Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket

February 19, 2020 updated by: Donna Berry, PhD, RN, FAAN, AOCN, Dana-Farber Cancer Institute

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
139

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02130
        • Brigham and Women's Faulkner Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Standard Care
-Standard Care pain medicine/management will be given
Other: Standard Care Pain medicine/management
Standard care pain medicine and management in hospitals where the study enrolls
Experimental: JACKI® RECOVERY JACKET + Standard Care
  • 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
Other: Standard Care Pain medicine/management
Standard care pain medicine and management in hospitals where the study enrolls
Device: Jacki Recovery jacket
An outer jacket that holds surgical drains and allows access for blood draws

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Intensity (on the 0-10 Pain Intensity Numeric Scale)
Time Frame: 1-2 weeks
Pain Intensity Numeric Scale (0-10)(higher scores = worse outcome)
1-2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Symptom Distress Scale - Pain Frequency
Time Frame: 1-2 weeks
1 item (score range 1-5); higher score = worse outcome
1-2 weeks
Symptom Distress Scale - Pain Intensity
Time Frame: 1-2 weeks
1 item (score range 1-5); higher score = worse outcome
1-2 weeks
PROMIS Pain Intensity Scale (Short Form 3a)
Time Frame: 1-2 weeks
3 items (T score 0-100); higher score = worse outcome
1-2 weeks
PROMIS Pain Interference Scale - Short Form 8a
Time Frame: 1-2 weeks
8 items (T score 0-100); higher score = worse outcome
1-2 weeks
EORTC QLQ-C30: Global QOL Scale
Time Frame: 1-2 weeks
2 items; score range 0-100 (higher score = better outcome)
1-2 weeks
EORTC QLQ-C30: Physical Functioning Scale
Time Frame: 1-2 weeks
5 items; score range 0-100 (higher score = better outcome)
1-2 weeks
EORTC QLQ-C30: Role Functioning Scale
Time Frame: 1-2 weeks
2 items; score range 0-100 (higher score = better outcome)
1-2 weeks
EORTC QLQ-C30: Emotional Functioning Scale
Time Frame: 1-2 weeks
4 items; score range 0-100 (higher score = better outcome)
1-2 weeks
EORTC QLQ-C30: Cognitive Functioning Scale
Time Frame: 1-2 weeks
2 items; score range 0-100 (higher score = better outcome)
1-2 weeks
EORTC QLQ-C30: Social Functioning Scale
Time Frame: 1-2 weeks
2 items; score range 0-100 (higher score = better outcome)
1-2 weeks
EORTC QLQ-BR23: Body Image Subscale
Time Frame: 1-2 weeks
4 items (score 0-100); higher score = worse outcome
1-2 weeks
EORTC QLQ-BR23: Sexual Functioning Subscale
Time Frame: 1-2 weeks
2 items (range 0-100); higher score = better outcome
1-2 weeks
EORTC QLQ-BR23: Sexual Enjoyment Subscale
Time Frame: 1-2 weeks
1 item (range 0-100); higher score = better outcome
1-2 weeks
EORTC QLQ-BR23: Future Perspective Subscale
Time Frame: 1-2 weeks
1 item (range 0-100); higher score = worse outcome
1-2 weeks
EORTC QLQ-BR23: Systemic Therapy Side Effects Subscale
Time Frame: 1-2 weeks
7 items (range 0-100); higher score = worse outcome
1-2 weeks
EORTC QLQ-BR23: Breast Symptoms Subscale
Time Frame: 1-2 weeks
4 items (range 0-100); higher score = worse outcome
1-2 weeks
EORTC QLQ-BR23: Arm Symptoms Subscale
Time Frame: 1-2 weeks
3 items (range 0-100); higher score = worse outcome
1-2 weeks
EORTC QLQ-BR23: Upset by Hair Loss Subscale
Time Frame: 1-2 weeks
1 item (range 0-100); higher score = worse outcome
1-2 weeks
Pain Patterns At Home: Average Daily Pain Intensity (Daily Diary)
Time Frame: 1 week
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)
Time Frame: 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)
1-2 weeks
Pain Management At Home: Use of Mastectomy Bra (Daily Diary)
Time Frame: 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)
1-2 weeks
Pain Management At Home: Use of Mastectomy Camisole (Daily Diary)
Time Frame: 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)
1-2 weeks
Patient-Reported Usage of Jacki Recovery Jacket (Daily Diary)
Time Frame: 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
1-2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dana-Farber Cancer Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Daisy Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Donna Berry, PhD, RN, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 11, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 11, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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