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| Name | Class |
|---|---|
| Daisy Foundation | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | Other | -Standard Care pain medicine/management will be given |
|
| JACKI® RECOVERY JACKET + Standard Care | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jacki Recovery jacket | Device | An outer jacket that holds surgical drains and allows access for blood draws |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity (on the 0-10 Pain Intensity Numeric Scale) | Pain Intensity Numeric Scale (0-10)(higher scores = worse outcome) | 1-2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Distress Scale - Pain Frequency | 1 item (score range 1-5); higher score = worse outcome | 1-2 weeks |
| Symptom Distress Scale - Pain Intensity | 1 item (score range 1-5); higher score = worse outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donna Berry, PhD, RN | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Faulkner Hospital | Boston | Massachusetts | 02130 | United States | ||
| Dana Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31612292 | Result | 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. |
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Recruitment dates: 03/09/2017-12/21/2017
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | JACKI® RECOVERY JACKET + Standard Care |
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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | JACKI® RECOVERY JACKET + Standard Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Intensity (on the 0-10 Pain Intensity Numeric Scale) | Pain Intensity Numeric Scale (0-10)(higher scores = worse outcome) | 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 | Posted | Mean | Standard Deviation | score on a scale | 1-2 weeks |
|
Adverse events were collected only when the participant was on study (usually 1-6 weeks).
Per protocol, adverse events that could reasonably be expected to relate to the NSR device (jacket) included:
Data were collected by chart review and patient report either verbally to the study coordinator or on the study diary.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Donna Berry, PhD, RN | Dana-Farber Cancer Institute | 617-632-1909 | donna_berry@dfci.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 13, 2017 | Jul 17, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Standard Care Pain medicine/management | Other | Standard care pain medicine and management in hospitals where the study enrolls |
|
| 1-2 weeks |
| PROMIS Pain Intensity Scale (Short Form 3a) | 3 items (T score 0-100); higher score = worse outcome | 1-2 weeks |
| PROMIS Pain Interference Scale - Short Form 8a | 8 items (T score 0-100); higher score = worse outcome | 1-2 weeks |
| EORTC QLQ-C30: Global QOL Scale | 2 items; score range 0-100 (higher score = better outcome) | 1-2 weeks |
| EORTC QLQ-C30: Physical Functioning Scale | 5 items; score range 0-100 (higher score = better outcome) | 1-2 weeks |
| EORTC QLQ-C30: Role Functioning Scale | 2 items; score range 0-100 (higher score = better outcome) | 1-2 weeks |
| EORTC QLQ-C30: Emotional Functioning Scale | 4 items; score range 0-100 (higher score = better outcome) | 1-2 weeks |
| EORTC QLQ-C30: Cognitive Functioning Scale | 2 items; score range 0-100 (higher score = better outcome) | 1-2 weeks |
| EORTC QLQ-C30: Social Functioning Scale | 2 items; score range 0-100 (higher score = better outcome) | 1-2 weeks |
| EORTC QLQ-BR23: Body Image Subscale | 4 items (score 0-100); higher score = worse outcome | 1-2 weeks |
| EORTC QLQ-BR23: Sexual Functioning Subscale | 2 items (range 0-100); higher score = better outcome | 1-2 weeks |
| EORTC QLQ-BR23: Sexual Enjoyment Subscale | 1 item (range 0-100); higher score = better outcome | 1-2 weeks |
| EORTC QLQ-BR23: Future Perspective Subscale | 1 item (range 0-100); higher score = worse outcome | 1-2 weeks |
| EORTC QLQ-BR23: Systemic Therapy Side Effects Subscale | 7 items (range 0-100); higher score = worse outcome | 1-2 weeks |
| EORTC QLQ-BR23: Breast Symptoms Subscale | 4 items (range 0-100); higher score = worse outcome | 1-2 weeks |
| EORTC QLQ-BR23: Arm Symptoms Subscale | 3 items (range 0-100); higher score = worse outcome | 1-2 weeks |
| EORTC QLQ-BR23: Upset by Hair Loss Subscale | 1 item (range 0-100); higher score = worse outcome | 1-2 weeks |
| 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) | 1 week |
| 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) | 1-2 weeks |
| 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) | 1-2 weeks |
| 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) | 1-2 weeks |
| 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 | 1-2 weeks |
| Boston |
| Massachusetts |
| 02215 |
| United States |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Pain Intensity Numeric (0-10) Scale (PINS) | 1 item (score 0-10); higher score = worse outcome | Mean | Standard Deviation | score on a scale |
|
| Symptom Distress Scale - Pain Frequency | 1 participant did not provide a response | Mean | Standard Deviation | units on a scale |
|
| Symptom Distress Scale - Pain Intensity | Mean | Standard Deviation | units on a scale |
|
| PROMIS Pain Intensity Short Form 3a | 3 items (T score 0-100); higher score = worse outcome | 2 participants did not complete the required items to calculate a total score | Mean | Standard Deviation | score on a scale |
|
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 |
|
|
| Secondary | Symptom Distress Scale - Pain Frequency | 1 item (score range 1-5); higher score = worse outcome | 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 | Posted | Mean | Standard Deviation | score on a scale | 1-2 weeks |
|
|
|
| Secondary | Symptom Distress Scale - Pain Intensity | 1 item (score range 1-5); higher score = worse outcome | 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 | Posted | Mean | Standard Deviation | score on a scale | 1-2 weeks |
|
|
|
| Secondary | PROMIS Pain Intensity Scale (Short Form 3a) | 3 items (T score 0-100); higher score = worse outcome | 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 | Posted | Mean | Standard Deviation | score on a scale | 1-2 weeks |
|
|
|
| Secondary | PROMIS Pain Interference Scale - Short Form 8a | 8 items (T score 0-100); higher score = worse outcome | 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 | Posted | Mean | Standard Deviation | score on a scale | 1-2 weeks |
|
|
|
| Secondary | EORTC QLQ-C30: Global QOL Scale | 2 items; score range 0-100 (higher score = better outcome) | T3 respondents | Posted | Mean | Standard Deviation | score on a scale | 1-2 weeks |
|
|
|
| Secondary | EORTC QLQ-C30: Physical Functioning Scale | 5 items; score range 0-100 (higher score = better outcome) | T3 respondents | Posted | Mean | Standard Deviation | score on a scale | 1-2 weeks |
|
|
|
| Secondary | EORTC QLQ-C30: Role Functioning Scale | 2 items; score range 0-100 (higher score = better outcome) | T3 respondents | Posted | Mean | Standard Deviation | score on a scale | 1-2 weeks |
|
|
|
| Secondary | EORTC QLQ-C30: Emotional Functioning Scale | 4 items; score range 0-100 (higher score = better outcome) | T3 respondents | Posted | Mean | Standard Deviation | score on a scale | 1-2 weeks |
|
|
|
| Secondary | EORTC QLQ-C30: Cognitive Functioning Scale | 2 items; score range 0-100 (higher score = better outcome) | T3 respondents | Posted | Mean | Standard Deviation | score on a scale | 1-2 weeks |
|
|
|
| Secondary | EORTC QLQ-C30: Social Functioning Scale | 2 items; score range 0-100 (higher score = better outcome) | T3 respondents | Posted | Mean | Standard Deviation | score on a scale | 1-2 weeks |
|
|
|
| Secondary | EORTC QLQ-BR23: Body Image Subscale | 4 items (score 0-100); higher score = worse outcome | Posted | Mean | Standard Deviation | score on a scale | 1-2 weeks |
|
|
|
| Secondary | EORTC QLQ-BR23: Sexual Functioning Subscale | 2 items (range 0-100); higher score = better outcome | Posted | Mean | Standard Deviation | score on a scale | 1-2 weeks |
|
|
|
| Secondary | EORTC QLQ-BR23: Sexual Enjoyment Subscale | 1 item (range 0-100); higher score = better outcome | The majority of respondents skipped this item because they were not sexually active in the time period immediately after surgery | Posted | Mean | Standard Deviation | score on a scale | 1-2 weeks |
|
|
|
| Secondary | EORTC QLQ-BR23: Future Perspective Subscale | 1 item (range 0-100); higher score = worse outcome | Posted | Mean | Standard Deviation | score on a scale | 1-2 weeks |
|
|
|
| Secondary | EORTC QLQ-BR23: Systemic Therapy Side Effects Subscale | 7 items (range 0-100); higher score = worse outcome | Posted | Mean | Standard Deviation | score on a scale | 1-2 weeks |
|
|
|
| Secondary | EORTC QLQ-BR23: Breast Symptoms Subscale | 4 items (range 0-100); higher score = worse outcome | Posted | Mean | Standard Deviation | score on a scale | 1-2 weeks |
|
|
|
| Secondary | EORTC QLQ-BR23: Arm Symptoms Subscale | 3 items (range 0-100); higher score = worse outcome | Posted | Mean | Standard Deviation | score on a scale | 1-2 weeks |
|
|
|
| Secondary | EORTC QLQ-BR23: Upset by Hair Loss Subscale | 1 item (range 0-100); higher score = worse outcome | Most participants did not answer this item as they had not experienced hair loss (did not receive chemotherapy prior to surgery) | Posted | Mean | Standard Deviation | score on a scale | 1-2 weeks |
|
|
|
| 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) | 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 | Posted | Median | Inter-Quartile Range | units on a scale | 1 week |
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| 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) | Participants who returned T2 diary with sufficient information on medication usage to calculate a 7-day average morphine equivalent dose | Posted | Median | Inter-Quartile Range | morphine equivalent dose units | 1-2 weeks |
|
|
|
| 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) | 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 | Posted | Median | Inter-Quartile Range | Proportion of days | 1-2 weeks |
|
|
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| 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) | 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 | Posted | Median | Inter-Quartile Range | Proportion of days | 1-2 weeks |
|
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| 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 | 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. | Posted | Median | Inter-Quartile Range | Proportion of days | 1-2 weeks |
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| 0 |
| 67 |
| 0 |
| 67 |
| 0 |
| 67 |
| EG001 | JACKI® RECOVERY JACKET + Standard Care |
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 | 0 | 72 | 0 | 72 | 0 | 72 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|