Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2021 Apr 29;22(1):314.
doi: 10.1186/s13063-021-05256-y.

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  1   2 , Myrick C Shinall Jr  3   4   5   6 , Aimee Hoskins  3 , Ellis Morgan  3 , Mohana Karlekar  5 , Sara F Martin  5 , E Wesley Ely  3   7   8 , Rameela Raman  9   3
Affiliations
Randomized Controlled Trial

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 et al. Trials. .

Abstract

Background: The 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 design: The 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.

Results: The 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.

Conclusion: This 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 registration: ClinicalTrials.gov NCT03436290 . Registered on 16 February 2018.

Keywords: Cancer; Palliative care; Randomized controlled trial; Statistical analysis plan; Surgical oncology.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

References

    1. Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010;363(8):733–42. doi: 10.1056/NEJMoa1000678. - DOI - PubMed
    1. El-Jawahri A, LeBlanc T, VanDusen H, Traeger L, Greer JA, Pirl WF, Jackson VA, Telles J, Rhodes A, Spitzer TR, McAfee S, Chen Y-BA, Lee SS, Temel JS. 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. doi: 10.1001/jama.2016.16786. - DOI - PMC - PubMed
    1. Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, Ahles TA. 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. doi: 10.1001/jama.2009.1198. - DOI - PMC - PubMed
    1. Zimmermann C, Swami N, Krzyzanowska M, Hannon B, Leighl N, Oza A, Moore M, Rydall A, Rodin G, Tannock I, et al. Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial. Lancet. 2014;383(9930):1721–30. doi: 10.1016/S0140-6736(13)62416-2. - DOI - PubMed
    1. Gamble C, Krishan A, Stocken D, Lewis S, Juszczak E, Doré C, Williamson PR, Altman DG, Montgomery A, Lim P, Berlin J, Senn S, Day S, Barbachano Y, Loder E. Guidelines for the content of statistical analysis plans in clinical trials. JAMA. 2017;318(23):2337–43. doi: 10.1001/jama.2017.18556. - DOI - PubMed

Associated data