Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket

Dana-Farber Cancer Institute139 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

139

Conditions

Mastectomy

Interventions

Jacki Recovery jacketDEVICE

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

Standard Care Pain medicine/managementOTHER

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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

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

Time frame: 1-2 weeks

Secondary Outcomes

Symptom Distress Scale - Pain Frequency

1 item (score range 1-5); higher score = worse outcome

Time frame: 1-2 weeks

Symptom Distress Scale - Pain Intensity

1 item (score range 1-5); higher score = worse outcome

Time frame: 1-2 weeks

PROMIS Pain Intensity Scale (Short Form 3a)

3 items (T score 0-100); higher score = worse outcome

Time frame: 1-2 weeks

PROMIS Pain Interference Scale - Short Form 8a

8 items (T score 0-100); higher score = worse outcome

Time frame: 1-2 weeks

EORTC QLQ-C30: Global QOL Scale

2 items; score range 0-100 (higher score = better outcome)

Time frame: 1-2 weeks

EORTC QLQ-C30: Physical Functioning Scale

5 items; score range 0-100 (higher score = better outcome)

Time frame: 1-2 weeks

EORTC QLQ-C30: Role Functioning Scale

2 items; score range 0-100 (higher score = better outcome)

Time frame: 1-2 weeks

EORTC QLQ-C30: Emotional Functioning Scale

Data from ClinicalTrials.gov

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4 items; score range 0-100 (higher score = better outcome)

Time frame: 1-2 weeks

EORTC QLQ-C30: Cognitive Functioning Scale

2 items; score range 0-100 (higher score = better outcome)

Time frame: 1-2 weeks

EORTC QLQ-C30: Social Functioning Scale

2 items; score range 0-100 (higher score = better outcome)

Time frame: 1-2 weeks

EORTC QLQ-BR23: Body Image Subscale

4 items (score 0-100); higher score = worse outcome

Time frame: 1-2 weeks

EORTC QLQ-BR23: Sexual Functioning Subscale

2 items (range 0-100); higher score = better outcome

Time frame: 1-2 weeks

EORTC QLQ-BR23: Sexual Enjoyment Subscale

1 item (range 0-100); higher score = better outcome

Time frame: 1-2 weeks

EORTC QLQ-BR23: Future Perspective Subscale

1 item (range 0-100); higher score = worse outcome

Time frame: 1-2 weeks

EORTC QLQ-BR23: Systemic Therapy Side Effects Subscale

7 items (range 0-100); higher score = worse outcome

Time frame: 1-2 weeks

EORTC QLQ-BR23: Breast Symptoms Subscale

4 items (range 0-100); higher score = worse outcome

Time frame: 1-2 weeks

EORTC QLQ-BR23: Arm Symptoms Subscale

3 items (range 0-100); higher score = worse outcome

Time frame: 1-2 weeks

EORTC QLQ-BR23: Upset by Hair Loss Subscale

1 item (range 0-100); higher score = worse outcome

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 1-2 weeks