Electronic Patient-Reported Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life
Conditions: Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer, Uterine Cancer, Vaginal Cancer, Vulvar Cancer
Sponsor: Memorial Sloan Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center 
IRB Protocol 
IRB#: 08-155A(8) 
Amended:2/28/14 
 
 
 
Electronic Patient-Reported Outcomes from Home in Patients Recovering from Major 
Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life 
 
MSKCC NON-THERAPEUTIC/DIAGNOSTIC PROTOCOL 
 
 
 
Principal Investigator/Department: Dennis S. Chi MD 
Surgery 
 
Co-Principal 
Investigator(s)/Department: 
Ethan Basch, MD 
Epidemiology and Biostatistics 
 
Investigator(s)/Department: 
Martee Hensley, MD 
Medicine 
 
 
 
Consenting 
Professional(s)/Department: 
Dennis S. Chi, MD 
Martee Hensley, MD 
Alexia Iasonos, PhD 
Richard R. Barakat, MD 
Carol L. Brown, MD 
Nadeem R. Abu-Rustum, MD 
Yukio Sonoda, MD 
Douglas Levine, MD 
Mario Leitao, MD 
Ginger Gardner, MD 
Elizabeth Jewell, MD 
Oliver Zivanovic, MD 
Fanny Dao, RSA 
Marissa Mezzancello, CRC 
Kaity Chang, RSA 
Jacquelin Mohr, CRM 
Nicholas Maffetone, RSA 
Shannon Frank, RSA 
Ansley Carnes, RSA 
Amanda Eisinger, RSA 
Surgery 
Medicine 
Epidemiology and Biostatistics 
Surgery 
Surgery 
Surgery 
Surgery 
Surgery 
Surgery 
Surgery 
Surgery 
Surgery 
Surgery 
Surgery 
Surgery 
Surgery 
Surgery 
Surgery 
Surgery 
Surgery 
 
Please Note: A Consenting Professional must have completed the mandatory Human 
Subjects Education and Certification Program. 
 
 
 
 
 
 
Memorial Sloan-Kettering Cancer Center 
1275 York Ave. New 
York, NY 10021 

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Table of Contents 
 
1.0 
PROTOCOL SUMMARY.................................................................................................. 1 
1.1 
BACKGROUND .................................................................................................... 1 
1.2 
SPECIFIC AIMS .................................................................................................... 1 
1.3 
METHODS ............................................................................................................. 2 
1.4 
SIGNIFICANCE..................................................................................................... 3 
2.0 
OBJECTIVES AND SCIENTIFIC AIMS .......................................................................... 4 
2.1 
OBJECTIVE ........................................................................................................... 4 
2.2 
SPECIFIC AIMS .................................................................................................... 4 
3.0 
BACKGROUND AND RATIONALE ............................................................................... 5 
3.1 
OVERVIEW OF PATIENT-REPORTED OUTCOMES (PROS)......................... 5 
3.2 
RATIONALE FOR PATIENT SELF-REPORTING DURING THE POST- 
OPERATIVE PERIOD ........................................................................................... 5 
3.3 
TYPICAL POST-OPERATIVE COURSE FOLLOWING GYNECOLOGIC 
SURGERY AT MSKCC......................................................................................... 8 
3.4 
THE DEVELOPMENT OF THE ONLINE PLATFORM AT MSKCC ................ 8 
3.5 
PRELIMINARY PRO RESEARCH AT MSKCC ................................................. 9 
3.6 
COMPUTER AND INTERNET USE AMONG MSKCC PATIENTS ................. 9 
3.7 
FUTURE DIRECTIONS ...................................................................................... 11 
4.0 
OVERVIEW OF STUDY DESIGN/INTERVENTION .................................................. 11 
4.1 
DESIGN ................................................................................................................ 11 
4.2 
INTERVENTION ................................................................................................. 14 
5.0 
CRITERIA FOR SUBJECT ELIGIBILITY ..................................................................... 17 
5.1 
SUBJECT INCLUSION CRITERIA.................................................................... 17 
5.2 
SUBJECT EXCLUSION CRITERIA................................................................... 17 
6.0 
RECRUITMENT PLAN................................................................................................... 18 
7.0 
ASSESSMENT/EVALUATION PLAN .......................................................................... 18 
7.1 
BASELINE INFORMATION QUESTIONNAIRE .............................................. 18 
7.2 
DEMOGRAPHIC DATA ..................................................................................... 18 
7.3 
WEBCORE QUESTIONNAIRE ITEMS ............................................................. 19 
7.4 
PATIENT SATISFACTION ................................................................................ 20 
7.5 
CLINICIAN EVALUATION OF WEBCORE .................................................... 20 
8.0 
TOXICITIES/SIDE EFFECTS ......................................................................................... 21 
9.0 
PRIMARY AND SECONDARY OUTCOMES .............................................................. 22 
9.1 
PRIMARY OUTCOME........................................................................................ 22 
9.2 
SECONDARY OUTCOMES ............................................................................... 23 
10.0   CRITERIA FOR REMOVAL FROM STUDY ................................................................ 24 
11.0   BIOSTATISTICS ............................................................................................................. 24 
11.1 
SAMPLE SIZE AND ACCRUAL ....................................................................... 24 
11.2 
PRIMARY OBJECTIVE ...................................................................................... 26 
11.3 
SECONDARY OUTCOMES FOR PATIENTS .................................................. 26 
11.4 
SECONDARY OUTCOMES FOR CLINICIANS............................................... 27 
11.5 
MISSING DATA .................................................................................................. 28 
 
 
 
Amended:2/28/14 

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Amended:2/28/14 
 
 
 
12.0   RESEARCH PARTICIPANT REGISTRATION PROCEDURES.................................. 29 
13.0   DATA  MANAGEMENT ISSUES .................................................................................. 29 
13.1 
QUALITY ASSURANCE .................................................................................... 29 
13.2 
WEB SECURITY ................................................................................................. 29 
13.3 
DATA AND SAFETY MONITORING ............................................................... 29 
14.0   PROTECTION OF HUMAN SUBJECTS ....................................................................... 30 
14.1 
RAPID REPORTING OF POTENTIALLY SERIOUS TOXICITIES 
(WEBCORE AUTOMATED ALERTS):............................................................. 30 
14.2 
PRIVACY ............................................................................................................. 31 
14.3 
SERIOUS ADVERSE EVENT (SAE) REPORTING.......................................... 31 
15.0   INFORMED CONSENT PROCEDURES ....................................................................... 32 
16.0   REFERENCE(S)............................................................................................................... 33 
17.0   APPENDICES .................................................................................................................. 36 

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1.0 
PROTOCOL SUMMARY 
 
1.1 
Background 
 
There is a paucity of research on health-related quality of life (HRQL) in patients 
with gynecologic cancer in the 6-week period after major cancer surgery. Publications 
from other surgical disciplines have found that physicians tend to underestimate 
patient symptoms [1, 2]. The NIH, the FDA, and other regulatory agencies [3-5] have 
recognized patient-reported outcomes (PROs) as important in evaluating disease and 
treatment. Reducing the burden of treatment-related symptoms, especially during 
aggressive therapy, is an important cancer care goal. Gynecologic cancer surgery is 
associated with multiple moderate to severe symptoms and potential severe surgical 
complications, especially during the first postoperative month. Effective symptom 
control is depending on timely symptom assessment and sufficient feedback from 
patients to practitioners so that adjustment in symptom control can be initiated. 
Patients are often reluctant to report symptoms, enduring high levels of symptoms. 
The main purpose of this pilot study is to clarify whether patients are willing to self- 
report common toxicity information and quality of life using the WEBCORE system 
via the Internet. Web-based patient self-reporting from home between clinic visits 
could potentially improve the quality of post-operative care through earlier detection 
of symptoms; improve patient-doctor communication; and provide an efficient means 
for data capture in clinical trials evaluating the effects of surgical interventions on 
patient safety and HRQL [6]. However, it is not known as to whether patients will be 
able or willing to self-report symptoms during this period, or if clinicians will find 
this information to be clinically useful. If WEBCORE is utilized and patient feedback 
is generally positive, future investigation will be considered reasonable in order to 
assess the potential value of WEBCORE in postoperative care of cancer patients and 
in the setting of clinical treatment trials. 
 
1.2 
Specific Aims 
 
1.2.1 Primary Aim 
 
This pilot study will assess patient use of WEBCORE, an online system designed 
for cancer patients to self-record toxicity-related symptoms based on NCI 
Common Terminology Criteria for Adverse Events and global quality of life 
(QoL) by European Organization for Research and Treatment of Cancer (EORTC 
QLQ-C30). The primary aim is to determine whether electronic capture of 
patient-reported symptoms and QoL from home is feasible in women recovering 
from major gynecologic cancer surgery during the 6-week post-operative period. 

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coverage will be provided by the designated RSA. In that event, the designated RSA 
Amended: 2/28/14 
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1.2.2 Secondary Aims 
 
1.   To measure the patient assessments of the usefulness of online symptom self- 
reporting in the early post-operative period, and clinician perceptions of its 
potential value in routine outpatient post-operative cancer care. 
 
2.   To evaluate the impact of online symptom self-reporting on patient care 
processes as measured by the number of telephone calls between nurses and 
patients, resulting interventions (as defined as new appointments scheduled, 
instructions to the patient to go to Urgent Care, or 
additions/subtractions/modifications to medications),  and patient satisfaction 
with care delivery. 
 
3.   To identify most commonly reported and most distressing symptoms reported 
by patients after gynecologic cancer surgery and to measure quality of life 
(QoL) during the immediate postoperative period. 
 
1.3 
Methods 
 
This is a single-arm pilot study in which patients with gynecologic malignancies will 
self-report their own symptoms and HRQL during the post-operative period using the 
online platform WEBCORE, which is currently in use in two other MSKCC protocols 
and has previously undergone extensive privacy and security review at MSKCC [7- 
13].  The purpose of the study is to clarify whether patients are willing to self-report 
common toxicity information, and QoL using the WEBCORE system via the internet. 
 
In an evaluation of feasibility, 110 patients recovering from major gynecologic cancer 
surgery with home internet access and regular email use undergoing surgery for 
presumed or confirmed gynecologic cancer will be recruited from MSKCC outpatient 
clinics. Participants will be encouraged to logon to WEBCORE and complete a 
questionnaire once pre-operatively and then weekly starting 7 days after surgery until 
the 6-week post-operative period has ended. Entered information will be stored in a 
secure database located on a firewall-protected MSKCC server. Patients will be 
reminded to logon via email (Appendix 10). Patients who do not logon will receive a 
backup phone call to complete the symptom questionnaire, and to ascertain reasons 
for non-completion of the online survey. 
 
A WEBCORE report summarizing patient symptom trends will be printed and made 
available to the clinician at the time of the post-operative visit. Additionally, if a 
patient submits a response that is concerning according to pre-specified limits set by 
the gynecologic oncology service, an automated email alert flagged as “urgent” and 
titled “severe Patient-reported symptom” will be sent in real-time to the research 
fellow, the designated RSA and the PI of the study. They will forward the email to the 
POA of the patient’s gynecologic oncologist and to the clinic nurse taking patient 
calls for that gynecologic oncologist that day.  (This is the same system used 
presently to triage patient phone calls.) If the research fellow is not available, 

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reporting also affords an opportunity to increase the response time of physicians to 
Amended: 2/28/14 
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will notify the POA of the patient’s gynecologic oncologist and the clinic nurse 
taking patient calls for that gynecologic oncologist that day. No specific responses to 
these emails will be required, but any actions taken in response to these alerts by 
clinicians will be tracked (ie, telephone calls, supportive medication prescriptions, 
new appointments made, etc) using a form emailed to the nurse after the automated 
email alert (Appendix 5) and the “Ambulatory Care Phone/Email Communication 
Form” in the EMR. The forms will be collected by the research fellow or by the 
designated RSA. 
 
It will be emphasized to patients that there is no regular monitoring of information 
entered into WEBCORE, and that they should call their physician’s office if they feel 
that they require medical attention. This will be emphasized to patients in the 
informed Consent, during a WEBCORE training session, and on the WEBCORE 
website. In addition, anytime a patient enters a potentially concerning response into 
WEBCORE, a popup box will appear on the screen reminding her to consider calling 
her physician. 
 
If 80% of enrolled patients with home Internet access login to WEBCORE at least 
four times during the study period we will consider WEBCORE a strategy warranting 
larger scale evaluation. Patient assessment of the usefulness of WEBCORE will be 
measured via an exit survey. Clinician perceptions of the potential value of 
WEBCORE will be evaluated via an email survey and questions asked at a team 
meeting.  Reasons for patient non-compliance will be assessed via results of the 
backup telephone calls to those who failed to login, and with the exit survey. 
 
Potential benefits of this use of the WEBCORE platform in this context will be 
assessed by measuring the number and type of clinical interventions made in response 
to WEBCORE alerts, and by analyzing patient use of WEBCORE in relation to dates 
of surgery and development of documented post-surgical complications. 
 
1.4 
Significance 
Cancer patients commonly express an interest in shared decision-making and access 
to information towards treatment decisions [14-17]. Reducing the burden of 
treatment-related symptoms, especially during aggressive therapy, is an important 
cancer care goal. Gynecologic cancer surgery is associated with multiple moderate to 
severe symptoms and potentially severe adverse events and complications, especially 
during the first postoperative month. Effective symptom control is depending on 
timely symptom assessment and sufficient feedback from patients to practitioners so 
that adjustment in symptom control can be effective. Patients are often reluctant to 
report symptoms, enduring high levels of symptoms. If electronic patient self- 
reporting is found to be a feasible strategy for post-operative monitoring of 
symptoms, this could potentially become a widespread approach for communicating 
with patients between visits, automatically monitoring for concerning symptoms, 
reducing morbidity, and improving patient satisfaction overall. Real-time electronic 

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severe toxicities, which may have particular relevance in the postoperative setting. 
Enhanced timely provider-patient communication about symptoms could reduce post- 
operative symptom burden, severity of complications and readmission/ 
hospitalization. In the future, data collected online, could be analyzed and used for the 
development of patient education tools.  In the clinical trial setting, this approach 
could improve the efficiency of collecting data from patients, and provide a source of 
symptom and HRQL information for use as clinical trial endpoints and/or toxicity 
documentation.  This is consistent with the mission of the NIH [4], and will inform 
future grant submissions. 
 
2.0 
OBJECTIVES AND SCIENTIFIC AIMS 
 
2.1 
Objective 
 
The overall objective of this study is to assess if online self-reporting of 
symptoms in the post-operative period is feasible and well-accepted by patients 
and clinicians. 
 
2.2 
Specific aims 
 
2.2.1 Primary Aim 
 
To determine whether electronic capture of patient-reported symptoms from 
home is feasible in women recovering from major gynecologic cancer surgery 
during the 6-week post-operative period. 
 
2.2.2 Secondary Aims 
 
• 
To measure patient assessments of the usefulness of online symptom self- 
reporting in the post-operative period, and clinician perceptions of its potential 
value in routine outpatient post-operative cancer care. 
 
• 
To evaluate the impact of online symptom self-reporting on patient care 
processes as measured by the number of telephone calls between nurses 
and patients, resulting interventions (as defined as new appointments 
scheduled, instructions to the patient to go to Urgent Care, or 
additions/subtractions/modifications to medications),  and patient 
satisfaction with care delivery. 
 
• 
To identify most commonly reported and most distressing symptoms reported 
by patients after gynecologic cancer surgery and to measure quality of life 
(QoL) during the acute postoperative period. 

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3.0 
BACKGROUND AND RATIONALE 
 
3.1 
Overview of Patient-Reported Outcomes (PROs) 
 
The purpose of this pilot study is to clarify whether patients are willing to self-report 
common toxicity information and quality of life using the WEBCORE system via the 
Internet. The impact on patients of cancer treatment and its adverse effects have been 
identified as essential outcomes for health professionals to consider during routine 
clinical practice and in clinical trials [3]. We are interested in two types of PRO’s: 
HRQL and post-operative symptoms.  HRQL has been described by Cella as, “the 
extent to which one’s usual or expected physical, emotional and social well-being is 
affected by a medical condition and/or its treatment” [3]. Patients are interested in 
how surgery will affect their HRQL, and surgeons are interested in how to maximize 
their patients’ HRQL.  Clinically speaking, post-operative symptoms and HRQL are 
important indicators of the impact of surgery and could be used for earlier 
identification of complications.  The FDA and NCI have asserted that these 
phenomena are best evaluated by patients directly without being filtered by clinicians 
or anyone else, in the form of patient reported outcomes (PROs)[5] 
According to the 2006 FDA Draft Guidance on the use of PROs in clinical research, 
“a PRO is any report that comes directly from a patient about a health condition or its 
treatment without interpretation of the patient’s response by a clinician or anyone 
else” [3,5].  As a result of this guidance, increasing emphasis has been placed on the 
appropriate use of PROs in clinical trials for detecting potentially concerning adverse 
effects and complications of cancer and its treatments.   The NIH has sponsored a 
national initiative (PROMIS), a key project of the Roadmap Initiative, with an 
overarching goal to improve assessment methods of self-reported symptoms and 
HRQL outcomes in chronic diseases including cancer [4].  Included in that project is 
the development of a national databank of PRO items and instruments. The NCI and 
the American Cancer Society have both prioritized the integration of PROs into 
clinical practice and research, as demonstrated by the joint NCI-ACS-FDA hosting of 
the Patient Reported Outcomes in Cancer Trials (PROACT) conference in September 
of 2006.  The conference sought to identify circumstances in which PROs are 
indicated, best practices for their use, and to establish a platform from which PROs 
can be efficiently incorporated into NCI clinical trails [18]. 
 
3.2 
Rationale for Patient Self-Reporting during the Post-Operative Period 
 
There is a paucity of data available regarding patient-reported symptoms and HRQL 
in gynecologic cancer patients in the immediate 6 weeks following surgery.  In most 
trials of post-operative gynecologic cancer patients, HRQL surveys have been 
administered at baseline and 3 months post-operatively, time points that do not 
address the immediate post-operative period.  The only well-publicized trial to do so 
was LAP-2, a Gynecologic Oncology Group (GOG) study comparing laparoscopy to 
laparotomy in early stage endometrial cancer that evaluated HRQL using validated 

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study have not yet been published.  Due to the lack of data on symptoms and HRQL 
in post-operative gynecologic cancer patients, gynecologic surgeons’ expectations of 
what symptoms “normally” occur in the post-operative period are based largely on 
anecdotal experiences. Furthermore, it is not clear which symptoms are most 
commonly reported and which are found to be most distressing for patients 
undergoing gynecologic cancer surgery. 
 
While there is no data on PROs in patients recovering from major gynecologic cancer 
surgery, there is data comparing patient-reported symptoms to surgeon’s observations 
from other surgical specialties.  Studies in urology indicate that physicians tend to 
underestimate patient symptoms [1, 2].  For example, in a review of patient-reported 
complications after radical prostatectomy, authors noted a discrepancy in estimates of 
urinary wetness and post-surgical procedures compared to clinician reports [1]. Over 
60% of study respondents reported some problem with wetness with 40% of patients 
stating that they drip urine when coughing or experiencing full bladders.  These 
figures were also greater overall than the weighted average number of patients having 
“any incontinence” based on published literature. Published rates of erectile 
dysfunction after various radical prostatectomy techniques based on clinician 
reporting have been reported as inaccurately low as well compared to patient 
reporting.  In a cohort study of self-reported sexual and urinary dysfunction among 
patients receiving nerve-sparing radical prostatectomy, patients did not report better- 
preserved postoperative sexual function despite younger age, better pre-operative 
sexual function and favorable clinical prognostic factors [19].  Recently, a group from 
M.D. Anderson presented their results of a randomized trial using a computerized 
telephone monitoring system to reduce postoperative symptoms in cancer patients 
after thoracic surgery [20]. Their goal was to see if enhancing timely provider-patient 
communication about symptoms would reduce post-operative symptom burden. They 
identified 5 most common and distressing symptoms reported by patients after 
surgery (pain, distress, sleep problems, shortness of breath and constipation). 
Providers were alerted via e-mail when symptom severity was exceeded. The used 
symptom tracking system was associated with fewer supra-threshold symptoms, 
reduced symptom severity, and lower symptom-related interference in cancer patients 
after thoracic surgery. 
 
The discrepancy between surgeons’ clinical impressions and patient’s self-reported 
symptoms underscores the need for patient-reported HRQL data. 
 
The lack of normative data available for the post-operative period has implications for 
patients and clinicians.  Without information on the post-operative period from the 
perspective of the patient, it is difficult to adequately prepare patients for what to 
expect as they recover from major surgery. Montgomery et al. found, in a cohort of 
women undergoing ambulatory breast cancer surgery, that post-surgical pain and 
fatigue is related to pre-surgical expectations [21]. A Cochrane review of pre- 

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scales administered in clinic at baseline, 3 weeks and 6 weeks.  The results of this 
 
 
 
operative patient education in patients undergoing knee or hip surgery found no 
significant decrease in post-operative pain related to the intervention, but a decrease 
in pre-operative anxiety was observed [22, 23]. A qualitative study of nurses working 
on a surgical unit at a large teaching hospital in Ireland revealed a wide variation in 
skill and comfort delivering pre-operative education, which was related to knowledge 
of the material and lack of structured programs [24].  Pre-operative teaching is likely 
hampered by limited knowledge about what symptoms and effects on HRQL are to be 
expected during the post-operative period. 
 
Home-reported symptom and HRQL data could be useful in the early identification of 
post-operative complications.  At our service, between 2001 and 2005 there was an 
8% rate of major complications (those that led to invasive radiologic intervention, re- 
operation, unplanned ICU admission, chronic disability or death within 30 days of 
surgery) associated with laparotomy on the gynecology service (internal data).  When 
considering all complications, major and minor, the rate is close to 15%.  Common 
complications include ileus, urinary tract infection, wound breakdown or wound 
infection.  Less common but more serious complications include pulmonary 
embolism, bleeding, abscess and small or large bowel obstruction. While it is possible 
to identify characteristics that place patients at higher risk for complications, 
definitive predictors have not yet been established.  Potentially a deviation from 
“normal” expected symptoms or HRQL in the post-operative course could be an early 
indicator of a developing complication (eg, increasing abdominal pain, intractable 
nausea, vomiting, appetite loss, change in bowel function, shortness of breath, 
excessive fatigue, etc). Effective symptom control is depending on timely symptom 
assessment and sufficient feedback from patients to practitioners so that adjustment in 
symptom control can be effective. Patients are often reluctant to report symptoms, 
enduring high levels of symptoms. Thus, enhanced timely provider-patient 
communication about symptoms could reduce post-operative symptom burden, 
severity of complications and readmission/ hospitalization. . 
 
Web-based reporting could be an efficient form of data capture for clinical trials that 
evaluate the effects of surgical interventions on patient safety and quality of life. 
Online PROs minimize error and allow for prospective data banking. Web-based 
surveys have the potential to decrease the number of steps involved in data collection, 
maximizing efficiency and minimizing error. With home internet access becoming 
more widespread, online surveys may increase the accessibility to subjects and, in 
turn, increase response rate. Studies of response rates in patients and physicians have 
been conflicting so far—in some studies internet response rates are lower than those 
with pen-and-paper, though others show internet response rates at higher than 90% 
[25-27]. It is unclear if patients recovering from major gynecologic cancer surgery 
will be more or less apt to respond to questionnaires electronically, which is a 
rationale for conducting this study of feasibility. 

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The goal of post-operative care is to identify and deal with potential surgical 
complications, as well as promote a rapid recovery to the maximal level of 
functioning attainable, and to control symptoms.  Patients are integral to these 
processes and are generally instructed to self-monitor for concerning symptoms and 
call or come to the Urgent Care Unit if specific or severe symptoms occur.  It is 
therefore already recognized that the patient is best equipped to evaluate her own 
level of functioning. 
 
However, there is currently no standard protocol for post-operative monitoring on the 
gynecology service at MSKCC, which is related to the lack of available data on 
symptoms in the post-operative period (Section 3.2).  Patients who have a vertical 
skin incision closed with staples return on average will be discharged on 
postoperative day 6 (internal data). They return to the hospital between ten to fourteen 
days following surgery for staple removal and an incision check by a physician’s 
assistant or fellow.  A post-operative visit with the attending surgeon occurs 
anywhere between 3 and 6 weeks after surgery, depending on surgeon preference.  If 
a patient has a problem after surgery, she will call the surgeon’s nurse, or at night, the 
fellow on call. Patients who have more concerning symptoms such as dyspnea, 
intractable emesis, obstipation or bleeding will be encouraged to come to the Urgent 
Care Center or to the office.  Less concerning symptoms like mild nausea, 
constipation or moderate pain often can be addressed via phone. This approach 
depends on the willingness of the patient to call and a clinician to respond and 
intervene in a timely manner.  However, patients have different thresholds for calling. 
Patients could be enduring unnecessary discomfort and experience potentially life- 
threatening conditions due to under-reporting or underestimation of the severity of 
specific symptoms – but this is currently unknown due to lack of data in this area. 
Enhanced timely provider-patient communication about symptoms could reduce post- 
operative symptom burden, severity of complications and readmission/ 
hospitalization. 
 
3.4 
The Development of the Online Platform at MSKCC 
 
The online platform we plan to use in his study is the WEBCORE system, which is 
currently being used in MSKCC protocols 04-020 and 07-034 (CALGB 70501) and 
has previously undergone security and privacy reviews at MSKCC.  The WEBCORE 
system was developed at MSKCC as a collaboration between study Investigators in 
the Departments of Medicine, Epidemiology and Biostatistics (including members of 
its Computing Resource group who maintain the infrastructure of the CRDB), and 
Information Systems.  During the creation of WEBCORE, aesthetic aspects of the 
questionnaire and user-friendliness of the interface were improved based on feedback 
from the initial cohort of patients in the gynecologic oncology clinic receiving 
chemotherapy. Usability testing was also conducted. The technical functionality of 

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Typical Post-operative Course following Gynecologic Surgery at MSKCC 
3.3 
returned questionnaires (223 patients and 220 companions).  The mean age of patients 
Amended: 2/28/14 
9
 
 
 
WEBCORE is maintained by software designers in Information Systems with 
collaboration from members of the Computing Resource Group in Epidemiology and 
Biostatistics.  Security issues are described in Section 13.2, the logistics of logging 
into WEBCORE in Section 4.2.3, and generation of WEBCORE Reports for clinician 
use in Section 4.2.4.  A diagram of the system architecture/server configuration is 
reproduced in Appendix 7. 
 
3.5 
Preliminary PRO Research at MSKCC 
 
Ethan Basch MD, a Co-Investigator for this protocol, conducted a feasibility study in 
110 patients with gynecologic malignancies receiving chemotherapy to evaluate 
patients’ ability and willingness to self-report toxicity-related symptoms of 
chemotherapy toxicity online or on clinic portals [13].  The WEBCORE secure web- 
based PRO platform was used for this study [10].  During an 8-week observation 
period, 80% of patients used the system to self-report without prompting. Most 
patients (96%) found WEBCORE easy to use, and 98% would recommend it to 
others.  In addition, clinicians responded to WEBCORE-generated alerts for 
potentially concerning symptoms: there were 42 automated email alerts sent to 
clinicians due to grade 3 or 4 chemotherapy toxicities triggered by 16 different 
patients from home computers.  These alerts prompted seven telephone contacts, 
three medication changes, and three new scheduled appointments. 
 
A follow-up study in 100 patients with lung cancer receiving chemotherapy yielded 
similar results [7, 10], demonstrating that WEBCORE has been pilot tested for 
general feasibility and acceptability.  Dr. Basch is currently conducting a randomized 
controlled trial to determine if patient self-reporting of symptoms during 
chemotherapy impacts on efficiency or clinical outcomes, as well as a multi-center 
feasibility study of PROs in the CALGB. 
 
While electronic capture of PROs has been shown to be longitudinally feasible in 
patients treated nonsurgically for gynecologic cancer [13, 28], this group is different 
than women undergoing extensive surgery, who experience significant short-term 
disability during recovery. The ability and willingness of gynecologic cancer patients 
to electronically report post-operative outcomes has not been assessed.  Symptom and 
HRQL information elicited via these methods could potentially improve outcomes 
and detect complications earlier. 
 
3.6 
Computer and Internet Use Among MSKCC Patients 
Implementation and evaluation of an Internet-based tool for patients depends on the 
ability of patients to access and use a computer/the Internet.  In order to characterize 
Internet use by MSKCC patients and their companions, Dr. Basch and Dr. Deborah 
Schrag conducted an anonymous waiting-room survey of patients presenting to the 
general surgical and medical oncology outpatient departments between December 
1999 and February 2000 [29].  Of the 625 individuals approached, 443 completed and 

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diagnosis (45%), followed by pancreatic/biliary (8%), gastro-esophageal (8%), 
hepatic (6%), sarcoma (5%), and endocrine (5%).  Among the respondents, 64% of 
patients and 76% of companions owned computers, and Internet access was available 
at home to 58% and 68% respectively (Table 1). 
 
Table 1: MSKCC Survey Results (12/99 – 2/00) 
 
Cancer patients with home computers 
64% 
Companions of cancer patients with home 
computers 
76% 
Cancer patients with home Internet access 
58% 
Companions of cancer patients with home 
Internet access 
68% 
 
In November-December 2003, Dr. Basch conducted an informal anonymous survey 
of 90 patients (30 with gynecologic malignancies, 30 with lung cancer, 30 with 
prostate cancer) in waiting-areas of the MSKCC outpatient clinics (Table 2).  Ages 
ranged from 40 to 84.  The majority of patients noted regular access to the Internet. 
All patients without regular access to a computer or the Internet were older than 75 
years, whereas all patients younger than 75 years had regular access.  Of the patients 
who used the Internet, one patient used the Internet at a library, all others at home. 
All patients with home access expressed interest in electronic symptom self-tracking. 
When shown a demonstration of WEBCORE (the version used for tracking 
chemotherapy toxicity), all patients with Internet experience stated they would be 
interested in regularly using WEBCORE. 
 
Table 2: Informal MSKCC Survey of 90 Outpatients Receiving 
Chemotherapy (11-12/03) 
 
GYN 
LUNG 
PROSTATE 
Do you have regular access to a 
computer (home, library, other)? 
83% 
68% 
83% 
Do you use the Internet regularly? 
(If not, is there somebody at home 
who does?) 
73% 
(50%) 
65% 
(56%) 
70% 
(60%) 
Do you use email? 
60% 
48% 
64% 
Would you be interested in 
regularly using WEBCORE to enter 
symptom information into an 
electronic diary over the Internet? 
80% 
70% 
88% 

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was 59-years-old, and 43% were female.  Colorectal cancer was the most common 
The overall objective of this study is to assess if online self-reporting of symptoms in 
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As of October 2007, 79% of U.S. adults are online, and of those, 72% access the 
internet from home. Use is generally greatest among individuals who are younger, 
more affluent, better-educated, and white, although use is increasing among those 
over 50 years-old and with incomes below $25,000 [30]. 
 
A 2006 study by the Pew Research Center found that 80 percent of internet users, or 
113 million U.S. adults, seek health information online, and that women are more 
likely to do so than men [31].  Surveys suggest significant numbers of patients want 
to communicate with physicians over the Internet [32, 33].  Many patients consider 
use of the Internet to enhance the patient-physician relationship [34, 35]. Most U.S. 
physicians regularly access the Internet and use daily email, and an increasing 
number communicate with patients via email [36-41]. Preliminary research suggests 
that online access to patient records and secure online communication with health 
providers may decrease the amount of patient follow up visits among chronically ill 
patients [42], leaving more time for new patient visits, or patients with more pressing 
concerns. 
 
Despite a large number of informational web sites available for cancer patients [43], 
there is little opportunity for patients to use electronic resources to record their 
symptoms or communicate with clinicians.  For cancer patients receiving routine 
outpatient care, the development of resources such as WEBCORE may allow for 
linking to more appropriate informational services, may foster better discussions with 
clinicians, save time, and inform better treatment decisions. 
 
3.7 
Future Directions 
 
If this preliminary work finds the PRO approach to data collection to be feasible in the 
post-operative setting, it could lay the groundwork for:1) further evaluations of 
feasibility in other populations (ie, underserved, non-English speaking);2) a 
randomized trial to determine if patient self-reporting in the post-operative setting 
improves clinical outcomes (complication rates/morbidity, satisfaction with care, etc); 
and 3) assessments of this data collection method in the multi-center clinical trial 
setting (eg, nested in a GOG or CALGB treatment trial).  In addition, follow-up work 
would be merited to refine the questionnaire items and electronic platform, and to 
devise backup data collection methods for patients who are unable or unwilling to 
complete electronic questionnaires. 
 
4.0 
OVERVIEW OF STUDY DESIGN/INTERVENTION 
4.1 
Design 
This pilot study will assess patient use of WEBCORE, an online system designed for 
cancer patients to self-record toxicity-related symptoms based on NCI Common 
Terminology Criteria for Adverse Events and global quality of life (QoL) by 
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the post-operative period is feasible and well-accepted by patients and clinicians. This 
is a single-arm pilot study in which patients with gynecologic malignancies will self- 
report their own symptoms and HRQL during the post-operative period using the 
online platform WEBCORE. 
Eighty patients with home internet access and regular email use undergoing 
laparotomy for presumed or confirmed gynecologic cancer will be recruited from 
MSKCC outpatient clinics. Enrollees will be sent weekly email reminders to login to 
WEBCORE from home (Appendix 10).  Participants will be expected to complete the 
questionnaire once pre-operatively and then weekly starting 7 days after surgery until 
the 6-week post-operative period has ended.  Entered information will be stored in a 
secure database located on a firewall-protected MSKCC server. If an enrolled patient 
fails to login and self-report within 24 hours of the automated reminder, a second 
reminder email will be sent.  If the patient again fails to respond, a backup telephone 
call to the patient will be made by the clinical research fellow coordinating this study. 
The back-up phone call will be made within a week of the initial missed 
questionnaire. If the patient is unreachable, a total of 3 attempts will be made to reach 
the patient.  The fellow will use a semi-scripted approach to complete the symptom 
questionnaire, and to ascertain reasons for non-completion of the online survey. 
 
A WEBCORE report summarizing patient symptom trends will be printed and made 
available to the clinician at the time of the post-operative visit. Additionally, if a 
patient submits a response that is concerning according to pre-specified limits set by 
the gynecologic oncology service, an automated email alert flagged as “urgent” and 
titled “severe Patient-reported symptom” will be sent in real-time to the research 
fellow, the designated RSA and the PI of the study. The research fellow will forward 
the email to the POA of the patient’s gynecologic oncologist and to the clinic nurse 
taking patient calls for that gynecologic oncologist that day.  (This is the same system 
used presently to triage patient phone calls.) If the research fellow is not available, 
coverage will be provided by the designated RSA. In that event, the designated RSA 
will notify the POA of the patient’s gynecologic oncologist and the clinic nurse 
taking patient calls for that gynecologic oncologist that day. No specific responses to 
these emails will be required, but any actions taken in response to these alerts by 
clinicians will be tracked (ie, telephone calls, supportive medication prescriptions, 
new appointments made, etc) using a form emailed to the nurse after the automated 
email alert (Appendix 5) and the “Ambulatory Care Phone/Email Communication 
Form” in the EMR. The forms will be collected by the research fellow or by the 
designated RSA. 
 
It will be emphasized to patients that there is no regular monitoring of information 
entered into WEBCORE.  In addition, anytime a patient enters a potentially 
concerning response into WEBCORE, a popup box will appear on the screen 
reminding her to consider calling her physician. 

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We will consider the results of this feasibility study to suggest that WEBCORE is a 
strategy warranting larger scale evaluation if approximately 80% of enrolled patients 
login to WEBCORE at least four times from the time of enrollment until six weeks 
following surgery.  Patient assessment of the usefulness of WEBCORE will be 
measured via an exit survey.  Clinician perceptions of the potential value of 
WEBCORE will be evaluated via an email survey and questions asked at a team 
meeting.  Reasons for patient non-compliance will be assessed via results of the 
backup telephone calls to those who failed to login, and with the exit survey. 
 
Potential benefits of this use of the WEBCORE platform in this context will be 
assessed by measuring the number and type of clinical interventions made in response 
to WEBCORE alerts, and by analyzing patient use of WEBCORE in relation to dates 
of surgery and development of documented post-surgical complications. 
 
4.1.2 Patient Accrual 
This pilot study will be undertaken in patients undergoing laparotomy for 
presumed or confirmed gynecologic malignancy at MSKCC.  Approximately 80% 
of all laparotomies on the gynecology service are performed for endometrial or 
ovarian cancer, split relatively evenly between the two (internal data).  We 
anticipate a similar representation in our study population. We will enroll the first 
5 patients of 110 patients as a small pilot to identify potential problems and 
correct any issues that may arise. After the evaluation of the first 5 patients the 
accrual period will remain open until at least 80 evaluable patients are enrolled. 
 
4.1.3 Study Period 
 
Duration: For each patient, we will define a study interval beginning on the day 
of the pre-operative consent when the baseline questionnaire is performed, until 
the exit patient satisfaction interview takes place, which will be 6-8 weeks 
following the operative date. 
 
Justification: There is no absolute definition of the post-operative period, 
although the Agency for Healthcare Research and Quality (AHRQ) [44] and the 
Surgical Care Improvement Project (SCIP) [45] generally set patient safety goals 
for the 30 day period following surgery. At Memorial Sloan-Kettering Cancer 
Center, post-operative complications are defined as those events occurring within 
30 days of surgery [46], and the gynecology service has prospectively tracked and 
graded surgical complications for the last several years. We chose to have patients 
report symptoms up to and including the sixth week post-operatively because the 
duration of the post-operative period is poorly defined, and there may be value to 
the data we collect beyond 30 days. We expect to see an improvement in patients’ 
scores on the EORTC QLQ-30, and the individual items from the CTCAE by the 
end of the reporting period (6 weeks). 

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4.2 
Intervention 
Descriptions of the specific instruments are available in Section 7, and the 
instruments themselves are available in the appendices. 
 
 
Table 3: List of Interventions 
 
Instrument 
Method of 
Administration 
Population Evaluates 
European Organization for 
Research and Treatment of Cancer 
QLQ-C30 
(Appendix 4) 
WEBCORE 
Patients 
HRQL, specific 
post-operative 
symptoms 
Common Toxicity Criteria 
(Appendix 3) 
WEBCORE 
Patients 
Urinary symptoms, 
wound symptoms 
Baseline Patient Information 
Questionnaire 
(Appendix 1) 
Paper 
Patients 
Demographics, 
computer 
knowledge 
Patient Satisfaction Interview 
(Appendix 2) 
WEBCORE 
Patients 
Satisfaction with 
WEBCORE 
Nurse Intervention Report 
(Appendix 5) 
Email 
Clinic 
Nurses 
Response(s) to 
automated email 
alerts 
Clinician Survey 
(Appendix 8) 
Email 
Clinic 
Nurses 
Satisfaction with 
WEBCORE 
Clinician Exit Meeting Questions 
(Appendix 6) 
Focus Group 
Physicians, 
Nurses, 
Session 
Assistants 
Satisfaction with 
WEBCORE 
 
4.2.1 The Online Platform 
This design consists of a homepage for patients to login to WEBCORE, followed 
by screens containing a single question on each page. This design was refined 
through usability testing at MSKCC. 
 
4.2.1 Patient Training Sessions 
 
At the time of enrollment, each subject will undergo a 10-minute training session 
for the WEBCORE system on an Internet-enabled computer.  This training 
session will be conducted by the clinical research fellow coordinating this study 
or a designated RSA/session assistant using a computer located in a private 

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patient computing area on the 6th floor of the MSKCC 53rd street outpatient clinic 

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building. The designated RSA will be trained by the research fellow before 
training the enrolled subjects. A wall-mounted touch-screen computer has 
previously been installed in a private area on this floor for 04-020 which may be 
used, or a wireless touch-screen laptop may be brought to the patient in a private 
area.  Training will be identical to the training in currently open WEBCORE 
studies, and will include: 
 
• Provision of a unique username/password and URL for WEBCORE. 
 
• Instruction on how to navigate to the WEBCORE data entry frontpage 
using the Internet. 
 
• Instructions on how to login to WEBCORE, enter personal information 
about symptoms and quality of life. 
 
• Instructions that information entered into WEBCORE will not be 
reviewed by MSKCC personnel in real-time.  It will be clearly stated 
during training that WEBCORE cannot be relied upon as a means of 
communicating information to clinicians.  Patients will therefore be 
instructed to contact their health care provider(s) by telephone in cases of 
severe or concerning symptoms that arise between appointments, exactly 
as they would be instructed to do in the absence of WEBCORE use. 
 
• A telephone number for technical assistance. 
 
4.2.2 Clinician Training 
Standardized training for participating MSKCC staff will be instituted prior to 
initiation of this protocol. In addition, a study investigator will be available 
during clinic visits to answer questions of staff, and to remind them of training 
points.  Initial staff training will include: 
• 
Showing applicable staff how to access and login to the WEBCORE 
administrative site using computers located in clinic. 
 
• 
Explaining logoff procedures in order to assure the privacy of PHI. 
 
• 
Demonstrating how to view and print WEBCORE Reports for participating 
patients, for use during clinic visits. 
 
• 
Explaining to clinicians how to interpret WEBCORE Reports. 
 
• 
Clarifying that printing WEBCORE Reports for inclusion with other visit 
materials is a mandatory part of this protocol, and must be done each time a 
participating patient has an appointment. 
 
• 
Encouraging clinicians to discuss the results of WEBCORE reports with 
patients during visits. 

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4.2.3 Logging into WEBCORE 
 
Subjects are expected to login to WEBCORE once weekly from a home computer 
to fill out the online questionnaire.  Subjects will be able to login to WEBCORE 
from any Internet-accessible computer whenever they wish to record symptoms, 
even if it is more frequently than the recommended weekly interval.  Patients will 
be sent email reminders on the day they are due to login to WEBCORE  which are 
identical to the email reminders currently in use in 04-020 (Appendix 10), and a 
follow-up email reminder email will be sent when they are overdue to login. 
Those who fail to respond to the follow-up email will receive a backup telephone 
call to administer the questionnaire and assess reasons for non-compliance. 
 
Each time a patient logs in to the WEBCORE website, he or she will respond to 
items in the questionnaire, and these responses will be securely stored in the 
MSKCC Clinical Research Database (CRDB). 
 
Technical assistance accessing the system will be available 24 hours.  Patients 
will not be offered any financial incentives to login. 
 
4.2.4 Generation of WEBCORE Reports at Outpatient Visits 
 
Based on information entered into WEBCORE and recorded in the WEBCORE 
database, it will be possible to generate summary “WEBCORE Reports” which 
track symptom trends over time for each patient who is assigned to use 
WEBCORE, in list or graphic form. 
 
When a study participant comes for an office visit either during the study time 
period and/or for her first visiting following the end of the study period, her 
WEBCORE Report will be printed by clinic session assistants or an RSA.  The 
report will then be added to other materials that are routinely reviewed by the 
nurse and/or gynecologic oncologist as a part of standard care (eg, laboratory test 
printouts, radiology results, procedure reports, or past clinic visit dictations).  The 
Report printout will be the second page of these materials. 
 
The technical functionality of WEBCORE will be designed such that information 
entered by patients just prior to clinic visits will be available immediately for 
printing in WEBCORE Reports (and thus for clinician review during that visit). 
Printing capabilities in the clinician work areas are readily available. 
 
4.2.5 Warning Emails and Popup Messages 
 
If a patient self-reports a severe or disabling level of severity for any symptom(s) 
into WEBCORE an automated warning email flagged as “urgent” and titled 
“severe Patient-related symptom” will be sent in real-time to the research fellow, 
the designated RSA and the PI of the study. They will forward the email to the 
POA of the patient’s gynecologic oncologist and to the clinic nurse taking patient 
calls for that gynecologic oncologist that day.  (This is the same system used 
presently to triage patient phone calls.) If the research fellow is not available, 

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coverage will be provided by the designated RSA. In that event, the designated 
RSA will notify the POA of the patient’s gynecologic oncologist and the clinic 
nurse taking patient calls for that gynecologic oncologist that day. No specific 
responses to these emails will be required, but any actions taken in response to 
these alerts by clinicians will be tracked (ie, telephone calls, supportive 
medication prescriptions, new appointments made, etc) using a form emailed to 
the nurse after the automated email alert (Appendix 5) and the “Ambulatory Care 
Phone/Email Communication Form” in the EMR. The forms will be collected by 
the research fellow or by the designated RSA. In addition, a warning popup 
message will advise the patient that WEBCORE information is not monitored in 
real-time and therefore to consider calling her physician’s office about the 
symptom of concern. 
 
5.0 
CRITERIA FOR SUBJECT ELIGIBILITY 
 
5.1 
Subject Inclusion Criteria 
 
• Participants must be 18 years or older. 
 
• Participants must be able to provide informed consent. 
 
• Participants must be scheduled to undergo laparotomy for presumed or known 
gynecologic cancer. 
 
• 
The assessments were designed and validated in English and are not currently 
available in other languages.  Translation of questionnaires into other languages 
would require reestablishing the reliability and validity of these measures.  Therefore, 
participants must be able to communicate in English to complete the tests. 
Participants must be able to speak and read English fluently. 
 
 
• Participants must have access to a home computer, have a personal email account, 
and check email at least once weekly by self-report 
5.2 
Subject Exclusion Criteria 
 
• Patients who have a cognitive or psychiatric deficit resulting in an inability to 
provide meaningful informed consent, as judged by the consenting professional, 
and/or as noted in the medical record. 
 
• Patients who are undergoing pelvic exenterative surgery (with the exception of 
patients undergoing modified pelvic exenteration in the context of debulking for 
ovarian or uterine cancer). 

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6.0 
RECRUITMENT PLAN 
 
The recruitment process will take place during office visits on the 6th floor of the MSKCC 
53rd street outpatient clinic building. New patients, scheduled to undergo surgery, and 
consent visits, who are potentially eligible for the study will be identified by the treatment 
team. The investigator/ research staff of the study will be notified by the patient’s 
treatment team. 
 
After identifying potentially eligible patients the patients will be approached  by the 
investigator/ research staff (Research Fellow and/ or Surgery RSA) either during the time 
of the initial visit or during the time of the consent for the surgical procedure. During the 
initial conversation between the investigator/research staff and the patient, the patient 
may be asked to provide certain health information that is necessary to the recruitment 
and enrollment process.  The investigator/research staff may also review portions of their 
medical records at MSKCC in order to further assess eligibility.  They will use the 
information provided by the patient and/or medical record to confirm that the patient is 
eligible and to inform the patient regarding study enrollment.  If the patient turns out to 
be ineligible for the research study, the research staff will destroy all information 
collected on the patient during the initial conversation and medical records review, except 
for any information that must be maintained for screening log purposes (see Appendix 9). 
 
7.0 
ASSESSMENT/EVALUATION PLAN 
 
7.1 
Baseline Information Questionnaire 
 
Variables that we expect may be predictors of WEBCORE utilization include age, 
education level, employment status, and prior Internet experience.  These will be 
measured at baseline via a paper patient questionnaire (Appendix 1).  This 
questionnaire will be administered by the consenting professional immediately after 
obtaining Informed Consent and Research Authorization.  The paper questionnaire 
will be done at the time of the initial training session. Together, the training and the 
questionnaire will take 15 minutes. 
 
7.2 
Demographic Data 
Basic demographic data, including age, race, American Society of Anesthesiologists 
Score (ASA), cancer type, stage of disease, current/planned therapy, procedure type, 
and details of any complications will be obtained by the research assistant or research 
fellow using the MSKCC electronic medical record. 
 
7.3 
WEBCORE Questionnaire Items 
Based on expert consultation and literature review, questionnaires and items were 
selected to upload to WEBCORE for this study in order to focus on symptoms that 
may reflect general and specific post-operative complications, or which might cause 
distressing symptoms. The WEBCORE Questionnaire is a composition of items of 
validated instruments with a focus on postoperative symptom and QoL assessment. 

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the NCI’s CTCAE developed for prior WEBCORE studies [13]; and the well- 
established HRQL instrument, the European Organization for Research and 
Treatment of Cancer’s QLQ-C30 [47].  Each validated instrument included in this 
protocol has undergone extensive prior psychometric testing and meets established 
standards for validity and reliability as detailed in the FDA Draft guidance for PROs 
[3, 5].  These questionnaires/items are described below: 
 
7.3.1 European Organization for Research and Treatment of Cancer QLQ-C30 
(EORTC QLQ-30 version 3.0) 
EORTC QLQ-30 version 3.0 (Appendix 4) is a validated instrument that broadly 
assesses health-related quality of life in cancer patients.  In addition, many of the 
specific questions address clinically relevant symptoms in the post-operative 
period, including nausea, vomiting, constipation, diarrhea, fatigue, shortness of 
breath and ability to ambulate.  It was developed by the EORTC Study Group on 
Quality of Life in response to a mandate to develop an integrated measurement 
system for evaluating HRQL of cancer patients participating in international 
clinical trials therefore the evaluation in the postoperative setting should be 
considered exploratory in nature [48]. The module has been tested in international 
populations of patients with heterogenous diagnoses including lung, breast, and 
ovarian cancers. The module is comprised of 30 items which evaluate 6 major 
sub-scales of functioning: physical, role, emotion, social, cognition and a global 
assessment of quality of life. In addition, three symptom scales are used to 
measure fatigue, pain, emesis; and six single items assess financial impact, 
dyspnea, sleep disturbance, appetite, diarrhea and constipation [49]. This core 
instrument covers a general range of quality of life issues relevant to all patients 
with cancer. All multi-items scales have been found to significantly correlate with 
each other (p<.001).  Cronbach’s alpha is near 0.80 or higher for all items.  Test- 
retest reliability has ranged from 0.63 to 0.91 depending on the subscale [47]. 
This measure generally takes approximately 6 minutes to complete. For the 
purposes of this pilot study patients will be asked to take the EORTC QLQ-30 at 
baseline, three weeks after surgery and 6 weeks after surgery. 
The first question of the EORTC QLQ-30 version 3.0 is, “Do you have any 
trouble doing strenuous activities, like carrying a heavy shopping bag or a 
suitcase?” and the available responses are “not at all”, “a little”, “quite a bit” and 
“very much”.  However, post-operatively patients are instructed to avoid lifting 
anything heavy, like a shopping bag or suitcase, for at least 6 weeks after surgery. 
After consultation with experts, including the Behavioral and Psychosocial 
Research Consultation Program at MSKCC, the decision was made to preserve 
the integrity of the validated instrument and to instruct the patients to choose the 
response “very much”. 

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7.3.2 Individual Symptom Items 
 
To assess symptoms not addressed within the QLQ-C30, individual items will be 
included for symptoms of potential concern in the post-operative period.  These 
symptoms were chosen based on expert consultation and literature search, and 
include general postoperative symptoms such as pain, fever, shortness of breath, 
surgical wound symptoms, nausea and vomiting, bowel function, fatigue  as well 
as more specific gynecologic symptoms such as dysuria, urinary retention, and 
finally cardiac, cardio-vascular and pulmonary symptoms . These will be assessed 
via patient adaptations of NCI CTCAE items [13]. 
 
7.4 
Patient Satisfaction 
 
Patient assessment of the usefulness of WEBCORE will be measured via an exit 
questionnaire (Appendix 2) available on WEBCORE 6 to 8 weeks after surgery. 
Items in this questionnaire are adapted from validated measures used in prior studies 
evaluating satisfaction with information technology interventions [50-54] and 
instruments developed by the Picker Institute [55], and makes use of an ordinal scale 
for recording responses.  Questions address two specific areas: ease of use (ease of 
login, ease of data entry, understandability of questions), and perceived usefulness 
(memory triggering, use of information by doctors/nurses, feeling of control over own 
care, feeling that care was improved). 
 
7.5 
Clinician Evaluation of WEBCORE 
 
7.5.1 Nurse Intervention Report 
 
If a patient submits a response that is concerning according to pre-specified limits 
set by the gynecologic oncology service, an automated email alert flagged as 
“urgent” and titled “sever Patient-reported symptom” will be sent in real-time to 
the research fellow, the designated RSA and the PI of the study. They will 
forward the email to the POA of the patient’s gynecologic oncologist and to the 
clinic nurse taking patient calls for that gynecologic oncologist that day.  (This is 
the same system used presently to triage patient phone calls.) If the research 
fellow is not available, coverage will be provided by the designated RSA. In that 
event, the designated RSA will notify the POA of the patient’s gynecologic 
oncologist and the clinic nurse taking patient calls for that gynecologic oncologist 
that day. No specific responses to these emails will be required, but any actions 
taken in response to these alerts by clinicians will be tracked (ie, telephone calls, 
supportive medication prescriptions, new appointments made, etc) using a form 
emailed to the nurse after the automated email alert (Appendix 5) and the 
“Ambulatory Care Phone/Email Communication Form” in the EMR. The forms 
will be collected by the research fellow or by the designated RSA. The form will 
list the patient’s name, diagnosis, date of surgery, surgery and the symptom(s) 

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that triggered the alert.  The form will take approximately 5 minutes to fill out.  If 
the nurse indicates that a patient was contacted as a result of the automated email, 
the research fellow or RSA will look at the “Ambulatory Care Phone/Email 
Communication Form” in the EMR and record what action was taken.  Forms will 
be collected by the research fellow or RSA.  Possible responses include: 
diagnostic test, prescription, office visit scheduled, UCC visit recommended, no 
action, other. 
 
7.5.2 Clinician Group Meeting Questions: Focus Group 
At the completion of the study period, a focus group will be scheduled with all 
clinicians and support personnel involved in the care of enrolled patients 
(physicians, nurses, Session Assistants).  Specific open-ended questions will be 
asked verbally to assess qualitative impressions of WEBCORE, and to obtain 
suggestions for future development of WEBCORE (Appendix 6).  Questions will 
include whether WEBCORE was felt to be useful overall, not useful, or 
detrimental; whether it saved or consumed time; whether summary reports should 
be used to replace other assessment documents in the patient chart; and whether 
clinicians feel that patient self-generated reports accurately depict levels of 
toxicity. 
 
7.5.3 Clinician Satisfaction 
 
At the completion of the study, nurses and physicians will be emailed a survey to 
evaluate clinician satisfaction, strengths and weaknesses of WEBCORE 
(Appendix 8).  It will take 10 minutes to complete. 
 
8.0 
TOXICITIES/SIDE EFFECTS 
 
Minimal risk of psychological distress is posed by study questions that ask participants to 
identify their current problems. However, since study items were chosen to reflect what 
are likely to be existing concerns, the present study is not expected to markedly increase 
participants’ psychological distress above their routine concerns. WEBCORE allows a 
participant to skip any question(s) that she chooses, without compromising her ability to 
complete the rest of the questionnaire.  Formal testing of depression is not included as part 
of the questionnaire, however, if a patient responds “quite a bit” or “very much” to the 
question, “Did you feel depressed?”, an automatic email alert will be sent to the clinic 
nurse and the research fellow, who will follow up with the patient.  In addition, any patient 
who communicates distress to the RSA or research fellow verbally will be referred for 
counseling.  In the unlikely event of significant acute distress, participants will be referred 
to a staff member from the Department of Psychiatry and Behavioral Sciences. If a 
research participant indicates that s/he is acutely suicidal and poses a significant and acute 
risk of self-harm, this information will be shared with their attending physician so that 
timely and appropriate psychiatric assessment and care can be provided by the MSKCC 

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Social Work or Psychiatry Service staff. There is no guarantee of benefit to participants 
based on study participation. Participants can withdraw from the study at any time. 
 
9.0 
PRIMARY AND SECONDARY OUTCOMES 
 
9.1 
Primary Outcome 
The primary objective of this study is to evaluate the feasibility of patients using 
WEBCORE to track their own symptoms and HRQL while recovering from 
laparotomy for presumed or confirmed gynecologic cancer.  In this pilot feasibility 
study, we will measure several parameters related to patients’ utilization of the 
WEBCORE system, in order to evaluate the potential for implementation of 
collecting patient self-reported measures in a gynecologic oncology practice and/or in 
clinical trials. 
• 
To gauge patients’ willingness to record their experiences we will record the ratio 
of the number of patients approached for study participation to the number who 
enroll. The proportion of patients approached versus consented will be tracked 
continuously by the Research Fellow and the designated Surgery RSA. 
 
• 
We will evaluate the extent to which patients who enroll in the protocol use the 
WEBCORE system to self-report symptoms and HRQL.  Specifically, we will 
measure how often each user accesses the WEBCORE system, and will note the 
time and date that utilization occurs.  Perfect compliance would be logging on and 
completing all the questions seven times: once pre-operatively, and then weekly 
for six weeks following surgery.  In keeping with standards for the assessment of 
feasibility of online platforms, as a crude measure of feasibility, we will consider 
the study results to suggest that WEBCORE is a strategy warranting larger scale 
evaluation if approximately 80% of participants login to WEBCORE at least four 
times during the study period [13].  In our analysis, we will look at WEBCORE 
utilization (1) over time and (2) in relation to the presence or absence of 
documented minor and major surgical complications.  The proportion of users 
who logged in with or without a follow-up reminder email will be tabulated.  We 
will assess for attrition of compliance over time by measuring the proportion of 
patients who login during each consecutive week of observation. 
 
• 
Results of backup telephone calls made when patients have not logged in will be 
tabulated to assess if the reported symptoms of such patients differ from reports of 
patients who have logged in on time, and reasons for non-compliance. 
 
• 
Variables that we expect may affect levels of utilization include cancer type 
diagnosis, procedure type, age, education level, employment status, prior Internet 
experience, baseline ASA score and baseline HRQL.  Therefore, these will be 
measured at baseline via a questionnaire (Appendix 1), chart review, and by the 
patient’s initial score on the EORTC QLQ-C30 when she logs in pre-operatively. 

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9.2 
Secondary Outcomes 
 
9.2.1 Patient Assessment of WEBCORE 
 
Patient assessment of the usefulness of WEBCORE will be measured via an exit 
questionnaire (Appendix 2). 
 
9.2.2 Clinician Assessment of WEBCORE 
 
At the completion of the study period, an email clinician survey will be 
administered (Appendix 8), and a focus group will be scheduled with all 
clinicians and support personnel involved in the care of enrolled patients 
(physicians, nurses, Session Assistants).  Specific open-ended questions will be 
asked verbally to assess qualitative impressions of WEBCORE, and to obtain 
suggestions for future development of WEBCORE (Appendix 6).  Questions will 
include whether WEBCORE was felt to be useful overall, not useful, or 
detrimental; whether it saved or consumed time; whether summary reports should 
be used to replace other assessment documents in the patient chart; and whether 
clinicians feel that patient self-generated reports accurately depict levels of 
toxicity. 
 
9.2.3 Clinician Responses to Alerts 
 
Each time an automated email alert is sent to the primary clinical team (nurse), 
the clinician will be emailed a form to assess the response to the alert (Appendix 
5), which the clinical fellow coordinating the study will collect.  If the nurse 
indicates that a patient was contacted as a result of the automated email, the 
research fellow or RSA will look at the “Ambulatory Care Phone/Email 
Communication Form” in the EMR and record what action was taken.  Possible 
responses include: diagnostic test, prescription, office visit scheduled, UCC visit 
recommended, no action, other. 
 
9.2.4 Individual Symptom items and Quality of Life 
EORTC, and Individual Symptom Items (ISI, NCI-CTC) as described in section 7 
will be collected at predefined time points. A composite score for the EORTC 
questionnaire will be calculated following the EORTC scoring manual at each 
time point. In addition, individual items from these instruments will be 
summarized at each time point and patients’ profiles over time will be described 
graphically to assess which of these items fluctuate over time, or whether they 
capture patients’ symptoms in this post-op period. A descriptive analysis of 
individual symptoms reported will be performed. Most commonly reported and 
most distressing symptoms will be documented. 

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Table 4. Study Timetable 
Pre-op 
Consent 
Visit 
Post-op 
Week 1 
Post-op 
Week 2 
Post-op 
Week 3 
Post-op 
Week 4 
Post-op 
Week 5 
Post-op 
Week 6 
Post-op 
Week 
6-8 
Informed Consent 
/ Research 
Authorization 
X 
Paper Baseline 
Questionnaire 
X 
Online Patient 
Study (CTC)- 
Questionnaire 
X 
X 
X 
X 
X 
X 
X 
Online Patient 
Study (EORTC)- 
Questionnaire 
X 
X 
X 
Patient 
Satisfaction 
Questionnaire 
X 
Clinician 
Feedback Email 
Questionnaire 
X 
Pre-op, Pre-operative; Post-op, Post-operative 
 
10.0 
CRITERIA FOR REMOVAL FROM STUDY 
 
If a patient is enrolled but does not subsequently undergo planned surgery, she will be 
removed from the study and will not be evaluated in the feasibility assessment.  A 
participant can be removed from the study at any time if her doctor believes it is in her 
best interest to do so, or if she develops cognitive impairment as judged by her doctor or 
noted in the medical record.  A participant may withdraw from the study at any time. 
 
11.0 
BIOSTATISTICS 
 
11.1 
Sample Size and Accrual 
 
The sample size of 110 patients is based on the personnel resources (one dedicated 
clinical fellow) and time available (approximately one year) to conduct this study. A 
responder is defined as a patient who logs in and completes at least half of the 
questionnaire at least 4/7 potential logins. The hypotheses being tested are: 80% is 
considered acceptable whereas 65% is considered too low. The study requires 79 
patients to show a difference from 65% to 80% in percent responders with 90% 
power and type I error of 4%.  If at the end of the study 58/79 are responders then the 
study will conclude that the use of WEBCORE in this population is feasible. 

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Based on prior MSKCC research in this population, we anticipate that 90% of 
approached patients will agree to participate, of which 75% will be regular email 
users [13].  We will track the proportion of patients approached who consent as one 
of the measures of feasibility. The proportion of patients approached versus consented 
will be tracked continuously by the Research Fellow and the designated Surgery 
RSA.  There are approximately 570 laparotomies performed on the gynecology 
service annually (internal data). We anticipate that accrual for the study will be 
complete within 6-9 months.   We will enroll the first 5 patients of 110 patients as a 
small pilot to identify potential problems and correct any issues that may arise. After 
the evaluation of the first 5 patients the accrual period will remain open until at least 
80 evaluable patients are enrolled.  The sequence of patient activities following 
accrual is shown in Figure 1. 
 
Figure 1: Sequence of Patient Activities 
 
Approach patients scheduled for laparotomy for study participation 
 
 
 
 
 
 
 
Sign Consent 
15 minutes for Internet training session and baseline paper survey 
 
 
 
 
 
 
Patient logs in to WEBCORE to fill out first online questionnaire 
(at home or in clin ic) 
 
 
 
 
 
 
Surgery 
 
 
Patient logs on weekly 
to fill out questionnaire 
x 6 weeks post-op 
 
Patient Satisfaction Questionnaire 
(6-8 weeks post-op) 

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11.2 
Primary Objective 
 
The primary objective of this study is to evaluate the feasibility of patients using 
WEBCORE to track their own symptoms and HRQL while recovering from 
laparotomy for presumed or confirmed gynecologic cancer.  We will calculate 
summary statistics for several measures of utilization, including the frequency with 
which each user logs in and completes a WEBCORE online questionnaire; the 
proportion of patients who log in at each sequential week of follow-up; and when 
utilization occurs in relation to surgery and/or complications.   If at the end of the 
study 58/79 are responders (a responder is a person who has logged in at least 4/7 
times and completed at least half of the questions each time) then we will conclude 
that the use of WEBCORE in this population is feasible. If this hypothesis is true, we 
will consider the study results to suggest that WEBCORE is a strategy warranting 
larger scale evaluation [13].  Baseline patient characteristics and disease information 
will be examined via a logistic regression for their relationship to a patient's 
likelihood of being a responder. The following predictors will be considered: type of 
cancer, type of surgery, stage of disease, computer experience/age/education 
 
In our analysis, we will look at WEBCORE utilization (1) over time and (2) in 
relation to the presence or absence of documented  minor and major surgical 
complications.  We will tabulate the proportion of users who logged in with or 
without a follow-up reminder email.  We will assess for attrition of compliance over 
time by measuring the proportion of patients who login during each consecutive week 
of observation.  Results of backup telephone calls made when patients have not 
logged in will be tabulated to assess if the reported symptoms of such patients differ 
from reports of patients who have logged in on time, and reasons for non-compliance. 
We will calculate the proportion of WEBCORE responders compared to the total 
number of enrollees (responders: enrollees), as well as the proportion of responders 
compared to total number of patients eligible (responders: eligible).  Baseline 
characteristics for those who refuse enrollment will be compared to those who agree 
to participate. 
 
11.3 
Secondary Outcomes for Patients 
 
QOL Measures: 
EORTC, and Individual Symptom Items (ISI, NCI-CTC) as described in section 7 will 
be collected at predefined time points. A composite score for the EORTC 
questionnaire will be calculated following the EORTC scoring manual at each time 
point. In addition, individual items from these instruments will be summarized at each 
time point and patients’ profiles over time will be described graphically to assess 
which of these items fluctuate over time, or whether they capture patients’ symptoms 
in this post-op period. 

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Exit survey: 
Patient assessment of the usefulness of WEBCORE will be measured via an exit 
patient satisfaction questionnaire which will be given via WEBCORE website.  This 
will take place between 6 and 8 weeks post-operatively, and will be given online via 
WEBCORE website (Appendix 2).  Items in this questionnaire are adapted from 
validated measures used in prior studies evaluating satisfaction with information 
technology interventions [50-54] and instruments developed by the Picker Institute 
[55], and makes use of an ordinal scale for recording responses. 
 
Patients who recover quickly from surgery may choose not to use WEBCORE 
because they feel well, whereas patients experiencing the most severe post-operative 
symptoms or complications may feel too ill to login.  The follow-up telephone call for 
those who fail to login is intended to address such questions.  In addition, in the 
patient exit survey, questions will specifically address reasons why WEBCORE was 
not used (Appendix 2).  The exit survey will be summarized descriptively in order to 
understand whether patients failed to use WEBCORE because of technical obstacles, 
or severity of symptoms, or if they used WEBCORE in a limited fashion despite their 
symptoms.  We anticipate that WEBCORE may be utilized less frequently by patients 
with the worst symptoms. 
 
11.4 
Secondary Outcomes for Clinicians 
 
We will tabulate the number of phone calls made to patients as a result of the 
automated alerts, and the actions that were taken.  This data will be purely descriptive 
and hypothesis-generating. If it appears that the automated alerts led to important 
patient contacts and interventions, further studies could be conducted to evaluate the 
use of WEBCORE in real time as an additional method of communication between 
nurses and patients in the post-operative period. 
 
Clinician qualitative impressions of WEBCORE will be gathered at the end of the 
study during a focus group, at which open-ended questions will be asked (Appendix 
6).  A Clinician’s Satisfaction Survey will be sent out once at the end of the study. 
This will be filled out by each participating clinician once, and will be summarized 
descriptively (Appendix 8). Information gathered from the focus group and the exit 
survey, and will be used towards future development of WEBCORE automated alerts 
and printed reports. 
 
Clinician impressions of WEBCORE are of interest because they may influence how 
WEBCORE or a similar system is used clinically. The purpose of this group meeting 
is to obtain feedback regarding how the WEBCORE system impacted clinician 
workflow.  Physicians and RNs will be asked for specific suggestions regarding how 
the system could be altered and whether it is perceived as potentially valuable, 
neutral, or a hindrance to the provision of patient care. 

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11.5 
Missing Data 
 
The WEBCORE system allows patients to skip individual items when completing the 
online form.  Therefore, we will tabulate the number of missing items from each of 
the included questionnaires in this study (BPI, QLQ-C30, and CTCAE).  These will 
be reported descriptively, to assess if any particular items are skipped with excess 
frequency compared to others.  Based on prior WEBCORE studies, however, we 
anticipate that the frequency of skipped individual items will be very low (~1%).  In 
addition, as a part of the overall feasibility evaluation, we will tabulate the frequency 
with which patients fail to complete the entire form on schedule. 
 
12.0 
RESEARCH PARTICIPANT REGISTRATION PROCEDURES 
 
12.1 
Research Participant Registration 
Confirm eligibility as defined in the section entitled Criteria for Patient/Subject 
Eligibility. 
 
 
Obtain informed consent, by following procedures defined in section entitled 
Informed Consent Procedures. 
 
 
During the registration process registering individuals will be requried to complete a 
protocol specific Eligibility Checklist. 
 
 
All participants must be registered through the Protocol Participant Registration 
(PPR) Office at Memorial Sloan-Kettering Cancer Center. PPR is available Monday 
through Friday from 8:30am-5:30pm at 646-735-8000.  Registrations must be 
submitted via the PPR Electronic Registration System (http://ppr/).  The completed 
signature page of the written consent/RA orverbal script/RA, a completed Eligibility 
Checklist and other relevant documents must be uploaded via the PPR Electronic 
Registration System. 
 
 
13.0 
DATA  MANAGEMENT ISSUES 
 
A dedicated Clinical Research Fellow and a Research Study Assistant (RSA) will be 
assigned to this study.  The responsibilities of the Clinical Research Fellow will include 
project compliance, data collection, abstraction and entry, data reporting, regulatory 
monitoring, problem resolution and prioritization, and coordination of the activities of the 
protocol study team. The responsibilities of the Surgery RSA will include project 
compliance, data collection, and  abstraction and entry. 
 
The data collected for this study will be entered into a secure database.  Source 
documentation will be available to support the computerized patient record. 

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13.1 
Quality Assurance 
 
Weekly registration reports will be generated to monitor patient accruals and 
completeness of registration data.  Routine data quality reports will be generated to 
assess missing data and inconsistencies.  A log of all eligible patients will be 
maintained.  Accrual rates and extent and accuracy of evaluations and follow-up will 
be monitored periodically throughout the study period and potential problems will be 
brought to the attention of the study team for discussion and action. 
 
Random-sample data quality and protocol compliance audits will be conducted by the 
study team, at a minimum of two times per year, more frequently if indicated. 
 
13.2 
Web Security 
 
This study will use the WEBCORE online platform which was developed at MSKCC 
and has previously undergone privacy and security review.  The current design for the 
WEBCORE system architecture is reproduced in a diagram in Appendix 7.  This 
configuration has been developed with input from and review by computer 
security/privacy experts in the MSKCC Information Systems office and is designed to 
assure that WEBCORE conforms with current MSKCC and HIPAA standards for the 
protection of PHI.  A Security Evaluation Peer Working Group (SEPWG) form has 
previously been reviewed by the MSKCC Information Security Department outlining 
the configuration and functionality of the WEBCORE system.  WEBCORE is 
currently being used in MSKCC protocols 04-020 and 07-034 (CALGB 70501). 
 
Patient data collected through WEBCORE will be stored in the secure MSKCC 
Clinical Research Database (CRDB).  Access to data will be password protected, and 
user-level access will be controlled to allow access to a specific patient’s data only for 
clinicians and research staff responsible for that specific patient.  Data will only be 
reviewed by staff when directly related to patient care or conduct of this study. 
 
13.3 
Data and Safety Monitoring 
 
The Data and Safety Monitoring (DSM) Plans at Memorial Sloan-Kettering Cancer 
Center were approved by the National Cancer Institute in September 2001.  The plans 
address the new policies set forth by the NCI in the document entitled “Policy of the 
National Cancer Institute for Data and Safety Monitoring of Clinical Trials” which 
can be found at:  http://cancertrials.nci.nih.gov/researchers/dsm/index.html.  The 
DSM Plans at MSKCC were established and are monitored by the Office of Clinical 
Research.  The MSKCC Data and Safety Monitoring Plans can be found on the 
MSKCC Intranet at: http://mskweb2.mskcc.org/irb/index.htm 
 
There are several different mechanisms by which clinical trials are monitored for 
data, safety and quality.  There are institutional processes in place for quality 

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therapeutic response, and staff education on clinical research QA) and departmental 
procedures for quality control,  plus there are two institutional committees that are 
responsible for monitoring the activities of our clinical trials programs.  The 
committees: Data and Safety Monitoring Committee (DSMC) for Phase I and II 
clinical trials, and the Data and Safety Monitoring Board (DSMB) for Phase III 
clinical trials, report to the Center’s Research Council and Institutional Review 
Board. 
 
During the protocol development and review process, each protocol will be assessed 
for it’s level of risk and degree of monitoring required.  Every type of protocol (e.g., 
NIH sponsored, in-house sponsored, industrial sponsored, NCI cooperative group, 
etc.) will be addressed and the monitoring procedures will be established at the time 
of protocol activation. 
 
14.0 
PROTECTION OF HUMAN SUBJECTS 
 
As this is an observational quality of life study of the impact of treatment on QOL, it is 
unlikely that there will be any adverse effects due to this protocol. Participation is 
voluntary and the protocol will not interfere with routine treatment. It is possible that 
patients may experience distress when answering questions.  Any participant who 
demonstrates severe depressive symptoms or requests counseling will be referred for 
counseling.  Participants can withdraw at any time.  Information for each participant will 
be recorded using a unique identification number in a separate database. This number will 
not be linked to personal data which may compromise the anonymity of the participant. 
Access to the database will be limited to the research team. All participants will be 18 
years or older. Each participant will be required to sign an informed consent prior to 
completing the baseline questionnaire. Consent forms will be signed by a consenting 
professional upon enrollment at which time all questions may be answered. There will be 
no financial burden incurred by participants. 
 
14.1 
Rapid Reporting of Potentially Serious Toxicities (WEBCORE Automated 
Alerts): 
Patients will be informed at multiple time points that WEBCORE is not a rapid 
response system, is not a replacement for contacting a physician’s office for serious 
health concerns (such as severe toxicity-related symptoms), and that there is no 
regular formal monitoring of information entered into WEBCORE.  This will be 
printed in the Informed Consent, told verbally to enrollees at the time of accrual, and 
will be included on a screen (browser page) in WEBCORE every time a patient logs 
in. 
 
In addition, for selected symptom items in the online questionnaire, if a patient self- 
reports a severe or disabling level grade (>7/10 for QLQ-C30, ≥ 4 for “pain now” and 
≥ 5 for “pain worst” on the BPI; >3 for CTCAE) [personal communication, CS 

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Cleeland], a popup box will appear on the screen recommending that the patient call 
her physician’s office. 
 
In such cases, an automated email alert will be generated by WEBCORE and sent to 
the primary clinicians (nurse and/or physician) as well as to the coordinating Clinical 
Research Fellow and designated study RSA. This e-mail will be flagged “urgent” and 
titled “severe Patient-reported symptom” to ensure prompt response by MSK.  No 
specific clinical response to the alert email will be required.  The WEBCORE - 
generated email will state the following, for example: “Jane Smith MRN #XXXXXXX, 
a patient of Dr. Chi, reported she vomited “quite a bit”, had “very much” 
constipation, in the last week, potentially serious symptoms, into the WEBCORE 
online system, at 4:47pm on 8/3/08.” Clinicians’ responses to the WEBCORE Report 
will be tracked by the Clinical Research Fellow (Appendix 5). 
 
 
14.2 
Privacy 
 
This study will involve the collection of confidential patient self-reports of HRQL 
and symptoms over the Internet.  Security and privacy precautions have been taken in 
the design of the WEBCORE online platform.  Patient data collected via WEBCORE 
will be stored in the secure MSKCC Clinical Research Database (CRDB).  User-level 
access to data will be password protected, and only individual patients, appropriate 
clinical staff, and research study staff will have access to data. 
 
 
MSKCC’s Privacy Office may allow the use and disclosure of protected health 
information pursuant to a completed and signed Research Authorization form.  The 
use and disclosure of protected health information will be limited to the individuals 
described in the Research Authorization form.  A Research Authorization form must 
be completed by the Principal Investigator and approved by the IRB and Privacy 
Board. 
 
14.3 
Serious Adverse Event (SAE) Reporting 
 
Only SAEs related to using the online WEBCORE system will be reported to the 
IRB. Any SAE must be reported to the IRB/PB as soon as possible but no later than 5 
calendar days. The IRB/PB requires a Clinical Research Database (CRDB) SAE 
report be submitted electronically to the SAE Office at sae@mskcc.org. This report 
should contain the following information: 
Fields populated from CRDB: 
• 
Subject’s name (generate the report with only initials if it will be sent 
outside of MSKCC) 
• 
Medical record number 
• 
Disease/histology (if applicable) 

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• 
Protocol number and title 
 
Data needing to be entered: 
• 
The date the adverse event occurred 
• 
The adverse event 
• 
Relationship of the adverse event to the treatment (drug, device, or 
intervention) 
• 
If the AE was expected 
• 
The severity of the AE 
• 
The intervention 
• 
Detailed text that includes the following information: 
 
A explanation of how the AE was handled 
 
A description of the subject's condition 
 
Indication if the subject remains on the study 
 
If an amendment will need to be made to the protocol and/or consent 
form 
 
The PI’s signature and the date it was signed are required on the completed report. 
 
 
15.0 
INFORMED CONSENT PROCEDURES 
 
Before protocol-specified procedures are carried out, consenting professionals will 
explain full details of the protocol and study procedures as well as the risks involved to 
participants prior to their inclusion in the study.  Participants will also be informed that 
they are free to withdraw from the study at any time. All participants must sign an 
IRB/PB-approved consent form indicating their consent to participate.  This consent form 
meets the requirements of the Code of Federal Regulations and the Institutional Review 
Board/Privacy Board of this Center.  The consent form will include the following: 
 
1.   The nature and objectives, potential risks and benefits of the intended study. 
2.   The length of study and the likely follow-up required. 
3.   Alternatives to the proposed study.  (This will include available standard and 
investigational therapies.  In addition, patients will be offered an option of 
supportive care for therapeutic studies.) 
4.   The name of the investigator(s) responsible for the protocol. 
5.   The right of the participant to accept or refuse study interventions/interactions 
and to withdraw from participation at any time. 
 
Before any protocol- specific procedures can be carried out, the consenting professional 
will fully explain the aspects of patient privacy concerning research specific information. 
In addition to signing the IRB Informed Consent, all patients must agree to the Research 
Authorization component of the informed consent form. 

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Each participant and consenting professional will sign the consent form. The participant 
must receive a copy of the signed informed consent form. 
 
16.0 
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17.0 
APPENDICES 
 
Appendix 1: Baseline Patient Information Questionnaire 
Appendix 2: Patient Satisfaction Interview Questions 
Appendix 3: CTC-Symptom Items 
Appendix 4: EORTC QLQ-C30 
Appendix 5: Nurse Intervention Report 
Appendix 6: Clinician Exit Meeting Questions 
Appendix 7: System Architecture Diagram 
Appendix 8: Clinician Survey 
Appendix 9: Screening Form 
Appendix 10:  Reminder Email