NCT04718324

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

May 17, 2021

Status Verified

May 1, 2021

Enrollment Period

1.6 years

First QC Date

December 26, 2020

Last Update Submit

May 14, 2021

Conditions

Breast DiseaseBreast CancerBreast Neoplasms

Keywords

Randomized Controlled TrialPROMSPREMS

Outcome Measures

Primary Outcomes (2)

  • Response rate

    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.

    Up to 8 weeks after receiving the questionnaires

  • Patient Reported Experience outcomes (PREMS)

    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.

    Up to 8 weeks after receiving the questionnaires

Secondary Outcomes (2)

  • Time of response

    Up to 8 weeks after receiving the questionnaires

  • Procedure-related costs

    Up to 8 weeks after receiving the questionnaires

Study Arms (2)

e-PROMS

EXPERIMENTAL

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

p-PROMS

ACTIVE COMPARATOR

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

Interventions

e-PROMSOTHER

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

e-PROMS
p-PROMSOTHER

Participants randomised to the p-PROMS arm will receive the PROMS and PREMS questionnaires and a unique identification number in paper form.

p-PROMS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Linguistic barriers.
  • Deprivation of liberty.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University Hospital

Uppsala, 75185, Sweden

Location

Related Publications (1)

  • Pantiora E, Hedman LC, Aristokleous I, Sjokvist O, Karakatsanis A, Schiza A. Effect of mode of delivery of patient reported outcomes in patients with breast disease: a randomised controlled trial. Int J Surg. 2024 Jan 1;110(1):176-182. doi: 10.1097/JS9.0000000000000815.

    PMID: 37800546DERIVED

MeSH Terms

Conditions

Breast DiseasesBreast Neoplasms

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesNeoplasms by SiteNeoplasms

Study Officials

  • Andreas Karakatsanis, PhD

    Uppsala University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 26, 2020

First Posted

January 22, 2021

Study Start

September 1, 2019

Primary Completion

March 30, 2021

Study Completion

April 30, 2021

Last Updated

May 17, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
2 years after publication

Locations

SE(1)