NCT02976103

Brief Summary

This research study is studying a garment called the Jacki® recovery jacket that can be worn after surgery as a possible way to manage pain from surgical drains. The study intervention involved in this study is:

  • "Jacki" recovery jacket

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

November 18, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

March 7, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2018

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

March 12, 2020

Completed
Last Updated

March 12, 2020

Status Verified

February 1, 2020

Enrollment Period

10 months

First QC Date

November 18, 2016

Results QC Date

February 19, 2020

Last Update Submit

February 19, 2020

Conditions

Mastectomy

Keywords

recoverypainsurgical drains

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity (on the 0-10 Pain Intensity Numeric Scale)

    Pain Intensity Numeric Scale (0-10)(higher scores = worse outcome)

    1-2 weeks

Secondary Outcomes (23)

  • Symptom Distress Scale - Pain Frequency

    1-2 weeks

  • Symptom Distress Scale - Pain Intensity

    1-2 weeks

  • PROMIS Pain Intensity Scale (Short Form 3a)

    1-2 weeks

  • PROMIS Pain Interference Scale - Short Form 8a

    1-2 weeks

  • EORTC QLQ-C30: Global QOL Scale

    1-2 weeks

  • +18 more secondary outcomes

Study Arms (2)

Standard Care

OTHER

-Standard Care pain medicine/management will be given

Other: Standard Care Pain medicine/management

JACKI® RECOVERY JACKET + Standard Care

EXPERIMENTAL

* Patient will be encouraged to use the Jacki Recovery Jacket at home * Patient will be taught how to tuck the drainage tubes in the jacket pocket * Patient will be taught how to un-tuck the drainage tubes from jacket pocket * Standard care pain medicine/management will be given

Device: Jacki Recovery jacketOther: Standard Care Pain medicine/management

Interventions

Jacki Recovery jacketDEVICE

An outer jacket that holds surgical drains and allows access for blood draws

JACKI® RECOVERY JACKET + Standard Care
Standard Care Pain medicine/managementOTHER

Standard care pain medicine and management in hospitals where the study enrolls

JACKI® RECOVERY JACKET + Standard CareStandard Care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are ≥ 18 years old.
  • Patients who speak and understand English.
  • Patients who have had mastectomy with reconstructive surgery in one or both breasts.

You may not qualify if:

  • Co-morbid delirium
  • Dementia
  • Mental illness, or neurocognitive deficit prohibiting informed consent and/or ability to complete study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Berry DL, Blonquist TM, Halpenny B, Hong F, Morrison-Ma SC, McCullough MC, Carelli K, Dominici LS, King TA. The Jacki Jacket after mastectomy with reconstruction: a randomized pilot study. Breast Cancer Res Treat. 2020 Jan;179(2):377-385. doi: 10.1007/s10549-019-05465-9. Epub 2019 Oct 14.

    PMID: 31612292RESULT

MeSH Terms

Conditions

Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Donna Berry, PhD, RN
Organization
Dana-Farber Cancer Institute
donna_berry@dfci.harvard.edu
617-632-1909

Study Officials

  • Donna Berry, PhD, RN

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Donna Berry, PhD, RN

Study Record Dates

First Submitted

November 18, 2016

First Posted

November 29, 2016

Study Start

March 7, 2017

Primary Completion

January 11, 2018

Study Completion

January 11, 2018

Last Updated

March 12, 2020

Results First Posted

March 12, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)