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Completed

NCT Number: NCT02976103

Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket

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

Completed

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Key information

Conditions

Mastectomy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Faulkner Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Jacki Recovery jacket

Device

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

Standard Care Pain medicine/management

Other

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Symptom Distress Scale - Pain Frequency

    Time frame: 1-2 weeks

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

  2. Symptom Distress Scale - Pain Intensity

    Time frame: 1-2 weeks

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

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

    Time frame: 1-2 weeks

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

  4. PROMIS Pain Interference Scale - Short Form 8a

    Time frame: 1-2 weeks

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

  5. EORTC QLQ-C30: Global QOL Scale

    Time frame: 1-2 weeks

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

  6. EORTC QLQ-C30: Physical Functioning Scale

    Time frame: 1-2 weeks

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

  7. EORTC QLQ-C30: Role Functioning Scale

    Time frame: 1-2 weeks

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

  8. EORTC QLQ-C30: Emotional Functioning Scale

    Time frame: 1-2 weeks

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

  9. EORTC QLQ-C30: Cognitive Functioning Scale

    Time frame: 1-2 weeks

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

  10. EORTC QLQ-C30: Social Functioning Scale

    Time frame: 1-2 weeks

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

  11. EORTC QLQ-BR23: Body Image Subscale

    Time frame: 1-2 weeks

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

  12. EORTC QLQ-BR23: Sexual Functioning Subscale

    Time frame: 1-2 weeks

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

  13. EORTC QLQ-BR23: Sexual Enjoyment Subscale

    Time frame: 1-2 weeks

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

  14. EORTC QLQ-BR23: Future Perspective Subscale

    Time frame: 1-2 weeks

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

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

    Time frame: 1-2 weeks

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

  16. EORTC QLQ-BR23: Breast Symptoms Subscale

    Time frame: 1-2 weeks

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

  17. EORTC QLQ-BR23: Arm Symptoms Subscale

    Time frame: 1-2 weeks

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

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

    Time frame: 1-2 weeks

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

  19. 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)

  20. 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)

  21. 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)

  22. 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)

  23. 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

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Daisy Foundation

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 29, 2016
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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