PREMs on PROMs in Breast Disease (PREMs_PROMs) (PREMs_PROMs)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04718324|
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Breast Disease Breast Cancer Breast Neoplasms||Other: e-PROMS Other: p-PROMS||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||230 participants|
|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|
Patients allocated to the e-PROMS arm will fill an online version of PROMS and then respond to the e-PREMS questionnaire.
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.
Participants randomised to the p-PROMS arm will receive the PROMS and PREMS questionnaires and a unique identification number in paper form.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Andreas Karakatsanis, PhDfirstname.lastname@example.org|
|Uppsala University Hospital||Recruiting|
|Uppsala, Sweden, 75185|
|Contact: Andreas U Karakatsanis +46765864826 email@example.com|
|Principal Investigator:||Andreas Karakatsanis, PhD||Uppsala University Hospital|