Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket

Mastectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02976103
• Other study ID #: 16-403
• Status: Completed
• Phase: N/A
• Start date: March 7, 2017
• Est. completion date: January 11, 2018

Study information

• Verified date: February 2020
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: January 11, 2018
• Est. primary completion date: January 11, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mastectomy

Intervention

Device:
• Jacki Recovery jacket
An outer jacket that holds surgical drains and allows access for blood draws

Other:
• Standard Care Pain medicine/management
Standard care pain medicine and management in hospitals where the study enrolls

Locations

Country	Name	City	State
United States	Brigham and Women's Faulkner Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Daisy Foundation

Country where clinical trial is conducted

United States, 

References & 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/s10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity (on the 0-10 Pain Intensity Numeric Scale)	Pain Intensity Numeric Scale (0-10)(higher scores = worse outcome)	1-2 weeks
Secondary	Symptom Distress Scale - Pain Frequency	1 item (score range 1-5); higher score = worse outcome	1-2 weeks
Secondary	Symptom Distress Scale - Pain Intensity	1 item (score range 1-5); higher score = worse outcome	1-2 weeks
Secondary	PROMIS Pain Intensity Scale (Short Form 3a)	3 items (T score 0-100); higher score = worse outcome	1-2 weeks
Secondary	PROMIS Pain Interference Scale - Short Form 8a	8 items (T score 0-100); higher score = worse outcome	1-2 weeks
Secondary	EORTC QLQ-C30: Global QOL Scale	2 items; score range 0-100 (higher score = better outcome)	1-2 weeks
Secondary	EORTC QLQ-C30: Physical Functioning Scale	5 items; score range 0-100 (higher score = better outcome)	1-2 weeks
Secondary	EORTC QLQ-C30: Role Functioning Scale	2 items; score range 0-100 (higher score = better outcome)	1-2 weeks
Secondary	EORTC QLQ-C30: Emotional Functioning Scale	4 items; score range 0-100 (higher score = better outcome)	1-2 weeks
Secondary	EORTC QLQ-C30: Cognitive Functioning Scale	2 items; score range 0-100 (higher score = better outcome)	1-2 weeks
Secondary	EORTC QLQ-C30: Social Functioning Scale	2 items; score range 0-100 (higher score = better outcome)	1-2 weeks
Secondary	EORTC QLQ-BR23: Body Image Subscale	4 items (score 0-100); higher score = worse outcome	1-2 weeks
Secondary	EORTC QLQ-BR23: Sexual Functioning Subscale	2 items (range 0-100); higher score = better outcome	1-2 weeks
Secondary	EORTC QLQ-BR23: Sexual Enjoyment Subscale	1 item (range 0-100); higher score = better outcome	1-2 weeks
Secondary	EORTC QLQ-BR23: Future Perspective Subscale	1 item (range 0-100); higher score = worse outcome	1-2 weeks
Secondary	EORTC QLQ-BR23: Systemic Therapy Side Effects Subscale	7 items (range 0-100); higher score = worse outcome	1-2 weeks
Secondary	EORTC QLQ-BR23: Breast Symptoms Subscale	4 items (range 0-100); higher score = worse outcome	1-2 weeks
Secondary	EORTC QLQ-BR23: Arm Symptoms Subscale	3 items (range 0-100); higher score = worse outcome	1-2 weeks
Secondary	EORTC QLQ-BR23: Upset by Hair Loss Subscale	1 item (range 0-100); higher score = worse outcome	1-2 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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