Clinical trial NCT02976103: Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket
Official title: Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket: Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mastectomy
Keywords: recovery
pain
surgical drains
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Daisy Foundation
First posted: 2016-11-29
Enrollment: 139
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Pain Intensity (on the 0-10 Pain Intensity Numeric Scale)
timeFrame: 1-2 weeks
Secondary outcomes:
measure: Symptom Distress Scale - Pain Frequency
timeFrame: 1-2 weeks
measure: Symptom Distress Scale - Pain Intensity
timeFrame: 1-2 weeks
measure: PROMIS Pain Intensity Scale (Short Form 3a)
timeFrame: 1-2 weeks
measure: PROMIS Pain Interference Scale - Short Form 8a
timeFrame: 1-2 weeks
measure: EORTC QLQ-C30: Global QOL Scale
timeFrame: 1-2 weeks
measure: EORTC QLQ-C30: Physical Functioning Scale
timeFrame: 1-2 weeks
measure: EORTC QLQ-C30: Role Functioning Scale
timeFrame: 1-2 weeks
measure: EORTC QLQ-C30: Emotional Functioning Scale
timeFrame: 1-2 weeks
measure: EORTC QLQ-C30: Cognitive Functioning Scale
timeFrame: 1-2 weeks
measure: EORTC QLQ-C30: Social Functioning Scale
timeFrame: 1-2 weeks
measure: EORTC QLQ-BR23: Body Image Subscale
timeFrame: 1-2 weeks
measure: EORTC QLQ-BR23: Sexual Functioning Subscale
timeFrame: 1-2 weeks
measure: EORTC QLQ-BR23: Sexual Enjoyment Subscale
timeFrame: 1-2 weeks
measure: EORTC QLQ-BR23: Future Perspective Subscale
timeFrame: 1-2 weeks
measure: EORTC QLQ-BR23: Systemic Therapy Side Effects Subscale
timeFrame: 1-2 weeks
measure: EORTC QLQ-BR23: Breast Symptoms Subscale
timeFrame: 1-2 weeks
measure: EORTC QLQ-BR23: Arm Symptoms Subscale
timeFrame: 1-2 weeks
measure: EORTC QLQ-BR23: Upset by Hair Loss Subscale
timeFrame: 1-2 weeks
measure: Pain Patterns At Home: Average Daily Pain Intensity (Daily Diary)
timeFrame: 1 week
measure: Pain Management At Home: Use of Pain Medication (Daily Diary)
timeFrame: 1-2 weeks
measure: Pain Management At Home: Use of Mastectomy Bra (Daily Diary)
timeFrame: 1-2 weeks
measure: Pain Management At Home: Use of Mastectomy Camisole (Daily Diary)
timeFrame: 1-2 weeks
measure: Patient-Reported Usage of Jacki Recovery Jacket (Daily Diary)
timeFrame: 1-2 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Faulkner Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Donna Berry, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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/s10549-019-05465-9. Epub 2019 Oct 14.