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

July 3, 2018 updated by: Göteborg University

Person-Centred Information and Communication for Patients Undergoing Colo-Rectal Surgery - the PINCORE Project: a Quasi-experimental Longitudinal Design

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background In Sweden, approximately 3,900 people are diagnosed with colon cancer and 1,900 with rectal cancer annually, split almost equally between women and men. The primary treatment for colorectal cancer (CRC) is surgery. A particular challenge in CRC care is meeting patients' information needs over time in order to improve their recovery. There is a need for comprehensive considerations and person-centred communication supporting patients to be prepared for the surgery and the following recovery.

Aim 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 surgery. 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. 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.

Communication in consultations will be supported by a innovative written interactive PEM with the goal to enhance the patient's knowledge seeking in order to be prepared for "the next step" in his/her care process. Here, person-centred communication refers to the patient-provider conversations where the patient is encouraged to tell about personal experiences, perceptions and worries in a dialogue format. An assumption is that dialogues unfolds when the two partners together are seeking to make sense of what is shared to each others.

Method Three hospitals. The study is performed at three surgical departments; university, regional and local hospitals; including public and private non-profit. Health care providers and patients from the three hospitals will be included in the development and evaluation of the intervention. A combination of quantitative and qualitative methods will be applied.

Initial analyses before the development of the intervention 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.

Evaluation in a quasi-experimental design

The design of the clinical intervention study is quasi-experimental and longitudinal; one group of patients before the introduction of the intervention will be compared to one group who have been part of the intervention (consecutively sampled). For the evaluation several types of data will be used:

  • patient reported answers in validated questionnaires
  • clinical and treatment data 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

Expected result The project will contribute a model for the enabling of person-centred communication in connection to CRC surgery. There are many people who will benefit of improved support for the specific group of patients, since CRC is a common type of cancer affecting women and men and where surgery is the most common treatment. Evaluations with a combination of methods increase the possibility to explain the significance of the intervention and how it can be implemented. The design of the intervention model, including a video and workshop outline for the introduction of the intervention model to health care professionals, facilitates direct clinical implementation if the evaluation will be proved effective. The written interactive PEM developed and tested is general for the Swedish context and include a generic approach for how to design the interactive PEM to other groups of patients.

Study Type

Interventional

Enrollment (Actual)

488

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • undergoing planned surgery for cancer in colon or rectum

Exclusion Criteria:

  • receiving preoperative chemotherapy
  • receiving long-term preoperative radiation
  • diagnosed metastasis
  • post-surgical diagnosis of benign tumors
  • undergoing emergency surgery
  • having reduced cognitive function
  • lacking ability to communicate in Swedish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group

Conventional care. Patients were receiving several written patient education materials (PEMs), mostly related to specific parts or procedures related to the surgery and the recovery.

Communication between patients and professionals during consultations occurred according to conventional care practice.
Experimental: Intervention group

I. Written interactive PEM structured into chapters/phases of the care process. Designed to serve three purposes:

  1. generic information of the surgery and recovery process on a group level to promote high readability, suitability and comprehensibility
  2. arena of dialogues between patient and professionals; voicing concerns, share perspectives
  3. for the patient to personally reflect on generic information.

II. Person-centred communication in dialogues using the PEM as a supportive tool, facilitated by four communication strategies:

  1. professionals guiding the patient through the care process
  2. communicating an introduction, agenda and closing
  3. being sensitive to the patient's questions, beliefs, experiences and resources
  4. dialogue based on story, posing open-ended questions, and following up.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Longitudinal Preparedness for Colorectal Cancer Surgery Questionnaire (PCSQ)
Time Frame: six months after surgery
measures change in preparedness for surgery and recovery over time in four domains: (i) searching for and making use of information (4 items), (ii) understanding and involvement in the care process (7 items), (iii) making sense of the recovery process (5 items), and (iv) support and access to medical care (7 items)
six months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EORTC QLQ-C30 version 3.0
Time Frame: (1) before surgery, (2) six weeks after surgery, (3) three months after surgery and (4) six months after surgery
Functional status scales measuring physical functioning (5 items), emotional functioning (4 items), role functioning (2 items), cognitive functioning (2 items) and social functioning (2 items) and global health status/QoL (2 items), and symptom scales for fatigue (3 items), nausea and vomiting (2 items), and pain (2 items), single items for dyspnoea, insomnia, appetite loss, constipation and diarrhoea, and financial difficulties.
(1) before surgery, (2) six weeks after surgery, (3) three months after surgery and (4) six months after surgery
The National Comprehensive Cancer Network (NCCS) Distress Thermometer (DT; Version 1.2013).
Time Frame: (1) before surgery, (2) one week after surgery, (3) six weeks after surgery, (4) three months after surgery and (5) six months after surgery
A one item thermometer visual analogue scale, accompanied with a Problem list categorized into five subscales: practical (6 items), family (4 items), emotional (6 items), physical (22 items), and spiritual/religious (1 items).
(1) before surgery, (2) one week after surgery, (3) six weeks after surgery, (4) three months after surgery and (5) six months after surgery
The Daily Coping Assessment instrument
Time Frame: (1) one week after surgery and (2) six weeks after surgery.
Number and types of pre-defined situational coping strategies used during the day to handle what the person perceives as the most stressful event, illness-related or not.
(1) one week after surgery and (2) six weeks after surgery.
Communication in consultations
Time Frame: Pre-surgery
Audio-recorded planned consultations between patients and professionals.
Pre-surgery
Patients experience of the recovery process
Time Frame: 6 months following surgery
Audio-recorded individual narrative interviews with patients.
6 months following surgery
Orientation to Life Questionnaire (OLQ-13)
Time Frame: (1) before surgery and (2) six months after surgery
13 items that measure sense of coherence on meaningfulness (4 items), manageability (4 items) and comprehensibility (5 items). Items are scored on 7-point scales.
(1) before surgery and (2) six months after surgery
Length of stay at hospital in relation to surgery
Time Frame: (1) before surgery and (2) within 6 months after surgery
Days hospitalised; obtained from patients' medical records
(1) before surgery and (2) within 6 months after surgery
Behaviour pertaining when and how to seek health care for recovery support: Telephone-calls
Time Frame: (1) before surgery and (2) within 6 months after surgery
Numbers of calls; obtained from patients' medical records
(1) before surgery and (2) within 6 months after surgery
Behaviour pertaining when and how to seek health care for recovery support: Visits at outpatients clinics
Time Frame: (1) before surgery and (2) within 6 months after surgery
Numbers of visits; obtained from patients' medical records
(1) before surgery and (2) within 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Investigators

  • Principal Investigator: Joakim Öhlén, PhD, Göteborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2012

Primary Completion (Actual)

December 30, 2015

Study Completion (Actual)

April 30, 2016

Study Registration Dates

First Submitted

April 25, 2018

First Submitted That Met QC Criteria

July 3, 2018

First Posted (Actual)

July 16, 2018

Study Record Updates

Last Update Posted (Actual)

July 16, 2018

Last Update Submitted That Met QC Criteria

July 3, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPCC core project PINCORE

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colorectal Neoplasms

Clinical Trials on person-centred communication

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe