Clinical trials participation is directly influenced by the information received by cancer patients (pts) and caregivers: Real-world evidence with the use of a specialized digital health platform.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18779-e18779
Author(s):  
Keren Greenfeld-Barsky ◽  
Lior Hasid ◽  
Daniel A. Vorobiof ◽  
Eliran Malki
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Treatment Option ◽  
Medical Staff ◽  
Digital Health ◽  
Participation Rate ◽  
Current Data ◽  
Common Reason ◽  
Sources Of Information ◽  
Common Diagnosis

e18779 Background: Clinical trials (CT) participation is both crucial for medical advancement and an important treatment option, at times the only one, for oncological pts. However, only an estimate of ̃3% of cancer pts worldwide enrolls into such trials. Different factors have been implicated in underlying this low participation rate, with little current data on patients’ own perspective. In this study, pts & caregivers’ perception, knowledge and experience with CT were assessed via a unique digital health platform. Methods: 290 American and Israeli members of Belong.life cancer application (app) anonymously & voluntarily replied to a 10 questions survey detailing their demographics, diagnosis, and experience with CT as a treatment option. Results: 234 participants were pts (81%) and 56 (19%) caregivers. 73% of participants were US based. 35 participants (12%) were < 50 years of age (yoa), 94 (32%) were 50-59 yoa, 117 (40%) were 60-69 and 44 (15%) were > 70 yoa. There were 79 males and 211 females.The most common diagnosis was breast cancer in 74 (26%), hematologic in 36 (12%), lung in 35 (12%), colorectal in 26 (9%) and ovarian in 26 (9%). Stages were 4 in 117 (40%) and 3 in 52 (18%), early (1&2) in 73 (25%). 134 (46%) have not heard about CT participation as a treatment option. Among 125 participants of the 134 who were not familiar with CT as a treatment option, 115 (92%) stated they would like to learn more about it. Among the 156 participants who were acquainted with this option, 52 (33%) heard about it from medical staff, 41(26%) from multiple online resources, and 39 (25%) only through the Belong.life app. Only 23 participants (8%) previously participated in a CT. The most common reason for not participating was not being offered this treatment option (55, 49%) followed by lack of suitable trials for their condition (26, 23%). The most common reason for considering it was to receive an innovative treatment (60, 44%). Conclusions: Almost half of the pts and caregivers were not aware of CT participation as a valid treatment option. Among them, nearly all have expressed an interest to be better informed. This significant dissonance was also evident among those aware but who were not offered to participate, while expressing a favorable perception regarding participation. While the medical staff is a key source for CT awareness, and whilst patients are exposed to multiple online sources of information, this survey confirmed that 25% of Belong.life members received information about CT availability and participation singly from the app and 8% of them actively participated in a clinical trial. In sum, emphasis should be placed on providing personally tailored CT information to all cancer patients and caregivers. Digital health platforms are an important source for patients CT awareness.

Perceptions concerning clinical trials in oncology patients.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e16533-e16533
Author(s):  
Dana Lee ◽  
Ju-Hsien Chao ◽  
Sandy Stevens ◽  
Goetz H. Kloecker
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Treatment Option ◽  
Phase 1 ◽  
Cancer Center ◽  
Line Treatment ◽  
Newly Diagnosed ◽  
First Line ◽  
Oncology Patients

e16533 Background: Accrual to clinical trials among adult cancer patients is persistently low. Patient preference plays an important role in enrollment. To identify the reasons why patients decline study participation, it is important, to evaluate the perceptions of newly diagnosed oncology patients about clinical trials. Methods: Patients were given a ten-question survey reflective of their attitudes regarding clinical trials as a treatment option at their initial visit. The self-directed questionnaire was scored on an ordinate scale from strongly agree (1) to strongly disagree (5). Results: Ninety-two new patients were surveyed in the cancer - specific multispecialty clinics in an academic cancer center. The patients expected information relating to eligible clinical trials and privacy protection by university sponsored studies as they strongly concurred with “I expect my doctor to inform me about clinical trials that I am eligible for” (mean score 2.15, p=0.001) followed by “all possible measures to protect my privacy are likely to be taken in a clinical trial that is sponsored by a university” (2.36, p=0.36). The strongest disagreement was “If enrolled in a clinical trial, I am comfortable being assigned by a method such as ‘flipping a coin’ or ‘throwing a dice’” (3.73, p=0.001) and “I would be willing to participate in a clinical trial as a first line treatment option” (3.50, p=0.001). Industry sponsored trials, phase 1 trials, second line treatment trials, privacy concerns and investigator initiated trials and time commitment and altruistic reasons did not significantly deviate from the mean preference (2.5) by a one sample T-test analysis. Conclusions: Patients consider the option of clinical trials as important in their treatment, and expect to be informed by their oncologist about clinical trials. Newly diagnosed cancer patients perceive randomization and first line trials negatively. Since randomized data provides new standards for care and hope for improved treatment, patients and their families must be educated about their importance.

scholarly journals Evaluation of a clinical decision support tool for matching cancer patients to clinical trials using simulation-based research

2021 ◽  
Author(s):  
Clarissa Judith Gardner ◽  
Jack Halligan ◽  
Gianluca Fontana ◽  
Roberto Fernandez Crespo ◽  
Matthew Stewart Prime ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Decision Support ◽  
Cancer Patients ◽  
Clinical Decision Support ◽  
Digital Health ◽  
Decision Support Tool ◽  
Clinical Decision ◽  
Support Tool ◽  
Simulation Based ◽  
The Difference

Simulation-based research (SBR) methods have been proposed as an alternative methodology for evaluating digital health solutions; however, applicability remains to be established. This study used SBR to evaluate a clinical decision support (CDS) tool used for matching cancer patients to clinical trials. 25 clinicians and research staff were recruited to match 10 synthetic patient cases to clinical trials using both the CDS tool and publicly available online trial databases. Participants were significantly more likely to report having sufficient time (p = 0.020) and to require less mental effort (p = 0.001) to complete trial matching with the CDS tool. Participants required less time for trial matching using the CDS tool, but the difference was not significant (p = 0.093). Most participants reported that they had sufficient guidance to participate in the simulations (96%). This study demonstrates the use of SBR methods is a feasible approach to evaluating digital health solutions.

Treatment and secondary prevention of venous thromboembolism in cancer patients

2012 ◽  
Vol 03 (03) ◽  
pp. 121-125
Author(s):  
I. Pabinger ◽  
C. Ay
Keyword(s):  
Clinical Trials ◽  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Oral Anticoagulants ◽  
Factor Xa ◽  
New Oral Anticoagulants ◽  
Phase Iii ◽  
Patients With Cancer ◽  
Potential Use

SummaryCancer is a major and independent risk factor of venous thromboembolism (VTE). In clinical practice, a high number of VTE events occurs in patients with cancer, and treatment of cancerassociated VTE differs in several aspects from treatment of VTE in the general population. However, treatment in cancer patients remains a major challenge, as the risk of recurrence of VTE as well as the risk of major bleeding during anticoagulation is substantially higher in patients with cancer than in those without cancer. In several clinical trials, different anticoagulants and regimens have been investigated for treatment of acute VTE and secondary prophylaxis in cancer patients to prevent recurrence. Based on the results of these trials, anticoagulant therapy with low-molecular-weight heparins (LMWH) has become the treatment of choice in cancer patients with acute VTE in the initial period and for extended and long-term anticoagulation for 3-6 months. New oral anticoagulants directly inhibiting thrombin or factor Xa, have been developed in the past decade and studied in large phase III clinical trials. Results from currently completed trials are promising and indicate their potential use for treatment of VTE. However, the role of the new oral thrombin and factor Xa inhibitors for VTE treatment in cancer patients still has to be clarified in further studies specifically focusing on cancer-associated VTE. This brief review will summarize the current strategies of initial and long-term VTE treatment in patients with cancer and discuss the potential use of the new oral anticoagulants.

A Critical Review of Second-generation anti-EGFR Monoclonal Antibodies in Metastatic Colorectal Cancer

2020 ◽  
Vol 21 ◽  
Author(s):  
Daniel Sur ◽  
Andrei Havasi ◽  
Alecsandra Gorzo ◽  
Claudia Burz
Keyword(s):  
Colorectal Cancer ◽  
Drug Resistance ◽  
Clinical Trials ◽  
Monoclonal Antibodies ◽  
Metastatic Colorectal Cancer ◽  
Second Generation ◽  
Current Data ◽  
Braf Mutations ◽  
Durable Response ◽  
Ongoing Research

Background: Anti-EGFR monoclonal antibodies (mAbs) have become a relevant solution for the treatment of patients with metastatic colorectal cancer. Current anti-EGFR monoclonal antibodies face a series of problems, including resistance and non-durable response, and RAS and BRAF mutations serve as exclusion criteria for treatment with anti-EGFR mAbs. Advances in molecular tumor profiling and information on subsequent pathways responsible for disease progression and drug resistance helped develop a new generation of anti-EGFR mAbs. These second-generation mAbs have been developed to overcome existing resistance mechanisms and to limit common side effects. For the moment, existing literature suggests that these novel anti-EGFR mAbs are far from finding their way to clinical practice soon. Objective: In this review, we summarize and evaluate current data regarding ongoing research and completed clinical trials for different second-generation anti-EGFR monoclonal antibodies. Conclusion: Anti-EGFR mAbs exhibit efficacy in advanced colorectal cancer, but second-generation mAbs failed to prove their benefit in the treatment of metastatic colorectal cancer. Understanding the biological basis of primary and acquired drug resistance could allow scientists to design better clinical trials and develop improved second-generation mAbs.

Analysis of the Market, Regulatory Landscape, and Current State of Clinical Trials Pertaining to Digital Health

2018 ◽  
Vol 5 (1) ◽  
pp. 21-34
Author(s):  
Cheyenne E. Allenby ◽  
Eric S. Babiash ◽  
Patrick N. Blank ◽  
Marco D. Carpenter ◽  
Isabelle G. Lee ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Digital Health ◽  
Current State ◽  
Regulatory Landscape

Measuring patient engagement among cancer patients in eHealth and mHealth interventions on symptom management: an integrated review (Preprint)

2020 ◽  
Author(s):  
Juqing Zhao ◽  
Pei Chen ◽  
Guangming Wan
Keyword(s):  
Cancer Patients ◽  
Patient Engagement ◽  
Symptom Management ◽  
Subjective Experience ◽  
Participation Rate ◽  
Sensor Data ◽  
Quality Of Data ◽  
Mhealth Intervention

BACKGROUND There has been an increase number of eHealth and mHealth interventions aimed to support symptoms among cancer survivors. However, patient engagement has not been guaranteed and standardized in these interventions. OBJECTIVE The objective of this review was to address how patient engagement has been defined and measured in eHealth and mHealth interventions designed to improve symptoms and quality of life for cancer patients. METHODS Searches were performed in MEDLINE, PsychINFO, Web of Science, and Google Scholar to identify eHealth and mHealth interventions designed specifically to improve symptom management for cancer patients. Definition and measurement of engagement and engagement related outcomes of each intervention were synthesized. This integrated review was conducted using Critical Interpretive Synthesis to ensure the quality of data synthesis. RESULTS A total of 792 intervention studies were identified through the searches; 10 research papers met the inclusion criteria. Most of them (6/10) were randomized trial, 2 were one group trail, 1 was qualitative design, and 1 paper used mixed method. Majority of identified papers defined patient engagement as the usage of an eHealth and mHealth intervention by using different variables (e.g., usage time, log in times, participation rate). Engagement has also been described as subjective experience about the interaction with the intervention. The measurement of engagement is in accordance with the definition of engagement and can be categorized as objective and subjective measures. Among identified papers, 5 used system usage data, 2 used self-reported questionnaire, 1 used sensor data and 3 used qualitative method. Almost all studies reported engagement at a moment to moment level, but there is a lack of measurement of engagement for the long term. CONCLUSIONS There have been calls to develop standard definition and measurement of patient engagement in eHealth and mHealth interventions. Besides, it is important to provide cancer patients with more tailored and engaging eHealth and mHealth interventions for long term engagement.

scholarly journals A Roadmap to Inform Development, Validation and Approval of Digital Mobility Outcomes: The Mobilise-D Approach

2020 ◽  
Vol 4 (1) ◽  
pp. 13-27 ◽  
Author(s):  
Lynn Rochester ◽  
Claudia Mazzà ◽  
Arne Mueller ◽  
Brian Caulfield ◽  
Marie McCarthy ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Health Care Professionals ◽  
Digital Health ◽  
Disease Status ◽  
Proximal Femoral Fracture ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Physical Mobility ◽  
High Level

Health care has had to adapt rapidly to COVID-19, and this in turn has highlighted a pressing need for tools to facilitate remote visits and monitoring. Digital health technology, including body-worn devices, offers a solution using digital outcomes to measure and monitor disease status and provide outcomes meaningful to both patients and health care professionals. Remote monitoring of physical mobility is a prime example, because mobility is among the most advanced modalities that can be assessed digitally and remotely. Loss of mobility is also an important feature of many health conditions, providing a read-out of health as well as a target for intervention. Real-world, continuous digital measures of mobility (digital mobility outcomes or DMOs) provide an opportunity for novel insights into health care conditions complementing existing mobility measures. Accepted and approved DMOs are not yet widely available. The need for large collaborative efforts to tackle the critical steps to adoption is widely recognised. Mobilise-D is an example. It is a multidisciplinary consortium of 34 institutions from academia and industry funded through the European Innovative Medicines Initiative 2 Joint Undertaking. Members of Mobilise-D are collaborating to address the critical steps for DMOs to be adopted in clinical trials and ultimately health care. To achieve this, the consortium has developed a roadmap to inform the development, validation and approval of DMOs in Parkinson’s disease, multiple sclerosis, chronic obstructive pulmonary disease and recovery from proximal femoral fracture. Here we aim to describe the proposed approach and provide a high-level view of the ongoing and planned work of the Mobilise-D consortium. Ultimately, Mobilise-D aims to stimulate widespread adoption of DMOs through the provision of device agnostic software, standards and robust validation in order to bring digital outcomes from concept to use in clinical trials and health care.

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