Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket
- Conditions
- Mastectomy
- Interventions
- Other: Standard Care Pain medicine/managementDevice: Jacki Recovery jacket
- Registration Number
- NCT02976103
- Lead Sponsor
- Dana-Farber Cancer Institute
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 139
- 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.
- Co-morbid delirium
- Dementia
- Mental illness, or neurocognitive deficit prohibiting informed consent and/or ability to complete study procedures.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Care Standard Care Pain medicine/management -Standard Care pain medicine/management will be given JACKI® RECOVERY JACKET + Standard Care Jacki Recovery jacket * 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 JACKI® RECOVERY JACKET + Standard Care Standard Care Pain medicine/management * 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
- Primary Outcome Measures
Name Time Method Pain Intensity (on the 0-10 Pain Intensity Numeric Scale) 1-2 weeks Pain Intensity Numeric Scale (0-10)(higher scores = worse outcome)
- Secondary Outcome Measures
Name Time Method EORTC QLQ-C30: Role Functioning Scale 1-2 weeks 2 items; score range 0-100 (higher score = better outcome)
EORTC QLQ-C30: Cognitive Functioning Scale 1-2 weeks 2 items; score range 0-100 (higher score = better outcome)
EORTC QLQ-BR23: Sexual Functioning Subscale 1-2 weeks 2 items (range 0-100); higher score = better outcome
EORTC QLQ-BR23: Future Perspective Subscale 1-2 weeks 1 item (range 0-100); higher score = worse outcome
EORTC QLQ-BR23: Systemic Therapy Side Effects Subscale 1-2 weeks 7 items (range 0-100); higher score = worse outcome
EORTC QLQ-BR23: Sexual Enjoyment Subscale 1-2 weeks 1 item (range 0-100); higher score = better outcome
EORTC QLQ-BR23: Breast Symptoms Subscale 1-2 weeks 4 items (range 0-100); higher score = worse outcome
EORTC QLQ-BR23: Arm Symptoms Subscale 1-2 weeks 3 items (range 0-100); higher score = worse outcome
Pain Patterns At Home: Average Daily Pain Intensity (Daily Diary) 1 week Average 0-10 Pain Intensity Numeric Scale Rating, for 7 days post-discharge, if at least 5 days reported (T2 diary)
Pain Management At Home: Use of Pain Medication (Daily Diary) 1-2 weeks Participant self-report of average daily morphine eqivalent dose taken in first 7 days post-discharge (if at least 5 days reported)
Symptom Distress Scale - Pain Intensity 1-2 weeks 1 item (score range 1-5); higher score = worse outcome
EORTC QLQ-C30: Emotional Functioning Scale 1-2 weeks 4 items; score range 0-100 (higher score = better outcome)
EORTC QLQ-C30: Social Functioning Scale 1-2 weeks 2 items; score range 0-100 (higher score = better outcome)
EORTC QLQ-BR23: Body Image Subscale 1-2 weeks 4 items (score 0-100); higher score = worse outcome
EORTC QLQ-C30: Global QOL Scale 1-2 weeks 2 items; score range 0-100 (higher score = better outcome)
PROMIS Pain Interference Scale - Short Form 8a 1-2 weeks 8 items (T score 0-100); higher score = worse outcome
EORTC QLQ-C30: Physical Functioning Scale 1-2 weeks 5 items; score range 0-100 (higher score = better outcome)
Symptom Distress Scale - Pain Frequency 1-2 weeks 1 item (score range 1-5); higher score = worse outcome
PROMIS Pain Intensity Scale (Short Form 3a) 1-2 weeks 3 items (T score 0-100); higher score = worse outcome
EORTC QLQ-BR23: Upset by Hair Loss Subscale 1-2 weeks 1 item (range 0-100); higher score = worse outcome
Pain Management At Home: Use of Mastectomy Bra (Daily Diary) 1-2 weeks Self-reported proportion of days in the first 7 days post discharge that participant wore a mastectomy bra (if at least 5 days reported)
Pain Management At Home: Use of Mastectomy Camisole (Daily Diary) 1-2 weeks Self-reported proportion of days in the first 7 days post discharge that participant wore a mastectomy camisole (if at least 5 days reported)
Patient-Reported Usage of Jacki Recovery Jacket (Daily Diary) 1-2 weeks 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
Trial Locations
- Locations (2)
Brigham and Women's Faulkner Hospital
🇺🇸Boston, Massachusetts, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States