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

Quality of Life Clinical Trial

Official title:

Intraduktaalisen Papillaarisen Musinoosisen Neoplasian Vuoksi Seurannassa Olevien Potilaiden elämänlaatu

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03131076
• Other study ID #: IPMN Quality of life
• Status: Not yet recruiting
• Phase: N/A
• First received: April 7, 2017
• Last updated: April 26, 2017
• Start date: May 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2017
• Source: Helsinki University Central Hospital
• Contact: Heini Nieminen
• Phone: 0035894711
• Email: heini.nieminen[@]hus.fi
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 31, 2019
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all patients under IPMN surveillance

Exclusion Criteria:

• no exclusion criteria, all patients under IPMN surveillance are included

Related Conditions & MeSH terms

• IPMN
• Quality of Life

Intervention

Diagnostic Test:
• IPMN follow up
Follow up with MRI and laboratory blood tests

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the quality of life and anxiety	15D quality of life and STAI -questionnaire	Before and 3 months after IPMN follow up MRI