NCT03307525

Brief Summary

This is a pilot observational study assessing various predictors for acute pain and persistent pain following breast surgery for cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Typical duration for all trials

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

June 20, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2017

Enrollment Period

3.5 years

First QC Date

October 3, 2017

Last Update Submit

October 24, 2023

Conditions

Breast CancerSurgery

Outcome Measures

Primary Outcomes (1)

  • Acute Pain

    Maximum pain score reported postoperatively

    72 hours after surgery

Secondary Outcomes (1)

  • Persistent Pain

    More than 6 months after surgery

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women undergoing elective breast cancer surgery

You may qualify if:

  • English speaking undergoing elective breast cancer surgery

You may not qualify if:

  • Patients with recurrent cancer, metastasis, and previous breast surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Habib AS, Kertai MD, Cooter M, Greenup RA, Hwang S. Risk factors for severe acute pain and persistent pain after surgery for breast cancer: a prospective observational study. Reg Anesth Pain Med. 2019 Feb;44(2):192-199. doi: 10.1136/rapm-2018-000040. Epub 2019 Jan 5.

    PMID: 30700614DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2017

First Posted

October 11, 2017

Study Start

June 20, 2012

Primary Completion

December 22, 2015

Study Completion

December 22, 2015

Last Updated

October 26, 2023

Record last verified: 2017-10