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NCT03743753: RESTORE

Educational Session To Optimize Patient's Breast Reconstruction Experience at McMaster

Completed NA Last updated 1 September 2022
What this trial tests

NA trial testing Experimental in Breast Reconstruction in 50 participants. Completed in 17 August 2022.

Timeline
1 May 2019
Primary endpoint
1 July 2021
17 August 2022

Quick facts

Lead sponsorMcMaster University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeother
Enrollment50
Start date1 May 2019
Primary completion1 July 2021
Estimated completion17 August 2022
Sites2 locations across Canada

Drugs / interventions tested

Conditions studied

Sponsor

McMaster University

Who can join

18 and older, female only, with Breast Reconstruction or Patient Education. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This pilot study uses a randomized controlled trial design to introduce an educational session for breast reconstruction patients. Participants will be randomly assigned to the (1) control group or the (2) experimental group. The control group will receive the current standard educational information from the surgeon along with an information package, while participants in the experimental group will also receive an additional education session before their operation about what to expect during their reconstructive journey. Satisfaction with care, anxiety about the procedure and recovery, and health related quality of life will be measured in all patients using established questionnaires. Additionally, feasibility outcomes will be reported and the results of this study will be used to demonstrate whether a larger version of this study can be successfully completed.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Experimental

Trials testing the same drug.

Other recruiting trials for Breast Reconstruction

Currently open trials in the same condition.

Other McMaster University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03743753.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing