An interventional study of person-centred communication in Colorectal Neoplasms, sponsored by Göteborg University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-16.
Sponsored by Göteborg University · Not applicable, Interventional, and Supportive care
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:
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:
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 488 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Göteborg University is the lead sponsor of 265 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
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)
Time frame: six months after surgery
EORTC QLQ-C30 version 3.0
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.
Time frame: (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).
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).
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
The Daily Coping Assessment instrument
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.
Time frame: (1) one week after surgery and (2) six weeks after surgery.
Communication in consultations
Audio-recorded planned consultations between patients and professionals.
Time frame: Pre-surgery
Patients experience of the recovery process
Audio-recorded individual narrative interviews with patients.
Time frame: 6 months following surgery
Orientation to Life Questionnaire (OLQ-13)
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.
Time frame: (1) before surgery and (2) six months after surgery
Length of stay at hospital in relation to surgery
Days hospitalised; obtained from patients' medical records
Time frame: (1) before surgery and (2) within 6 months after surgery
Behaviour pertaining when and how to seek health care for recovery support: Telephone-calls
Numbers of calls; obtained from patients' medical records
Time frame: (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
Numbers of visits; obtained from patients' medical records
Time frame: (1) before surgery and (2) within 6 months after surgery
No study locations are listed for this record.
Plan to share: Undecided
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Göteborg University