sloan Kettering Cancer Center, we aimed to identify clinical variables associated with COVID-19 severity and assess lymphocyte populations. Methods: We retrospectively investigated patients diagnosed between March 15th and May 7th, 2020. In a subset of patients, lymphocyte immunophenotyping, quantitative real-time PCR from nasopharyngeal swabs, and SARS-CoV-2 antibody status were available. Results: We identified 77 SARS-CoV-2 + cellular therapy recipients (Allo = 35, Auto = 37, CAR-T = 5; median time from cellular therapy 782 days (IQR 354,1611). Overall survival at 30 days was 78%. Clinical variables significantly associated with the composite endpoint of non-rebreather or higher oxygen requirement and death (n events = 25/77) included number of co-morbidities (HR 5.41, P = 0.004), infiltrates (HR 3.08, P = 0.032), and neutropenia (HR 1.15, P = 0.04). Worsening graft-versus-host-disease was not identified among Allo subjects. Immune profiling revealed reductions and rapid recovery in lymphocyte populations across lymphocyte subsets. Antibody responses were seen in a subset of patients. Conclusion: In this series of Allo, Auto, and CAR-T recipients, we report overall favorable clinical outcomes for COVID-19 patients without active malignancy and provide preliminary insights into the lymphocyte populations that are key for the anti-viral response and immune reconstitution. Funding: NIH P01 CA23766, NIH/NCI P30 CA008748.
Background Several small studies on patients with COVID-19 and haematological malignancies are available showing a high mortality in this population. The Italian Hematology Alliance on COVID-19 aimed to collect data from adult patients with haematological malignancies who required hospitalisation for COVID-19. Methods This multicentre, retrospective, cohort study included adult patients (aged ≥18 years) with diagnosis of a WHO-defined haematological malignancy admitted to 66 Italian hospitals between Feb 25 and May 18, 2020, with laboratory-confirmed and symptomatic COVID-19. Data cutoff for this analysis was June 22, 2020. The primary outcome was mortality and evaluation of potential predictive parameters of mortality. We calculated standardised mortality ratios between observed death in the study cohort and expected death by applying stratum-specific mortality rates of the Italian population with COVID-19 and an Italian cohort of 31 993 patients with haematological malignancies without COVID-19 (data up to March 1, 2019). Multivariable Cox proportional hazards model was used to identify factors associated with overall survival. This study is registered with, NCT04352556, and the prospective part of the study is ongoing. Findings We enrolled 536 patients with a median follow-up of 20 days (IQR 10–34) at data cutoff, 85 (16%) of whom were managed as outpatients. 440 (98%) of 451 hospitalised patients completed their hospital course (were either discharged alive or died). 198 (37%) of 536 patients died. When compared with the general Italian population with COVID-19, the standardised mortality ratio was 2·04 (95% CI 1·77–2·34) in our whole study cohort and 3·72 (2·86–4·64) in individuals younger than 70 years. When compared with the non-COVID-19 cohort with haematological malignancies, the standardised mortality ratio was 41·3 (38·1–44·9). Older age (hazard ratio 1·03, 95% CI 1·01–1·05); progressive disease status (2·10, 1·41–3·12); diagnosis of acute myeloid leukaemia (3·49, 1·56–7·81), indolent non-Hodgin lymphoma (2·19, 1·07–4·48), aggressive non-Hodgkin lymphoma (2·56, 1·34–4·89), or plasma cell neoplasms (2·48, 1·31–4·69), and severe or critical COVID-19 (4·08, 2·73–6·09) were associated with worse overall survival. Interpretation This study adds to the evidence that patients with haematological malignancies have worse outcomes than both the general population with COVID-19 and patients with haematological malignancies without COVID-19. The high mortality among patients with haematological malignancies hospitalised with COVID-19 highlights the need for aggressive infection prevention strategies, at least until effective vaccination or treatment strategies are available. Funding Associazione italiana contro le leucemie, linfomi e mieloma–Varese Onlus.
e14103 Background: The rapid development of digital technology holds enormous potential to transform the delivery of cancer care. Despite these digital innovations, we still face significant challenges in healthcare in using these emerging digital technologies in the clinical setting. Clinicians generally underestimate the severity and extent of chemotherapy toxicity of patients. This project seeks to conduct an exploratory field study to collect patient feedback on their experiences, and the design/functionality of the prototype of the digital health service platform designed to monitor their symptoms. Methods: Using the National Cancer Institute item library addressing the most common symptoms for chemotherapy toxicity, a digital health platform was designed by Samsung Research America (SRA) and University Hospitals. Patients age ≥ 18 years old, willingness to agree to the consent document, ability to understand use of wearable device and willingness to answer patient reported outcomes questions were included in this study. Patients who are not undergoing oral chemotherapy treatment for their cancer were excluded. Patients were given a phone that had our designed platform along with a watch. The watch had the capability of tracking blood pressure, heart rate, and pulse oximetry. Patients were set up with an electronic account that queried them on patient Reported Outcomes (PRO) regarding potential toxicity they may be experiencing. They were also able to track medication consumption and input their weight. Subjects were be asked to use the wearable device and phone for at least 28 days and no more than 90 days. At the end of the study, a phone survey was attempted. Results: Total patients enrolled: 21. 18/21 (85.7%) patients completed the 90 days of the study. Only 9 patients provided PRO with total number of side effects reported 28 times. Watch device was only utilized by 15/21 (71.4%) patients. On an average across 90 days, these patients wore the watch 430 minutes per day. At the end of the treatment, 5 patients agreed to participate in the phone survey. Three patients stated that they would do similar study in the future noting that the digital platform helped them stay on track and monitor symptoms accurately. Every patient questioned had a complaint regarding the watch functionality. Patients also found it difficult to carry a second phone in addition to their personal phone. Conclusions: Improving our digital health service platform will get us closer to achieving effective bi-lateral patient communication and ultimately improving patient care.
Mobile technology has become a ubiquitous part of everyday life and is changing the way we offer clinical care and perform clinical research. We have unprecedented access to data for one's self-care as well as for sharing with health care providers. Meeting the challenge posed by the influx of wearable device data requires a multidisciplinary team of researchers, clinicians, software developers, information technologists, and statisticians. Although the possibility of what can be achieved with the ever-evolving wearable technologies seems to be unlimited, regulatory agencies have provided a framework to establish standards for clinical applications, which will also affect research applications. Clinical programs and electronic medical records vendors should prepare to establish a framework to implement these technologies into clinicians' workflow and to allow feedback to measure the impact on clinical outcome. In this article, we discuss how a new brand of multidisciplinary care is evolving around mobile health devices and present a vision of up-and-coming technology in this space.
As the availability and sophistication of mobile health (mHealth) technology (wearables, mobile technology, and sensors) continues to increase, there is great promise that these tools will be transformative for clinical trials and drug development. This review provides an overview of the current landscape of potential measurement options, including the various types of data collected, methods/tools for collecting them, and a crosswalk of available options. The opportunities and potential drawbacks of mHealth in cancer clinical trials are discussed. Specific concerns related to data accuracy, provenance, and regulatory issues are highlighted, with suggestions for how to address these in future research. Next steps for establishing mHealth methods and tools as legitimate and accepted measures in oncology clinical trials include continuation of regulatory definition by the FDA; establishment of security standards and protocols; refinement and implementation of methods to establish and document data accuracy; and finally, creation of feedback loops wherein regulators receive updates from researchers with better and more timely data, which should decrease trial times and lessen drug development costs. Implementing mHealth technologies into cancer clinical trials has the potential to transform and propel oncology drug development and precision medicine to keep pace with the rapidly increasing developments in genomics and immunology.
Clinical characteristics and risk factors associated with COVID-19 severity in patients with haematological malignancies in Italy: a retrospective, multicentre, cohort study
  • F Passamonti
  • C Cattaneo
  • L Arcaini
  • R Bruna
  • M Cavo
  • F Merli
  • Ita-Hema-Cov Investigators
Passamonti F, Cattaneo C, Arcaini L, Bruna R, Cavo M, Merli F, ITA-HEMA-COV Investigators. Clinical characteristics and risk factors associated with COVID-19 severity in patients with haematological malignancies in Italy: a retrospective, multicentre, cohort study. Lancet Haematol 2020 Oct;7(10):e737-e745 [FREE Full text] [doi: 10.1016/S2352-3026(20)30251-9] [Medline: 32798473]