NCT04061902

Brief Summary

Patients that are involved in their health care is associated with improved treatment outcomes, rehabilitation and recovery. In this research project we aim to assess patient participation among patients who had surgery for liver, bile duct (cholangiocarcinoma) and pancreatic cancer and follow a fast-track recovery program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2016

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

3.2 years

First QC Date

August 16, 2019

Last Update Submit

September 2, 2020

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Treatment planning

    Higher clinical significant score in the subscale Treatment planning in a questionnarie to measure patient participation (Arnetz et al). All scale items ask the patient to rate a specific statement on a 4-point Likert scale ranging from 1 (no, not at all) to 4 (yes, to a great degree). For all scales, higher scores indicate more positive ratings.

    Two weeks post discharge

Interventions

Participation with enhanced patient perioperative informationOTHER

Improved information and dialogue about the care goals in the fast track protocol.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who had surgery for liver, bile duct and pancreatic cancer and follow a fast-track recovery program.

You may not qualify if:

  • \- patients who had surgery for liver, bile duct and pancreatic cancer and follow a fast-track recovery program \>18 years old
  • cognitive dysfunction
  • could not master the Swedish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, County Council of Östergötland

Linköping, Sweden

Location

Related Publications (1)

  • Amin A, Norden M, Fomichov V, Bjornsson B, Lindhoff Larsson A, Sandstrom P, Drott J. Patient-reported participation in hepatopancreatobiliary surgery cancer care: A pilot intervention study with patient-owned fast-track protocols. Eur J Cancer Care (Engl). 2022 May;31(3):e13570. doi: 10.1111/ecc.13570. Epub 2022 Mar 10.

    PMID: 35274386DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered nurse, PhD

Study Record Dates

First Submitted

August 16, 2019

First Posted

August 20, 2019

Study Start

December 1, 2016

Primary Completion

February 19, 2020

Study Completion

August 1, 2020

Last Updated

September 3, 2020

Record last verified: 2020-09

Locations

SE(1)