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- Wendy H. Oldenmenger (Rotterdam, Netherlands)
Efficiency of eHealth and digital innovations in cancer care
- Andreas Charalambous (Limassol, Cyprus)
Development and implementation of virtual pre-chemotherapy consultations
- Catherine Oakley (London, United Kingdom)
CN1 - Patient-reported symptom monitoring improves health-related quality of life in lung cancer patients: The SYMPRO-Lung trial
- Nicole E. Billingy (Amsterdam, Netherlands)
Abstract
Background
The use of patient reported outcomes measures (PROMs) to monitor symptoms during and after cancer treatment can improve health-related quality of life (HRQOL) and overall survival (OS), especially when linked to an alert system. While previous studies only used alerts that were sent to the health care provider (HCP), an approach in which patients themselves receive alerts could be more clinically feasible. The primary aim of the SYMPRO-Lung study was to compare the effect of weekly online PROM symptom monitoring (intervention group, IG) with care as usual (control group, CG) on HRQOL 15 weeks after start of treatment for lung cancer. We also investigated the effect of a reactive approach (patient receives alert) vs. an active approach (HCP receives alert).
Methods
SYMPRO-Lung is a Dutch multicenter randomized trial using a stepped wedge design. Inclusion criteria were (non-)small cell lung cancer stage I-IV, starting treatment. Patients in the IG reported PRO symptoms weekly using the PRO-CTCAE subset. If symptoms exceeded a validated threshold, an alert was sent. HRQOL was measured by the EORTC QLQ-C30 at baseline and 15 weeks after start of treatment. Linear regression analyses were used to assess differences in HRQOL at 15 weeks, accounting for HRQOL at baseline and confounding. Cohen’s
Results
In total, 515 patients were included in the study (266 control, 249 intervention). In the IG, 244 patients completed 2412 symptom checklists during the first 15 weeks of treatment, M 10 per patient (SD 4.3). A total of 673 alerts (28%) were triggered, M 3 (SD 2.1). The IG had statistically and clinically significant better physical functioning (ES 0.50) and less dyspnea (ES 0.38), as compared to the CG. While the HRQOL overall summary score (ES 0.34), role – (ES 0.31), and social functioning (ES 0.26), fatigue (ES 0.27), and constipation (ES 0.16) were only statistically significant. No significant differences were found in HRQOL between the two intervention groups.
Conclusions
PROM symptom monitoring significantly improves HRQOL in lung cancer patients. The logistically less intensive, reactive approach may be a better fit for some hospitals.
Clinical trial identification
Netherlands Trial Register: Trial NL7897.
Legal entity responsible for the study
Amsterdam UMC, location VUmc.
Funding
Roche, Zorg Innovatiefonds, and Stichting Kwaliteitsgelden Medisch Specialisten (SKMS).
Disclosure
C. Van den Hurk: Financial Interests, Institutional, Principal Investigator: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Merck; Financial Interests, Institutional, Project Lead: Ipsen. All other authors have declared no conflicts of interest.
CN2 - A public involvement process to enhance diversity in technology clinical trials
- Leanna Goodwin (Manchester, United Kingdom)
Abstract
Background
Clinical trials exist to determine safety and efficacy of emerging interventions and should be representative of all patients. The digital Experimental Cancer Medicine Team (dECMT) conducts technology clinical trials (TechCT) to develop new technologically-enabled healthcare pathways through patient involvement. However, there is a growing appreciation of the digital divide in healthcare technology which may limit access to technologically-enabled healthcare pathways.
Methods
A collaboration between Vocal (a Manchester-based not-for-profit organisation which brings people and health research together) and dECMT facilitated 3 half-day workshops over 6 months. These involved patients and their representatives from diverse backgrounds, healthcare workers and researchers with an interest in digital healthcare and inclusion. Participants were reimbursed for their time. The aim of the workshops was to create inclusivity guidance for development of TechCT across the Greater Manchester Region (GMR), ensuring that technologically-enabled healthcare pathway development is designed for all.
Results
The 3 key stages of developing, establishing and running a TechCT were discussed and evaluated. This enabled all participants to interrogate each stage and process for opportunities to encourage inclusivity. Presentations, groups discussion and case studies were used to generate discussion and highlight areas for change. The outcome of this work has also been compiled into a guidance document and infographic for easy use, and will be shared with researchers across GMR via an established forum and with partners in the UK and Europe. It will also be fed back to the participants.
Conclusions
This process helped us to reflect on trial design from different perspectives. The workshops highlighted immediate changes we could make and changes to trial management processes and communication that we will adopt in our trial processes. More broadly, it highlighted the value of collaborating with others to both question practice and identify solutions. The legacy of this project will be to make our processes and practice more inclusive in all future TechCT, and to contribute to the wider discussion of addressing the digital divide in clinical research.
Legal entity responsible for the study
The authors.
Funding
Manchester Academic Health Science Centre (MAHSC).
Disclosure
D.M. Graham: Financial Interests, Personal, Advisory Board, Consulting role on advisory board: Clinigen; Financial Interests, Personal, Invited Speaker: Cancer Drug Development Fund; Financial Interests, Personal, Advisory Board: McCann Health; Financial Interests, Institutional, Invited Speaker, Institutional funding from study: MSD, Codiak Biosciences, Starpharma, Faron Pharmaceuticals, Synthon, Janssen; Financial Interests, Institutional, Other, Sub-I: Institutional funding from study: AstraZeneca, Roche, BerGenBio, GlaxoSmithKline, Bayer, Bicycle pharmaceuticals, Carrick, Taiho Pharmaceuticals, CytomX Therapeutics, RedX Pharma PLC, Eisai Inc, Octimet, Orion Pharma, Kinex pharmaceuticals, Boehringer Ingelheim, BMS, Turning Point Therapeutics, Immutep, Agalimmune, Kymab, Blueprint, Astellas, Cellcentric, UCB Biopharma USL, Eli Lily, Seagen, Repare Therapeutics, Timepoint Therapeutics, Astex, Stemline, Crescendo Biologics Ltd, ADC Therapeutics, Genentech, Avacta Life Sciences Ltd, Nurix Therapeutics Inc; Financial Interests, Institutional, Other, Sub-I: Institutional finding from study: Chugai Pharmaceuticals; Financial Interests, Institutional, Invited Speaker: Incyte. All other authors have declared no conflicts of interest.