- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05808712
Quality of Care in Relationship to Aborted Cancer Surgery
Developing Patient-centered Interventions to Improve the Quality of Care in Relationship to Aborted Cancer Surgery
Surgery is often a central curative treatment for gastrointestinal tumors. Surgical treatment of diagnosed cancer tumors is decided after a comprehensive assessment of the patient's physical status, radiological assessments and after careful evaluation at the multidisciplinary conference. Despite the careful preoperative assessment of patients for curative surgery, the planned operation may unexpectedly need to be canceled. Of the patients who were planned for curative resection for pancreatic cancer in 2021 in Sweden, 90% received the intended surgery, and 10% of planned surgery was canceled. The reason for this was disseminated cancer or locally advanced disease in which radical resection is considered impossible to carry out. A systematic review of knowledge reveals a significant lack of evidence regarding patient-centered research and aborted cancer surgery.
The studies in the project have different study designs and methods, and include focus group interviews with staff, translation and validation of a questionnaire to measure care needs, estimation of supportive care needs and patient experiences.
An improved understanding and knowledge of patients' preferences and needs is needed to design interventions that can improve health-related quality of life. This project is dedicated to studying patients undergoing aborted cancer surgery, with the aim of improving the quality of care and meeting patients' care needs.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The overall objective of this research project is to:
- describe the patients experiences and assess supportive care needs following aborted cancer gastrointestinal surgery
- increase knowledge of the healthcare professionals' experiences of aborted cancer surgery from a multi-professional and continuum of cancer care perspective
- increase our clinical knowledge of patient preferences and healthcare professionals' perspective to develop tailored patient-centered interventions with the goal to improve quality of cancer care
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jenny Drott, PhD
- Phone Number: +46 732701839
- Email: Jenny.Drott@liu.se
Study Contact Backup
- Name: Per Sandström, Prof
- Phone Number: +46 7034058581
- Email: per.sandstrom@liu.se
Study Locations
-
-
-
Linköping, Sweden, 581 83
- Recruiting
- Jenny Drott
-
Contact:
- Jenny Drott
- Phone Number: +46709544489
- Email: Jenny.Drott@liu.se
-
Linköping, Sweden, 58185
- Recruiting
- Department of Surgery
-
Contact:
- Per Sandström
- Phone Number: +467034058581
- Email: per.sandstrom@liu.se
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- >18 years
- cancer patients with different gastrointestinal cancer diagnosis
Exclusion Criteria:
- not able to answer the questionnarie SCNS-SF34 in Swedish.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Translation and validation design
To translate the English version of The Supportive Care Needs Survey-short form (SCNS-SF34) questionnaire into Swedish and to test the reliability and validity. Design: Translation and validation design A multicenter national validation study, in three university hospital in Sweden. Consecutive sampling procedure during a one-year period (2023), to evaluate internal consistency and test-retest reliability of the SCNS-SF34 in Swedish. Number is calculated to be 300 patients, and test-rest (reliability) in 50 patients. Inclusion criteria = >18 years, cancer patients with different gastrointestinal cancer diagnosis. Exclusion criteria= not able to answer a questionnaire in Swedish. Demographical and clinical data will be collected using a case report form. The survey will be distributed to patients via a web-based questionnaire or paper and pen questionnaire procedure. |
Translation and validation design
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
supportive care needs, questonnarie
Time Frame: March 2023 - March 2024
|
psychometric properties in the swedish version of the questionnarie SCNS-SF34
|
March 2023 - March 2024
|
|
Rate of supportive care needs in cancer
Time Frame: March 2023 - March 2024
|
assessment of supportive care needs via the questionnarie SCNS-SF34 (in Swedish)
|
March 2023 - March 2024
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jenny Drott, Kirurgiska kliniken, Region Östergötland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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