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

NCT03587818 | Completed

• 1 other identifier: GPCC core project PINCORE
• Study Type: interventional
• Target: 488
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Patient-Centered Care; Health Communication; Clinical trial; Colorectal neoplasms; Colorectal surgery; Continuity of patient care; Medical-surgical nursing; Qualitative Research

Outcome Measures

Primary Outcomes (1)

• The Longitudinal Preparedness for Colorectal Cancer Surgery Questionnaire (PCSQ)

  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 Outcomes (9)

• EORTC QLQ-C30 version 3.0

  (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).

  (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

  (1) one week after surgery and (2) six weeks after surgery.

• Communication in consultations

  Pre-surgery

• Patients experience of the recovery process

  6 months following surgery

Study Arms (2)

Control group

NO INTERVENTION

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.

Intervention group

EXPERIMENTAL

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

Interventions

person-centred communication OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing planned surgery for cancer in colon or rectum

You may not qualify if:

• 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

Sponsors & Collaborators

• Göteborg University: lead

Related Publications (9)

• Smith F, Carlsson E, Kokkinakis D, Forsberg M, Kodeda K, Sawatzky R, Friberg F, Ohlen J. Readability, suitability and comprehensibility in patient education materials for Swedish patients with colorectal cancer undergoing elective surgery: a mixed method design. Patient Educ Couns. 2014 Feb;94(2):202-9. doi: 10.1016/j.pec.2013.10.009. Epub 2013 Nov 5.

  PMID: 24290242 RESULT

• Oresland S, Friberg F, Maatta S, Ohlen J. Disclosing discourses: biomedical and hospitality discourses in patient education materials. Nurs Inq. 2015 Sep;22(3):240-8. doi: 10.1111/nin.12097. Epub 2015 Apr 6.

  PMID: 25847051 RESULT

• Carlsson E, Pettersson M, Hyden LC, Ohlen J, Friberg F. Structure and content in consultations with patients undergoing surgery for colorectal cancer. Eur J Oncol Nurs. 2013 Dec;17(6):820-6. doi: 10.1016/j.ejon.2013.07.002. Epub 2013 Sep 5.

  PMID: 24012188 RESULT

• Pettersson ME, Ohlen J, Friberg F, Hyden LC, Carlsson E. Topics and structure in preoperative nursing consultations with patients undergoing colorectal cancer surgery. Scand J Caring Sci. 2017 Dec;31(4):674-686. doi: 10.1111/scs.12378. Epub 2016 Nov 8.

  PMID: 27859450 RESULT

• Friberg F, Liden E, Hakanson C, Ohlen J. Communicating bodily changes: physicians' ways of enabling patient understanding in gastrointestinal cancer consultations. Palliat Support Care. 2015 Jun;13(3):661-71. doi: 10.1017/S1478951514000352. Epub 2014 May 2.

  PMID: 24784141 RESULT

• Carlsson E, Pettersson M, Ohlen J, Sawatzky R, Smith F, Friberg F. Development and validation of the preparedness for Colorectal Cancer Surgery Questionnaire: PCSQ-pre 24. Eur J Oncol Nurs. 2016 Dec;25:24-32. doi: 10.1016/j.ejon.2016.09.002. Epub 2016 Sep 21.

  PMID: 27865249 RESULT

• Sawatzky R, Russell L, Friberg F, Carlsson EK, Pettersson M, Ohlen J. Longitudinal person-centered measurement: A psychometric evaluation of the Preparedness for Colorectal Cancer Surgery Questionnaire (PCSQ). Patient Educ Couns. 2017 May;100(5):827-835. doi: 10.1016/j.pec.2016.11.010. Epub 2016 Nov 15.

  PMID: 27955903 RESULT

• Smith F, Ohlen J, Persson LO, Carlsson E. Daily Assessment of Stressful events and Coping in early post-operative recovery after colorectal cancer surgery. Eur J Cancer Care (Engl). 2018 Mar;27(2):e12829. doi: 10.1111/ecc.12829. Epub 2018 Jan 24.

  PMID: 29363821 RESULT

• Smith F, Wallengren Gustafsson C & Öhlén J. (2017) Participatory design in education materials in health care context. Action Research 15(3), 310-336.

  RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Joakim Öhlén, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A before and after design was performed; the control group were included from November 2012 to January 2014. This was followed by introducing the intervention to the clinicians, and the intervention group were included from March 2014 to June 2015. Patients were assigned consecutively at the three hospitals. No blinding was applied.

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: July 16, 2018
• Study Start: November 1, 2012
• Primary Completion: December 30, 2015
• Study Completion: April 30, 2016
• Last Updated: July 16, 2018

Record last verified: 2018-07