Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket: Randomized Trial
Phase: NA
Conditions: Mastectomy
Sponsor: Dana-Farber Cancer Institute

1 
 
NCI Protocol #: 
Not applicable 
 
DF/HCC Protocol #: 16-403  
 
 
TITLE:  Reduction of Post Mastectomy Pain with the Jacki® Recovery Jacket: Randomized 
Trial 
 
 
Coordinating Center: 
 
 
Dana-Farber Cancer Institute 
 
Principal Investigator (PI): 
Donna Berry, PhD, RN 
 
Dana-Farber Cancer Institute 
 
donna_berry@dfci.harvard.edu  
 
Other Investigators: 
Michele McCullough, RN 
 
Brigham and Women’s – Faulkner Hospital 
 
mmccullough3@partners.org 
 
 
 
Statistician: 
 
Study Coordinator:  
 
 
 
Fangxin Hong, PhD 
Barbara Halpenny, MA 
 
Dana-Farber Cancer Institute 
Dana-Farber Cancer Institute 
 
 
450 Brookline Ave, LW-521 
 
 
617-582-7124 
 
 
617-582-8550 
 
fxhong@jimmy.harvard.edu 
barbara_halpenny@dfci.harvard.edu 
 
 
 
 
Study Exempt from IND Requirements per 21 CFR 312.2(b).   
 
 
Protocol Type / Version # / Version Date: 
Original / Version 8 / 11.13.2017 
 
 

NCI Protocol #: N/A 
DF/HCC Protocol #: 16-403 
Protocol Version Date: 11/13/2017 
 
2 
SCHEMA 
 
 
 
 
 
 
 
1) Screen, consent 
 
 
Inpatient post 
mastectomy, first (or 
second) day post-op:  
2) Baseline measures 
of pain (T1) 
 
3) RANDOMIZE 
 
USUAL CARE (UC) 
Usual pain management post-discharge 
JACKI® RECOVERY JACKET + UC (JACKI) 
Jacki + usual pain management post-discharge 
At home (T2):  
Daily pain diary post-discharge 
until all drains are removed (~7-42 
days) 
At follow-up clinic when 
all drains are removed 
(T3):  
Follow-up measures of 
pain, pain management, 
symptoms, quality of life 

NCI Protocol #: N/A 
DF/HCC Protocol #: 16-403 
Protocol Version Date: 11/13/2017 
 
3 
TABLE OF CONTENTS 
 
SCHEMA .........................................................................................................................................2 
1. 
OBJECTIVES ......................................................................................................................5 
1.1 
Study Design ............................................................................................................5 
1.2 
Primary Objectives ...................................................................................................5 
1.3 
Secondary Objectives ...............................................................................................5 
2. 
BACKGROUND .................................................................................................................5 
2.1 
Study Disease(s).......................................................................................................5 
2.2 
IND Agent(s) ...........................................................................................................6 
2.3 
Other Agent(s) ..........................................................................................................6 
2.4 
Rationale ..................................................................................................................6 
2.5 
Preliminary Data ......................................................................................................7 
3. 
PARTICIPANT SELECTION .............................................................................................7 
3.1 
Eligibility Criteria ....................................................................................................7 
3.2 
Exclusion Criteria ....................................................................................................7 
3.3 
Inclusion of Women and Minorities ........................................................................8 
4. 
REGISTRATION PROCEDURES .....................................................................................8 
4.1 
General Guidelines for DF/HCC Institutions ..........................................................8 
4.2 
Registration Process for DF/HCC Institutions .........................................................8 
4.3 
General Guidelines for Other Investigative Sites ....................................................8 
4.4 
Registration Process for Other Investigative Sites ...................................................8 
5. 
TREATMENT AND/OR IMAGING PLAN .......................................................................9 
5.1 
Treatment Regimen ..................................................................................................9 
5.2 
Pre-Treatment Criteria ...........................................................................................11 
5.3 
Agent Administration .............................................................................................11 
5.4 
Definition of Dose-Limiting Toxicity (DLT) ........................................................11 
5.5 
General Concomitant Medication and Supportive Care Guidelines ......................11 
5.6 
Criteria for Taking a Participant Off Protocol Therapy .........................................11 
5.7 
Duration of Follow Up ...........................................................................................11 
5.8 
Criteria for Taking a Participant Off Study ...........................................................12 
6. 
DOSING DELAYS/DOSE MODIFICATIONS................................................................12 
7. 
ADVERSE EVENTS:  LIST AND REPORTING REQUIREMENTS ............................12 
7.1 
Adverse Events ......................................................................................................12 
7.2 
Adverse Event Characteristics ...............................................................................13 
7.3 
Expedited Adverse Event Reporting ......................................................................13 
7.4 
Routine Adverse Event Reporting .........................................................................13 
8. 
PHARMACEUTICAL and/or IMAGING AGENT INFORMATION .............................13 

NCI Protocol #: N/A 
DF/HCC Protocol #: 16-403 
Protocol Version Date: 11/13/2017 
 
4 
9. 
BIOMARKER, CORRELATIVE, AND SPECIAL STUDIES ........................................13 
10. 
STUDY CALENDAR .......................................................................................................13 
11. 
MEASUREMENT OF EFFECT........................................................................................14 
11.1 
Antitumor Effect – Solid Tumors ..........................................................................14 
11.2 
Antitumor Effect – Hematologic Tumors ..............................................................14 
11.3 
Other Response Parameters ...................................................................................14 
12. 
DATA REPORTING / REGULATORY REQUIREMENTS ...........................................14 
12.1 
Data Reporting .......................................................................................................14 
12.2 
Data Safety Monitoring ..........................................................................................15 
12.3 
Multicenter Guidelines ...........................................................................................15 
12.4 
Collaborative Agreements Language .....................................................................15 
13. 
STATISTICAL CONSIDERATIONS...............................................................................15 
13.1 
Study Design/Endpoints.........................................................................................15 
13.2 
Sample Size, Accrual Rate and Study Duration ....................................................15 
13.3 
Stratification Factors ..............................................................................................16 
13.4 
Interim Monitoring Plan ........................................................................................17 
13.5 
Analysis of Primary Endpoints ..............................................................................17 
13.6 
Analysis of Secondary Endpoints ..........................................................................17 
13.7 
Reporting and Exclusions ......................................................................................17 
14. 
PUBLICATION PLAN .....................................................................................................18 
REFERENCES ..............................................................................................................................18 
APPENDIX A 
PARTICIPANT QUESTIONNAIRES ......................................................20 
 
 
 

NCI Protocol #: N/A 
DF/HCC Protocol #: 16-403 
Protocol Version Date: 11/13/2017 
 
5 
1. OBJECTIVES 
 
 
1.1 
Study Design 
 
The study is a randomized trial of the Jacki® recovery jacket garment versus usual care 
for post-discharge pain management in patients who had mastectomy and reconstructive 
surgery in one or both breasts.  
 
1.2 
Primary Objectives 
 
1. Compare pain intensity on a 0-10 numeric scale at the post-surgical follow-up 
clinic when all surgical drains are removed between usual care pain management 
(UC) and “Jacki” plus usual care (Jacki) groups. 
 
1.3 
Secondary Objectives 
 
1. Explore differences in health related quality of life (HRQOL) and breast 
symptoms between groups at the follow-up clinic. 
2. Evaluate at-home (from discharge to follow-up) pain patterns and pain 
management by group. 
3. Evaluate patient-reported Jacki usage frequencies in the intervention group. 
 
2. BACKGROUND 
 
2.1 
Study Disease(s) and Health Setting 
 
Patients have mastectomy either in treatment for breast cancer or as prophylaxis, and may 
have reconstructive surgery at the same time. In 2016, it is estimated that 246,660 new 
cases of invasive breast cancer will be diagnosed in women in the U.S. along with 60,290 
cases of in situ breast cancer.1 Treatment options for early-stage breast cancer are 
generally breast conserving surgery with adjuvant radiation or mastectomy. An analysis 
of the National Cancer Database published in 20152 found that national rates of 
mastectomy for early-stage breast cancer rose from 34.3% in 1998, the first year in the 
study, to 37.8% in 2011, the last year, with much of the increase in the last eight years. 
Rates of reconstructive surgery in patients having mastectomy rose from 11.6% in 1998 
to 36.4% in 2011. During the same period, the rate of patients with unilateral breast 
cancer who elected contralateral prophylactic mastectomy (CPM) rose from 1.9% to 
11.2%,2 a trend that will likely continue3 despite lack of evidence favoring CPM outside a 
high risk setting.4 Rates of bilateral prophylactic mastectomy (BPM) for those with no 
cancer diagnosis but genetic and/or family risk are more difficult to estimate due to lack 
of cancer diagnosis and registry, but studies have estimated these surgeries may be in the 
hundreds to thousands per year in the U.S.5,6and expected to increase with increased 
awareness of genetic breast cancer and increased uptake of genetic testing.6  

NCI Protocol #: N/A 
DF/HCC Protocol #: 16-403 
Protocol Version Date: 11/13/2017 
 
6 
 
 
2.2 
IND Agent(s) 
 
Not applicable. 
 
 
2.3 
Other Agent(s) 
 
Not applicable. 
  
2.4 
Rationale 
 
Patients who have mastectomy and reconstructive surgery often experience discomfort from 
not only the surgical incisions, but also from the drainage tubes inserted at the incision sites. 
The tubes and drainage receptacles are often difficult to manage when patients are discharged 
from the hospital, wearing typical clothing and returning to regular daily activities.  
 
Most women are able, at the time of mastectomy, to have breast reconstruction surgery to 
rebuild and contour breast shape. Post-operative care is more complex than mastectomy 
alone and requires an inpatient stay of two to four nights. The accumulation of fluid – a 
seroma – is a frequent complication following breast surgery and warrants the insertion of 
drainage tubes for prevention. In a review investigating techniques in the prevention and 
management of seromas after breast surgery, drains produced a significant reduction in 
seroma incidence.7  The number of drains depends on the type of surgery and preference of 
the surgeon and ranges from 2 for unilateral and from 4 for bilateral mastectomy.8,9 Patients 
after mastectomy and breast reconstruction experience soreness in the chest, underarm and 
shoulder, as well as numbness at the drainage site. Patients have reported the greatest 
discomfort at the drain insertion sites. The number of drains after mastectomy has also been 
associated with increased pain in the post mastectomy patient, although the number of drains 
was not associated with the rate or number of seromas.8,10 If axillary lymph nodes are 
removed, patients may experience some numbness in the arm and also are at risk for 
lymphedema,11 a build-up of lymph that causes swelling in the arm, hand, breast, underarm, 
chest, trunk and/or back. 
 
Post-operative pain experienced by women undergoing mastectomy and breast reconstruction 
can contribute to limited range of motion in the upper body, resulting in worsening stiffness 
and edema that have a negative impact on quality of life (QOL) and activities of daily living 
(ADL). It is vital that early upper body exercise and movement is performed to prevent 
lymphedema or swelling.12 Increased activity can reduce the side effects of surgery, shorten 
recovery time, and ultimately improve long-term outcomes.13,14 This was demonstrated in a 
study of 35 post-operative mastectomy patients randomized to participate in an early physical 
rehabilitation program: participants in the program reported significant improvement in pain 
reduction and QOL.15 Consequently, studies have demonstrated that inadequately managed 
pain in the acute post-operative period is one of the greatest predictors of chronic pain 
syndromes in breast surgery patients.16-21  

NCI Protocol #: N/A 
DF/HCC Protocol #: 16-403 
Protocol Version Date: 11/13/2017 
 
7 
 
Traditional clothing options for women post mastectomy are undergarments such as post 
mastectomy camisoles, tank tops, and customized mastectomy bras. Camisoles are usually 
worn as nightwear or under loose fitting clothing until surgical drains are removed. The Jacki 
is a post mastectomy garment that was developed by a breast cancer survivor as a means to 
manage and hold the drainage system. The jacket is professionally manufactured, made with 
high quality material (cotton and Polartec® microfleece), and is suitable for business casual 
attire. Anecdotally-reported patient experiences suggest that use of the Jacki immediately 
after surgery is an early intervention that may reduce pain and prevent activity limitations 
over time.22,23  The Jacki is unique as outer apparel that can be worn in the workplace, at 
social events, and during usual activity, and that allows full range of motion. The Jacki 
allows the patient to discreetly place drainage tubes in hidden and secure inside pockets that 
reduce the possibility of dislodgement and pulling. Velcro sleeves allow for easy access 
when patients return for follow-up appointments that require taking blood pressure, IV 
access, injections and medical exams. In particular, women have described24 how the Jacki 
has put them at ease when in public venues that otherwise would have created feelings of 
vulnerability and self-consciousness because of body changes and functional limitations from 
surgery.  
 
2.5 
Preliminary Data 
 
A preliminary survey study was conducted to explore self-reported pain intensity levels (just 
before discharge to ambulatory care) in patients post mastectomy in the Boston area. The 
sample (n=88) had a nearly equal distribution of age above and below 50 years; most were 
college educated and married/partnered. Of the 88 participants, 39% reported moderate to 
severe pain intensity, 53% reported pain several times a week to constantly, and 34% 
reported pain intensity as fair to almost unbearable soon after surgery. Sixty percent of 
participants had received a bilateral mastectomy, and 43% of these had bilateral implant 
reconstruction. Mean scores on the 0-10 pain intensity scale were 5.26 (SD=2.28) for those 
who had bilateral mastectomy and 2.5 (SD=2.13) for those having single mastectomy; 
participants who had reconstruction at the time of surgery pain averaged 4.98 (SD=2.18). 
 
 
3. PARTICIPANT SELECTION 
 
3.1 
Eligibility Criteria  
 
1. Patients who are ≥ 18 years old. 
2. Patients who speak and understand English. 
3. Patients who have had mastectomy with reconstructive surgery in one or both breasts. 
3.2 
Exclusion Criteria 
 
1. Co-morbid delirium, dementia, mental illness, or neurocognitive deficit prohibiting 
informed consent and/or ability to complete study procedures. 

NCI Protocol #: N/A 
DF/HCC Protocol #: 16-403 
Protocol Version Date: 11/13/2017 
 
8 
 
 
3.3 
Inclusion of Women and Minorities 
 
The sample will be entirely women (although men are at risk for, or diagnosed with, breast 
cancer, they do not have reconstructive surgery post mastectomy). English-speaking women 
of all races and ethnic groups are eligible and will be recruited for this trial. 
 
 
 
4. REGISTRATION PROCEDURES 
 
 
4.1 
General Guidelines for DF/HCC Institutions 
 
Institutions will register eligible participants in the Clinical Trials Management System 
(CTMS) OnCore. Registrations must occur prior to the initiation of protocol therapy (i.e., 
discharge from the hospital). Any participant not registered to the protocol within this 
timeframe will be considered ineligible and registration will be denied. 
 
A member of the study team will complete the protocol-specific eligibility checklist. 
 
 
4.2 
Registration Process for DF/HCC Institutions 
 
DF/HCC Standard Operating Procedure for Human Subject Research Titled Subject 
Protocol Registration (SOP #: REGIST-101A for Centralized Registration) must be 
followed. Research staff at enrolling institutions will fax the signed informed consent 
form and eligibility checklist to the protocol registrar at the Office of Data Quality 
(ODQ) at 617-632-2295, who will confirm eligibility and complete centralized 
registration of the participant in OnCore.  
 
4.3 
General Guidelines for Other Investigative Sites 
 
Not applicable. 
 
4.4 
Registration Process for Other Investigative Sites 
 
Not applicable. 
 
 
 
 

NCI Protocol #: N/A 
DF/HCC Protocol #: 16-403 
Protocol Version Date: 11/13/2017 
 
9 
5. TREATMENT AND/OR IMAGING PLAN 
 
 
5.1 
Treatment Regimen 
 
5.1.1 
Enrolling Sites and Study Entry 
 
A sample of 130 women who have had or will have mastectomy with reconstruction will be 
recruited.  
 
Screening will be conducted by a research team member using the clinical surgery and post-op 
schedule to identify eligible patients. A clinical care nurse or clinical research associate who is a 
member of the research study team will invite the participant to hear about the study, and if the 
patient agrees to participate, will consent the participant. The research team member will 
complete the eligibility checklist. 
 
The research team member will fax the consent form and eligibility checklist to the Office of 
Data Quality to register the participant and will receive the participant’s randomized study group 
assignment. Participants will be randomly assigned in blocks of random permuted size, stratified 
by site and unilateral vs bilateral mastectomy, to the usual care pain management (UC) or 
“Jacki” plus usual care (Jacki) groups.  
 
The research team member will meet the participant in the hospital on the first day post-surgery 
(or second day, if the patient is too sick, has a surgical complication, or is in too much pain or 
distress to be approached the first day) to collect the baseline (T1) questionnaire and will provide 
the post-discharge daily diary questionnaires (T2) to the participant, answer questions, and make 
arrangements for collection of the follow-up questionnaire (T3) with the participant at the clinic 
visit when all the post-surgical drains are removed. The research team member will telephone or 
email the participant at home the first or second day after discharge to remind her to fill out the 
T2 daily questionnaire; if the participant has multiple follow-up visits before all drains are 
removed, the research team member may also telephone, email or meet the participant at follow-
up visits to remind her to continue filling out the T2 daily questionnaire until all drains are 
removed. 
 
5.1.2 
Treatment Regimen 
 
A clinical care nurse will provide instruction to participants allocated to the Jacki arm on safe 
and appropriate use of the Jacki (for example, how to put on the jacket and tuck drainage tubes 
into jacket pockets, and the need to remove drainage tubes from jacket pockets prior to removing 
the jacket). Participants in the Jacki arm will be encouraged to use the jacket at home between 
discharge and their follow-up clinic appointment; no minimum amount of use is required.  
 
Participants in both groups will receive all usual pain management including prescription of pain 
medications and instructions on pain management post-discharge as standard of care. 
 

NCI Protocol #: N/A 
DF/HCC Protocol #: 16-403 
Protocol Version Date: 11/13/2017 
 
10 
The treatment period for participants in both arms is from discharge from the hospital post 
mastectomy until the follow-up clinic appointment at which all drains are removed, usually in 7-
14 days, sometimes as long as 28 or (rarely) 42 days. 
 
5.1.3 
Instruments Measuring Study Outcomes 
 
Participants will complete study questionnaires self-reporting pain, pain management, breast 
symptoms and health related quality of life at three time points (see section 10, Study Calendar). 
Questionnaires will be answered using pen and paper in the hospital on the first (or second) day 
post-surgery (T1), at home (T2), or in follow-up clinic after all drains are removed (T3). If 
participants cannot answer the T3 questionnaire in clinic, a research coordinator will contact the 
participant to administer the questionnaire within 24 hours of the follow-up appointment via 
telephone interview or secure file exchange (using the Partners Biscom Delivery Server). 
Instruments are the following: 
 
Demographic questionnaire (T1) 
The questionnaire includes age, language spoken at home, ethnicity, race, marital status, 
education, and occupational status.  
 
Pain Intensity Numeric Scale (PINS) (T1, T2, T3) 
The PINS measures pain intensity with a single item, on a 0-10 scale and is in common clinical 
use.  
 
Pain Frequency and Pain Intensity Distress (Symptom Distress Scale) (T1, T3) 
Two items from the Symptom Distress Scale25,26 measure pain frequency and pain intensity in 
the past week, on a 5-point scale. 
 
Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Intensity (T1, 
T3) 
This 3-item instrument from the PROMIS item bank27 measures pain intensity over the past 
week and right now, on a 5-point scale (PROMIS Item Bank v.1.0 – Pain Intensity – Short Form 
3a). 
 
Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Interference 
(T3) 
This 8-item instrument from the PROMIS item bank27 measures the interference of pain with 
daily activities and social relations, on a 5-point scale (PROMIS Item Bank v.1.0 – Pain 
Interference – Short Form 8a). 
 
Pain Management (T2) 
Participants will keep a daily pain diary between hospital discharge and follow-up clinic 
appointment (the T2 period) to document pain intensity, use of pain medications, and whether 
and how long they wear post mastectomy garments each day. 
 
EORTC QLC-C30 (T3) 

NCI Protocol #: N/A 
DF/HCC Protocol #: 16-403 
Protocol Version Date: 11/13/2017 
 
11 
The EORTC QLQ- C3028 is a 30-item questionnaire with 5 functional subscales, global health 
status quality of life subscale, and 9 symptom subscales/items. The time it takes to complete the 
questionnaire is approximately 11 minutes. The C30 has been used in over 3000 clinical trials 
and in 81 languages.29 Authors of a recent meta-analysis30 of the C30 performance concluded 
that all subscales perform reliably except cognitive function, a 2-item subscale assessing memory 
and concentration. Raw scores for the QLQ-C30 range from 0 to 100 and can be transformed and 
compared to reference values published in the EORTC QLQ-C30 manual.  
 
EORTC QLQ-BR23 (T3) 
The QLQ-BR23 supplementary Breast Cancer Module is comprised of 23 questions in five 
multi-item scales to assess side effects of surgery, arm and breast symptoms, body image, sexual 
functioning and future perspective. Cronbach’s alpha coefficient results for QLQ-BR23 have 
been reported at 0.873.29 
 
Medical Record Review (T1 and T3) 
A member of the study team will record clinical data, such as cancer diagnosis (if any) and 
surgery details at T1 prior to the participant’s hospital discharge, and documentation from the 
medical record of pain and pain management post-discharge  within 1 week after the T3 visit. 
 
 
 
5.2 
Pre-Treatment Criteria 
 
Not applicable. 
 
5.3 
Agent Administration 
 
Not applicable. 
 
 
5.4 
Definition of Dose-Limiting Toxicity (DLT)  
 
Not applicable. 
 
5.5 
General Concomitant Medication and Supportive Care Guidelines 
 
Not applicable. 
 
5.6 
Criteria for Taking a Participant Off Protocol Therapy 
 
Not applicable. 
 
 
5.7 
Duration of Follow Up 
 
Not applicable. 

NCI Protocol #: N/A 
DF/HCC Protocol #: 16-403 
Protocol Version Date: 11/13/2017 
 
12 
5.8 
Criteria for Taking a Participant Off Study 
 
Participants will be removed from study when any of the following criteria apply: 
 Lost to follow-up 
 Withdrawal of consent for data submission 
 Death 
 It is considered to be in the participant’s best interest 
 The study device or procedures are found to be unsafe or ineffective 
 There is any problem with using the study device or following study procedures 
 The participant’s condition worsens 
 A decision is made to close the study 
 Or for any other unforeseen reasons that make it necessary to stop the participant’s 
participation in the research study 
 
The reason for taking a participant off study, and the date the participant was removed, must be 
documented in the case report form (CRF). 
 
For Centralized  Subject Registrations, the research team submits a completed Off Treatment/Off 
Study form to ODQ when a participant comes off study. This form can be found on the ODQ 
website or obtained from the ODQ registration staff. 
 
 
6. DOSING DELAYS/DOSE MODIFICATIONS 
 
Not applicable. 
 
7. ADVERSE EVENTS:  LIST AND REPORTING REQUIREMENTS  
 
7.1 
Adverse Events 
 
7.1.1.1 
Adverse Event List for the Jacki Recovery Jacket 
 
The Jacki has not previously been studied, and no adverse events or serious adverse 
events have been reported to A Little Easier Recovery® or at the enrolling study sites, 
which have previously provided jackets to some post-operative patients.  
 
Potential adverse events include the following: 
 
1.) A participant wearing the jacket may remove the jacket without first removing the 
drains from the pockets. This may cause pain and/or the drains to be dislodged, 
which would require a trip to the hospital to have them re-inserted. It could also 
lead to a greater risk of infection at the site of the drains. 
2.) A participant wearing the jacket may become too warm in warm weather or may 
develop a skin reaction to the jacket, which is made of 50% cotton and 50% 
polyester. 

NCI Protocol #: N/A 
DF/HCC Protocol #: 16-403 
Protocol Version Date: 11/13/2017 
 
13 
 
7.2 
Adverse Event Characteristics 
 
Adverse events are not graded. 
 
7.3 
 Expedited Adverse Event Reporting  
 
7.3.1 Investigators must report to the Overall PI any adverse event that occurs while the 
subject is on study. The event must be reported to the Overall PI within 24 hours. 
  
 
7.4 
Routine Adverse Event Reporting 
 
All Adverse Events must be reported in routine study data submissions to the Overall PI 
on the clinical data forms. AEs reported through expedited processes must also be 
reported in routine study data submissions. 
 
 
8. PHARMACEUTICAL AND/OR IMAGING AGENT INFORMATION 
Not applicable. 
 
 
9. BIOMARKER, CORRELATIVE, AND SPECIAL STUDIES 
Not applicable. 
 
 
10. STUDY CALENDAR 
Measure 
Inpatient Post 
Mastectomy (T1) 
At Home Post-
Discharge (T2) 
Follow-up Clinic 
Appointment (T3) 
Participant Demographics 
X
 
Pain Intensity Numeric Scale 
(0-10) 
X 
X 
X 
Pain Frequency and Intensity 
Symptom Distress Scores 
X 
 
X 
Health Related Quality of 
Life 
 
 
X 
Breast Symptoms 
X 
Pain Management  
X
 
Post-Discharge Pain, Pain 
Management, Complications 
(Documented in Electronic 
Medical Record) 
 
 
X 
Participant Clinical 
Characteristics (Diagnosis, 
Treatment Regimen 
 
 
 

NCI Protocol #: N/A 
DF/HCC Protocol #: 16-403 
Protocol Version Date: 11/13/2017 
 
14 
Documented in the Medical 
Record) 
T1: First (or second) day post mastectomy, during inpatient stay 
T2: Exclusive of day discharged and day of follow-up when all drains are removed, 
daily for 7-42 days 
T3: Day of follow-up clinic appointment when all drains are removed 
 
 
11. MEASUREMENT OF EFFECT 
 
 
11.1 
Antitumor Effect – Solid Tumors 
 
Not applicable. 
 
11.2 
Antitumor Effect – Hematologic Tumors 
 
Not applicable. 
 
11.3 
Other Response Parameters 
 
Other endpoints include pain, breast cancer symptoms, and health related quality of life 
and are measured as described in section 5. 
 
 
12. DATA REPORTING / REGULATORY REQUIREMENTS 
 
Adverse event lists, guidelines, and instructions for AE reporting can be found in Section 7.0 
(Adverse Events: List and Reporting Requirements). 
 
12.1 
Data Reporting 
 
12.1.1 Method 
 
The Dana-Farber research study team will collect, manage, and perform quality checks 
on the data for this study. 
 
 
12.1.2 Responsibility for Data Submission 
 
Investigative sites within DF/HCC or DF/PCC are responsible for submitting data and/or 
data forms to the Dana-Farber research study team according to the schedule set by the 
Dana-Farber research study team. All data will be submitted within 10 days of the 
participant’s T3 appointment. 
 
 

NCI Protocol #: N/A 
DF/HCC Protocol #: 16-403 
Protocol Version Date: 11/13/2017 
 
15 
12.2 
Data Safety Monitoring 
 
The PI will monitor the study, including review of study conduct, enrollment, adverse 
events with prompt reporting of AEs and other study-related information to the IRB, 
sponsor, and other agencies as appropriate. Good Clinical Practice (GCP) will be 
followed for conduct of the study and modifications; deviations will be reported to the 
IRB, along with an annual status report as per IRB guidelines. 
   
12.3 
Multicenter Guidelines 
 
Not applicable. 
 
 
12.4 
Collaborative Agreements Language 
 
Not applicable. 
 
 
 
 
13. STATISTICAL CONSIDERATIONS 
 
 
13.1 
Study Design/Endpoints 
 
The study is a randomized trial of the Jacki recover jacket versus usual care for post-
discharge pain management in patients who received mastectomy with reconstructive 
surgery in one or both breasts. All participants will complete questionnaires measuring 
pain, pain management, breast symptoms, and health-related quality of life (Appendix 
A). Questionnaires will be completed at three time points: pre-discharge (T1), at home 
over approximately 7-14 (up to 42) days (T2), and at follow-up clinic when all drains are 
removed (T3). Participants will receive usual pain management or the Jacki plus usual 
pain management post-discharge. Clinical data will be collected by a member of the 
research study team using a clinical data form. 
 
 
 
13.2 
Sample Size, Accrual Rate and Study Duration 
 
The primary objective of this study will be to compare pain intensity (measured on the 0-
10 scale, PINS) at the follow-up clinic appointment when all drains are removed (T3) 
between those randomized to UC or Jacki groups. A reduction of 1.0 on the PINS is 
thought to be clinically significant. With a sample size of 130 there is 80% power to 
detect a 1-point difference in PINS between UC and Jacki groups using a Wilcoxon rank 
sum test at the 2-sided 0.1 significance level assuming a standard deviation of 2.2 from 

NCI Protocol #: N/A 
DF/HCC Protocol #: 16-403 
Protocol Version Date: 11/13/2017 
 
16 
the preliminary study. The following table depicts the impact on power if the standard 
deviation at the follow-up visits is smaller or larger than estimated. 
 
Standard Deviation
Power
1.8
91%
2.0
86%
2.2
80%
2.4
74%
2.6
68%
 
 
With a projected 13% rate of attrition, a total of 149 participants enrolled will yield an 
analytic sample of 130 evaluable participants. This number of participants will be 
accrued and will complete data collection within 10 months, based on clinical volume . 
 
 
Accrual Targets 
Ethnic Category 
Sex/Gender
Females
Males
 
Total
Hispanic or Latino 
39
+
0
= 
39 
Not Hispanic or Latino 
91
+
0
= 
91 
Ethnic Category: Total of all subjects 
130
+
0
= 
 
130
Racial Category 
 
American Indian or Alaskan Native 
0
+
0
= 
0 
Asian 
6
+
0
= 
6 
Black or African American 
13
+
0
= 
13 
Native Hawaiian or other Pacific 
Islander 
0 
+
0 
= 
0 
White 
111
+
0
= 
111 
Racial Category: Total of all subjects
130
+
0
= 
 
130
 
 
No interim analyses are planned due to the short duration, minimal risk, and minimal burden 
of the study. There are no early stopping rules. 
 
 
13.3 
Stratification Factors 
 
Randomization will be stratified by enrolling hospital and unilateral vs bilateral 
mastectomy following a permuted block randomization supplied by the statistician.  
 
 
 

NCI Protocol #: N/A 
DF/HCC Protocol #: 16-403 
Protocol Version Date: 11/13/2017 
 
17 
13.4 
Interim Monitoring Plan 
 
Data and safety monitoring is described in section 12.  
 
13.5 
Analysis of Primary Endpoints 
 
All randomized patients will be included in all analyses. Minimal missing data is 
expected; therefore, in the event of missing data, no imputation will be performed. The 
analyzable sample for the primary endpoint includes participants who are randomized 
and have reported a pain score at T3 regardless of intervention use. The primary endpoint 
is pain intensity measured on the 0-10 scale at the follow-up clinic appointment (T3). The 
pain score will be summarized at each time point and plotted. The T3 pain score will be 
compared between UC and Jacki groups using a Wilcoxon rank sum test. Due to the 
nature of the pain measure (i.e., integers on a 0-10 scale), there will be ties in pain score, 
and the number of ties could affect the performance of the non-parametric test. 
Depending on the structure of the data, a t-test may be considered with a possible 
transformation. Assumptions will be examined and a method selected prior to testing.     
 
Additionally an analysis of covariance (ANCOVA) approach may be considered. Factors 
that may be associated with the T3 pain score (baseline score, time since discharge, 
unilateral vs bilateral mastectomy, number of post-surgical drains, neoadjuvant 
chemotherapy, axillary lymph node dissection, pain management at home with pain 
medication, and post mastectomy clothing) will be assessed univariately and then 
adjusted in a multivariable model. The change in pain over time will also be evaluated 
using linear mixed models.    
 
 
 
13.6 
Analysis of Secondary Endpoints 
 
Other secondary endpoints include other pain measures, breast cancer symptoms, and 
HRQOL which will be measured as described in sections 5 and 10. Scoring and handling 
of missing data will follow the user manual for the EORTC QLQ-C30 and QLQ-BR23. 
Analyses conducted at the final time point will be consistent with the analyses described 
in section 13.5. The change from discharge (T1) to follow-up (T3) will also be evaluated 
for all secondary measures that are measured at both timepoints.  
 
 
13.7 
Reporting and Exclusions 
 
13.7.1 Evaluation of Toxicity 
 
Not applicable. 
 
 
 

NCI Protocol #: N/A 
DF/HCC Protocol #: 16-403 
Protocol Version Date: 11/13/2017 
 
18 
13.7.2 Evaluation of the Primary Efficacy Endpoint 
 
Efficacy will be established if a statistically significant difference of 1.0 or greater on the 
PINS is detected. 
 
 
14. PUBLICATION PLAN 
 
The results should be made public within 24 months of reaching the end of the study. The 
end of the study is the time point at which the last data items are to be reported, or after the 
outcome data are sufficiently mature for analysis, as defined in the section on Sample Size, 
Accrual Rate and Study Duration. If a report is planned to be published in a peer-reviewed 
journal, then that initial release may be an abstract that meets the requirements of the 
International Committee of Medical Journal Editors. A full report of the outcomes should be 
made public no later than three (3) years after the end of the study.  
 
 
 
REFERENCES 
 
 
1. 
Society AC: Breast Cancer, 2016 
 
2. 
Kummerow KL, Du L, Penson DF, et al: Nationwide trends in 
mastectomy for early-stage breast cancer. JAMA Surg 150:9-16, 2015 
 
3. 
Mamtani A, Morrow M: Why Are There So Many Mastectomies in the 
United States? Annu Rev Med, 2016 
 
4. 
Wong SM, Freedman RA, Sagara Y, et al: Growing Use of Contralateral 
Prophylactic Mastectomy Despite no Improvement in Long-term Survival for Invasive Breast 
Cancer. Ann Surg, 2016 
 
5. 
Cemal Y, Albornoz CR, Disa JJ, et al: A paradigm shift in U.S. breast 
reconstruction: Part 2. The influence of changing mastectomy patterns on reconstructive rate and 
method. Plast Reconstr Surg 131:320e-6e, 2013 
 
6. 
Tuttle TM, Abbott A, Arrington A, et al: The increasing use of 
prophylactic mastectomy in the prevention of breast cancer. Curr Oncol Rep 12:16-21, 2010 
 
7. 
Turner EJ, Benson JR, Winters ZE: Techniques in the prevention and 
management of seromas after breast surgery. Future Oncol 10:1049-63, 2014 
 
8. 
Saratzis A, Soumian S, Willetts R, et al: Use of mulitple drains after 
mastectomy is associate with more patient discomfort and longer postoperative stay. Clinical 
Breast Cancer 9:243-246, 2009 
 
9. 
Brett P, Wang E, Mirrer J, et al: Current practice among plastic surgeons 
of antibiotic prophylaxis and closed-suction drains in breast reconstruction: Experience, 
evidence, and implications for postoperative care. Future Oncol 10:1049-63, 2014 
 
10. 
Weaver C: Caring for a patient after mastectomy. Nursing 39:44-8, 2009 
 
11. 
Komen S: The who, what, where, when and sometimes, why, 2015 
 
12. 
American Cancer Society: What to do after surgery or radiation to help 
reduce swelling, 2015 
 
13. 
Cheng S, Yang L, Cheng P, et al: Implementation of arm exercise in post-

NCI Protocol #: N/A 
DF/HCC Protocol #: 16-403 
Protocol Version Date: 11/13/2017 
 
19 
mastectomy breast cancer patients: current status and related factors. Journal of Nursing 47:33-
42, 2000 
 
14. 
Chang S, Mehta V, Langford R: Acute and chronic pain following breast 
surgery. Acute Pain 11:1-4, 2009 
 
15. 
Testa A, Iannace C, Di Libero L: Strengths of early physical rehabilitation 
programs in surgical breast cancer patients: results of a randomized controlled study. Eur J Phys 
Rehabil Med 50:275-84, 2014 
 
16. 
Vadivelu N, Schreck M, Lopez J, et al: Invited commentary: Pain after 
mastectomy and breast reconstruction. The American Surgeon 74:285-96, 2008 
 
17. 
Bruce J, Thornton AJ, Powell R, et al: Psychological, surgical, and 
sociodemographic predictors of pain outcomes after breast cancer surgery: a population-based 
cohort study. Pain 155:232-43, 2014 
 
18. 
Poleshuck EL, Katz J, Andrus CH, et al: Risk factors for chronic pain 
following breast cancer surgery: a prospective study. J Pain 7:626-34, 2006 
 
19. 
Kudel I, Edwards RR, Kozachik S, et al: Predictors and consequences of 
multiple persistent postmastectomy pains. J Pain Symptom Manage 34:619-27, 2007 
 
20. 
Macdonald L, Bruce J, Scott NW, et al: Long-term follow-up of breast 
cancer survivors with post-mastectomy pain syndrome. Br J Cancer 92:225-30, 2005 
 
21. 
Schreiber KL, Martel MO, Shnol H, et al: Persistent pain in 
postmastectomy patients: comparison of psychophysical, medical, surgical, and psychosocial 
characteristics between patients with and without pain. Pain 154:660-8, 2013 
 
22. 
A little Easier Recovery, 2014 
 
23. 
A Little Easier Recovery: Mass General Hospital thank you letter from 
MGH program participants, 2014 
 
24. 
Recovery ALE: Jacki Patient Feedback, 2015, pp 1-48 
 
25. 
McCorkle R, Cooley M, Shea J: A User's Manual for the Symptom 
Distress Scale, 2000 
 
26. 
McCorkle R, Young K: Development of a symptom distress scale. Cancer 
Nurs 1:373-8, 1978 
 
27. 
(PROMIS) P-ROMIS, U.S. Department of Health and Human Services 
 
28. 
Fayers P, Aaronson NK, Bjordal K, et al: EORTC QLQ-C30 scoring 
manual. (ed 3rd ). Brussels, EORTC, 2001  
 
29. 
Kanatas A, Velikova G, Roe B, et al: Patient-reported outcomes in breast 
oncology: a review of validated outcome instruments. Tumori 98:678-88, 2012 
 
30. 
Smith AB, Cocks K, Taylor M, et al: Most domains of the European 
Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 are 
reliable. Journal of Clinical Epidemiology  67:952-957, 2014 
 
 
 

NCI Protocol #: N/A 
DF/HCC Protocol #: 16-403 
Protocol Version Date: 11/13/2017 
 
20 
APPENDIX A 
PARTICIPANT QUESTIONNAIRES 
 

21 
 
Participant Information Form 
 
For each of the following questions, please write your answer in the space provided or circle the number for the 
appropriate response. 
Age:  
 
_____ (on your last birthday) 
Ethnicity:  
1 = Hispanic/Latino 
2 = Not Hispanic/Latino 
3 = Prefer not to answer 
Race: 
 
1 = White/Caucasian 
2 = Black/African American 
3 = Native American/Alaska Native 
4 = Native Hawaiian/Pacific Islander 
5 = Asian 
6 = Prefer not to answer 
Language you 
 
  speak at home: 
1=English 
 
 
2=Spanish 
 
 
3=Other:  _______________________ 
Marital status: 
1 = Single, never married 
2 = Married/partnered 
3 = Separated, divorced, or widowed 
Education: 
1 = Grade school 
2 = Some high school 
3 = High school graduate or G.E.D 
4 = Some college, business or technical school 
5 = College graduate 
6 = Post-graduate degree 
7 = Prefer not to answer 
Work status: 
1 = Retired 
2 = Working part-time 
3 = Working full-time 
4 = Unemployed 
5 = Homemaker 
6 = Student 
7 = Disability 
8 = Other: ______________________ 
 
 
(Circle 1 or more) 
(Highest level) 
(Circle 1 or more) 

 
22 
Reduction of Post Mastectomy Pain with the Jacki® Recovery Jacket:  
Randomized Trial 
 
 
 
QUESTIONNAIRE 1 
 
 
 
 
 
 
Thank you 
 
Thank you in advance for filling out this questionnaire, which asks about your pain level after your 
recent surgery. 
 
All of your answers will be kept private, and you can skip any questions that you do not feel 
comfortable answering. Skipping questions will not affect your treatment in any way. 
 
We hope to learn more about patient’s experiences and how better to manage pain in patients after 
surgery. 
 
When you are finished, please give the questionnaire to the research study coordinator. 
 
 
 
 

 
23 
Please rate today's pain or discomfort on a scale of 0-10 by circling one of the numbers below, 
where 0 means no pain or discomfort and 10 is the worst you could imagine. 
 
 
 
 
 
 
Think about what each statement says, then choose the one statement that most closely indicates 
how you have been feeling during the past week including today.   
 
Pain Frequency 
 
1. I almost never have pain 
2. I have pain once in a while 
3. I have pain several times a week 
4. I am usually in some degree of pain 
5. I am in some degree of pain almost constantly 
 
 
Pain Intensity 
   (If you had no pain during the past week, please choose the first answer.) 
 
1. When I have pain, it is very mild 
2. When I do have pain, it is mildly distressing 
3. When I do have pain, it is fairly intense 
4. The pain I have is very intense 
5. The pain I have is almost unbearable 
 
 

 
2 4 
Pl e a s e r e s p o n d t o e a c h it e m b y m ar ki n g o n e a n s w er p er r o w. 
 
 
I n t h e p a st 7 d a y s... 
 
H a d n o 
p ai n 
Mil d  
M o d er at e  
S e v er e  
V er y 
s e v er e 
H o w i nt e n s e w a s y o ur p ai n at it s 
w or st ?............................ .............. 
 
1 
 
2 
 
3 
 
4 
 
5 
H o w i nt e n s e w a s y o ur a v er a g e 
p ai n ?.............. .............................. 
 
1 
 
2 
 
3 
 
4 
 
5 
 
N o p ai n  
Mil d  
M o d er at e  
S e v er e  
V er y 
s e v er e
W h at i s y o ur l e v el of p ai n ri g ht 
n o w ?.............................. ............. 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
 

 
25 
Reduction of Post Mastectomy Pain with the Jacki® Recovery Jacket:  
Randomized Trial 
 
 
 
QUESTIONNAIRE 3 
 
 
 
 
 
 
Thank you 
 
Thank you in advance for filling out this questionnaire, which asks about your pain level after your 
recent surgery, other side effects, and how you feel about your body and appearance. 
For questions that ask about the “past week” or “past 7 days,” please think about the time 
since you left the hospital after your surgery, even if it has been slightly more or less than one 
week. 
 
All of your answers will be kept private, and you can skip any questions that you do not feel 
comfortable answering. Skipping questions will not affect your treatment in any way. 
 
We hope to learn more about patient’s experiences and how better to manage pain in patients after 
surgery. 
 
When you are finished, please give the questionnaire to the research study coordinator. 
 
 
 
 

 
26 
Please rate today's pain or discomfort on a scale of 0-10 by circling one of the numbers below, 
where 0 means no pain or discomfort and 10 is the worst you could imagine. 
 
 
 
 
 
 
Think about what each statement says, then choose the one statement that most closely indicates 
how you have been feeling during the past week including today.   
 
Pain Frequency 
 
6. I almost never have pain 
7. I have pain once in a while 
8. I have pain several times a week 
9. I am usually in some degree of pain 
10. I am in some degree of pain almost constantly 
 
Pain Intensity 
   (If you had no pain during the past week, please choose the first answer.) 
 
6. When I have pain, it is very mild 
7. When I do have pain, it is mildly distressing 
8. When I do have pain, it is fairly intense 
9. The pain I have is very intense 
10. The pain I have is almost unbearable 
 
 

 
2 7 
Pl e a s e r e s p o n d t o e a c h it e m b y m ar ki n g o n e a n s w er p er r o w. 
 
 
I n t h e p a st 7 d a y s... 
 
H a d n o 
p ai n 
Mil d  
M o d er at e  
S e v er e  
V er y 
s e v er e 
H o w i nt e n s e w a s y o ur p ai n at it s 
w or st ?............................ .............. 
 
1 
 
2 
 
3 
 
4 
 
5 
H o w i nt e n s e w a s y o ur a v er a g e 
p ai n ?.............. .............................. 
 
1 
 
2 
 
3 
 
4 
 
5 
 
N o p ai n  
Mil d  
M o d er at e  
S e v er e  
V er y 
s e v er e
W h at i s y o ur l e v el of p ai n ri g ht 
n o w ?.............................. ............. 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
 
I n t h e p a st 7 d a y s... 
 
N ot at all  
A littl e bit
S o m e w h a
t 
Q uit e a 
bit 
 V er y 
m u c h 
H o w m u c h di d p ai n i nt erf er e wit h 
y o ur d a y t o d a y a c ti viti e s ?........... 
 
1 
 
2 
 
3 
 
4 
 
5 
H o w m u c h di d p ai n i nt erf er e wit h 
w or k ar o u n d t h e h o m e ?............... 
 
1 
 
2 
 
3 
 
4 
 
5 
H o w m u c h di d p ai n i nt erf er e wit h 
y o ur a bilit y t o p arti ci p at e i n s o ci al 
a cti viti e s ?....................... ............. 
 
1 
 
2 
 
3 
 
4 
 
5 
H o w m u c h di d p ai n i nt erf er e wit h 
y o ur h o u s e h ol d c h or e s ?.............. 
 
1 
 
2 
 
3 
 
4 
 
5 
H o w m u c h di d p ai n i nt erf er e wit h 
t hi n g s y o u u s u all y d o f or f u n ?..... 
 
1 
 
2 
 
3 
 
4 
 
5 
H o w m u c h di d p ai n i nt erf er e wit h 
y o ur e nj o y m e nt of s o ci al 
a cti viti e s ?....................... .............. 
 
1 
 
2 
 
3 
 
4 
 
5 
H o w m u c h di d p ai n i nt erf er e wit h 
y o ur e nj o y m e nt of lif e ?................. 
 
1 
 
2 
 
3 
 
4 
 
5 
H o w m u c h di d p ai n i nt erf er e wit h 
y o ur f a mil y lif e ?....... .................... 
 
1 
 
2 
 
3 
 
4 
 
5 
 
If t h er e i s a n yt hi n g el s e y o u w o ul d li k e t o t ell u s a b o ut y o ur p ai n a n d p ai n r eli ef si n c e y o u l eft t h e 
h o s pit al, pl e a s e writ e y o ur c o m m e nt s h er e: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

 
28 
 
We are interested in some things about you and your health. Please answer all of the questions 
yourself by circling the number that best applies to you. There are no "right" or "wrong" answers. 
The information that you provide will remain strictly confidential. 
 
 
 
Not at
All 
A 
Little 
Quite 
a Bit 
Very
Much
1. Do you have any trouble doing strenuous activities,
 
 
like carrying a heavy shopping bag or a suitcase?
1
2 
3
4
 
2. 
 
Do you have any trouble taking a long walk? 
1 
2 
 
3 
4 
 
3. 
 
Do you have any trouble taking a short walk outside of the 
house? 
1 
2 
 
3 
4 
 
4. 
 
Do you need to stay in bed or a chair during the day? 
1 
2 
 
3 
4 
 
5. 
 
Do you need help with eating, dressing, washing
 
 
 
 
 
yourself or using the toilet? 
1
2 
3
4
 
During the past week: 
Not at
All 
A 
Little 
Quite 
a Bit 
Very
Much
 
6. 
 
Were you limited in doing either your work or other daily 
activities? 
1 
2 
 
3 
4 
 
7. 
 
Were you limited in pursuing your hobbies 
or other leisure time activities? 
1 
2 
 
3 
4 
 
8. 
 
Were you short of breath? 
1 
2 
 
3 
4 
 
9. 
 
Have you had pain? 
1 
2 
 
3 
4 
 
10. 
 
Did you need to rest? 
1 
2 
 
3 
4 
 
11. 
 
Have you had trouble sleeping? 
1 
2 
 
3 
4 
 
12. 
 
Have you felt weak? 
1 
2 
 
3 
4 
 
13. 
 
Have you lacked appetite? 
1 
2 
 
3 
4 
 
14. 
 
Have you felt nauseated? 
1 
2 
 
3 
4 
 
15. 
 
Have you vomited? 
1 
2 
 
3 
4 
 
16. 
 
Have you been constipated? 
1 
2 
 
3 
4 
 
 
 

 
29 
 
During the past week: 
Not at
All 
A 
Little 
Quite 
a Bit 
Very
Much
 
17. 
 
Have you had diarrhea? 
1 
2 
 
3 
4 
 
18. 
 
Were you tired? 
1 
2 
 
3 
4 
 
19. 
 
Did pain interfere with your daily activities? 
1 
2 
 
3 
4 
 
20. 
 
Have you had difficulty in concentrating on 
things, like reading a newspaper or 
watching television? 
1 
2 
 
3 
4 
 
21. 
 
Did you feel tense? 
1 
2 
 
3 
4 
 
22. 
 
Did you worry? 
1 
2 
 
3 
4 
 
23. 
 
Did you feel irritable? 
1 
2 
 
3 
4 
 
24. 
 
Did you feel depressed? 
1 
2 
 
3 
4 
 
25. 
 
Have you had difficulty remembering things? 
1 
2 
 
3 
4 
 
26. 
 
Has your physical condition or medical 
treatment interfered with your family life? 
1 
2 
 
3 
4 
 
27. 
 
Has your physical condition or medical 
treatment interfered with your social 
activities? 
1 
2 
 
3 
4 
 
28. 
 
Has your physical condition or medical 
treatment caused you financial 
1 
2 
 
3 
4 
 
 
For the following questions please circle the number between 1 and 7 that best applies to 
you 
 
29.    How would you rate your overall health during the past week? 
 
1                2                3                4                5                6                   7 
Very poor                                                                                                     Excellent 
 
 
30.    How would you rate your overall quality of life during the past week? 
 
1                2                3                4                5                6                   7 
Very poor                                                                                                     Excellent 
 
 

 
30 
Patients sometimes report that they have the following symptoms or problems. Please indicate 
the extent to which you have experienced these symptoms or problems during the past week. 
  
During the past week: 
Not at 
All 
A 
Little 
 
Quite 
a Bit 
 
Very 
Much 
31. Did you have a dry mouth? 
1 
2 
3 
4 
 
32. 
 
Did food and drink taste different than usual? 
1 
2 
 
3 
 
4 
 
33. 
 
Were your eyes painful, irritated or watery? 
1 
2 
 
3 
 
4 
 
34. 
 
Have you lost any hair? 
1 
2 
 
3 
 
4 
 
35. 
 
Answer this question only if you had any 
hair loss: Were you upset by the loss of 
your hair? 
1 
2 
 
3 
 
4 
 
36. 
 
Did you feel ill or unwell? 
1 
2 
 
3 
 
4 
 
37. 
 
Did you have hot flushes? 
1 
2 
 
3 
 
4 
 
38. 
 
Did you have headaches? 
1 
2 
 
3 
 
4 
 
39. 
 
Have you felt physically less 
attractive as a result of your 
disease or treatment? 
1 
2 
 
3 
 
4 
 
40. 
 
Have you been feeling less feminine as 
a result of your disease or treatment? 
1 
2 
 
3 
 
4 
 
41. 
 
Did you find it difficult to look at yourself naked? 
1 
2 
 
3 
 
4 
 
42. 
 
Have you been dissatisfied with your body? 
1 
2 
 
3 
 
4 
 
43. 
 
Were you worried about your health in the 
future? 
1 
2 
 
3 
 
4 
 
Du 
 
ring the past four weeks: 
Not at 
A 
 
Quite 
 
Very 
 
 
All
Little 
a Bit 
Much
 
44. 
 
To what extent were you interested in sex? 
1 
2 
 
3 
 
4 
45. To what extent were you sexually 
active? (with or without intercourse) 
1 
2 
 
3 
 
4 
46. Answer this question only if you have been 
sexually active: To what extent was sex 
enjoyable for you? 
1 
2 
 
3 
 
4 
 
 

 
31 
During the past week: 
Not at 
All 
A 
Little 
Quite 
a Bit 
Very
Much
47. Did you have any pain in your arm or shoulder? 
1 
2 
3 
4
 
48. 
 
Did you have a swollen arm or hand? 
1 
2 
 
3 
 
4
 
49. 
 
Was it difficult to raise your arm or to 
move it sideways? 
1 
2 
 
3 
 
4
 
50. 
 
Have you had any pain in the area 
of your affected breast? 
1 
2 
 
3 
 
4
 
51. 
 
Was the area of your affected breast swollen? 
1 
2 
 
3 
 
4
 
52. 
 
Was the area of your affected breast 
oversensitive? 
1 
2 
 
3 
 
4
 
53. 
 
Have you had skin problems on or in 
the area of your affected breast (e.g., 
itchy, dry, flaky)? 
1 
2 
 
3 
 
4
 
 

 
32 
Reduction of Post Mastectomy Pain with the Jacki® Recovery Jacket:  
Randomized Trial 
 
 
 
QUESTIONNAIRE 2 
 
 
 
 
 
 
Thank you 
 
Thank you in advance for filling out this daily diary questionnaire, which asks about your pain, 
medications for pain, and clothing you wear each day at home after your surgery until you return for 
your follow-up appointment. Please answer the daily diary questionnaire at the end of each day. 
 
All of your answers will be kept private, and you can skip any questions that you do not feel 
comfortable answering. Skipping questions will not affect your treatment in any way. 
 
We hope to learn more about patient’s experiences and how better to manage pain in patients after 
surgery. 
 
Please bring the daily diary questionnaire to your follow-up appointment and give the questionnaire to 
the research study coordinator. 
 
 
 
 
 

 
33 
DAY 1 (The day AFTER you leave the hospital)      
Day of the Week ______________________ 
1. Please enter each pain medication you take throughout the day. If you don’t recall the time or 
number of pills/ tablets for any time you took a pain medication, please enter “unsure”. 
Time of Day 
Name of Pain 
Medication 
Number of Pills/ 
Tablets
Dose per 
Pill/Tablet*
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
 
2. Answer at the end of the day: Did you wear any of the following clothing today? 
Clothing Type 
Worn?   
     (circle your answer)
If Yes,  
     Number of Hours Worn
Jacki® recovery jacket 
Yes      No 
 
Mastectomy bra 
Yes      No 
 
Mastectomy camisole or  
     tank top 
Yes      No 
 
 
 
 
 
3. Answer at the end of the day: Please rate today's pain or discomfort on a scale of 0-10 by 
circling one of the numbers below, where 0 means no pain or discomfort and 10 is the worst you 
could imagine.
 

 
34 
DAY 2  
 
 
 
 
 
Day of the Week___________________ 
1. Please enter each pain medication you take throughout the day. If you don’t recall the time or 
number of pills/ tablets for any time you took a pain medication, please enter “unsure”. 
Time of Day 
Name of Pain 
Medication 
Number of Pills/ 
Tablets
Dose per 
Pill/Tablet*
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
 
2. Answer at the end of the day: Did you wear any of the following clothing today? 
Clothing Type 
Worn?   
     (circle your answer)
If Yes,  
     Number of Hours Worn
Jacki® recovery jacket 
Yes      No 
 
Mastectomy bra 
Yes      No 
 
Mastectomy camisole or  
     tank top 
Yes      No 
 
 
 
 
 
3. Answer at the end of the day: Please rate today's pain or discomfort on a scale of 0-10 by 
circling one of the numbers below, where 0 means no pain or discomfort and 10 is the worst you 
could imagine. 
 

 
35 
DAY 3  
 
 
 
 
 
Day of the Week __________________ 
1. Please enter each pain medication you take throughout the day. If you don’t recall the time or 
number of pills/ tablets for any time you took a pain medication, please enter “unsure”. 
Time of Day 
Name of Pain 
Medication 
Number of Pills/ 
Tablets
Dose per 
Pill/Tablet*
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
 
2. Answer at the end of the day: Did you wear any of the following clothing today? 
Clothing Type 
Worn?   
     (circle your answer)
If Yes,  
     Number of Hours Worn
Jacki® recovery jacket 
Yes      No 
 
Mastectomy bra 
Yes      No 
 
Mastectomy camisole or  
     tank top 
Yes      No 
 
 
 
 
 
3. Answer at the end of the day: Please rate today's pain or discomfort on a scale of 0-10 by 
circling one of the numbers below, where 0 means no pain or discomfort and 10 is the worst you 
could imagine. 

 
36 
DAY 4  
 
 
 
 
 
Day of the Week___________________ 
1. Please enter each pain medication you take throughout the day. If you don’t recall the time or 
number of pills/ tablets for any time you took a pain medication, please enter “unsure”. 
Time of Day 
Name of Pain 
Medication 
Number of Pills/ 
Tablets
Dose per 
Pill/Tablet*
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
 
2. Answer at the end of the day: Did you wear any of the following clothing today? 
Clothing Type 
Worn?   
     (circle your answer)
If Yes,  
     Number of Hours Worn
Jacki® recovery jacket 
Yes      No 
 
Mastectomy bra 
Yes      No 
 
Mastectomy camisole or  
     tank top 
Yes      No 
 
 
 
 
 
3. Answer at the end of the day: Please rate today's pain or discomfort on a scale of 0-10 by 
circling one of the numbers below, where 0 means no pain or discomfort and 10 is the worst you 
could imagine. 
 

 
37 
DAY 5  
 
 
 
 
 
Day of the Week __________________ 
1. Please enter each pain medication you take throughout the day. If you don’t recall the time or 
number of pills/ tablets for any time you took a pain medication, please enter “unsure”. 
Time of Day 
Name of Pain 
Medication 
Number of Pills/ 
Tablets
Dose per 
Pill/Tablet*
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
 
2. Answer at the end of the day: Did you wear any of the following clothing today? 
Clothing Type 
Worn?   
     (circle your answer)
If Yes,  
     Number of Hours Worn
Jacki® recovery jacket 
Yes      No 
 
Mastectomy bra 
Yes      No 
 
Mastectomy camisole or  
     tank top 
Yes      No 
 
 
 
 
 
3. Answer at the end of the day: Please rate today's pain or discomfort on a scale of 0-10 by 
circling one of the numbers below, where 0 means no pain or discomfort and 10 is the worst you 
could imagine. 

 
38 
DAY 6  
 
 
 
 
 
Day of the Week __________________ 
1. Please enter each pain medication you take throughout the day. If you don’t recall the time or 
number of pills/ tablets for any time you took a pain medication, please enter “unsure”. 
Time of Day 
Name of Pain 
Medication 
Number of Pills/ 
Tablets
Dose per 
Pill/Tablet*
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
 
2. Answer at the end of the day: Did you wear any of the following clothing today? 
Clothing Type 
Worn?   
     (circle your answer)
If Yes,  
     Number of Hours Worn
Jacki® recovery jacket 
Yes      No 
 
Mastectomy bra 
Yes      No 
 
Mastectomy camisole or  
     tank top 
Yes      No 
 
 
 
 
 
3. Answer at the end of the day: Please rate today's pain or discomfort on a scale of 0-10 by 
circling one of the numbers below, where 0 means no pain or discomfort and 10 is the worst you 
could imagine. 

 
39 
DAY 7  
 
 
 
 
 
Day of the Week __________________ 
1. Please enter each pain medication you take throughout the day. If you don’t recall the time or 
number of pills/ tablets for any time you took a pain medication, please enter “unsure”. 
Time of Day 
Name of Pain 
Medication 
Number of Pills/ 
Tablets
Dose per 
Pill/Tablet*
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
 
2. Answer at the end of the day: Did you wear any of the following clothing today? 
Clothing Type 
Worn?   
     (circle your answer)
If Yes,  
     Number of Hours Worn
Jacki® recovery jacket 
Yes      No 
 
Mastectomy bra 
Yes      No 
 
Mastectomy camisole or  
     tank top 
Yes      No 
 
 
 
 
 
3. Answer at the end of the day: Please rate today's pain or discomfort on a scale of 0-10 by 
circling one of the numbers below, where 0 means no pain or discomfort and 10 is the worst you 
could imagine. 

 
40 
DAY 8  
 
 
 
 
 
Day of the Week __________________ 
1. Please enter each pain medication you take throughout the day. If you don’t recall the time or 
number of pills/ tablets for any time you took a pain medication, please enter “unsure”. 
Time of Day 
Name of Pain 
Medication 
Number of Pills/ 
Tablets
Dose per 
Pill/Tablet*
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
 
2. Answer at the end of the day: Did you wear any of the following clothing today? 
Clothing Type 
Worn?   
     (circle your answer)
If Yes,  
     Number of Hours Worn
Jacki® recovery jacket 
Yes      No 
 
Mastectomy bra 
Yes      No 
 
Mastectomy camisole or  
     tank top 
Yes      No 
 
 
 
 
 
3. Answer at the end of the day: Please rate today's pain or discomfort on a scale of 0-10 by 
circling one of the numbers below, where 0 means no pain or discomfort and 10 is the worst you 
could imagine. 

 
41 
DAY 9  
 
 
 
 
 
Day of the Week __________________ 
1. Please enter each pain medication you take throughout the day. If you don’t recall the time or 
number of pills/ tablets for any time you took a pain medication, please enter “unsure”. 
Time of Day 
Name of Pain 
Medication 
Number of Pills/ 
Tablets
Dose per 
Pill/Tablet*
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
 
2. Answer at the end of the day: Did you wear any of the following clothing today? 
Clothing Type 
Worn?   
     (circle your answer)
If Yes,  
     Number of Hours Worn
Jacki® recovery jacket 
Yes      No 
 
Mastectomy bra 
Yes      No 
 
Mastectomy camisole or  
     tank top 
Yes      No 
 
 
 
 
 
3. Answer at the end of the day: Please rate today's pain or discomfort on a scale of 0-10 by 
circling one of the numbers below, where 0 means no pain or discomfort and 10 is the worst you 
could imagine. 

 
42 
DAY 10   
 
 
 
 
Day of the Week __________________ 
1. Please enter each pain medication you take throughout the day. If you don’t recall the time or 
number of pills/ tablets for any time you took a pain medication, please enter “unsure”. 
Time of Day 
Name of Pain 
Medication 
Number of Pills/ 
Tablets
Dose per 
Pill/Tablet*
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
              AM/PM 
 
 
                          mg 
 
2. Answer at the end of the day: Did you wear any of the following clothing today? 
Clothing Type 
Worn?   
     (circle your answer)
If Yes,  
     Number of Hours Worn
Jacki® recovery jacket 
Yes      No 
 
Mastectomy bra 
Yes      No 
 
Mastectomy camisole or  
     tank top 
Yes      No 
 
 
 
 
 
3. Answer at the end of the day: Please rate today's pain or discomfort on a scale of 0-10 by 
circling one of the numbers below, where 0 means no pain or discomfort and 10 is the worst you 
could imagine.