Quality of Life Assessment in Patients Who Are Under Surveillance for IPMN
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|ClinicalTrials.gov Identifier: NCT03131076|
Recruitment Status : Unknown
Verified April 2017 by Heini Nieminen, Helsinki University Central Hospital.
Recruitment status was: Not yet recruiting
First Posted : April 27, 2017
Last Update Posted : April 27, 2017
|Condition or disease||Intervention/treatment|
|IPMN Quality of Life||Diagnostic Test: IPMN follow up|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||300 participants|
|Target Follow-Up Duration:||3 Months|
|Official Title:||Intraduktaalisen Papillaarisen Musinoosisen Neoplasian Vuoksi Seurannassa Olevien Potilaiden elämänlaatu|
|Estimated Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||August 31, 2018|
|Estimated Study Completion Date :||December 31, 2019|
- Diagnostic Test: IPMN follow up
Follow up with MRI and laboratory blood tests
- Change in the quality of life and anxiety [ Time Frame: Before and 3 months after IPMN follow up MRI ]15D quality of life and STAI -questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131076
|Contact: Heini Nieminenfirstname.lastname@example.org|
|Contact: Hanna Seppänenemail@example.com|
|Principal Investigator:||Heini Nieminen||Helsinki Universtity Hospital|