N/A
N=139
Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket
Mastectomy
Bottom Line
View on ClinicalTrials.gov: NCT02976103 ↗Enrolled (actual)
139
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Pain Intensity (on the 0-10 Pain Intensity Numeric Scale) — 1.9; 2.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Jacki Recovery jacket (Device); Standard Care Pain medicine/management (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity (on the 0-10 Pain Intensity Numeric Scale) |
1.9; 2.1 | — |
| SECONDARY Symptom Distress Scale - Pain Frequency |
2.9; 2.9 | — |
| SECONDARY Symptom Distress Scale - Pain Intensity |
2.0; 2.1 | — |
| SECONDARY PROMIS Pain Intensity Scale (Short Form 3a) |
46.8; 46.1 | — |
| SECONDARY PROMIS Pain Interference Scale - Short Form 8a |
58.9; 59.1 | — |
| SECONDARY EORTC QLQ-C30: Global QOL Scale |
66.0; 64.1 | — |
| SECONDARY EORTC QLQ-C30: Physical Functioning Scale |
76.3; 71.7 | — |
| SECONDARY EORTC QLQ-C30: Role Functioning Scale |
36.1; 40.3 | — |
| SECONDARY EORTC QLQ-C30: Emotional Functioning Scale |
72.8; 73.3 | — |
| SECONDARY EORTC QLQ-C30: Cognitive Functioning Scale |
84.0; 81.0 | — |
| SECONDARY EORTC QLQ-C30: Social Functioning Scale |
59.0; 56.5 | — |
| SECONDARY EORTC QLQ-BR23: Body Image Subscale |
56.6; 64.8 | — |
| SECONDARY EORTC QLQ-BR23: Sexual Functioning Subscale |
18.0; 15.8 | — |
| SECONDARY EORTC QLQ-BR23: Sexual Enjoyment Subscale |
54.9; 57.6 | — |
| SECONDARY EORTC QLQ-BR23: Future Perspective Subscale |
49.4; 53.1 | — |
| SECONDARY EORTC QLQ-BR23: Systemic Therapy Side Effects Subscale |
13.4; 15.4 | — |
| SECONDARY EORTC QLQ-BR23: Breast Symptoms Subscale |
32.8; 31.4 | — |
| SECONDARY EORTC QLQ-BR23: Arm Symptoms Subscale |
30.9; 30.9 | — |
| SECONDARY EORTC QLQ-BR23: Upset by Hair Loss Subscale |
25.0; 24.2 | — |
| SECONDARY Pain Patterns At Home: Average Daily Pain Intensity (Daily Diary) |
3.6; 4.4 | — |
| SECONDARY Pain Management At Home: Use of Pain Medication (Daily Diary) |
6.9; 10.7 | — |
| SECONDARY Pain Management At Home: Use of Mastectomy Bra (Daily Diary) |
1.0; 1.0 | — |
| SECONDARY Pain Management At Home: Use of Mastectomy Camisole (Daily Diary) |
0.8; 0.1 | — |
| SECONDARY Patient-Reported Usage of Jacki Recovery Jacket (Daily Diary) |
0.9 | — |
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02976103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.