Colorectal NeoplasmsPINCORENCT03587818
Person-Centred Information and Communication for Patients Undergoing Colo-Rectal Surgery - the PINCORE Project
A study testing person-centred communication in people with Colorectal Neoplasms, run by Göteborg University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- person-centred communication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2012to 30 Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing planned surgery for cancer in colon or rectum
Who cannot join
- 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
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Colorectal Neoplasms
- Being tested
- person-centred communication
- Keywords
- Patient-Centered Care, Health Communication, Clinical trial, Colorectal neoplasms, Colorectal surgery, Continuity of patient care, Medical-surgical nursing, Qualitative Research
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
person-centred communicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: person-centred communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: six months after surgery
Secondary outcomes (9)
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.
Measured: (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).
Measured: (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.
Measured: (1) one week after surgery and (2) six weeks after surgery.
Communication in consultations
Audio-recorded planned consultations between patients and professionals.
Measured: Pre-surgery
Patients experience of the recovery process
Audio-recorded individual narrative interviews with patients.
Measured: 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.
Measured: (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
Measured: (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
Measured: (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
Measured: (1) before surgery and (2) within 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start1 Nov 2012
- Primary completion30 Dec 2015
- Study completion30 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joakim Öhlén, PhD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587818
- Sponsor's protocol ID
- GPCC core project PINCORE
- Acronym
- PINCORE
- Status last verified
- Jul 2018
- First submitted
- 25 Apr 2018
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24290242Oresland 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.
PubMed 25847051Carlsson 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.
PubMed 24012188Pettersson 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.
PubMed 27859450Friberg 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.
PubMed 24784141Carlsson 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.
PubMed 27865249Sawatzky 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.
PubMed 27955903Smith 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.
PubMed 29363821Smith F, Wallengren Gustafsson C & Öhlén J. (2017) Participatory design in education materials in health care context. Action Research 15(3), 310-336.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Person-Centred Information and Communication for Patients Undergoing Colo-Rectal Surgery - the PINCORE Project: a Quasi-experimental Longitudinal Design
- ClinicalTrials.gov ID
- NCT03587818
- Acronym / sponsor ID
- PINCORE / GPCC core project PINCORE
- Conditions
- Colorectal Neoplasms
- Keywords
- Patient-Centered Care, Health Communication, Clinical trial, Colorectal neoplasms, Colorectal surgery, Continuity of patient care, Medical-surgical nursing, Qualitative Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 1 Nov 2012 (actual)
- Primary completion
- 30 Dec 2015 (actual)
- Study completion
- 30 Apr 2016 (actual)
- First posted
- 16 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: person-centred communicationI. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- undergoing planned surgery for cancer in colon or rectum
Key exclusion criteria (7 listed)
- receiving preoperative chemotherapy
- receiving long-term preoperative radiation
- diagnosed metastasis
- post-surgical diagnosis of benign tumors
- undergoing emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| person-centred communicationThe 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. | Other | Intervention group |
Primary outcome
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)
9 secondary outcomes
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
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
The Daily Coping Assessment instrument
Time frame: (1) one week after surgery and (2) six weeks after surgery.
Communication in consultations
Time frame: Pre-surgery
Patients experience of the recovery process
Time frame: 6 months following surgery
Orientation to Life Questionnaire (OLQ-13)
Time frame: (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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
- Results publication: PubMed 24290242Smith 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.
- Results publication: PubMed 25847051Oresland 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.
- Results publication: PubMed 24012188Carlsson 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.
- Results publication: PubMed 27859450Pettersson 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.
- Results publication: PubMed 24784141Friberg 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.
- Results publication: PubMed 27865249Carlsson 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.
- Results publication: PubMed 27955903Sawatzky 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.
- Results publication: PubMed 29363821Smith 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.
- Results publicationSmith F, Wallengren Gustafsson C & Öhlén J. (2017) Participatory design in education materials in health care context. Action Research 15(3), 310-336.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joakim Öhlén, PhD principal investigator
Göteborg University
Questions about this trial
What is this clinical trial studying?
A study testing person-centred communication in people with Colorectal Neoplasms, run by Göteborg University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Longitudinal Preparedness for Colorectal Cancer Surgery Questionnaire (PCSQ) (time frame: six months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03587818, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2018.