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

Sponsor

Helsinki University Central Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03131076

Collaborator

(none)

300

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
IPMN Quality of Life	Diagnostic Test: IPMN follow up

Detailed Description

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Intraduktaalisen Papillaarisen Musinoosisen Neoplasian Vuoksi Seurannassa Olevien Potilaiden elämänlaatu

Anticipated Study Start Date :

May 1, 2017

Anticipated Primary Completion Date :

Aug 31, 2018

Anticipated Study Completion Date :

Dec 31, 2019

Outcome Measures

Primary Outcome Measures

Change in the quality of life and anxiety [Before and 3 months after IPMN follow up MRI]
15D quality of life and STAI -questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

all patients under IPMN surveillance

Exclusion Criteria:

no exclusion criteria, all patients under IPMN surveillance are included

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Helsinki University Central Hospital

Investigators

Principal Investigator: Heini Nieminen, Helsinki Universtity Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Heini Nieminen, licensed physician, Helsinki University Central Hospital

ClinicalTrials.gov Identifier:

NCT03131076

Other Study ID Numbers:

IPMN Quality of life

First Posted:

Apr 27, 2017

Last Update Posted:

Apr 27, 2017

Last Verified:

Apr 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 27, 2017