NCT05808712

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Mar 2023

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Mar 2023Dec 2028

Study Start

First participant enrolled

March 1, 2023

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 11, 2023

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

June 8, 2025

Status Verified

June 1, 2025

Enrollment Period

5.8 years

First QC Date

March 28, 2023

Last Update Submit

June 4, 2025

Conditions

Keywords

cancer nursing,patient preferencespatient-centered care

Outcome Measures

Primary Outcomes (2)

  • supportive care needs, questonnarie

    psychometric properties in the swedish version of the questionnarie SCNS-SF34

    March 2023 - March 2024

  • Rate of supportive care needs in cancer

    assessment of supportive care needs via the questionnarie SCNS-SF34 (in Swedish)

    March 2023 - March 2024

Study Arms (1)

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.

Other: validation

Interventions

Translation and validation design

Translation and validation design

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cancer patients with different gastrointestinal cancer diagnosis

You may qualify if:

  • \>18 years
  • cancer patients with different gastrointestinal cancer diagnosis

You may not qualify if:

  • \- not able to answer the questionnarie SCNS-SF34 in Swedish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jenny Drott

Linköping, 581 83, Sweden

RECRUITING

Department of Surgery

Linköping, 58185, Sweden

RECRUITING

MeSH Terms

Conditions

NeoplasmsGastrointestinal NeoplasmsPatient Preference

Interventions

Validation Studies as Topic

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesPatient SatisfactionTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Evaluation Studies as TopicInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Jenny Drott

    Kirurgiska kliniken, Region Östergötland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny Drott, PhD

CONTACT

Per Sandström, Prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, PhD, Associate Professor

Study Record Dates

First Submitted

March 28, 2023

First Posted

April 11, 2023

Study Start

March 1, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

June 8, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations