Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket

Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket: Randomized Trial

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

Study Overview

• Status: Completed
• Conditions: Mastectomy
• Intervention / Treatment: Other: Standard Care Pain medicine/management; Device: Jacki Recovery jacket

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
    • Boston, Massachusetts, United States, 02130
      • Brigham and Women's Faulkner Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard Care; -Standard Care pain medicine/management will be given	Other: Standard Care Pain medicine/management; Standard care pain medicine and management in hospitals where the study enrolls
Experimental: JACKI® RECOVERY JACKET + Standard Care; 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	Other: Standard Care Pain medicine/management; Standard care pain medicine and management in hospitals where the study enrolls; Device: Jacki Recovery jacket; An outer jacket that holds surgical drains and allows access for blood draws

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity (on the 0-10 Pain Intensity Numeric Scale)	Pain Intensity Numeric Scale (0-10)(higher scores = worse outcome)	1-2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom Distress Scale - Pain Frequency	1 item (score range 1-5); higher score = worse outcome	1-2 weeks
Symptom Distress Scale - Pain Intensity	1 item (score range 1-5); higher score = worse outcome	1-2 weeks
PROMIS Pain Intensity Scale (Short Form 3a)	3 items (T score 0-100); higher score = worse outcome	1-2 weeks
PROMIS Pain Interference Scale - Short Form 8a	8 items (T score 0-100); higher score = worse outcome	1-2 weeks
EORTC QLQ-C30: Global QOL Scale	2 items; score range 0-100 (higher score = better outcome)	1-2 weeks
EORTC QLQ-C30: Physical Functioning Scale	5 items; score range 0-100 (higher score = better outcome)	1-2 weeks
EORTC QLQ-C30: Role Functioning Scale	2 items; score range 0-100 (higher score = better outcome)	1-2 weeks
EORTC QLQ-C30: Emotional Functioning Scale	4 items; score range 0-100 (higher score = better outcome)	1-2 weeks
EORTC QLQ-C30: Cognitive Functioning Scale	2 items; score range 0-100 (higher score = better outcome)	1-2 weeks
EORTC QLQ-C30: Social Functioning Scale	2 items; score range 0-100 (higher score = better outcome)	1-2 weeks
EORTC QLQ-BR23: Body Image Subscale	4 items (score 0-100); higher score = worse outcome	1-2 weeks
EORTC QLQ-BR23: Sexual Functioning Subscale	2 items (range 0-100); higher score = better outcome	1-2 weeks
EORTC QLQ-BR23: Sexual Enjoyment Subscale	1 item (range 0-100); higher score = better outcome	1-2 weeks
EORTC QLQ-BR23: Future Perspective Subscale	1 item (range 0-100); higher score = worse outcome	1-2 weeks
EORTC QLQ-BR23: Systemic Therapy Side Effects Subscale	7 items (range 0-100); higher score = worse outcome	1-2 weeks
EORTC QLQ-BR23: Breast Symptoms Subscale	4 items (range 0-100); higher score = worse outcome	1-2 weeks
EORTC QLQ-BR23: Arm Symptoms Subscale	3 items (range 0-100); higher score = worse outcome	1-2 weeks
EORTC QLQ-BR23: Upset by Hair Loss Subscale	1 item (range 0-100); higher score = worse outcome	1-2 weeks
Pain Patterns At Home: Average Daily Pain Intensity (Daily Diary)	Average 0-10 Pain Intensity Numeric Scale Rating, for 7 days post-discharge, if at least 5 days reported (T2 diary)	1 week
Pain Management At Home: Use of Pain Medication (Daily Diary)	Participant self-report of average daily morphine eqivalent dose taken in first 7 days post-discharge (if at least 5 days reported)	1-2 weeks
Pain Management At Home: Use of Mastectomy Bra (Daily Diary)	Self-reported proportion of days in the first 7 days post discharge that participant wore a mastectomy bra (if at least 5 days reported)	1-2 weeks
Pain Management At Home: Use of Mastectomy Camisole (Daily Diary)	Self-reported proportion of days in the first 7 days post discharge that participant wore a mastectomy camisole (if at least 5 days reported)	1-2 weeks
Patient-Reported Usage of Jacki Recovery Jacket (Daily Diary)	Self-reported proportion of days in the first 7 days post-discharge that participant wore the Jacki recovery jacket at all; no score is better or worse	1-2 weeks

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Daisy Foundation
• Investigators: Principal Investigator: Donna Berry, PhD, RN, Dana-Farber Cancer Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2017
• Primary Completion (Actual): January 11, 2018
• Study Completion (Actual): January 11, 2018

Study Registration Dates

• First Submitted: November 18, 2016
• First Submitted That Met QC Criteria: November 28, 2016
• First Posted (Estimate): November 29, 2016

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: pain; recovery; surgical drains
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics
• Other Study ID Numbers: 16-403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes