SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung): study protocol for a stepped-wedge randomised controlled trial

IntroductionLung cancer and its treatment cause a wide range of symptoms impacting the patients’ health-related quality of life (HRQoL). The use of patient-reported outcomes (PRO) to monitor symptoms during and after cancer treatment has been shown not only to improve symptom management but also to improve HRQoL and overall survival (OS). Collectively, these results favour implementation of PRO-symptom monitoring in daily clinical care. However, these promising outcomes have been obtained under trial conditions in which patients were selected based on stringent inclusion criteria, and in countries with a dissimilar healthcare system than in the Netherlands.The primary aim of the SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung) study is to evaluate the effect of PRO-symptom monitoring during and after lung cancer treatment on HRQoL in daily clinical practice. Secondary objectives include assessing the effect of PRO-symptom monitoring on progression-free survival, OS, the incidence and grade of PRO symptoms, medication adherence, implementation fidelity and cost-effectiveness.Methods and analysisThe SYMPRO-Lung study is a prospective, multicentre trial with a stepped wedge cluster randomised design. Study participants (n=292 intervention, n=292 controls) include patients with lung cancer (stages I–IV) starting treatment with surgery, systemic treatment, targeted treatment and/or radiotherapy.Every participating centre will consecutively switch from the control period to the intervention period, in which patients report their symptoms weekly via an online tool. In the intervention group, we evaluate two alert approaches: the active and reactive approach. If the symptoms exceed a predefined threshold, an alert is sent to the healthcare provider (active approach) or to the patient (reactive approach). Both the control and intervention group complete HRQoL questionnaires at 4 time points: at baseline, 15 weeks, 6 months and 1-year post treatment). Differences in HRQoL between the groups will be compared using linear mixed modelling analyses, accounting for within-centre clustering, potential time effects and confounding.Ethics and disseminationThe study protocol was approved by the Institutional Review Board and the Medical Ethics Committee of the Amsterdam UMC (under number NL 68440.029.18) and the institutional review boards of the participating study sites. The dissemination of the results will be conducted through publication in peer-reviewed journals and through scientific conferences.Trial registration numberTrial register identifier: Netherlands Trial register Trial NL7897. Date of registration: 24 July 2019. https://www.trialregister.nl/trial/7897.

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1234TiP SYMptom monitoring with patient-reported outcomes using a web application among lung cancer patients in the Netherlands (SYMPRO-Lung)

Annals of Oncology ◽

10.1016/j.annonc.2020.08.1436 ◽

2020 ◽

Vol 31 ◽

pp. S801

Author(s):

N.E. Billingy ◽

E. Veldhuijzen ◽

V. Tromp ◽

J. Belderbos ◽

N. Aaronson ◽

...

Keyword(s):

Lung Cancer ◽

The Netherlands ◽

Cancer Patients ◽

Web Application ◽

Patient Reported Outcomes ◽

Symptom Monitoring ◽

Lung Cancer Patients ◽

Patient Reported

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Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial

Journal of Clinical Oncology ◽

10.1200/jco.2015.63.0830 ◽

2016 ◽

Vol 34 (6) ◽

pp. 557-565 ◽

Cited By ~ 758

Author(s):

Ethan Basch ◽

Allison M. Deal ◽

Mark G. Kris ◽

Howard I. Scher ◽

Clifford A. Hudis ◽

...

Keyword(s):

Usual Care ◽

Cancer Care ◽

Patient Reported Outcomes ◽

Controlled Trial ◽

Intervention Group ◽

Cancer Center ◽

Symptom Monitoring ◽

Outpatient Chemotherapy ◽

Patient Reported ◽

E Mail

Purpose There is growing interest to enhance symptom monitoring during routine cancer care using patient-reported outcomes, but evidence of impact on clinical outcomes is limited. Methods We randomly assigned patients receiving routine outpatient chemotherapy for advanced solid tumors at Memorial Sloan Kettering Cancer Center to report 12 common symptoms via tablet computers or to receive usual care consisting of symptom monitoring at the discretion of clinicians. Those with home computers received weekly e-mail prompts to report between visits. Treating physicians received symptom printouts at visits, and nurses received e-mail alerts when participants reported severe or worsening symptoms. The primary outcome was change in health-related quality of life (HRQL) at 6 months compared with baseline, measured by the EuroQol EQ-5D Index. Secondary endpoints included emergency room (ER) visits, hospitalizations, and survival. Results Among 766 patients allocated, HRQL improved among more participants in the intervention group than usual care (34% v 18%) and worsened among fewer (38% v 53%; P < .001). Overall, mean HRQL declined by less in the intervention group than usual care (1.4- v 7.1-point drop; P < .001). Patients receiving intervention were less frequently admitted to the ER (34% v 41%; P = .02) or hospitalized (45% v 49%; P = .08) and remained on chemotherapy longer (mean, 8.2 v 6.3 months; P = .002). Although 75% of the intervention group was alive at 1 year, 69% with usual care survived the year (P = .05), with differences also seen in quality-adjusted survival (mean of 8.7 v. 8.0 months; P = .004). Benefits were greater for participants lacking prior computer experience. Most patients receiving intervention (63%) reported severe symptoms during the study. Nurses frequently initiated clinical actions in response to e-mail alerts. Conclusion Clinical benefits were associated with symptom self-reporting during cancer care.

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Selecting a PRO-CTCAE based subset for patient reported symptom monitoring during lung cancer treatment (Preprint)

10.2196/preprints.26574 ◽

2020 ◽

Author(s):

Evalien Veldhuijzen ◽

Iris Walraven ◽

Jose Belderbos

Keyword(s):

Lung Cancer ◽

Clinical Practice ◽

Cancer Patients ◽

Treatment Modalities ◽

European Organization ◽

Specific Patient ◽

Symptom Monitoring ◽

Lung Cancer Patients ◽

Wide Range ◽

Patient Reported

BACKGROUND The Patient Reported Outcomes Version of the Common Terminology Criteria of Adverse Events (PRO-CTCAE) item library covers a wide range of symptoms relevant for oncology care. To enable implementation of PRO-CTCAE-based symptom monitoring in clinical practice, there is a need to select a subset of items relevant for specific patient populations. OBJECTIVE The aim of this study was to develop a PRO-CTCAE subset relevant for patients with lung cancer. METHODS The PRO-CTCAE-based subset for lung cancer patients was generated using a mixed methods approach based on the European Organization for Research and Treatment of Cancer (EORTC) guidelines for developing questionnaires, consisting of a literature review and semi-structured interviews with both lung cancer patients and health care practitioners (HCPs). Both patients and HCPs were queried on the relevance and impact of all PRO-CTCAE items. Results were summarized and, after a final round of expert review, a selection of clinically relevant items for lung cancer patients was made. RESULTS A heterogeneous group of lung cancer patients (n=25) from different treatment modalities and HCPs (n=22) participated in the study. A final list of eight relevant PRO-CTCAE items was created: decreased appetite, cough, shortness of breath, fatigue, constipation, nausea, sadness, and pain (general). CONCLUSIONS Based on literature and both professional and patient input, a subset of PRO-CTCAE items has been identified for use in lung cancer patients in clinical practice. Future work is needed to confirm the validity and effectiveness of this PRO-CTCAE lung cancer subset internationally, and in the real-world clinical practice setting.

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