Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Care | Study protocol

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

Authors: Myrick C. Shinall Jr, Aimee Hoskins, Alexander T. Hawkins, Christina Bailey, Alaina Brown, Rajiv Agarwal, Maria C. Duggan, Laura M. Beskow, Vyjeyanthi S. Periyakoil, David F. Penson, Ryan T. Jarrett, Rameela Chandrasekhar, E. Wesley Ely

Published in: Trials | Issue 1/2019

Login to get access

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
Literature
1.
Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, et al. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010;363(8):733–42.CrossRef
2.
Rummans TA, Clark MM, Sloan JA, Frost MH, Bostwick JM, Atherton PJ, et al. Impacting quality of life for patients with advanced cancer with a structured multidisciplinary intervention: a randomized controlled trial. J Clin Oncol Off J Am Soc Clin Oncol. 2006;24(4):635–42.CrossRef
3.
Bakitas MA, Tosteson TD, Li Z, Lyons KD, Hull JG, Li Z, et al. Early versus delayed initiation of concurrent palliative oncology care: patient outcomes in the ENABLE III randomized controlled trial. J Clin Oncol Off J Am Soc Clin Oncol. 2015;33(13):1438–45.CrossRef
4.
Lowther K, Selman L, Simms V, Gikaara N, Ahmed A, Ali Z, et al. Nurse-led palliative care for HIV-positive patients taking antiretroviral therapy in Kenya: a randomised controlled trial. Lancet HIV. 2015;2(8):e328–34.CrossRef
5.
Zimmermann C, Swami N, Krzyzanowska M, Hannon B, Leighl N, Oza A, et al. Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial. Lancet. 2014;383(9930):1721–30.CrossRef
6.
Wong FKY, Ng AYM, Lee PH, Lam P-T, Ng JSC, Ng NHY, et al. Effects of a transitional palliative care model on patients with end-stage heart failure: a randomised controlled trial. Heart. 2016;102(14):1100–8.CrossRef
7.
El-Jawahri A, LeBlanc T, VanDusen H, Traeger L, Greer JA, Pirl WF, et al. Effect of inpatient palliative care on quality of life 2 weeks after hematopoietic stem cell transplantation: a randomized clinical trial. JAMA. 2016;316(20):2094–103.CrossRef
8.
9.
Wallen GR, Baker K, Stolar M, Miller-Davis C, Ames N, Yates J, et al. Palliative care outcomes in surgical oncology patients with advanced malignancies: a mixed methods approach. Qual Life Res Int J Qual Life Asp Treat Care Rehab. 2012;21(3):405–15.
10.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81.CrossRef
11.
Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, et al. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009;302(7):741–9.CrossRef
12.
Webster K, Cella D, Yost K. The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System: properties, applications, and interpretation. Health Qual Life Outcomes. 2003;1:79.CrossRef
13.
Ruggiero KJ, Ben KD, Scotti JR, Rabalais AE. Psychometric properties of the PTSD checklist—civilian version. J Trauma Stress. 2003;16(5):495–502.CrossRef
14.
Hall DE, Arya S, Schmid KK, Blaser C, Carlson MA, Bailey TL, et al. Development and initial validation of the Risk Analysis Index for measuring frailty in surgical populations. JAMA Surg. 2017;152(2):175–82.CrossRef
15.
Galvin JE, Roe CM, Powlishta KK, Coats MA, Muich SJ, Grant E, et al. The AD8: a brief informant interview to detect dementia. Neurology. 2005;65(4):559–64.CrossRef
16.
Koenig HG, George LK, Titus P. Religion, spirituality, and health in medically ill hospitalized older patients. J Am Geriatr Soc. 2004;52(4):554–62.CrossRef
17.
Schalet BD, Pilkonis PA, Yu L, Dodds N, Johnston KL, Yount S, et al. Clinical validity of PROMIS Depression, Anxiety, and Anger across diverse clinical samples. J Clin Epidemiol. 2016;73:119–27.CrossRef
18.
Westbrook KW, Babakus E, Grant CC. Measuring patient-perceived hospital service quality: validity and managerial usefulness of HCAHPS scales. Health Mark Q. 2014;31(2):97–114.CrossRef
19.
Tedeschi RG, Calhoun LG. The Posttraumatic Growth Inventory: measuring the positive legacy of trauma. J Trauma Stress. 1996;9(3):455–71.CrossRef
20.
Bedard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: a new short version and screening version. Gerontologist. 2001;41(5):652–7.CrossRef
21.
Baker PS, Bodner EV, Allman RM. Measuring life-space mobility in community-dwelling older adults: LIFE-SPACE MOBILITY. J Am Geriatr Soc. 2003;51(11):1610–4.CrossRef
22.
Casarett D, Shreve S, Luhrs C, Lorenz K, Smith D, De Sousa M, et al. Measuring families’ perceptions of care across a health care system: preliminary experience with the Family Assessment of Treatment at End of Life Short Form (FATE-S). J Pain Symptom Manag. 2010;40(6):801–9.CrossRef
23.
Harrell FE. Regression modeling strategies with applications to linear models, logistic regression, and survival analysis. New York: Springer; 2010.
24.
Tchetgen Tchetgen EJ. Identification and estimation of survivor average causal effects. Stat Med. 2014;33(21):3601–28.CrossRef
25.
Lachin JM. Worst-rank score analysis with informatively missing observations in clinical trials. Control Clin Trials. 1999;20(5):408–22.CrossRef
26.
Cook RJ, Farewell VT. Multiplicity considerations in the design and analysis of clinical trials. J R Stat Soc A Stat Soc. 1996;159:93–110.CrossRef
27.
Rothman KJ. No adjustments are needed for multiple comparisons. Epidemiology. 1990;1(1):43–6.CrossRef
28.
Wang R, Lagakos SW, Ware JH, Hunter DJ, Drazen JM. Statistics in medicine--reporting of subgroup analyses in clinical trials. N Engl J Med. 2007;357(21):2189–94.CrossRef
29.
Kavalieratos D, Corbelli J, Zhang D, Dionne-Odom JN, Ernecoff NC, Hanmer J, et al. Association between palliative care and patient and caregiver outcomes: a systematic review and meta-analysis. JAMA. 2016;316(20):2104–14.CrossRef
Metadata
Title
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
Authors
Myrick C. Shinall Jr
Aimee Hoskins
Alexander T. Hawkins
Christina Bailey
Alaina Brown
Rajiv Agarwal
Maria C. Duggan
Laura M. Beskow
Vyjeyanthi S. Periyakoil
David F. Penson
Ryan T. Jarrett
Rameela Chandrasekhar
E. Wesley Ely
Publication date
01-12-2019
Publisher
BioMed Central
Keyword
Care
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3754-0

Other articles of this Issue 1/2019

Trials 1/2019 Go to the issue

Study protocol

Transmuscular quadratus lumborum block versus thoracic paravertebral block for acute pain and quality of recovery after laparoscopic renal surgery: study protocol for a randomized controlled trial

Study protocol

Promoting mental health and wellbeing in schools: examining Mindfulness, Relaxation and Strategies for Safety and Wellbeing in English primary and secondary schools: study protocol for a multi-school, cluster randomised controlled trial (INSPIRE)

Study protocol

Combination therapy of vitamin C and thiamine for septic shock in a multicentre, double-blind, randomized, controlled study (ATESS): study protocol for a randomized controlled trial

Study protocol

KONTAKT© for Australian adolescents on the autism spectrum: protocol of a randomized control trial

Study protocol

Glibenclamide in aneurysmatic subarachnoid hemorrhage (GASH): study protocol for a randomized controlled trial

Study protocol

A manual-based family intervention for families living with the consequences of traumatic injury to the brain or spinal cord: a study protocol of a randomized controlled trial