NCT04125225

Brief Summary

Complete cytoreductive surgery (CCRS) is an extensive, and potentially curative, procedure utilised for peritoneal malignancies including Pseudomyxoma peritonei (PMP). This study aims to provide a nuanced understanding of the lived experience of recovery following CCRS over time, with the view to inform future supportive measures for CCRS patients in particular. This study also provides the opportunity to longitudinally examine patient perceptions of 'recovery' in the context of major illness and/or treatment; i.e. what it is to experience recovery, what is important during recovery, perhaps how this changes over time, and what it is to be 'recovered', if this is possible. A greater understanding of the term may have implications in how it is used, or how patients following major illness are approached by healthcare professionals. Interpretive Phenomenological Analysis (IPA) will be utilised as the guiding methodology in order to answer the study objectives. Potential participants will be approached by the clinical nurse specialist (CNS) involved in the patient's care, and will be offered a 'research study pack', containing a participant information sheet (PIS). A maximum of ten consenting participants will be interviewed on up to six occasions (although only five are planned) across a timeframe of little more than a year, both before and after their surgery. Interviews may take place face-to-face, or via telephone. Data analysis will involve a cyclical process of identifying patterns within the interview transcripts of each participant at each time point, across time points, and between participants. This design will provide an effective means of gathering and analysing rich data from each participant, thus affording a comprehensive insight into the meanings that participants attribute over time to their recovery following CCRS. This study has been devised in partial fulfilment of a doctorate degree at the University of Southampton.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

January 31, 2020

Status Verified

January 1, 2020

Enrollment Period

1.3 years

First QC Date

October 10, 2019

Last Update Submit

January 29, 2020

Conditions

Pseudomyxoma PeritoneiCytoreductive SurgeryRecovery

Outcome Measures

Primary Outcomes (2)

  • To gather an in-depth understanding of the experiences of patients following complete cytoreductive surgery, using interpretative phenomenological analysis

    The primary objective of the study is to elicit an in-depth understanding of the lived experience of 'recovery' in the year following CCRS. Up to ten study participants will be interviewed on up to six occasions, and the data produced will be analysed using interpretative phenomenological analysis.

    1 Year

  • To gather an in-depth understanding of the meaning of recovery to patients after complete cytoreductive surgery, using interpretative phenomenological analysis

    The secondary objective of the study is to identify the meaning(s) of 'recovery' to study participants over time in the year following CCRS. Up to ten study participants will be interviewed on up to six occasions, and the data produced will be analysed using interpretative phenomenological analysis.

    1 Year

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Potential participants are likely to be approached at outpatient appointments by clinical nurse specialists.

You may qualify if:

  • Patients are eligible to be invited to participate in the study if…
  • They are electively booked in…
  • … for Complete Cytoreducive Surgery (CCRS)…
  • … for 'four-quadrant' Pseudomyxoma peritonei (PMP)…
  • … at Basingstoke and North Hampshire Hospital (BNHH).
  • They are 16 years old or over.
  • They live within an approximate 100 mile radius of BNHH.
  • They are able to converse in English, without the assistance of others.
  • They are deemed able to independently make an informed decision whether or not to participate in the study (i.e. the individual must appear able to understand, retain and use or weigh up information as part of decision making processes)

You may not qualify if:

  • Potential participants are excluded if they have had a previous diagnosis of cancer.
  • Potential participants are also excluded if they have had, or are due to have, a treatment of systemic chemotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basingstoke and North Hampshire Hospital

Basingstoke, Hampshire, RG24 9NA, United Kingdom

Location

Related Publications (10)

  • Glehen O, Kwiatkowski F, Sugarbaker PH, Elias D, Levine EA, De Simone M, Barone R, Yonemura Y, Cavaliere F, Quenet F, Gutman M, Tentes AA, Lorimier G, Bernard JL, Bereder JM, Porcheron J, Gomez-Portilla A, Shen P, Deraco M, Rat P. Cytoreductive surgery combined with perioperative intraperitoneal chemotherapy for the management of peritoneal carcinomatosis from colorectal cancer: a multi-institutional study. J Clin Oncol. 2004 Aug 15;22(16):3284-92. doi: 10.1200/JCO.2004.10.012.

    PMID: 15310771BACKGROUND

  • Sugarbaker PH. Peritonectomy procedures. Ann Surg. 1995 Jan;221(1):29-42. doi: 10.1097/00000658-199501000-00004.

    PMID: 7826158BACKGROUND

  • Chua TC, Yan TD, Saxena A, Morris DL. Should the treatment of peritoneal carcinomatosis by cytoreductive surgery and hyperthermic intraperitoneal chemotherapy still be regarded as a highly morbid procedure?: a systematic review of morbidity and mortality. Ann Surg. 2009 Jun;249(6):900-7. doi: 10.1097/SLA.0b013e3181a45d86.

    PMID: 19474692BACKGROUND

  • Dube P, Sideris L, Law C, Mack L, Haase E, Giacomantonio C, Govindarajan A, Krzyzanowska MK, Major P, McConnell Y, Temple W, Younan R, McCart JA. Guidelines on the use of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in patients with peritoneal surface malignancy arising from colorectal or appendiceal neoplasms. Curr Oncol. 2015 Apr;22(2):e100-12. doi: 10.3747/co.22.2058.

    PMID: 25908915BACKGROUND

  • Shan LL, Saxena A, Shan BL, Morris DL. Quality of life after cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy for peritoneal carcinomatosis: A systematic review and meta-analysis. Surg Oncol. 2014 Dec;23(4):199-210. doi: 10.1016/j.suronc.2014.10.002. Epub 2014 Oct 28.

    PMID: 25466850BACKGROUND

  • Stearns AT, Malcomson L, Punnett G, Abudeeb H, Aziz O, Selvasekar CR, Fulford PE, Wilson MS, Renehan AG, O'Dwyer ST. Long-term Quality of Life After Cytoreductive Surgery and Heated Intraperitoneal Chemotherapy for Pseudomyxoma Peritonei: A Prospective Longitudinal Study. Ann Surg Oncol. 2018 Apr;25(4):965-973. doi: 10.1245/s10434-017-6326-0. Epub 2018 Jan 8.

    PMID: 29313146BACKGROUND

  • Jess P, Iversen LH, Nielsen MB, Hansen F, Laurberg S, Rasmussen PC. Quality of life after cytoreductive surgery plus early intraperitoneal postoperative chemotherapy for pseudomyxoma peritonei: a prospective study. Dis Colon Rectum. 2008 Jun;51(6):868-74. doi: 10.1007/s10350-008-9223-6. Epub 2008 Feb 23.

    PMID: 18297361BACKGROUND

  • Seretis C, Youssef H. Quality of life after cytoreductive surgery and intraoperative hyperthermic intraperitoneal chemotherapy for peritoneal surface malignancies: a systematic review. Eur J Surg Oncol. 2014 Dec;40(12):1605-13. doi: 10.1016/j.ejso.2014.08.477. Epub 2014 Sep 6.

    PMID: 25242382BACKGROUND

  • Smith JA, Flowers P and Larkin M (2009) IPA Theory, Method and Research. Sage Publications, Great Britain

    BACKGROUND

  • Smith JA (1996) Beyond the divide between cognition and discourse: Using interpretative phenomenological analysis in health psychology. Psychology and health 11(2): 261-71

    BACKGROUND

MeSH Terms

Conditions

Pseudomyxoma Peritonei

Condition Hierarchy (Ancestors)

Adenocarcinoma, MucinousAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Cystic, Mucinous, and Serous
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Doctoral Research Fellowship

Study Record Dates

First Submitted

October 10, 2019

First Posted

October 14, 2019

Study Start

November 1, 2019

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

January 31, 2020

Record last verified: 2020-01

Locations

GB(1)