MO037SYMPTOM MONITORING WITH FEEDBACK TRIAL (SWIFT) PILOT TO EXPLORE THE FEASIBILITY AND ACCEPTABILITY OF ELECTRONIC PATIENT REPORTED OUTCOME MEASURES (E-PROMS) DATA CAPTURE AND FEEDBACK

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Andrea Viecelli ◽  
Kathryn Dansie ◽  
Stephen McDonald ◽  
Shilpanjali Jesudason ◽  
Emily Duncanson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Trial ◽  
Data Capture ◽  
Short Report ◽  
Symptom Monitoring ◽  
Cluster Randomised ◽  
Sleeping Problems ◽  
Patient Reported ◽  
Anzdata Registry

Abstract Background and Aims People on haemodialysis (HD) often experience overwhelming and debilitating symptoms of fatigue, pain, nausea, itching, sleeping problems and depression that contribute to poor quality of life. Trials in oncology have shown that active symptom monitoring can improve quality of life and survival, but it remains unknown if this intervention is effective in people on HD. The use of PROMs is increasing in nephrology care; but they are not routinely collected in kidney registries. The SWIFT pilot aims to assess the feasibility and acceptability of tablet-based symptom monitoring with feedback to clinicians in preparation of a large-scale, registry-based cluster-randomised trial to assess the clinical- and cost-effectiveness of this intervention in HD (SWIFT; ACTRN12618001976279). Method This pragmatic, multicenter cluster-randomised controlled pilot study tests the hypothesis that 3-monthly tablet-based PROMs monitoring using the Integrated Palliative Outcome Scale-Renal Symptom Tool with electronic feedback to clinicians using the Australia and New Zealand Dialysis and Transplant Registry (ANZDATA) compared with usual care will improve health-related quality of life measured by EQ-5D-5L and is technically feasible and clinically acceptable to patients, nurses and nephrologists in different HD settings. Acceptability and feasibility outcomes are assessed through a process evaluation using the Medical Research Council framework: (1) patient acceptability of ePROMS (5-point Likert scale; focus groups with 20 purposively sampled participants), (2) feasibility of embedding ePROMS in routine care (response rates, time from data capture to feedback, ease of generating PROMs reports by the ANZDATA registry), (3) acceptability and usefulness of ePROMs data for nephrologists and nurses (qualitative semi-structured interviews with thematic analysis). Results 163 adult patients from 4 HD units across Australia were enrolled (83 in the intervention units and 80 to the control units) and completed baseline PROMs, representing 77% of eligible patients (range 44-90%). At 3-months, 61% of enrolled patients in the intervention units completed the PROMs (range 48-73%). Reasons for non-completion included transfer to another unit and lack of ability to read English. Severe or overwhelming symptoms were reported by 30 of 83 enrolled patients (36%) at baseline and by 32 of 62 (52%) at 3 months. Technical feasibility was demonstrated by successful development of a Qualtrics survey platform presented on tablet computers, use of QR reader codes for linkage with the ANZDATA registry which captures clinical outcomes, and linkage to the relevant survey for the patient’s allocation and trial timepoint. Emails containing a short report of any symptoms identified as severe or overwhelming along with a summary of evidence-based guidelines for management of those symptoms were sent to and opened by treating clinicians. Assessment of patient and clinician acceptability of the feedback mechanism is ongoing. Conclusion Electronic symptom monitoring in adults on HD with feedback to clinicians is feasible and provides a template for ongoing registry-based monitoring of PROMs to facilitate patient-centred care and the infrastructure for future evaluations of interventions to improve patients’ quality of life and survival.

scholarly journals DOP24 Patient-reported health-related quality-of-life outcomes with vedolizumab vs. adalimumab treatment of ulcerative colitis: Results of the VARSITY trial

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S063-S063
Author(s):  
E V Loftus ◽  
S W Schreiber ◽  
S Danese ◽  
L Peyrin-Biroulet ◽  
J F Colombel ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ulcerative Colitis ◽  
Randomised Trial ◽  
Double Blind ◽  
Specific Domain ◽  
Faecal Calprotectin ◽  
Meaningful Improvement ◽  
Treatment Difference ◽  
Patient Reported

Abstract Background Patients with ulcerative colitis (UC) experience substantial impairment in quality of life (QOL). Patient QOL endpoints are important measures of treatment outcome. We evaluated the effects of intravenous vedolizumab vs. adalimumab on QOL in VARSITY, the first head-to-head trial comparing the efficacy and safety of biologics in patients with moderately to severely active UC. Methods VARSITY was a phase 3b, double-blind, double-dummy, randomised trial (NCT02497469; EudraCT 2015-000939-33). QOL was assessed using the inflammatory bowel disease questionnaire (IBDQ) at baseline, Week (Week) 30, and Week 52. Endpoints included clinically meaningful IBDQ improvement (defined as an increase in total score of ≥16 points from baseline to Week 52), IBDQ remission (defined as a total score of >170 points at Week 52) and change from baseline in IBDQ-specific domain scores (bowel symptoms, systemic symptoms, emotional function, and social function) at Week 30 and Week 52. Serum C-reactive protein (CRP) and faecal calprotectin (FCP) were also assessed as indicators of disease activity. Results Among randomised patients, 383 (vedolizumab) and 386 (adalimumab) patients received ≥1 dose of study drug (N=769). At Week 52, clinically meaningful IBDQ improvement was observed in 52.0% (vedolizumab) vs. 42.2% (adalimumab) of patients (treatment difference 9.7%; 95% confidence interval [CI], 2.7% to 16.7%), while IBDQ remission was achieved by 50.1% (vedolizumab) vs. 40.4% (adalimumab) of patients (treatment difference 9.6%; 95% CI, 2.8% to 16.5%). Mean (standard deviation [SD]) changes in IBDQ total score from baseline for observed cases favoured vedolizumab over adalimumab (Week 30: 61.3 [39.8] vs. 52.6 [42.8]; Week 52: 66.1 [41.8] vs. 60.4 [42.2]; Figure 1). IBDQ subscores showed similar favourable trends for vedolizumab (Figure 2). At Week 52, mean (SD) changes from baseline in CRP for patients treated with vedolizumab vs. adalimumab were –50.9 (174.8) nmol/l vs. –37.2 (169.2) nmol/l and for FCP were –2187.3 (7440.4) µg/g vs. –1846.6 (4560.6) µg/g (Figure 3). Among patients with FCP >250 µg/g at baseline, the proportion of patients achieving FCP ≤250 µg/g was 33.9% vs. 24.5% at Week 30 and 35.2% vs. 28.9% at Week 52 for patients treated with vedolizumab vs. adalimumab, respectively. Conclusion Based on IBDQ total score and subscores, more patients with UC treated with vedolizumab than with adalimumab achieved clinically meaningful improvement and clinical remission. Reduced inflammation, as indicated by improvements in CRP and FCP, was consistent with improvements in QOL.

scholarly journals Quality of life and added value of a tailored palliative care intervention in patients with soft tissue sarcoma undergoing treatment with trabectedin: a multicentre, cluster-randomised trial within the German Interdisciplinary Sarcoma Group (GISG)

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e035546
Author(s):  
Leopold Hentschel ◽  
Stephan Richter ◽  
Hans-Georg Kopp ◽  
Bernd Kasper ◽  
Annegret Kunitz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Functional Assessment ◽  
Patient Reported Outcomes ◽  
Statistical Significance ◽  
Case Vignette ◽  
Cluster Randomised ◽  
Patient Reported

ObjectivesThe choice of drug treatment in advanced soft tissue sarcoma (STS) continues to be a challenge regarding efficacy, quality of life (QoL) and toxicity. Unlike other cancer types, where integrating patient-reported outcomes (PRO) has proven to be beneficial for QoL, there is no such evidence in patients with STS as of now. The YonLife trial aimed to explore the effect of a tailored multistep intervention on QoL, symptoms and survival in patients with advanced STS undergoing treatment with trabectedin as well as identifying predictors of QoL.DesignYonLife is a cluster-randomised, open-label, proof-of-concept study. The intervention incorporates electronic PRO assessment, a case vignette and expert-consented treatment recommendations.ParticipantsSix hospitals were randomised to the control arm (CA) or interventional arm (IA). Seventy-nine patients were included of whom 40 were analysed as per-protocol analysis set.Primary and secondary outcome measuresThe primary end point was the change of Functional Assessment for Cancer Therapy (FACT-G) total score after 9 weeks. Secondary outcomes included QoL (FACT-G subscales), anorexia and cachexia (Functional Assessment of Anorexia/Cachexia Therapy (FAACT)), symptoms (MD Anderson Symptom Inventory (MDASI)), anxiety and depression (HADS), pain intensity and interference (Brief Pain Inventory (BPI)) and survival assessment.ResultsAfter 9 weeks of treatment, QoL declined less in the IA (ΔFACT-G total score: −2.4, 95% CI: −9.2 to 4.5) as compared with CA (ΔFACT-G total score: −3.9; 95% CI:−11.3 to 3.5; p=0.765). In almost all FACT-G subscales, average declines were lower in IA, but without reaching statistical significance. Smaller adverse trends between arms were observed for MDASI, FAACT, HADS and BPI scales. These trends failed to reach statistical significance. Overall mean survival was longer in IA (648 days) than in CA (389 days, p=0.110). QoL was predicted by symptom severity, symptom interference, depression and anxiety.ConclusionOur data suggest a potentially favourable effect of an electronic patient-reported outcomes based intervention on QoL that needs to be reappraised in confirmatory studies.Trial registration numberClinicalTrials.gov Identifier (NCT02204111).

scholarly journals A Cluster-Randomised Trial of Staff Education to Improve the Quality of Life of People with Dementia Living in Residential Care: The DIRECT Study

PLoS ONE ◽  
2011 ◽  
Vol 6 (11) ◽  
pp. e28155 ◽  
Author(s):  
Christopher Beer ◽  
Barbara Horner ◽  
Leon Flicker ◽  
Samuel Scherer ◽  
Nicola T. Lautenschlager ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Residential Care ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Staff Education ◽  
Direct Study ◽  
Cluster Randomised ◽  
People With Dementia

scholarly journals Mobile-Health Tool to Improve Care of Patients with Hematological Malignancies

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 35-36
Author(s):  
Amit Sanyal ◽  
James M. Heun ◽  
Jessica Sweeney ◽  
Clemens Janssen
Keyword(s):  
Quality Of Life ◽  
Patient Experience ◽  
Cancer Care ◽  
Hematological Malignancies ◽  
Distress Thermometer ◽  
Myelogenous Leukemia ◽  
Shortness Of Breath ◽  
Symptom Monitoring ◽  
Patient Reported

INTRODUCTION Adverse effects are common during treatment of hematological malignancies. Treatment toxicities can impact quality of life [1], impose financial hardship and cause cancer related distress[2]. Symptom monitoring using electronic technology can facilitate early detection of complications[3], reduce symptom burden[4], cost of care[5] and improve survival[6]. Cancer treatment also increases risk of mortality from infections such as coronavirus disease 2019 (COVID-19) and routine screening has been recommended[7]. METHODS We developed an application that periodically delivers toxicity questionnaires to patients during treatment . Based on NCI- PRO-CTCAE™, the questions are delivered through SMS or e-mail. Patient responses crossing prespecified thresholds trigger automated alerts on a dashboard, resulting in additional interventions as needed. Nature and time to intervention is tracked. Patient experience is measured using a Likert-scale and free-text box. Centers for Disease Control recommended COVID-19 screening questions were incorporated. Finally, a distress thermometer for cancer distress screening has been recently added. The app was offered to patients with hematological cancers in a community-based cancer center. RESULTS Since introduction in April 2020, we have enrolled 37 patients. 9 patients had chronic lymphocytic leukemia, 6 diffuse large B cell, 5 mantle cell, 4 Hodgkin's and 3 follicular lymphoma. 2 each had chronic myelogenous, multiple myeloma and Richter's syndrome. 1 each had hairy cell leukemia, acute myelogenous leukemia and T Cell lymphoma. Median age was 64 years (range 24-85). Patient experience has been favorable. On a scale of 1-5, 85.5% rated the experience as 3 or higher. Median patient engagement, calculated by dividing the number of forms completions by number of days enrolled was 34.2% (0.9-66.2 %). Symptom tracker captured 536 responses. Fatigue (153), no symptoms (152), shortness of breath (57), nausea/vomiting, diarrhea (46) and numbness/tingling (28) were the most common response categories. Of 1107 completed check ins, 75 triggered flags. There were 2 hospitalizations for neutropenic fever with the remainder managed as outpatients. Average time between patient generated response and provider intervention was 90.9 minutes. 88% follow-ups were completed within 1 business day. COVID-19 screening module captured 1096 responses. 988 were no symptoms. All positive responses (44 diarrhea, 39 cough, 23 shortness of breath and 2 fever) were false positives. Distress thermometer implemented a week before data cut-off captured 2 responses, 1 in the physical and 1 in the psychological domain. CONCLUSION We demonstrate feasibility of electronic capture of treatment toxicities and offer proof of concept that a mobile app can be used for infection screening. Additionally, the quick response time by care team indicated a high adoption rate. REFERENCES Doorduijn J, B.I., Holt B, Steijaert M, Uyl-de Groot C, Sonneveld P., Self-reported quality of life in elderly patients with aggressive non-Hodgkin's lymphoma treated with CHOP chemotherapy. . European Journal of Hemtology 2005. 75(2): p. 116-123.Troy JD, L.S., Samsa GP, Feliciano J, Richhariya A, LeBlanc TW., Patient-reported distress in Hodgkin lymphoma across the survivorship continuum. Supportive Care Cancer, 2019. 27(7): p. 2453-2462.Stover A M, H.S., Deal A M, Stricker C T, Bennett A V, Carr P M, Jansen J, Kottschade L A, Dueck A C, Basch E M, Methods for alerting clinicians to concerning symptom questionnaire responses during cancer care: Approaches from two randomized trials (STAR, AFT-39 PRO-TECT). Journal of Clinical Oncology 2018. 36(30 supplement): p. 158.Mooney KH, B.S., Wong B, Whisenant M, Donaldson G, Automated home monitoring and management of patient-reported symptoms during chemotherapy: results of the symptom care at home RCT. Cancer Medicine, 2017. 6(3): p. 537-546.Barkley R, S.M.-J., Wang J, Blau S, Page RD, Reducing Cancer Costs Through Symptom Management and Triage Pathways. Journal of Oncology Practice, 2019. 15(2): p. e91-e97.Denis F, B.E., Septans AL, Urban T, Dueck AC, Letellier C., Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer. JAMA, 2019. 321(3): p. 306-307.ASCO Special Report: A guide to cancer care delivery during COVID-19 pandemic. 2020, ASCO: Alexandria, VA. Disclosures Janssen: wellbe Inc.: Current Employment.

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