Participation in Surgical Cancer Care (Particip)

Participation in Surgical Cancer Care; Patient, Next of Kin and Health Care Professionals' Perspective

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Participation with enhanced patient perioperative information

Detailed Description

Implementation of Fast-track surgery programs for patients with tumors in the upper GI-tract are steadily increasing because of the decreased costs, shorter hospital stays and a decrease in morbidity, mortality and post-operative complications associated with Fast-track programs. The health care team follows a standardized care program consisting of a check list with day-to-day evidence based procedures which reduces postoperative complications. Postoperative recovery is described as a process in which patients strive for a return to a normalized daily life.

Major surgeries are associated with pain, nausea, postoperative ileus , fatigue, post-operative complications such as wound infections , heart or lung dysfunctions and thromboembolic complications. In the last 20 years perioperative care, anesthesia and surgery for patients suffering from tumors has developed greatly. This has led to development and evaluation of concepts to enhance the patients recovery after different types of surgery. Fast-track surgery concepts results in decreased morbidity and enhanced recovery by implemented evidence based principles in analgesia, anesthesia, fluid management, nutrition, ambulation, minimal invasive surgery and reduction of surgical stress.

In recent years there's been a shift in focus of patient care. Patients are moving from a passive role to being more participant in their care. In Sweden, patients have the legal right to participate in their own care, and health care should be individualized for each patient's needs and abilities. Being involved in your own health care contributes to increased motivation and an improvement of the situation. This may in some cases lead to better treatment outcomes and greater satisfaction with the given care. A severe symptom burden can make the patient a passive recipient of health care without initiative or strength to be involved in the care. In patients with malignancies of the upper gastrointestinal tract monitoring and symptom relief of importance to stimulate opportunities for participation.

Aim

To investigate and describe patient participation among patients who had surgery for liver, bile duct (cholangiocarcinoma) and pancreatic cancer and follow a fast-track recovery program.

Specific aims

• To identify and describe patient participation in patients who follow a fast track-care concept
• To explore patients experiences of patient participation
• To identify, describe and evaluate patient assessed health related quality of life; and relations with patient participation

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden
    • Department of Surgery, County Council of Östergötland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Consecutive sampling strategy, patients will be screened and asked for participation both in verbal and written information. The responsibility health care professionals judge about the patient's condition to participate in the study, according to the inclusion and exclusion criteria.

Inclusion Criteria:

- patients who had surgery for liver, bile duct and pancreatic cancer and follow a fast-track recovery program >18 years old

Exclusion Criteria:

• cognitive dysfunction
• could not master the Swedish language

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Linkoeping University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): February 19, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: August 16, 2019
• First Submitted That Met QC Criteria: August 16, 2019
• First Posted (Actual): August 20, 2019

Study Record Updates

• Last Update Posted (Actual): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Part.19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No