Patient-reported outcomes for monitoring symptomatic toxicities in cancer patients treated with immune-checkpoint inhibitors: A Delphi study

Lopes, André Manuel da Silva; Colomer‐Lahiguera, Sara; Alfonso, Nuria Mederos; Aedo-Lopez, Veronica; Spurrier-Bernard, Gilliosa; Tolstrup, Lærke Kjær; Pappot, Helle; Aspeslagh, Sandrine; Rogiers, Anne; Neyns, Bart; Haanen, John B.A.G.; Mitchell, Sandra A.; Addeo, Alfredo; Michielin, Olivier; Eicher, Manuela

doi:10.1016/j.ejca.2021.08.026

Cited by 13 publications

(5 citation statements)

References 24 publications

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“… 97 Nevertheless, there is a need to strengthen the validity of PRO measures used to monitor patients receiving ICI therapy. 98 In addition, it may be difficult to distinguish the immune pathogenesis of an adverse event from other causes, especially if the ICI is combined with other therapies. This bias might have influenced the results of our analyses.…”

Section: Discussionmentioning

confidence: 99%

Immune-related adverse events as potential surrogates of immune checkpoint inhibitors’ efficacy: a systematic review and meta-analysis of randomized studies

Amoroso¹,

Gallo²,

Alberti³

et al. 2023

ESMO Open

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Section: Discussionmentioning

confidence: 99%

Immune-related adverse events as potential surrogates of immune checkpoint inhibitors’ efficacy: a systematic review and meta-analysis of randomized studies

Amoroso¹,

Gallo²,

Alberti³

et al. 2023

ESMO Open

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“…Out of the 66 PPI articles, 16 originated in the United Kingdom, 31–46 14 in the United States, 47–60 12 in Australia, 61–72 7 in Canada, 73–79 2 in China, 80,81 and 1 in Japan 82 . European countries included: Switzerland ( n = 2), 83,84 The Netherlands ( n = 2), 85,86 and Spain ( n = 1), 87 as well as two studies comprising several countries ( n = 2) 88,89 . Northern European countries included Norway ( n = 3), 90–92 Denmark ( n = 2), 93,94 Sweden ( n = 2) 95,96 (Figure 2A).…”

Section: Resultsmentioning

confidence: 99%

Patient and public involvement in cancer research: A scoping review

Colomer‐Lahiguera,

Steimer,

Ellis

et al. 2023

Cancer Medicine

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IntroductionPatient and public involvement (PPI) in research emphasizes the importance of doing research with, rather than for people with lived health/illness experience(s). The purpose of this scoping review is to investigate the breadth and depth of scientific literature on PPI in cancer research and to identify how is PPI applied and reported in cancer research.MethodsWe searched MEDLINE, Embase, CINAHL, and PsycInfo up to March 2022. All titles/abstracts and full‐text results were screened by two reviewers. Data were analyzed and are presented in both narrative and tabular format.ResultsWe screened 22,009 titles/abstract, reviewed 375 full‐text articles, of which 101 studies were included in this review. 66 papers applied PPI; 35 used co‐design methodologies. PPI in cancer research in published research has increased steadily since 2015 and often includes those with a past diagnosis of cancer or relatives/informal caregivers. The most common applied methods were workshops or interviews. PPI was generally used at the level of consultation/advisor and occurred mainly in early stages of research. Costs related to PPI were mentioned in 25 papers and four papers described training provided for PPI.ConclusionsResults of our review demonstrate the nature and extent of PPI expansion in cancer research. Researchers and research organizations entering the fray of PPI should consider planning and reporting elements such as the stage, level, and role type of PPI, as well as methods and strategies put in place to assure diversity. Furthermore, a thorough evaluation of whether all these elements meet the stated PPI purpose will help to grasp its impact on research outcomes.Patient or Public ContributionTwo patients participated in the stakeholder consultation as part of the scoping review methodology, contributed to the discussion on refining the results, and critically reviewed the manuscript. Both are co‐authors of this manuscript.

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“…The first phase focused on the development of a PRO measure based on the PRO version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [ 40 ]. The development of this measure has been detailed in a previously published Delphi study [ 41 ]. The second phase was concerned with the development of the ePRO-based model of care being tested in the RCT [ 42 ].…”

Section: Methodsmentioning

confidence: 99%

“…Symptom data in the intervention group are collected using a weekly PRO-CTCAE that includes symptom terms categorized as of the highest importance to monitor during ICI treatment. Thirty of the 37 symptom terms were identified through the Delphi study conducted in the first phase of the IePRO project [ 41 ]. The remaining 7 were selected by the IePRO project’s clinical team and principal investigators.…”

Section: Methodsmentioning

confidence: 99%

Testing a Model of Care for Patients on Immune Checkpoint Inhibitors Based on Electronic Patient-Reported Outcomes: Protocol for a Randomized Phase II Controlled Trial

da Silva Lopes,

Colomer-Lahiguera,

Darnac

et al. 2023

JMIR Res Protoc

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Background Management of severe symptomatic immune-related adverse events (IrAEs) related to immune checkpoint inhibitors (ICIs) can be facilitated by timely detection. As patients face a heterogeneous set of symptoms outside the clinical setting, remotely monitoring and assessing symptoms by using patient-reported outcomes (PROs) may result in shorter delays between symptom onset and clinician detection. Objective We assess the effect of a model of care for remote patient monitoring and symptom management based on PRO data on the time to detection of symptomatic IrAEs from symptom onset. The secondary objectives are to assess its effects on the time between symptomatic IrAE detection and intervention, IrAE grade (severity), health-related quality of life, self-efficacy, and overall survival at 6 months. Methods For this study, 198 patients with cancer receiving systemic treatment comprising ICIs exclusively will be recruited from 2 Swiss university hospitals. Patients are randomized (1:1) to a digital model of care (intervention) or usual care (control group). Patients are enrolled for 6 months, and they use an electronic app to complete weekly Functional Assessment of Cancer Therapy-General questionnaire and PROMIS (PROs Measurement Information System) Self-Efficacy to Manage Symptoms questionnaires. The intervention patient group completes a standard set of 37 items in a weekly PROs version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire, and active symptoms are reassessed daily for the first 3 months by using a modified 24-hour recall period. Patients can add items from the full PRO-CTCAE item library to their questionnaire. Nurses call patients in the event of new or worsening symptoms and manage them by using a standardized triage algorithm based on the United Kingdom Oncology Nursing Society 24-hour triage tool. This algorithm provides guidance on deciding if patients should receive in-person care, if monitoring should be increased, or if self-management education should be reinforced. Results The Institut Suisse de Recherche Expérimentale sur le Cancer Foundation and Kaiku Health Ltd funded this study. Active recruitment began since November 2021 and is projected to conclude in November 2023. Trial results are expected to be published in the first quarter of 2024 and will be disseminated through publications submitted at international scientific conferences. Conclusions This trial is among the first trials to use PRO data to directly influence routine care of patients treated with ICIs and addresses some limitations in previous studies. This trial collects a wider spectrum of self-reported symptom data daily. There are some methodological limitations brought by changes in evolving treatment standards for patients with cancer. This trial's results could entail further academic discussions on the challenges of diagnosing and managing symptoms associated with treatment remotely by providing further insights into the burden symptoms represent to patients and highlight the complexity of care procedures involved in managing symptomatic IrAEs. Trial Registration ClinicalTrials.gov NCT05530187; https://www.clinicaltrials.gov/study/NCT05530187 International Registered Report Identifier (IRRID) DERR1-10.2196/48386

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Patient-reported outcomes for monitoring symptomatic toxicities in cancer patients treated with immune-checkpoint inhibitors: A Delphi study

Cited by 13 publications

References 24 publications

Immune-related adverse events as potential surrogates of immune checkpoint inhibitors’ efficacy: a systematic review and meta-analysis of randomized studies

Immune-related adverse events as potential surrogates of immune checkpoint inhibitors’ efficacy: a systematic review and meta-analysis of randomized studies

Patient and public involvement in cancer research: A scoping review

Testing a Model of Care for Patients on Immune Checkpoint Inhibitors Based on Electronic Patient-Reported Outcomes: Protocol for a Randomized Phase II Controlled Trial

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