scholarly journals Effects of training oncology physicians advising patients on complementary and integrative therapies on patient‐reported outcomes: A multicenter, cluster‐randomized trial

Cancer ◽  
2021 ◽  
Author(s):  
Alizé A. Rogge ◽  
Stefanie M. Helmer ◽  
Ryan King ◽  
Claudia Canella ◽  
Katja Icke ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Patient Reported Outcomes ◽  
Cluster Randomized Trial ◽  
Patient Reported ◽  
Cluster Randomized ◽  
Integrative Therapies

Digital symptom monitoring with patient-reported outcomes in community oncology practices: A U.S. national cluster randomized trial.

2021 ◽  
Vol 39 (36_suppl) ◽  
pp. 349527-349527
Author(s):  
Ethan Basch ◽  
Deborah Schrag ◽  
Jennifer Jansen ◽  
Sydney Henson ◽  
Angela M. Stover ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Physical Function ◽  
Patient Reported Outcomes ◽  
Symptom Control ◽  
Cluster Randomized Trial ◽  
Symptom Monitoring ◽  
Community Oncology ◽  
Electronic Alerts ◽  
Patient Reported ◽  
Cluster Randomized

349527 Background: Symptoms are common during cancer care but often go undetected. Digital systems that elicit patient-reported outcomes (PRO) surveys may detect symptoms early and prompt clinicians to intervene, thereby alleviating suffering and averting complications. Methods: In a cluster-randomized trial, U.S.-based community oncology practices were randomized 1:1 to digital symptom monitoring with PRO surveys, or to usual care control. Patients receiving systemic treatment for metastatic cancer were eligible. At PRO practices, participants were invited to complete a weekly survey via web or automated telephone system for up to one year, including questions about nine common symptoms, performance status, and falls. Severe or worsening symptoms triggered electronic alerts to care team nurses, and reports showing longitudinal symptom data were available to oncologists at visits. Pre-specified secondary outcomes included impact on physical function, symptom control, and health-related quality of life (HRQL). The primary outcome of survival is not yet mature. Results: At 52 practices, 1,191 patients were eligible and enrolled (593 PRO; 598 control). Clinically meaningful benefits were experienced in physical function by 13.8% more patients with PRO versus control (P=0.009); symptom control by 16.1% (P=0.003); and HRQL by 13.4% (P=0.006). Mean changes from baseline were superior with PRO versus control for physical function (mean difference 2.47, 95% CI 0.41-4.53; P=0.02), symptom control (2.56, 0.95-4.17; P=0.002), and HRQL (2.43, 0.90-3.96; P=0.002). Patients completed 20,565/22,486 (91.5%) of expected weekly PRO surveys. Conclusions: Digital symptom monitoring during cancer treatment confers clinical benefits. Clinical trial information: NCT03249090.

scholarly journals Improving Veteran Access to Integrated Management of Back Pain (AIM-Back): Protocol for an Embedded Pragmatic Cluster-Randomized Trial

Pain Medicine ◽  
2020 ◽  
Vol 21 (Supplement_2) ◽  
pp. S62-S72
Author(s):  
Steven Z George ◽  
Cynthia J Coffman ◽  
Kelli D Allen ◽  
Trevor A Lentz ◽  
Ashley Choate ◽  
...  
Keyword(s):  
Back Pain ◽  
Randomized Trial ◽  
Short Form ◽  
Integrated Management ◽  
Cluster Randomized Trial ◽  
Care Utilization ◽  
Measurement Information ◽  
Care Pathways ◽  
Patient Reported ◽  
Cluster Randomized

Abstract Background Coordinated efforts between the National Institutes of Health, the Department of Defense, and the Department of Veterans Affairs have built the capacity for large-scale clinical research investigating the effectiveness of nonpharmacologic pain treatments. This is an encouraging development; however, what constitutes best practice for nonpharmacologic management of low back pain (LBP) is largely unknown. Design The Improving Veteran Access to Integrated Management of Back Pain (AIM-Back) trial is an embedded pragmatic cluster-randomized trial that will examine the effectiveness of two different care pathways for LBP. Sixteen primary care clinics will be randomized 1:1 to receive training in delivery of 1) an integrated sequenced-care pathway or 2) a coordinated pain navigator pathway. Primary outcomes are pain interference and physical function (Patient-Reported Outcomes Measurement Information System Short Form [PROMIS-SF]) collected in the electronic health record at 3 months (n=1,680). A subset of veteran participants (n=848) have consented to complete additional surveys at baseline and at 3, 6, and 12 months for supplementary pain and other measures. Summary AIM-Back care pathways will be tested for effectiveness, and treatment heterogeneity will be investigated to identify which veterans may respond best to a given pathway. Health care utilization patterns (including opioid use) will also be compared between care pathways. Therefore, the AIM-Back trial will provide important information that can inform the future delivery of nonpharmacologic treatment of LBP.

scholarly journals Clinical Effects of Assessing Electronic Patient-Reported Outcomes Monitoring Symptomatic Toxicities During Breast Cancer Therapy – A Nationwide and Population-Based Study

2020 ◽  
Author(s):  
Helle Pappot ◽  
Christina W. Baeksted ◽  
Aase Nissen ◽  
Ann Knoop ◽  
Sandra A. Mitchell ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Patient Reported Outcomes ◽  
Empirical Studies ◽  
Cluster Randomized Trial ◽  
Population Based ◽  
Public Health Care ◽  
Clinical Effects ◽  
Cultural Narrative ◽  
Patient Reported ◽  
Cluster Randomized

Abstract The involvement of cancer patients in symptom reporting talks into our cultural narrative of empowerment and participation in decisions in health of both patients and professionals. Electronic Patient Reported Outcomes (ePRO) is a tool applied for use in such interaction. Based on limited evidence and few empirical studies, health systems are rapidly implementing this instrument in managing patients in active treatment and in follow-up. In a cluster randomized trial of all Danish oncology departments treating breast cancer with adjuvant chemotherapy, we applied ePRO in 347 patients consecutively recruited. Our primary outcome, which was at least one treatment adjustment, was not significantly influenced using ePRO, 34% in the ePRO arm and 41% in the usual care arm received at least one treatment adjustment, p=0,095. Number of hospitalizations and events of febrile neutropenia was not influenced by the intervention. We believe that one of the main reasons for this finding could be the application of PRO in a well-regulated treatment setting within a public health care system where the most impacting symptomatic toxicities are already taken care off.ClinicalTrials.gov Identifier: NCT02996201, registered 19 December 2016, retrospectively registered.

Impact of an Automatically Generated Cancer Survivorship Care Plan on Patient-Reported Outcomes in Routine Clinical Practice: Longitudinal Outcomes of a Pragmatic, Cluster Randomized Trial

2015 ◽  
Vol 33 (31) ◽  
pp. 3550-3559 ◽  
Author(s):  
Kim A.H. Nicolaije ◽  
Nicole P.M. Ezendam ◽  
M. Caroline Vos ◽  
Johanna M.A. Pijnenborg ◽  
Dorry Boll ◽  
...  
Keyword(s):  
Usual Care ◽  
Patient Reported Outcomes ◽  
Cluster Randomized Trial ◽  
Care Physician ◽  
Routine Clinical Practice ◽  
Care Plan ◽  
Survivorship Care Plan ◽  
Survivorship Care ◽  
Patient Reported ◽  
Cluster Randomized

Purpose This study was conducted to longitudinally assess the impact of an automatically generated survivorship care plan (SCP) on patient-reported outcomes in routine clinical practice. Primary outcomes were patient satisfaction with information and care. Secondary outcomes included illness perceptions and health care use. Methods Twelve hospitals were randomly assigned to SCP care or usual care in a pragmatic, cluster randomized trial. Newly diagnosed patients with endometrial cancer completed questionnaires after diagnosis (n = 221; 75% response), 6 months (n = 158), and 12 months (n = 147). An SCP application was built in the Web-based ROGY (Registration System Oncological Gynecology). By clicking the SCP button, a patient-tailored SCP was generated. Results In the SCP care arm, 74% of patients received an SCP. They reported receiving more information about their treatment (mean [M] = 57, standard deviation [SD] = 20 v M = 47, SD = 24; P = .03), other services (M = 35, SD = 22 v M = 25, SD = 22; P = .03), and different places of care (M = 27, SD = 25 v M = 23, SD = 26; P = .04) than the usual care arm (scales, 0 to 100). However, there were no differences regarding satisfaction with information or care. Patients in the SCP care arm experienced more symptoms (M = 3.3, SD = 2.0 v M = 2.6, SD = 1.6; P = .03), were more concerned about their illness (M = 4.4, SD = 2.3 v M = 3.9, SD = 2.1; P = .03), were more affected emotionally (M = 4.0, SD = 2.2 v M = 3.7, SD = 2.2; P = .046), and reported more cancer-related contact with their primary care physician (M = 1.8, SD = 2.0 v M = 1.1, SD = 0.9; P = .003) than those in the usual care arm (scale, 1 to 10). These effects did not differ over time. Conclusion The present trial showed no evidence of a benefit of SCPs on satisfaction with information and care. Furthermore, SCPs increased patients' concerns, emotional impact, experienced symptoms, and the amount of cancer-related contact with the primary care physician. Whether this may ultimately lead to more empowered patients should be investigated further.

Reducing mental-illness stigma via high school clubs: A matched-pair, cluster-randomized trial.

2020 ◽  
Vol 5 (2) ◽  
pp. 230-239
Author(s):  
Shaikh I. Ahmad ◽  
Bennett L. Leventhal ◽  
Brittany N. Nielsen ◽  
Stephen P. Hinshaw
Keyword(s):  
High School ◽  
Mental Illness ◽  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Mental Illness Stigma ◽  
Matched Pair ◽  
Cluster Randomized
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