Quality of Life Assessment in Patients Who Are Under Surveillance for IPMN

NCT ID: NCT03131076

Last Updated: 2017-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Over 500 patients were participating in the IPMN follow up between september 2014 and august 2016 at the Helsinki University Hospital. In this study we are going to determine the effects of the IPMN surveillance on the quality of life and anxiety levels of the patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Intraductal papillary mucinous neoplasm (IPMN) is a cystic neoplasm of the pancreas. The incidence of the tumors has increased during the last years. Some of the IPMN-tumors develop over time increasing dysplasia and at the end IPMN associated carcinoma. All IPMN-patients are kept under surveillance because of the cancer risk. This follow up can last decades and includes MRI and blood samples every 6 to 12 months. This is very expensive and the effects on the patients quality of life have not been studied before to our knowledge.

This study determines the effects of the surveillance on the patients quality of life and anxiety levels. The study will be conducted by 15D- quality of life -questionnaire and state-trait anxiety inventory (STAI) -questionaire. Both will be send to the patients before a IPMN follow up MRI and 3 months later. It is anticipated that the anxiety and the effect on the quality of life would be the highest right before the MRI and would normalize a few months after the MRI.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

IPMN Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IPMN follow up

Follow up with MRI and laboratory blood tests

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* all patients under IPMN surveillance
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Heini Nieminen

licensed physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Heini Nieminen

Role: PRINCIPAL_INVESTIGATOR

Helsinki Universtity Hospital

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Heini Nieminen

Role: CONTACT

0035894711

Hanna Seppänen

Role: CONTACT

0035894711

References

Explore related publications, articles, or registry entries linked to this study.

Nieminen H, Roine R, Ristimaki A, Lantto E, Valimaa N, Kirveskari E, Sintonen H, Haglund C, Seppanen H. Health-related quality of life and anxiety levels among patients under surveillance for intraductal papillary mucinous neoplasm. BMC Gastroenterol. 2023 Jan 16;23(1):14. doi: 10.1186/s12876-023-02639-0.

Reference Type DERIVED
PMID: 36647007 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IPMN Quality of life

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

68Ga-P16-093 PET/CT Imaging in Glioma Patients
NCT05569434 UNKNOWN PHASE1/PHASE2
Hippocampus Avoidance PCI vs PCI
NCT01780675 COMPLETED PHASE3
A Study of 68Ga-PSMA-11 PET Scans in People With Brain Tumors
NCT06209567 ACTIVE_NOT_RECRUITING EARLY_PHASE1