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

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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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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Longitudinal patient-reported outcomes and survival among early-stage non-small cell lung cancer patients receiving stereotactic body radiotherapy

Radiotherapy and Oncology ◽

10.1016/j.radonc.2021.12.021 ◽

2021 ◽

Author(s):

Kea Turner ◽

Naomi C. Brownstein ◽

Zachary Thompson ◽

Issam El Naqa ◽

Yi Luo ◽

...

Keyword(s):

Lung Cancer ◽

Small Cell Lung Cancer ◽

Cancer Patients ◽

Stereotactic Body Radiotherapy ◽

Patient Reported Outcomes ◽

Early Stage ◽

Small Cell ◽

Small Cell Lung ◽

Lung Cancer Patients ◽

Patient Reported

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Patient-reported outcomes in light of supportive medications in treatment-naïve lung cancer patients

Supportive Care in Cancer ◽

10.1007/s00520-019-05004-8 ◽

2019 ◽

Vol 28 (4) ◽

pp. 1809-1816

Author(s):

Johnny M. Hoang ◽

Navneet Upadhyay ◽

Dozie N. Dike ◽

Jaekyu Lee ◽

Michael L. Johnson ◽

...

Keyword(s):

Lung Cancer ◽

Cancer Patients ◽

Patient Reported Outcomes ◽

Lung Cancer Patients ◽

Patient Reported ◽

Treatment Naïve

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What bothers lung cancer patients the most? A prospective, longitudinal electronic patient-reported outcomes study in advanced non-small cell lung cancer

Supportive Care in Cancer ◽

10.1007/s00520-015-2699-4 ◽

2015 ◽

Vol 23 (12) ◽

pp. 3455-3463 ◽

Cited By ~ 23

Author(s):

Thomas W. LeBlanc ◽

Myles Nickolich ◽

Christel N. Rushing ◽

Gregory P. Samsa ◽

Susan C. Locke ◽

...

Keyword(s):

Lung Cancer ◽

Small Cell Lung Cancer ◽

Cancer Patients ◽

Patient Reported Outcomes ◽

Small Cell ◽

Small Cell Lung ◽

Lung Cancer Patients ◽

Patient Reported ◽

Outcomes Study ◽

Prospective Longitudinal

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Real Life Data on Patient-Reported Outcomes and Neuro-Cognitive Functioning of Lung Cancer Patients: The PRO-Long Study

Frontiers in Oncology ◽

10.3389/fonc.2021.685605 ◽

2021 ◽

Vol 11 ◽

Author(s):

Lotte Van Der Weijst ◽

Veerle Surmont ◽

Wim Schrauwen ◽

Yolande Lievens

Keyword(s):

Lung Cancer ◽

Cancer Patients ◽

Visual Memory ◽

Patient Reported Outcomes ◽

Post Treatment ◽

Lung Cancer Patients ◽

Systemic Treatments ◽

Patient Reported ◽

The Impact ◽

Over Time

IntroductionThis report investigates the impact of systemic treatments (chemotherapy or immunotherapy) with(out) loco-regional radiotherapy, on HRQoL, toxicity and neurocognitive functioning (NCF) in locally advanced and metastatic non-small cell lung cancer patients enrolled in the PRO-Long study.Materials and MethodsData on patient-reported HRQoL and fourteen toxicities was collected, while NCF was tested, up to one-year post-treatment. HRQoL was assessed using the European Organisation for Research and Treatment of Cancer QLQ-C30. Lung cancer, treatment and neuro-psychological related toxicities were scored with the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. NCF was evaluated with six neurocognitive tests. Mixed model analyses were conducted to determine statistical significance (p = .01). Meaningful clinical important differences (MCIDs) were applied for changes in HRQoL and NCF data, while toxicities were compared to baseline values.ResultsIn total, 50 patients were enrolled. Overall HRQoL (p = .357) nor its domains (physical, p = .643; role, p = .069; emotional, p = .254; cognitive, p = 494; social, p = .735) changed significantly over time. Meaningful improvements in overall HRQoL were seen in 22, 38 and 39% and deteriorations in 22, 5 and 28% of patients at 2–3, 6 and 12 months respectively post-treatment. Overall toxicity (p = .007), lack of appetite (p = .001), nausea (p = .004) and dysphagia (p = .000) significantly decreased over time. Treatment caused acute toxicity, such as dyspnoea (45%) and memory problems (42%), but also alleviated pre-existing symptoms, including lack of appetite (32%), anxiety (29%) and depression (28%) at 2/3 months. The NCF domains of visual memory (p = .000) and cognitive processing speed (p = .000) showed significant improvements over time. In terms of MCIDs, at 2–3 months (18%) and 6 months (15%), verbal memory was particularly impacted; at 12 months, visual memory (18%) and executive function (18%) deteriorated primarily.ConclusionThe results suggest that therapy has no significant negative impact on overall HRQoL, its domains, and NCF. About one-third of patients reported a meaningful improved HRQoL at 1 year post-treatment. Treatment caused toxicity, but also alleviated pre-existing symptoms.

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