Quality of life after VATS lung resection and SABR for early-stage non-small cell lung cancer: A longitudinal study.

INTRODUCTION: Video-assisted thoracoscopic (VATS) lung resection is the recommended curative treatment for early-stage non-small cell lung cancer (NSCLC). Patients considered at high surgical risk, are treated with stereotactic ablative body radiotherapy (SABR) as a lower morbidity alternative. This study aims to investigate the impact of SABR and VATS resection on patients' quality of life (QoL) over the first year after treatment. METHODS: A prospective longitudinal observational study recruiting early-stage NSCLC patients from a single UK centre. QoL was assessed with EORTC QLQ-C30 and Lung Cancer Module LC13 at baseline, 6 weeks and 3, 6 and 12 months post-treatment. RESULTS: From 01.03.2017 till 01.03.2018, 244/281 patients (87%) consented to participate, 225 (95 SABR and 130 VATS) were included in the analysis. SABR patients had significantly worse baseline QoL scores than VATS patients, even after adjusting for preoperative clinical factors (C-30 Global Health mean: SABR = 53.8, VATS = 71.2; Physical Functioning mean: SABR = 57, VATS = 82.2; Fatigue mean: SABR = 43.5, VATS = 23.7; C30 Dyspnea mean: SABR = 49.5, VATS = 26.2). During the 12 months post SABR treatment patients' QoL scores remained stable. In the VATS group, there was a deterioration 6-weeks after treatment in Role, Physical, Social Functions, Global Health, Fatigue, C30/LC13 Dyspnoea, Pain, Appetite loss, Constipation, LC13 Pain in Chest and Arms. The scores improved by 12 months without reaching the preoperative values. CONCLUSIONS: Although QoL outcomes for SABR and VATS are not comparable due to different medical selection criteria, the QoL impact of the two treatments during the first year showed different trends which will inform patients and clinicians during decision-making discussions.

Phase III Randomized Controlled Trial of eRAPID: eHealth Intervention During Chemotherapy.

PURPOSE: Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) is an online eHealth system for patients to self-report symptoms during cancer treatment. It provides automated severity-dependent patient advice guiding self-management or medical contact and displays the reports in electronic patient records. This trial evaluated the impact of eRAPID on symptom control, healthcare use, patient self-efficacy, and quality of life (QOL) in a patient population treated predominantly with curative intent. METHODS: Patients with colorectal, breast, or gynecological cancers commencing chemotherapy were randomly assigned to usual care (UC) or the addition of eRAPID (weekly online symptom reporting for 18 weeks). Primary outcome was symptom control (Functional Assessment of Cancer Therapy-General, Physical Well-Being subscale [FACT-PWB]) assessed at 6, 12, and 18 weeks. Secondary outcomes were processes of care (admissions or chemotherapy delivery), patient self-efficacy, and global quality of life (Functional Assessment of Cancer Therapy-General, EQ5D-VAS, and EORTC QLQ-C30 summary score). Multivariable mixed-effects repeated-measures models were used for analyses. Trial registration: ISRCTN88520246. RESULTS: Participants were 508 consenting patients (73.6% of 690 eligible) and 55 health professionals. eRAPID compared to UC showed improved physical well-being at 6 (P = .028) and 12 (P = .039) weeks and no difference at 18 weeks (primary end point) (P = .69). Fewer eRAPID patients (47%) had clinically meaningful physical well-being deterioration than UC (56%) at 12 weeks. Subgroup analysis found benefit in the nonmetastatic group at 6 weeks (P = .0426), but not in metastatic disease. There were no differences for admissions or chemotherapy delivery. At 18 weeks, patients using eRAPID reported better self-efficacy (P = .007) and better health on EQ5D-VAS (P = .009). Average patient compliance with weekly symptom reporting was 64.7%. Patient adherence was associated with clinician's data use and improved FACT-PWB at 12 weeks. CONCLUSION: Real-time monitoring with electronic patient-reported outcomes improved physical well-being (6 and 12 weeks) and self-efficacy (18 weeks) in a patient population predominantly treated with curative intent, without increasing hospital workload.

Electronic Patient Reporting of Adverse Events and Quality of Life: A Prospective Feasibility Study in General Oncology.

PURPOSE: Adverse event (AE) reporting is essential in clinical trials. Clinician interpretation can result in under-reporting; therefore, the value of patient self-reporting has been recognized. The National Cancer Institute has developed a Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for direct patient AE reporting. A nonrandomized prospective cohort feasibility study aimed to explore the compliance and acceptability of an electronic (Internet or telephone) system for collecting patient self-reported AEs and quality of life (QOL). METHODS: Oncology patients undergoing treatment (chemotherapy, targeted agents, hormone therapy, radiotherapy, and/or surgery) at 2 hospitals were sent automated weekly reminders to complete PRO-CTCAE once a week and QOL (for a maximum of 12 weeks). Patients had to speak/understand English and have access to the Internet or a touch-tone telephone. Primary outcome was compliance (proportion of expected questionnaires), and recruitment rate, attrition, and patient/staff feedback were also explored. RESULTS: Of 520 patients, 249 consented (47.9%)-mean age was 62 years, 51% were male, and 70% were married-and 230 remained on the study at week 12. PRO-CTCAE was completed at 2,301 (74.9%) of 3,074 timepoints and QOL at 749 (79.1%) of 947 timepoints. Individual weekly/once every 4 weeks compliance reduced over time but was more than 60% throughout. Of 230 patients, 106 (46.1%) completed 13 or more PRO-CTCAE, and 136 (59.1%) of 230 patients completed 4 QOL questionnaires. Most were completed on the Internet (82.3%; mean age, 60.8 years), which was quicker, but older patients preferred the telephone option (mean age, 70.0 years). Positive feedback was received from patients and staff. CONCLUSION: Self-reporting of AEs and QOL using an electronic home-based system is feasible and acceptable. Implementation of this approach in cancer clinical trials may improve the precision and accuracy of AE reporting.

Patients' views of routine quality of life assessment following a diagnosis of early-stage non-small cell lung cancer.

OBJECTIVES: There is an increasing interest in the quality of life (QoL) evaluation following video-assisted thoracoscopic anatomical lung resection or stereotactic ablative body radiotherapy for early-stage non-small-cell lung cancer (NSCLC). A qualitative interview study was conducted to gain insight into the optimal methods of assessing and discussing QoL in clinical practice. METHODS: A prospective observational longitudinal study of patients with early-stage NSCLC was conducted where repeated QoL measures were administered either online or on paper. A subset of participants was invited for qualitative interviews after the 6-month assessment or at the end of the study. The semi-structured interviews were transcribed verbatim and thematically analysed. RESULTS: Twenty-three patients were interviewed. Generally, patients were content with recruitment and data collection procedures. Most opted to complete the assessments on paper instead of online; this choice was influenced by the level of technology literacy. Some found the questionnaires too generic to reflect their experiences. Barriers to questionnaire completion were mostly practical, and many acknowledged benefits of QoL assessment including allowing them to express problems and health issues, and following changes over time. Generally, participants would like to discuss QoL results during clinical consultations, but reported this rarely happened. CONCLUSIONS: Lung cancer patient interviews confirm the acceptability of repeated QoL assessments, but online data capture is limited. Patients highlight the importance of discussing QoL aspects with their clinical team. Future strategies are needed to optimize the routine collection of patient-reported outcomes in clinical practice.

Patients' confidence in treatment decisions for early stage non-small cell lung cancer (NSCLC).

BACKGROUND: In early-stage Non-Small Cell Lung Cancer (NSCLC) patients, little is known about how to measure patient participation in Shared-Decision Making (SDM). We examined the psychometric properties and clinical acceptability of the Decision Self-Efficacy scale (DSE) in a cohort of patients undergoing to Stereotactic Ablative Radiotherapy (SABR) or Video-assisted Thoracoscopic Surgery (VATS) to capture patient involvement in treatment decisions. METHODS: In the context of a prospective longitudinal study (Life after Lung Cancer-LiLAC) involving 244 patients with early-stage NSCLC, 158 (64.7%) patients completed the DSE either on paper or electronically online prior to treatment with SABR or VATS pulmonary resection. DSE psychometric properties were examined using: principal components analysis of item properties and internal structure, and internal construct validity; we also performed a sensitivity analysis according to Eastern Cooperative Oncology Group Performance Status (ECOG PS), gender, age and treatment received (VATS or SABR) difference. RESULTS: Exploratory factor analysis using polychoric correlations substantiated that the 11 item DSE is one scale accounting for 81% of the variance. We calculated a value of 0.96 for Cronbach's alpha for the total DSE score. DSE scores did not differ by gender (p = 0.37), between the two treatment groups (p = 0.09) and between younger and older patients (p = 0.4). However, patients with an ECOG PS > 1 have a DSE mean of 73.8 (SD 26) compared to patients with a PS 0-1 who have a DSE mean of 85.8 (SD 20.3 p = 0.002). CONCLUSION: Findings provide preliminary evidence for the reliability and validity of the DSE questionnaire in this population. However, future studies are warranted to identify the most appropriate SDM tool for clinical practice in the lung cancer treatment field.

Online tool for monitoring adverse events in patients with cancer during treatment (eRAPID): field testing in a clinical setting.

OBJECTIVES: Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) is an online system developed to support patient care during cancer treatment by improving the detection and management of treatment-related symptoms. Patients can complete symptom reports from home and receive severity-based self-management advice, including notifications to contact the hospital for severe symptoms. Patient data are available in electronic records for staff to review. Prior to the commencement of a randomised controlled trial (RCT), field testing of the intervention was undertaken to troubleshoot practical issues with intervention integration in clinical practice. DESIGN: Observational clinical field testing. SETTING: Medical oncology breast service in a UK cancer centre. PARTICIPANTS: 12 patients receiving chemotherapy for early breast cancer and 10 health professionals (oncologists and specialist nurses). INTERVENTION: Patients were asked to use the eRAPID intervention and complete weekly online symptom reports during four cycles of chemotherapy. Clinical staff were invited to access and use patient data in clinical assessments. ANALYSIS: Descriptive data on the frequency of online symptom report completion and severe symptom notifications were collated. Verbal and written feedback was collected from patients and staff and semistructured interviews were conducted to explore patient experiences. Interviews were transcribed and analysed thematically. RESULTS: The testing ran from January 2014 to March 2014. Feedback from patients and staff was largely positive. Patients described eRAPID as 'reassuring' and 'comforting' and valued the tailored management advice. Several changes were made to refine eRAPID. In particular, improvement of the clinical notification, patient reminder systems and changes to patient and staff training. CONCLUSIONS: The field testing generated valuable results used to guide refinement of eRAPID prior to formal intervention evaluation. Feedback indicated that eRAPID has the potential to improve patients' self-efficacy, knowledge and confidence with managing symptoms during treatment. A large-scale RCT is underway with data collection due to finish in October 2018.

Electronic Systems for Patients to Report and Manage Side Effects of Cancer Treatment: Systematic Review.

BACKGROUND: There has been a dramatic increase in the development of electronic systems to support cancer patients to report and manage side effects of treatment from home. Systems vary in the features they offer to patients, which may affect how patients engage with them and how they improve patient-centered outcomes. OBJECTIVE: This review aimed to (1) describe the features and functions of existing electronic symptom reporting systems (eg, symptom monitoring, tailored self-management advice), and (2) explore which features may be associated with patient engagement and patient-centered outcomes. METHODS: The review was registered with the International Prospective Register of Systematic Reviews (PROSPERO) and followed guidelines from the Centre for Reviews and Dissemination (University of York, United Kingdom). Primary searches were undertaken of MEDLINE, Embase, PsycInfo, Web of Science, Cochrane Central Register of Controlled Trials, and the Health Technology Assessment databases. Secondary searches were undertaken by screening reference lists and citations. Two researchers applied broad inclusion criteria to identify and select relevant records. Data were extracted and summarized using Microsoft Excel. In order to meet the aims, the study selection, data extraction, and data synthesis comprised two stages: (1) identifying and characterizing available systems and (2) summarizing data on patient engagement and patient-centered outcomes. RESULTS: We identified 77 publications relating to 41 distinct systems. In Stage 1, all publications were included (N=77). The features identified that supported clinicians and care were facility for health professionals to remotely access and monitor patient-reported data (24/41, 58%) and function to send alerts to health professionals for severe symptoms (17/41, 41%). Features that supported patients were facility for patients to monitor/review their symptom reports over time (eg, graphs) (19/41, 46%), general patient information about cancer treatment and side effects (17/41, 41%), tailored automated patient advice on symptom management (12/41, 29%), feature for patients to communicate with the health care team (6/41, 15%), and a forum for patients to communicate with one another (4/41, 10%). In Stage 2, only publications that included some data on patient engagement or patient-centered outcomes were included (N=29). A lack of consistency between studies in how engagement was defined, measured, or reported, and a wide range of methods chosen to evaluate systems meant that it was not possible to compare across studies or make conclusions on relationships with system features. CONCLUSIONS: Electronic systems have the potential to help patients manage side effects of cancer treatment, with some evidence to suggest a positive effect on patient-centered outcomes. However, comparison across studies is difficult due to the wide range of assessment tools used. There is a need to develop guidelines for assessing and reporting engagement with systems, and a set of core outcomes for evaluation. We hope that this review will contribute to the field by introducing a taxonomy for characterizing system features. TRIAL REGISTRATION: PROSPERO CRD42016035915; www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42016035915.