Mastectomy
Conditions
Keywords
recovery, pain, surgical drains
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.
Interventions
DEVICEJacki Recovery jacket
An outer jacket that holds surgical drains and allows access for blood draws
OTHERStandard Care Pain medicine/management
Standard care pain medicine and management in hospitals where the study enrolls
Sponsors
Daisy Foundation
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity (on the 0-10 Pain Intensity Numeric Scale) | 1-2 weeks | Pain Intensity Numeric Scale (0-10)(higher scores = worse outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Distress Scale - Pain Intensity | 1-2 weeks | 1 item (score range 1-5); higher score = worse outcome |
| PROMIS Pain Intensity Scale (Short Form 3a) | 1-2 weeks | 3 items (T score 0-100); higher score = worse outcome |
| PROMIS Pain Interference Scale - Short Form 8a | 1-2 weeks | 8 items (T score 0-100); higher score = worse outcome |
| EORTC QLQ-C30: Global QOL Scale | 1-2 weeks | 2 items; score range 0-100 (higher score = better outcome) |
| EORTC QLQ-C30: Physical Functioning Scale | 1-2 weeks | 5 items; score range 0-100 (higher score = better outcome) |
| EORTC QLQ-C30: Role Functioning Scale | 1-2 weeks | 2 items; score range 0-100 (higher score = better outcome) |
| EORTC QLQ-C30: Emotional Functioning Scale | 1-2 weeks | 4 items; score range 0-100 (higher score = better outcome) |
| EORTC QLQ-C30: Cognitive Functioning Scale | 1-2 weeks | 2 items; score range 0-100 (higher score = better outcome) |
| EORTC QLQ-C30: Social Functioning Scale | 1-2 weeks | 2 items; score range 0-100 (higher score = better outcome) |
| EORTC QLQ-BR23: Body Image Subscale | 1-2 weeks | 4 items (score 0-100); higher score = worse outcome |
| EORTC QLQ-BR23: Sexual Functioning Subscale | 1-2 weeks | 2 items (range 0-100); higher score = better outcome |
| Symptom Distress Scale - Pain Frequency | 1-2 weeks | 1 item (score range 1-5); higher score = worse outcome |
| EORTC QLQ-BR23: Future Perspective Subscale | 1-2 weeks | 1 item (range 0-100); higher score = worse outcome |
| EORTC QLQ-BR23: Systemic Therapy Side Effects Subscale | 1-2 weeks | 7 items (range 0-100); higher score = worse outcome |
| EORTC QLQ-BR23: Breast Symptoms Subscale | 1-2 weeks | 4 items (range 0-100); higher score = worse outcome |
| EORTC QLQ-BR23: Arm Symptoms Subscale | 1-2 weeks | 3 items (range 0-100); higher score = worse outcome |
| EORTC QLQ-BR23: Upset by Hair Loss Subscale | 1-2 weeks | 1 item (range 0-100); higher score = worse outcome |
| Pain Patterns At Home: Average Daily Pain Intensity (Daily Diary) | 1 week | Average 0-10 Pain Intensity Numeric Scale Rating, for 7 days post-discharge, if at least 5 days reported (T2 diary) |
| Pain Management At Home: Use of Pain Medication (Daily Diary) | 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) |
| Pain Management At Home: Use of Mastectomy Bra (Daily Diary) | 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) |
| Pain Management At Home: Use of Mastectomy Camisole (Daily Diary) | 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) |
| Patient-Reported Usage of Jacki Recovery Jacket (Daily Diary) | 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 |
| EORTC QLQ-BR23: Sexual Enjoyment Subscale | 1-2 weeks | 1 item (range 0-100); higher score = better outcome |
Countries
United States
Participant flow
Recruitment details
Recruitment dates: 03/09/2017-12/21/2017
Participants by arm
| Arm | Count |
|---|---|
| Standard Care -Standard Care pain medicine/management will be given
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls | 67 |
| 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
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls | 72 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 12 | 8 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Standard Care | JACKI® RECOVERY JACKET + Standard Care | Total |
|---|---|---|---|
| Age, Continuous | 49 years | 47 years | 48 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 5 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 60 Participants | 67 Participants | 127 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Pain Intensity Numeric (0-10) Scale (PINS) | 4.7 score on a scale STANDARD_DEVIATION 2.2 | 4.7 score on a scale STANDARD_DEVIATION 2 | 4.7 score on a scale STANDARD_DEVIATION 2.1 |
| PROMIS Pain Intensity Short Form 3a | 54.4 score on a scale STANDARD_DEVIATION 6.7 | 53.7 score on a scale STANDARD_DEVIATION 5.4 | 54.0 score on a scale STANDARD_DEVIATION 6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 60 Participants | 62 Participants | 122 Participants |
| Region of Enrollment United States | 67 participants | 72 participants | 139 participants |
| Sex: Female, Male Female | 67 Participants | 72 Participants | 139 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Symptom Distress Scale - Pain Frequency | 3.9 units on a scale STANDARD_DEVIATION 1 | 3.8 units on a scale STANDARD_DEVIATION 1.1 | 3.9 units on a scale STANDARD_DEVIATION 1.1 |
| Symptom Distress Scale - Pain Intensity | 3.0 units on a scale STANDARD_DEVIATION 1 | 2.8 units on a scale STANDARD_DEVIATION 0.8 | 3.0 units on a scale STANDARD_DEVIATION 1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 72 |
| other Total, other adverse events | 0 / 67 | 0 / 72 |
| serious Total, serious adverse events | 0 / 67 | 0 / 72 |
Outcome results
Primary
Pain Intensity (on the 0-10 Pain Intensity Numeric Scale)
Pain Intensity Numeric Scale (0-10)(higher scores = worse outcome)
Time frame: 1-2 weeks
Population: Standard Care arm (n=54): 52 of 54 participants who answered T3 with a PINS score, plus 2 participants who answered for the same day in their T2 diary Jacki+Standard Care arm (n=68): 64 of 64 participants who answered T3 with a PINS score, plus 4 participants who answered for the same day in their T2 diary
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Pain Intensity (on the 0-10 Pain Intensity Numeric Scale) | 1.9 score on a scale | Standard Deviation 1.7 |
| JACKI® RECOVERY JACKET + Standard Care | Pain Intensity (on the 0-10 Pain Intensity Numeric Scale) | 2.1 score on a scale | Standard Deviation 1.9 |
Secondary
EORTC QLQ-BR23: Arm Symptoms Subscale
3 items (range 0-100); higher score = worse outcome
Time frame: 1-2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | EORTC QLQ-BR23: Arm Symptoms Subscale | 30.9 score on a scale | Standard Deviation 20.2 |
| JACKI® RECOVERY JACKET + Standard Care | EORTC QLQ-BR23: Arm Symptoms Subscale | 30.9 score on a scale | Standard Deviation 19.8 |
Secondary
EORTC QLQ-BR23: Body Image Subscale
4 items (score 0-100); higher score = worse outcome
Time frame: 1-2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | EORTC QLQ-BR23: Body Image Subscale | 56.6 score on a scale | Standard Deviation 29.8 |
| JACKI® RECOVERY JACKET + Standard Care | EORTC QLQ-BR23: Body Image Subscale | 64.8 score on a scale | Standard Deviation 25 |
Secondary
EORTC QLQ-BR23: Breast Symptoms Subscale
4 items (range 0-100); higher score = worse outcome
Time frame: 1-2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | EORTC QLQ-BR23: Breast Symptoms Subscale | 32.8 score on a scale | Standard Deviation 21.9 |
| JACKI® RECOVERY JACKET + Standard Care | EORTC QLQ-BR23: Breast Symptoms Subscale | 31.4 score on a scale | Standard Deviation 21.7 |
Secondary
EORTC QLQ-BR23: Future Perspective Subscale
1 item (range 0-100); higher score = worse outcome
Time frame: 1-2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | EORTC QLQ-BR23: Future Perspective Subscale | 49.4 score on a scale | Standard Deviation 30.2 |
| JACKI® RECOVERY JACKET + Standard Care | EORTC QLQ-BR23: Future Perspective Subscale | 53.1 score on a scale | Standard Deviation 30.1 |
Secondary
EORTC QLQ-BR23: Sexual Enjoyment Subscale
1 item (range 0-100); higher score = better outcome
Time frame: 1-2 weeks
Population: The majority of respondents skipped this item because they were not sexually active in the time period immediately after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | EORTC QLQ-BR23: Sexual Enjoyment Subscale | 54.9 score on a scale | Standard Deviation 35.2 |
| JACKI® RECOVERY JACKET + Standard Care | EORTC QLQ-BR23: Sexual Enjoyment Subscale | 57.6 score on a scale | Standard Deviation 29.4 |
Secondary
EORTC QLQ-BR23: Sexual Functioning Subscale
2 items (range 0-100); higher score = better outcome
Time frame: 1-2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | EORTC QLQ-BR23: Sexual Functioning Subscale | 18.0 score on a scale | Standard Deviation 18.3 |
| JACKI® RECOVERY JACKET + Standard Care | EORTC QLQ-BR23: Sexual Functioning Subscale | 15.8 score on a scale | Standard Deviation 19 |
Secondary
EORTC QLQ-BR23: Systemic Therapy Side Effects Subscale
7 items (range 0-100); higher score = worse outcome
Time frame: 1-2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | EORTC QLQ-BR23: Systemic Therapy Side Effects Subscale | 13.4 score on a scale | Standard Deviation 12.6 |
| JACKI® RECOVERY JACKET + Standard Care | EORTC QLQ-BR23: Systemic Therapy Side Effects Subscale | 15.4 score on a scale | Standard Deviation 12.8 |
Secondary
EORTC QLQ-BR23: Upset by Hair Loss Subscale
1 item (range 0-100); higher score = worse outcome
Time frame: 1-2 weeks
Population: Most participants did not answer this item as they had not experienced hair loss (did not receive chemotherapy prior to surgery)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | EORTC QLQ-BR23: Upset by Hair Loss Subscale | 25.0 score on a scale | Standard Deviation 38.8 |
| JACKI® RECOVERY JACKET + Standard Care | EORTC QLQ-BR23: Upset by Hair Loss Subscale | 24.2 score on a scale | Standard Deviation 33.6 |
Secondary
EORTC QLQ-C30: Cognitive Functioning Scale
2 items; score range 0-100 (higher score = better outcome)
Time frame: 1-2 weeks
Population: T3 respondents
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | EORTC QLQ-C30: Cognitive Functioning Scale | 84.0 score on a scale | Standard Deviation 22.9 |
| JACKI® RECOVERY JACKET + Standard Care | EORTC QLQ-C30: Cognitive Functioning Scale | 81.0 score on a scale | Standard Deviation 21.6 |
Secondary
EORTC QLQ-C30: Emotional Functioning Scale
4 items; score range 0-100 (higher score = better outcome)
Time frame: 1-2 weeks
Population: T3 respondents
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | EORTC QLQ-C30: Emotional Functioning Scale | 72.8 score on a scale | Standard Deviation 20.1 |
| JACKI® RECOVERY JACKET + Standard Care | EORTC QLQ-C30: Emotional Functioning Scale | 73.3 score on a scale | Standard Deviation 21.7 |
Secondary
EORTC QLQ-C30: Global QOL Scale
2 items; score range 0-100 (higher score = better outcome)
Time frame: 1-2 weeks
Population: T3 respondents
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | EORTC QLQ-C30: Global QOL Scale | 66.0 score on a scale | Standard Deviation 17.2 |
| JACKI® RECOVERY JACKET + Standard Care | EORTC QLQ-C30: Global QOL Scale | 64.1 score on a scale | Standard Deviation 16.7 |
Secondary
EORTC QLQ-C30: Physical Functioning Scale
5 items; score range 0-100 (higher score = better outcome)
Time frame: 1-2 weeks
Population: T3 respondents
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | EORTC QLQ-C30: Physical Functioning Scale | 76.3 score on a scale | Standard Deviation 23.9 |
| JACKI® RECOVERY JACKET + Standard Care | EORTC QLQ-C30: Physical Functioning Scale | 71.7 score on a scale | Standard Deviation 20 |
Secondary
EORTC QLQ-C30: Role Functioning Scale
2 items; score range 0-100 (higher score = better outcome)
Time frame: 1-2 weeks
Population: T3 respondents
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | EORTC QLQ-C30: Role Functioning Scale | 36.1 score on a scale | Standard Deviation 27.2 |
| JACKI® RECOVERY JACKET + Standard Care | EORTC QLQ-C30: Role Functioning Scale | 40.3 score on a scale | Standard Deviation 24.6 |
Secondary
EORTC QLQ-C30: Social Functioning Scale
2 items; score range 0-100 (higher score = better outcome)
Time frame: 1-2 weeks
Population: T3 respondents
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | EORTC QLQ-C30: Social Functioning Scale | 59.0 score on a scale | Standard Deviation 28.7 |
| JACKI® RECOVERY JACKET + Standard Care | EORTC QLQ-C30: Social Functioning Scale | 56.5 score on a scale | Standard Deviation 26.7 |
Secondary
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)
Time frame: 1-2 weeks
Population: Participants who returned a T2 diary with sufficient data on wearing a mastectomy bra to calculate a proportion for the first 7 days post-discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care | Pain Management At Home: Use of Mastectomy Bra (Daily Diary) | 1.0 Proportion of days |
| JACKI® RECOVERY JACKET + Standard Care | Pain Management At Home: Use of Mastectomy Bra (Daily Diary) | 1.0 Proportion of days |
Secondary
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)
Time frame: 1-2 weeks
Population: Participants who returned a T2 diary with sufficient data on wearing a mastectomy camisole to calculate a proportion for the first 7 days post-discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care | Pain Management At Home: Use of Mastectomy Camisole (Daily Diary) | 0.8 Proportion of days |
| JACKI® RECOVERY JACKET + Standard Care | Pain Management At Home: Use of Mastectomy Camisole (Daily Diary) | 0.1 Proportion of days |
Secondary
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)
Time frame: 1-2 weeks
Population: Participants who returned T2 diary with sufficient information on medication usage to calculate a 7-day average morphine equivalent dose
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care | Pain Management At Home: Use of Pain Medication (Daily Diary) | 6.9 morphine equivalent dose units |
| JACKI® RECOVERY JACKET + Standard Care | Pain Management At Home: Use of Pain Medication (Daily Diary) | 10.7 morphine equivalent dose units |
Secondary
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)
Time frame: 1 week
Population: 16 in Jacki arm and 21 in Standard Care arm did not return T2 diary; 2 in Standard Care arm returned diary with missing data, for a total of 23 missing this measure in Standard Care arm
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care | Pain Patterns At Home: Average Daily Pain Intensity (Daily Diary) | 3.6 units on a scale |
| JACKI® RECOVERY JACKET + Standard Care | Pain Patterns At Home: Average Daily Pain Intensity (Daily Diary) | 4.4 units on a scale |
Secondary
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
Time frame: 1-2 weeks
Population: Summary measure for participants in the Jacki Recovery Jacket + Standard Care arm only. A proportion score was calculated if the measure was reported for at least 5 of the first 7 days post-discharge. Of 73 participants assigned to this arm, 53 returned a T2 diary, and 49 had sufficient data to calculate a proportion score.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care | Patient-Reported Usage of Jacki Recovery Jacket (Daily Diary) | 0.9 Proportion of days |
Secondary
PROMIS Pain Intensity Scale (Short Form 3a)
3 items (T score 0-100); higher score = worse outcome
Time frame: 1-2 weeks
Population: 13 participants in the Standard Care arm and 9 in the Jacki Jacket arm (Total of 21) did not provide complete data to calculate this scale
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | PROMIS Pain Intensity Scale (Short Form 3a) | 46.8 score on a scale | Standard Deviation 7 |
| JACKI® RECOVERY JACKET + Standard Care | PROMIS Pain Intensity Scale (Short Form 3a) | 46.1 score on a scale | Standard Deviation 5.3 |
Secondary
PROMIS Pain Interference Scale - Short Form 8a
8 items (T score 0-100); higher score = worse outcome
Time frame: 1-2 weeks
Population: 13 participants in the Standard Care arm and 10 in the Jacki Jacket arm (total of 23) did not complete answer the T3 questionnaire or did not answer all items required to calculate a score
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | PROMIS Pain Interference Scale - Short Form 8a | 58.9 score on a scale | Standard Deviation 8.4 |
| JACKI® RECOVERY JACKET + Standard Care | PROMIS Pain Interference Scale - Short Form 8a | 59.1 score on a scale | Standard Deviation 7.5 |
Secondary
Symptom Distress Scale - Pain Frequency
1 item (score range 1-5); higher score = worse outcome
Time frame: 1-2 weeks
Population: 13 participants in the standard care arm and 8 in the Jacki Jacket arm (total of 21) did not answer the T3 questionnaire or did not answer this item
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Symptom Distress Scale - Pain Frequency | 2.9 score on a scale | Standard Deviation 1.2 |
| JACKI® RECOVERY JACKET + Standard Care | Symptom Distress Scale - Pain Frequency | 2.9 score on a scale | Standard Deviation 1.1 |
Secondary
Symptom Distress Scale - Pain Intensity
1 item (score range 1-5); higher score = worse outcome
Time frame: 1-2 weeks
Population: 14 participants in the standard care arm and 8 in the Jacki Jacket arm (total of 21) did not answer the T3 questionnaire or did not answer this item
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Symptom Distress Scale - Pain Intensity | 2.0 score on a scale | Standard Deviation 0.9 |
| JACKI® RECOVERY JACKET + Standard Care | Symptom Distress Scale - Pain Intensity | 2.1 score on a scale | Standard Deviation 0.9 |