Person-Centred Information and Communication for Patients Undergoing Colo-Rectal Surgery - the PINCORE Project

NCT03587818 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 488

Last updated 2018-07-16

No results posted yet for this study

Summary

An overarching aim is to create prerequisites for person-centred information and communication. The specific aim is to evaluate if an intervention with a written information and communication support tool and person-centred dialogues can increase patients' health-related quality of life and preparedness and well-being pre-surgery and during recovery in connection to colorectal cancer (CRC) surgery. Further, the aim is to explain variations in patients' recovery trajectories during the six months following CRC surgery in order to identify particularly vulnerable sub-groups of patients.

The hypothesis is that person-centred information and communication supported by an interactive patient information and education material (PEM) for patients undergoing CRC surgery will lead to improved preparedness for surgery and recovery during recovery 6 months following surgery. Secondary outcomes were decreased length of stay at hospital in relation to surgery, changed behaviour pertaining when and how to seek health care for recovery support, and improved emotional, role and social function, general health status and distress.

The study is performed at three surgical departments in Sweden. A combination of quantitative and qualitative methods will be applied. The project started with analysis of existing patient written information and education materials aimed for the patient group at Swedish surgical departments and analyses of conversations between patients and providers in consultations occurring over time before and following surgery. These results provided the basis for the development of the person-centred communication intervention developed in collaboration between people who had undergone CRC surgery, professionals from CRC surgery clinics and researchers with expertise in patient education, person-centred care and CRC surgery.

The design is quasi-experimental and longitudinal. Patients are consecutively sampled. Types of data:

* patient reported answers in validated questionnaires
* information about diagnosis, type of treatments and course of care obtained from patients' records
* recorded consultation conversations with patients between patients and health care providers
* narrative interviews with patients 6 months following discharge regarding their recovery after surgery
* focus group discussions and individual interviews with professionals regarding how they have perceived using the intervention and how it has functioned.

Conditions

  • Colorectal Neoplasms

Interventions

OTHER

person-centred communication

The intervention aimed to actively make use of a person-centred approach to support patients undergoing CRC surgery to be prepared for surgery, discharge and recovery in relation to CRC. This was accomplished through person-centred communication, which was based on a standardized dialogue tool with tailored written information material (component I), in combination with an approach for professionals to facilitate person-centred communication (component II) in consultations.

Sponsors & Collaborators

  • Göteborg University

    lead OTHER

Principal Investigators

  • Joakim Öhlén, PhD · Göteborg University

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-01
Primary Completion
2015-12-30
Completion
2016-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03587818 on ClinicalTrials.gov