CancerNCT05808712
Quality of Care in Relationship to Aborted Cancer Surgery
An observational study of Cancer and Gastrointestinal Cancer, run by Linkoeping University at 2 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Gastrointestinal Cancer
- What is being tested?
- validation
- How many people
- 350 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Mar 2023to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Cancer patients with different gastrointestinal cancer diagnosis
Who may be able to join
- >18 years
- cancer patients with different gastrointestinal cancer diagnosis
Who cannot join
- not able to answer the questionnarie SCNS-SF34 in Swedish.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Jenny Drott
Linköping, 581 83
Jenny Drott, +46709544489, Jenny.Drott@liu.se
- Recruiting
Department of Surgery
Linköping, 58185
Per Sandström, +467034058581, per.sandstrom@liu.se
About this study
Official title: 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.
Read the 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
- Conditions
- Cancer, Gastrointestinal Cancer
- Being tested
- validation
- Keywords
- cancer nursing,, patient preferences, patient-centered care
- Medical subject headings
- Neoplasms, Gastrointestinal Neoplasms, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
validationOther
Translation and validation design
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: validation |
What is being measured
The primary outcome is the main question the study is designed to answer.
supportive care needs, questonnarie
psychometric properties in the swedish version of the questionnarie SCNS-SF34
Measured: March 2023 - March 2024
Rate of supportive care needs in cancer
assessment of supportive care needs via the questionnarie SCNS-SF34 (in Swedish)
Measured: March 2023 - March 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start1 Mar 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Linkoeping 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jenny Drott, Linkoeping University
- Investigators
- Jenny Drott, Principal investigator, Kirurgiska kliniken, Region Östergötland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808712
- Sponsor's protocol ID
- ACS
- Status last verified
- Jun 2025
- First submitted
- 28 Mar 2023
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Patient-centered Interventions to Improve the Quality of Care in Relationship to Aborted Cancer Surgery
- ClinicalTrials.gov ID
- NCT05808712
- Acronym / sponsor ID
- ACS
- Conditions
- Cancer, Gastrointestinal Cancer
- Keywords
- cancer nursing,, patient preferences, patient-centered care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Apr 2023 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Translation and validation design | – | Other: validationTo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Cancer patients with different gastrointestinal cancer diagnosis
Key inclusion criteria (2 listed)
- >18 years
- cancer patients with different gastrointestinal cancer diagnosis
Key exclusion criteria (1 listed)
- not able to answer the questionnarie SCNS-SF34 in Swedish.
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 |
|---|---|---|
| validationTranslation and validation design | Other | Translation and validation design |
Primary outcome
supportive care needs, questonnarie
Time frame: March 2023 - March 2024
psychometric properties in the swedish version of the questionnarie SCNS-SF34
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Jenny Drott principal investigator
Kirurgiska kliniken, Region Östergötland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Gastrointestinal Cancer, run by Linkoeping University at 2 sites in Sweden.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenny Drott, PhD (+46 732701839, Jenny.Drott@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
supportive care needs, questonnarie (time frame: March 2023 - March 2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2025.