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NCT03743753: RESTORE
Educational Session To Optimize Patient's Breast Reconstruction Experience at McMaster
NA trial testing Experimental in Breast Reconstruction in 50 participants. Completed in 17 August 2022.
1 July 2021
Quick facts
| Lead sponsor | McMaster University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | other |
| Enrollment | 50 |
| Start date | 1 May 2019 |
| Primary completion | 1 July 2021 |
| Estimated completion | 17 August 2022 |
| Sites | 2 locations across Canada |
Drugs / interventions tested
- Experimental — full drug profile →
Conditions studied
- Breast Reconstruction — all drugs for Breast Reconstruction →
- Patient Education — all drugs for Patient Education →
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:
- PubMed search for NCT03743753
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03743753 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by McMaster University
- Last refreshed: 1 September 2022
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.
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