Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mastectomy

Intervention / Treatment
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* Device: Jacki Recovery jacket
* Other: Standard Care Pain medicine/management


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, recovery, surgical drains