AzTrials
AzTrials

MastectomyNCT02976103

Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket

A study testing Jacki Recovery jacket in people with Mastectomy, run by Dana-Farber Cancer Institute at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Mastectomy
What is being tested?
Jacki Recovery jacket
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
139 participants
Where
2 sitesUnited States
Study dates
7 Mar 2017to 11 Jan 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Co-morbid delirium
  • Dementia
  • Mental illness, or neurocognitive deficit prohibiting informed consent and/or ability to complete study procedures.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Brigham and Women's Faulkner Hospital

    Boston, Massachusetts, 02130

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: 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

Read the 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.

Conditions
Mastectomy
Being tested
Jacki Recovery jacket, Standard Care Pain medicine/management
Keywords
recovery, pain, surgical drains
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Jacki Recovery jacketDevice

    An outer jacket that holds surgical drains and allows access for blood draws

  • Standard Care Pain medicine/managementOther

    Standard care pain medicine and management in hospitals where the study enrolls

Study groups in NCT02976103
Study groupRoleWhat they receive
Standard CareOther-Standard Care pain medicine/management will be given
Receives: Other: Standard Care Pain medicine/management
JACKI® RECOVERY JACKET + Standard CareExperimental* 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
Receives: Device: Jacki Recovery jacket; Other: Standard Care Pain medicine/management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Intensity (on the 0-10 Pain Intensity Numeric Scale)

    Pain Intensity Numeric Scale (0-10)(higher scores = worse outcome)

    Measured: 1-2 weeks

Secondary outcomes (23)

  1. Symptom Distress Scale - Pain Frequency

    1 item (score range 1-5); higher score = worse outcome

    Measured: 1-2 weeks

  2. Symptom Distress Scale - Pain Intensity

    1 item (score range 1-5); higher score = worse outcome

    Measured: 1-2 weeks

  3. PROMIS Pain Intensity Scale (Short Form 3a)

    3 items (T score 0-100); higher score = worse outcome

    Measured: 1-2 weeks

  4. PROMIS Pain Interference Scale - Short Form 8a

    8 items (T score 0-100); higher score = worse outcome

    Measured: 1-2 weeks

  5. EORTC QLQ-C30: Global QOL Scale

    2 items; score range 0-100 (higher score = better outcome)

    Measured: 1-2 weeks

  6. EORTC QLQ-C30: Physical Functioning Scale

    5 items; score range 0-100 (higher score = better outcome)

    Measured: 1-2 weeks

  7. EORTC QLQ-C30: Role Functioning Scale

    2 items; score range 0-100 (higher score = better outcome)

    Measured: 1-2 weeks

  8. EORTC QLQ-C30: Emotional Functioning Scale

    4 items; score range 0-100 (higher score = better outcome)

    Measured: 1-2 weeks

  9. EORTC QLQ-C30: Cognitive Functioning Scale

    2 items; score range 0-100 (higher score = better outcome)

    Measured: 1-2 weeks

  10. EORTC QLQ-C30: Social Functioning Scale

    2 items; score range 0-100 (higher score = better outcome)

    Measured: 1-2 weeks

  11. EORTC QLQ-BR23: Body Image Subscale

    4 items (score 0-100); higher score = worse outcome

    Measured: 1-2 weeks

  12. EORTC QLQ-BR23: Sexual Functioning Subscale

    2 items (range 0-100); higher score = better outcome

    Measured: 1-2 weeks

  13. EORTC QLQ-BR23: Sexual Enjoyment Subscale

    1 item (range 0-100); higher score = better outcome

    Measured: 1-2 weeks

  14. EORTC QLQ-BR23: Future Perspective Subscale

    1 item (range 0-100); higher score = worse outcome

    Measured: 1-2 weeks

  15. EORTC QLQ-BR23: Systemic Therapy Side Effects Subscale

    7 items (range 0-100); higher score = worse outcome

    Measured: 1-2 weeks

  16. EORTC QLQ-BR23: Breast Symptoms Subscale

    4 items (range 0-100); higher score = worse outcome

    Measured: 1-2 weeks

  17. EORTC QLQ-BR23: Arm Symptoms Subscale

    3 items (range 0-100); higher score = worse outcome

    Measured: 1-2 weeks

  18. EORTC QLQ-BR23: Upset by Hair Loss Subscale

    1 item (range 0-100); higher score = worse outcome

    Measured: 1-2 weeks

  19. 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)

    Measured: 1 week

  20. 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)

    Measured: 1-2 weeks

  21. 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)

    Measured: 1-2 weeks

  22. 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)

    Measured: 1-2 weeks

  23. 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

    Measured: 1-2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2016 (estimated)
  2. Study start7 Mar 2017
  3. Primary completion11 Jan 2018
  4. Study completion11 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02976103
Sponsor's protocol ID
16-403
Status last verified
Feb 2020
First submitted
18 Nov 2016
Last updated
12 Mar 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 31612292

Questions about this trial

What is this clinical trial studying?

A study testing Jacki Recovery jacket in people with Mastectomy, run by Dana-Farber Cancer Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity (on the 0-10 Pain Intensity Numeric Scale) (time frame: 1-2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02976103, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in