Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket

Dana-Farber Cancer Institute

Status: Completed

Conditions: Mastectomy

Treatments: Other: Standard Care Pain medicine/management; Device: Jacki Recovery jacket

Study type: Interventional

Funder types: Other

Identifiers

NCT02976103

16-403

Details and patient eligibility

About

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

Full description

In this research study, the investigators are studying the Jacki, a garment that can be worn post-mastectomy with pockets that hold post-surgical drains. The Jacki was invented by a cancer survivor who leads A Little Easier Recovery®, a non-profit organization in Massachusetts, and may help participants manage the pain of post-surgical drains to increase comfort and ease of daily living. The jacket has not previously been tested in a research study. The investigators are hoping to learn whether the jacket is effective in reducing pain and discomfort from the time participants leave the hospital until they return to have their drains removed.

Enrollment: 139 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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139 participants in 2 patient groups

Standard Care

Other group

Description:

-Standard Care pain medicine/management will be given

Treatment:

Other: Standard Care Pain medicine/management

JACKI® RECOVERY JACKET + Standard Care

Experimental group

Description:

* 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

Treatment:

Other: Standard Care Pain medicine/management

Device: Jacki Recovery jacket