Trial Outcomes & Findings for Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket (NCT NCT02976103)
NCT ID: NCT02976103
Last Updated: 2020-03-12
Results Overview
Pain Intensity Numeric Scale (0-10)(higher scores = worse outcome)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
139 participants
Primary outcome timeframe
1-2 weeks
Results posted on
2020-03-12
Participant Flow
Recruitment dates: 03/09/2017-12/21/2017
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
72
|
|
Overall Study
COMPLETED
|
54
|
64
|
|
Overall Study
NOT COMPLETED
|
13
|
8
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
12
|
8
|
Baseline Characteristics
1 participant did not provide a response
Baseline characteristics by cohort
| Measure |
Standard Care
n=67 Participants
-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
|
JACKI® RECOVERY JACKET + Standard Care
n=72 Participants
* 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
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
n=67 Participants
|
47 years
n=72 Participants
|
48 years
n=139 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=67 Participants
|
72 Participants
n=72 Participants
|
139 Participants
n=139 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=67 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=139 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=67 Participants
|
5 Participants
n=72 Participants
|
10 Participants
n=139 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=67 Participants
|
67 Participants
n=72 Participants
|
127 Participants
n=139 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=67 Participants
|
0 Participants
n=72 Participants
|
2 Participants
n=139 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=67 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=139 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=67 Participants
|
3 Participants
n=72 Participants
|
4 Participants
n=139 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=67 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=139 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=67 Participants
|
5 Participants
n=72 Participants
|
9 Participants
n=139 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=67 Participants
|
62 Participants
n=72 Participants
|
122 Participants
n=139 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=67 Participants
|
1 Participants
n=72 Participants
|
1 Participants
n=139 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=67 Participants
|
1 Participants
n=72 Participants
|
3 Participants
n=139 Participants
|
|
Region of Enrollment
United States
|
67 participants
n=67 Participants
|
72 participants
n=72 Participants
|
139 participants
n=139 Participants
|
|
Pain Intensity Numeric (0-10) Scale (PINS)
|
4.7 score on a scale
STANDARD_DEVIATION 2.2 • n=67 Participants
|
4.7 score on a scale
STANDARD_DEVIATION 2.0 • n=72 Participants
|
4.7 score on a scale
STANDARD_DEVIATION 2.1 • n=139 Participants
|
|
Symptom Distress Scale - Pain Frequency
|
3.9 units on a scale
STANDARD_DEVIATION 1.0 • n=67 Participants • 1 participant did not provide a response
|
3.8 units on a scale
STANDARD_DEVIATION 1.1 • n=71 Participants • 1 participant did not provide a response
|
3.9 units on a scale
STANDARD_DEVIATION 1.1 • n=138 Participants • 1 participant did not provide a response
|
|
Symptom Distress Scale - Pain Intensity
|
3.0 units on a scale
STANDARD_DEVIATION 1.0 • n=67 Participants
|
2.8 units on a scale
STANDARD_DEVIATION 0.8 • n=72 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 1.0 • n=139 Participants
|
|
PROMIS Pain Intensity Short Form 3a
|
54.4 score on a scale
STANDARD_DEVIATION 6.7 • n=65 Participants • 2 participants did not complete the required items to calculate a total score
|
53.7 score on a scale
STANDARD_DEVIATION 5.4 • n=72 Participants • 2 participants did not complete the required items to calculate a total score
|
54.0 score on a scale
STANDARD_DEVIATION 6.0 • n=137 Participants • 2 participants did not complete the required items to calculate a total score
|
PRIMARY outcome
Timeframe: 1-2 weeksPopulation: 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
Pain Intensity Numeric Scale (0-10)(higher scores = worse outcome)
Outcome measures
| Measure |
Standard Care
n=54 Participants
-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
|
JACKI® RECOVERY JACKET + Standard Care
n=68 Participants
* 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
|
|---|---|---|
|
Pain Intensity (on the 0-10 Pain Intensity Numeric Scale)
|
1.9 score on a scale
Standard Deviation 1.7
|
2.1 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 1-2 weeksPopulation: 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
1 item (score range 1-5); higher score = worse outcome
Outcome measures
| Measure |
Standard Care
n=54 Participants
-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
|
JACKI® RECOVERY JACKET + Standard Care
n=64 Participants
* 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
|
|---|---|---|
|
Symptom Distress Scale - Pain Frequency
|
2.9 score on a scale
Standard Deviation 1.2
|
2.9 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 1-2 weeksPopulation: 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
1 item (score range 1-5); higher score = worse outcome
Outcome measures
| Measure |
Standard Care
n=53 Participants
-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
|
JACKI® RECOVERY JACKET + Standard Care
n=64 Participants
* 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
|
|---|---|---|
|
Symptom Distress Scale - Pain Intensity
|
2.0 score on a scale
Standard Deviation 0.9
|
2.1 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 1-2 weeksPopulation: 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
3 items (T score 0-100); higher score = worse outcome
Outcome measures
| Measure |
Standard Care
n=54 Participants
-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
|
JACKI® RECOVERY JACKET + Standard Care
n=63 Participants
* 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
|
|---|---|---|
|
PROMIS Pain Intensity Scale (Short Form 3a)
|
46.8 score on a scale
Standard Deviation 7.0
|
46.1 score on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: 1-2 weeksPopulation: 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
8 items (T score 0-100); higher score = worse outcome
Outcome measures
| Measure |
Standard Care
n=54 Participants
-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
|
JACKI® RECOVERY JACKET + Standard Care
n=62 Participants
* 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
|
|---|---|---|
|
PROMIS Pain Interference Scale - Short Form 8a
|
58.9 score on a scale
Standard Deviation 8.4
|
59.1 score on a scale
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: 1-2 weeksPopulation: T3 respondents
2 items; score range 0-100 (higher score = better outcome)
Outcome measures
| Measure |
Standard Care
n=54 Participants
-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
|
JACKI® RECOVERY JACKET + Standard Care
n=64 Participants
* 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
|
|---|---|---|
|
EORTC QLQ-C30: Global QOL Scale
|
66.0 score on a scale
Standard Deviation 17.2
|
64.1 score on a scale
Standard Deviation 16.7
|
SECONDARY outcome
Timeframe: 1-2 weeksPopulation: T3 respondents
5 items; score range 0-100 (higher score = better outcome)
Outcome measures
| Measure |
Standard Care
n=53 Participants
-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
|
JACKI® RECOVERY JACKET + Standard Care
n=62 Participants
* 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
|
|---|---|---|
|
EORTC QLQ-C30: Physical Functioning Scale
|
76.3 score on a scale
Standard Deviation 23.9
|
71.7 score on a scale
Standard Deviation 20.0
|
SECONDARY outcome
Timeframe: 1-2 weeksPopulation: T3 respondents
2 items; score range 0-100 (higher score = better outcome)
Outcome measures
| Measure |
Standard Care
n=54 Participants
-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
|
JACKI® RECOVERY JACKET + Standard Care
n=62 Participants
* 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
|
|---|---|---|
|
EORTC QLQ-C30: Role Functioning Scale
|
36.1 score on a scale
Standard Deviation 27.2
|
40.3 score on a scale
Standard Deviation 24.6
|
SECONDARY outcome
Timeframe: 1-2 weeksPopulation: T3 respondents
4 items; score range 0-100 (higher score = better outcome)
Outcome measures
| Measure |
Standard Care
n=54 Participants
-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
|
JACKI® RECOVERY JACKET + Standard Care
n=64 Participants
* 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
|
|---|---|---|
|
EORTC QLQ-C30: Emotional Functioning Scale
|
72.8 score on a scale
Standard Deviation 20.1
|
73.3 score on a scale
Standard Deviation 21.7
|
SECONDARY outcome
Timeframe: 1-2 weeksPopulation: T3 respondents
2 items; score range 0-100 (higher score = better outcome)
Outcome measures
| Measure |
Standard Care
n=54 Participants
-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
|
JACKI® RECOVERY JACKET + Standard Care
n=64 Participants
* 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
|
|---|---|---|
|
EORTC QLQ-C30: Cognitive Functioning Scale
|
84.0 score on a scale
Standard Deviation 22.9
|
81.0 score on a scale
Standard Deviation 21.6
|
SECONDARY outcome
Timeframe: 1-2 weeksPopulation: T3 respondents
2 items; score range 0-100 (higher score = better outcome)
Outcome measures
| Measure |
Standard Care
n=54 Participants
-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
|
JACKI® RECOVERY JACKET + Standard Care
n=64 Participants
* 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
|
|---|---|---|
|
EORTC QLQ-C30: Social Functioning Scale
|
59.0 score on a scale
Standard Deviation 28.7
|
56.5 score on a scale
Standard Deviation 26.7
|
SECONDARY outcome
Timeframe: 1-2 weeks4 items (score 0-100); higher score = worse outcome
Outcome measures
| Measure |
Standard Care
n=53 Participants
-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
|
JACKI® RECOVERY JACKET + Standard Care
n=64 Participants
* 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
|
|---|---|---|
|
EORTC QLQ-BR23: Body Image Subscale
|
56.6 score on a scale
Standard Deviation 29.8
|
64.8 score on a scale
Standard Deviation 25.0
|
SECONDARY outcome
Timeframe: 1-2 weeks2 items (range 0-100); higher score = better outcome
Outcome measures
| Measure |
Standard Care
n=49 Participants
-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
|
JACKI® RECOVERY JACKET + Standard Care
n=57 Participants
* 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
|
|---|---|---|
|
EORTC QLQ-BR23: Sexual Functioning Subscale
|
18.0 score on a scale
Standard Deviation 18.3
|
15.8 score on a scale
Standard Deviation 19.0
|
SECONDARY outcome
Timeframe: 1-2 weeksPopulation: The majority of respondents skipped this item because they were not sexually active in the time period immediately after surgery
1 item (range 0-100); higher score = better outcome
Outcome measures
| Measure |
Standard Care
n=17 Participants
-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
|
JACKI® RECOVERY JACKET + Standard Care
n=22 Participants
* 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
|
|---|---|---|
|
EORTC QLQ-BR23: Sexual Enjoyment Subscale
|
54.9 score on a scale
Standard Deviation 35.2
|
57.6 score on a scale
Standard Deviation 29.4
|
SECONDARY outcome
Timeframe: 1-2 weeks1 item (range 0-100); higher score = worse outcome
Outcome measures
| Measure |
Standard Care
n=54 Participants
-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
|
JACKI® RECOVERY JACKET + Standard Care
n=64 Participants
* 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
|
|---|---|---|
|
EORTC QLQ-BR23: Future Perspective Subscale
|
49.4 score on a scale
Standard Deviation 30.2
|
53.1 score on a scale
Standard Deviation 30.1
|
SECONDARY outcome
Timeframe: 1-2 weeks7 items (range 0-100); higher score = worse outcome
Outcome measures
| Measure |
Standard Care
n=54 Participants
-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
|
JACKI® RECOVERY JACKET + Standard Care
n=64 Participants
* 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
|
|---|---|---|
|
EORTC QLQ-BR23: Systemic Therapy Side Effects Subscale
|
13.4 score on a scale
Standard Deviation 12.6
|
15.4 score on a scale
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: 1-2 weeks4 items (range 0-100); higher score = worse outcome
Outcome measures
| Measure |
Standard Care
n=54 Participants
-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
|
JACKI® RECOVERY JACKET + Standard Care
n=64 Participants
* 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
|
|---|---|---|
|
EORTC QLQ-BR23: Breast Symptoms Subscale
|
32.8 score on a scale
Standard Deviation 21.9
|
31.4 score on a scale
Standard Deviation 21.7
|
SECONDARY outcome
Timeframe: 1-2 weeks3 items (range 0-100); higher score = worse outcome
Outcome measures
| Measure |
Standard Care
n=54 Participants
-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
|
JACKI® RECOVERY JACKET + Standard Care
n=64 Participants
* 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
|
|---|---|---|
|
EORTC QLQ-BR23: Arm Symptoms Subscale
|
30.9 score on a scale
Standard Deviation 20.2
|
30.9 score on a scale
Standard Deviation 19.8
|
SECONDARY outcome
Timeframe: 1-2 weeksPopulation: Most participants did not answer this item as they had not experienced hair loss (did not receive chemotherapy prior to surgery)
1 item (range 0-100); higher score = worse outcome
Outcome measures
| Measure |
Standard Care
n=8 Participants
-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
|
JACKI® RECOVERY JACKET + Standard Care
n=11 Participants
* 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
|
|---|---|---|
|
EORTC QLQ-BR23: Upset by Hair Loss Subscale
|
25.0 score on a scale
Standard Deviation 38.8
|
24.2 score on a scale
Standard Deviation 33.6
|
SECONDARY outcome
Timeframe: 1 weekPopulation: 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
Average 0-10 Pain Intensity Numeric Scale Rating, for 7 days post-discharge, if at least 5 days reported (T2 diary)
Outcome measures
| Measure |
Standard Care
n=44 Participants
-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
|
JACKI® RECOVERY JACKET + Standard Care
n=16 Participants
* 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
|
|---|---|---|
|
Pain Patterns At Home: Average Daily Pain Intensity (Daily Diary)
|
3.6 units on a scale
Interval 3.0 to 5.0
|
4.4 units on a scale
Interval 2.9 to 5.4
|
SECONDARY outcome
Timeframe: 1-2 weeksPopulation: Participants who returned T2 diary with sufficient information on medication usage to calculate a 7-day average morphine equivalent dose
Participant self-report of average daily morphine eqivalent dose taken in first 7 days post-discharge (if at least 5 days reported)
Outcome measures
| Measure |
Standard Care
n=42 Participants
-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
|
JACKI® RECOVERY JACKET + Standard Care
n=52 Participants
* 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
|
|---|---|---|
|
Pain Management At Home: Use of Pain Medication (Daily Diary)
|
6.9 morphine equivalent dose units
Interval 2.3 to 16.1
|
10.7 morphine equivalent dose units
Interval 2.2 to 28.3
|
SECONDARY outcome
Timeframe: 1-2 weeksPopulation: 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
Self-reported proportion of days in the first 7 days post discharge that participant wore a mastectomy bra (if at least 5 days reported)
Outcome measures
| Measure |
Standard Care
n=42 Participants
-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
|
JACKI® RECOVERY JACKET + Standard Care
n=52 Participants
* 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
|
|---|---|---|
|
Pain Management At Home: Use of Mastectomy Bra (Daily Diary)
|
1.0 Proportion of days
Interval 0.0 to 1.0
|
1.0 Proportion of days
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: 1-2 weeksPopulation: 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
Self-reported proportion of days in the first 7 days post discharge that participant wore a mastectomy camisole (if at least 5 days reported)
Outcome measures
| Measure |
Standard Care
n=42 Participants
-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
|
JACKI® RECOVERY JACKET + Standard Care
n=52 Participants
* 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
|
|---|---|---|
|
Pain Management At Home: Use of Mastectomy Camisole (Daily Diary)
|
0.8 Proportion of days
Interval 0.0 to 1.0
|
0.1 Proportion of days
Interval 0.0 to 0.9
|
SECONDARY outcome
Timeframe: 1-2 weeksPopulation: 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.
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
Outcome measures
| Measure |
Standard Care
n=49 Participants
-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
|
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
|
|---|---|---|
|
Patient-Reported Usage of Jacki Recovery Jacket (Daily Diary)
|
0.9 Proportion of days
Interval 0.6 to 1.0
|
—
|
Adverse Events
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
JACKI® RECOVERY JACKET + Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place