Effect of Early Palliative Care on the Quality of Life of Patients with Advanced Head and Neck Cancers: A Phase 3 Randomized Controlled Trial

2020 ◽  
Author(s):  
Vijay Maruti Patil ◽  
Pankaj Singhai ◽  
Vanita Noronha ◽  
Atanu Bhattacharjee ◽  
Jayita Deodhar ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Palliative Care ◽  
Randomized Controlled Trial ◽  
Head And Neck ◽  
Controlled Trial ◽  
Advanced Head ◽  
Phase 3 ◽  
Early Palliative Care ◽  
Randomized Controlled

scholarly journals Efficacy and cost-utility of the eHealth application ‘Oncokompas’, supporting patients with incurable cancer in finding optimal palliative care, tailored to their quality of life and personal preferences: a study protocol of a randomized controlled trial

2019 ◽  
Vol 18 (1) ◽  
Author(s):  
Anouk S. Schuit ◽  
Karen Holtmaat ◽  
Nienke Hooghiemstra ◽  
Femke Jansen ◽  
Birgit I. Lissenberg-Witte ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Palliative Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Utility ◽  
Control Group ◽  
Incurable Cancer ◽  
Randomized Controlled

Abstract Background Patients with incurable cancer have to deal with a wide range of symptoms due to their disease and treatment, influencing their quality of life. Nowadays, patients are expected to adopt an active role in managing their own health and healthcare. Oncokompas is an eHealth self-management application developed to support patients in finding optimal palliative care, tailored to their quality of life and personal preferences. A randomized controlled trial will be carried out to determine the efficacy and cost-utility of Oncokompas compared to care as usual. Methods 136 adult patients with incurable lung, breast, colorectal and head and neck cancer, lymphoma and glioma, will be included. Eligible patients have no curative treatment options and a prognosis of at least three months. Patients will be randomly assigned to the intervention group or the control group. The intervention group directly has access to Oncokompas alongside care as usual, while the waiting list control group receives care as usual and will have access to Oncokompas after three months. The primary outcome measure is patient activation, which can be described as a patient’s knowledge, skills and confidence to manage his or her own health and healthcare. Secondary outcome measures comprise self-efficacy, health-related quality of life, and costs. Measures will be assessed at baseline, two weeks after randomization, and three months after the baseline measurement. Discussion This study will result in knowledge on the efficacy and cost-utility of Oncokompas among patients with incurable cancer. Also, more knowledge will be generated into the need for and costs of palliative care from a societal and healthcare perspective. Trial registration Netherlands Trial Register identifier: NTR 7494. Registered on 24 September 2018.

scholarly journals A randomized trial of a specialist palliative care intervention for patients undergoing surgery for cancer: rationale and design of the Surgery for Cancer with Option of Palliative Care Expert (SCOPE) Trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Myrick C. Shinall ◽  
Aimee Hoskins ◽  
Alexander T. Hawkins ◽  
Christina Bailey ◽  
Alaina Brown ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Palliative Care ◽  
Randomized Controlled Trial ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Specialist Palliative Care ◽  
Randomized Controlled ◽  
Care Intervention ◽  
Scope Trial

Abstract Background In medical oncology settings, early specialist palliative care interventions have demonstrated improvements in patient quality of life and survival compared with usual oncologic care. However, the effect of early specialist palliative care interventions in surgical oncology settings is not well studied. Methods The Surgery for Cancer with Option for Palliative Care Expert (SCOPE) Trial is a single-center, prospective, single-blind, randomized controlled trial of a specialist palliative care intervention for cancer patients undergoing non-palliative surgery. It will enroll 236 patients scheduled for major abdominal operations for malignancy, who will be randomized 1:1 at enrollment to receive usual care (control arm) or specialist palliative care consultation (intervention arm). Intervention arm patients will receive consultations from a palliative care specialist (physician or nurse practitioner) preoperatively and postoperatively. The primary outcome is physical and functional wellbeing at 90 days postoperatively. Secondary outcomes are quality of life at 90 days postoperatively, posttraumatic stress disorder symptoms at 180 days postoperatively, days alive at home without an emergency room visit in the first 90 postoperative days, and overall survival at 1 year postoperatively. Participants will be followed for 3 years after surgery for exploratory analyses of their ongoing quality of life, healthcare utilization, and mortality. Discussion SCOPE is an ongoing randomized controlled trial evaluating specialist palliative care interventions for cancer patients undergoing non-palliative oncologic surgery. Findings from the study will inform ways to identify and improve care of surgical patients who will likely benefit from specialist palliative care services. Trial registration ClinicalTrials.gov Identifier: NCT03436290 First Registered: 16 February 2018 Enrollment Began: 1 March 2018 Last Update: 20 December 2018

Sodium oxybate improves function and quality of life in fibromyalgia – results from a phase 3, randomized, controlled trial

2010 ◽  
Vol 11 (4) ◽  
pp. S41 ◽  
Author(s):  
K. Jones ◽  
R. Bennett ◽  
S. Alvarez-Horine ◽  
Y. Wang ◽  
D. Guinta ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Sodium Oxybate ◽  
Phase 3 ◽  
Randomized Controlled

Effect of early integration of specialized palliative care into standard oncologic treatment on the quality of life of patients with advanced head and neck cancers: A phase III randomized controlled trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12013-12013
Author(s):  
Pankaj Singhai ◽  
Vijay Maruti Patil ◽  
Mary Ann Muckaden ◽  
Jayita Deodhar ◽  
Naveen Salins ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Palliative Care ◽  
Overall Survival ◽  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Systemic Therapy ◽  
Phase 3 ◽  
Early Palliative Care

12013 Background: Early palliative care is an important aspect of palliative treatment but has never been evaluated in head and neck cancer. Hence we performed this study. Methods: This was an open-label phase 3 randomised study which enrolled adult patients with squamous cell carcinoma of the head and neck region which warranted palliative systemic therapy. They were 1:1 allocated to either systemic therapy with (EPC arm) or without the addition of early palliative care service (STD arm). Patients were administered the Edmonton Symptom Assessment Scale (ESAS-r) and FACIT HN questionnaire at baseline and 4 weekly thereafter for 12 weeks. The primary endpoint was change in the quality of life (QOL) measured using FACIT HN 12 weeks after randomization. The secondary endpoints were changed in symptom burden at 12 weeks in ESAS-r and overall survival. A repeated-measures analysis of covariance (ANCOVA) was performed to examine the effects of arm and stratum on change in QOL (or symptom score), after controlling for baseline score. Results: Ninety patients were randomised in each arm between 1st June 2016 to 14th August 2017. The compliance with the questionnaires was 100% at baseline. In EPC arm the 70 patients were alive at 3 months and 67 (95.7%) completed the FACIT HN and 64 (91.4%) completed ESAS-r questionnaires. While in the STD arm out of 69 alive the corresponding figures were 61(88.4%) and 59 (85.5%) respectively. There was no statistical difference in change in QOL scores and ΔESAS-r at 12 weeks between the 2 arms (Table). The median overall survival was similar between the 2 arms. (Hazard ratio for death-1.006 (95%CI 0.7347-1.346)). Conclusion: In this phase 3 study, integration of early palliative care in head and neck cancer patients did not result in improvement in the quality of life scores, symptom scores or overall survival. Clinical trial information: CTRI/2016/03/006693 . [Table: see text]

scholarly journals Effects of Solriamfetol on Quality-of-Life Measures from a 12-Week Phase 3 Randomized Controlled Trial

2020 ◽  
Vol 17 (8) ◽  
pp. 998-1007 ◽  
Author(s):  
Terri E. Weaver ◽  
Christopher L. Drake ◽  
Heike Benes ◽  
Thomas Stern ◽  
James Maynard ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Phase 3 ◽  
Randomized Controlled ◽  
Quality Of Life Measures
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