Evidence map›Paper›PMID 33926535›Full record

Trial reportTrials2021

Statistical analysis plan for the Surgery for Cancer with Option of Palliative Care Expert (SCOPE) trial: a randomized controlled trial of a specialist palliative care intervention for patients undergoing surgery for cancer.

Onur M Orun, Myrick C Shinall, Aimee Hoskins, Ellis Morgan, Mohana Karlekar, Sara F Martin, E Wesley Ely, Rameela Raman

Registry-linked trialOpen access · goldAbstract readLetterRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03436290 (Surgery for Cancer With Option of Palliative Care Expert), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 44% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03436290 naactive not recruitingnot on this map

Surgery for Cancer With Option of Palliative Care Expert: A Randomized Trial of an Early Palliative Care Intervention for Patients Undergoing Surgery for Cancer

TypeinterventionalSponsorVanderbilt University Medical CenterRan2018 to 2026Enrolled236ConditionsCancerArmsPalliative Care Intervention
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Onur M OrunDepartment of Biostatistics, Vanderbilt University Medical Center, 2525 West End, Suite 1100, Nashville, 37203, TN, USA. onur.m.orun@vumc.org.ORCID http://orcid.org/0000-0002-1368-040X
Myrick C ShinallCritical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center, Nashville,, TN, USA.
Aimee HoskinsCritical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center, Nashville,, TN, USA.
Ellis MorganCritical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center, Nashville,, TN, USA.
Mohana KarlekarSection of Palliative Care, Department of Medicine, Vanderbilt University Medical Center, Nashville,, TN, USA.
Sara F MartinSection of Palliative Care, Department of Medicine, Vanderbilt University Medical Center, Nashville,, TN, USA.
E Wesley ElyCritical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center, Nashville,, TN, USA.
Rameela RamanDepartment of Biostatistics, Vanderbilt University Medical Center, 2525 West End, Suite 1100, Nashville, 37203, TN, USA.
Vanderbilt University Medical Center · USValley Health System · US

Funding

Vanderbilt Clinical Oncology Research Career Development ProgramK12CA090625 · NCI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Debra L. Friedman, Paula Jill Hurley · 2001 to 2026
$16.9M
Specialist Palliative Care in Surgical OncologyK76AG068436 · NIA · VANDERBILT UNIVERSITY MEDICAL CENTER · PI SHINALL, MYRICK C · 2020 to 2022
$714k
The Surgery for Cancer with Option of Palliative Care Expert (SCOPE) TrialR03AG060085 · NIA · VANDERBILT UNIVERSITY MEDICAL CENTER · PI SHINALL, MYRICK C · 2018 to 2019
$237k
NCI NIH HHS K12 CA090625NCI NIH HHS K12CA090625NIA NIH HHS K76 AG068436NIA NIH HHS K76AG068436NIA NIH HHS R03 AG060085NIA NIH HHS R03AG060085
6 · The paper itself

Abstract

backgroundThe impact of specialist palliative care intervention in patients undergoing surgery for cancer has not been studied extensively. The SCOPE randomized controlled trial will investigate the effect of specialist palliative care intervention in cancer patients undergoing surgery for selected abdominal malignancies. The study protocol of the SCOPE Trial was published in December 2019. METHODS AND

designThe SCOPE Trial is a single-center, single-blind, prospective, randomized controlled trial that will investigate specialist palliative care intervention for cancer patients undergoing surgery for selected abdominal malignancies. The study plans to enroll 236 patients that will be randomized to specialist palliative care (intervention arm) and usual care (control arm) in a 1:1 ratio.

resultsThe primary outcome of the study is the Functional Assessment of Cancer Therapy-General (FACT-G) Trial Outcome Index (TOI) at 90 days postoperatively. Secondary outcomes of the study include the total FACT-G score at 90 days postoperatively, days alive at home without an emergency room visit within 90 days of operation, and all-cause mortality at 1 year after operation. Time frames for all outcomes will start on the day of surgery.

conclusionThis manuscript serves as the formal statistical analysis plan (version 1.0) for the SCOPE randomized controlled trial. The statistical analysis plan was completed on 6 April 2021.

trial registrationClinicalTrials.gov NCT03436290 . Registered on 16 February 2018.

Indexed as

COVID-19NeoplasmsHumansPalliative CareProspective StudiesSARS-CoV-2Single-Blind MethodTreatment OutcomeCancerPalliative careRandomized controlled trialStatistical analysis planSurgical oncology

Identifiers

PMID33926535
PMCPMC8082922
OpenAlexW3159129872

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.