OptiBra Study, Optimal Postoperative Bra After Breastcancer Surgery

NCT04059835 | Unknown Phase 3

• 1 other identifier: KarolinskaUD
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates how two different types of postoperative bra 1) standard bra, soft VS 2) compression bra compression after breast cancer surgery affect pain, seroma, other symptoms and complications, and the womans experience of comfort

Conditions

Bra; Breast Cancer Surgery; Complication; Compression; Symptoms

Outcome Measures

Primary Outcomes (1)

• Pain intensity measure

  VAS scale ( Visual analoge scale) , each item is score, 0= no pain to 10= pain as bad as can be. yielding at total between 0 and 10

  21 days from operations day

Secondary Outcomes (4)

• Postoperative breastsymptoms

  report every day, 21 days after operation

• Seroma

  This will be examine 21 days after the surgery at the revisit to surgon

• Patients experience of symptoms and comfort

  Reported basline and 21 days after operation

• Pain medication intake after surgery

  Report every day, 21 days after operation

Study Arms (2)

standard

ACTIVE COMPARATOR

Standard bra, soft

Other: OptiBra study

compression bra

EXPERIMENTAL

experimental bra, compression and stabile

Other: OptiBra study

Interventions

OptiBra study OTHER

compare two different bra after breast cancer surgery

compression bra; standard

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women from 18 years
• Malignant tumor of the breast gland to undergo surgery.

You may not qualify if:

• Men with breast cancer Women with benign tumors Women with health factors where the assessment is that BRA use is not necessary or possible.

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 46, Sweden

RECRUITING

Related Publications (2)

• Fallbjörk U, Salander P & Rasmussen BH. From

  RESULT

• Backman M, Hassan-Nur M, Fridblom K, Johansson H, Fredholm H, Fredriksson I. OptiBra study, a randomized controlled trial on optimal postoperative bra support after breast cancer surgery. Eur J Oncol Nurs. 2023 Apr;63:102285. doi: 10.1016/j.ejon.2023.102285. Epub 2023 Feb 15.

  PMID: 36893575 DERIVED

Study Officials

• Malin Backman

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Backman

CONTACT

+46739167393; malin.backman@sll.se

Fredriksson

CONTACT

+46739808830; irma.fredriksson@sll.se

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not blinded but randomized
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medicine Doctor, Oncologynurse

Model Details: Randomized controlled trial two Groups

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: August 16, 2019
• Study Start: May 20, 2019
• Primary Completion: May 30, 2020
• Study Completion: May 30, 2020
• Last Updated: August 16, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)