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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
Sponsor:
Information provided by (Responsible Party):
Heini Nieminen, Helsinki University Central Hospital

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
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety


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


Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients under IPMN follow up
Criteria

Inclusion Criteria:

  • all patients under IPMN surveillance

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Contacts
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Contact: Heini Nieminen 0035894711 heini.nieminen@hus.fi
Contact: Hanna Seppänen 0035894711 hanna.seppanen@hus.fi

Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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Principal Investigator: Heini Nieminen Helsinki Universtity Hospital
Additional Information:

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Responsible Party: Heini Nieminen, licensed physician, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT03131076    
Other Study ID Numbers: IPMN Quality of life
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will not be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No