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PREMs on PROMs in Breast Disease (PREMs_PROMs) (PREMs_PROMs)

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ClinicalTrials.gov Identifier: NCT04718324
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Andreas Karakatsanis, Uppsala University

Brief Summary:
In recent years, large interest in the conduct and focus of clinical trials has focused to patient related outcomes and value-based healthcare. Patient Reported Outcome MeasureS, (PROMs) has become one of the standard instruments used for measuring outcomes; multiple PROMS have been extensively validated and are used in many clinical studies, but also in clinical routine. Additionally, Patient Reported Experience MeasureS (PREMS) allow for real-time feedback on the integration of care and can subsequently drive changes in health provision systems. In the present trial, the mode of delivery of PROMS is examined in terms of effectivity and patient experience (PREMS) in the setting of breast disease.

Condition or disease Intervention/treatment Phase
Breast Disease Breast Cancer Breast Neoplasms Other: e-PROMS Other: p-PROMS Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Electronic Patient Reported Outcome Measures (ePROMs) in Patients With Breast Disease: An Open-label, Randomized Controlled Trial on Patient Reported Experience Measures (PREMs) and Effectivity (PREMs_PROMs)
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Diseases

Arm Intervention/treatment
Experimental: e-PROMS
Patients allocated to the e-PROMS arm will fill an online version of PROMS and then respond to the e-PREMS questionnaire.
Other: e-PROMS
Participants randomised to the e-PROMS arm will receive a safe link to the e-PROMS and a unique identification number in the electronic form, so as to preserve anonymity. This is a one-time intervention

Active Comparator: p-PROMS
Patients allocated to the p-PROMS arm will fill in PROMS in paper form (p-PROMS) and then respond to the p-PREMS questionnaire.
Other: p-PROMS
Participants randomised to the p-PROMS arm will receive the PROMS and PREMS questionnaires and a unique identification number in paper form.




Primary Outcome Measures :
  1. Response rate [ Time Frame: Up to 8 weeks after receiving the questionnaires ]
    Number of participants who answered the questionnaires divided by number of participants who were allocated to the respective arm. Analyses will be performed without and with "reminders", per intention-to-treat and per protocol.

  2. Patient Reported Experience outcomes (PREMS) [ Time Frame: Up to 8 weeks after receiving the questionnaires ]
    PREMS score per respective arm. The PREMS score will be standard Likert items ranging from 1 to 7 and 1 to 5, with higher scores meaning a better outcome. Analyses will be performed without and with "reminders", per intention-to-treat and per protocol.


Secondary Outcome Measures :
  1. Time of response [ Time Frame: Up to 8 weeks after receiving the questionnaires ]
    Average time of response per arm. Analyses will be performed without and with "reminders", per intention-to-treat and per protocol.

  2. Procedure-related costs [ Time Frame: Up to 8 weeks after receiving the questionnaires ]
    Monetary costs per arm, including direct monetary costs and working hours for researchers and healthcare professionals to obtain PROMS. Analyses will be performed without and with "reminders", per intention-to-treat and per protocol.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients seeking or being treated for perceived or verified, benign or malignant breast disease.
  • Women undergoing screening mammography.

Exclusion Criteria:

  • Linguistic barriers.
  • Deprivation of liberty.

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): NCT04718324


Contacts
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Contact: Andreas Karakatsanis, PhD +46765864826 andreas.karakatsanis@surgsci.uu.se

Locations
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Sweden
Uppsala University Hospital Recruiting
Uppsala, Sweden, 75185
Contact: Andreas U Karakatsanis    +46765864826    andreas.karakatsanis@surgsci.uu.se   
Sponsors and Collaborators
Uppsala University
Investigators
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Principal Investigator: Andreas Karakatsanis, PhD Uppsala University Hospital
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Responsible Party: Andreas Karakatsanis, Principal Investigator, Uppsala University
ClinicalTrials.gov Identifier: NCT04718324    
Other Study ID Numbers: UUBreast02
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 2 years after publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andreas Karakatsanis, Uppsala University:
Randomized Controlled Trial
PROMS
PREMS
Additional relevant MeSH terms:
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Breast Neoplasms
Breast Diseases
Neoplasms by Site
Neoplasms
Skin Diseases