Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00870233
First received: March 26, 2009
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

This study is being done to see if most patients are willing and able to report how they are feeling after surgery using the internet, and if this information can help doctors and nurses detect concerning symptoms after surgery.

This study uses a special new website called WEBCORE. Patients can logon to WEBCORE and answer questions about how they are feeling. Then, doctors and nurses can look at this information during clinic appointments. We are doing this study to see if WEBCORE is a helpful way for us to keep track of information about how patients are feeling and quality of life. If WEBCORE is helpful, we will use it in the future to collect more information about patients' symptoms and quality of life. We can use what we learn to help find better ways of helping patients to prepare for what they will go through while they recover from surgery.


Condition Intervention
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cancer
Uterine Cancer
Vaginal Cancer
Vulvar Cancer
Behavioral: online platform WEBCORE

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Electronic Patient-Reported Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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. [ Time Frame: once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To measure the feasibility of online symptom self-reporting in the early postoperative period, and clinician perceptions of its potential value in routine outpatient post-operative cancer care. [ Time Frame: once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended ] [ Designated as safety issue: No ]
  • 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 and patient satisfaction with care delivery. [ Time Frame: two years ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: weekly starting 7 days after surgery until the 6-week post-operative period ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: March 2009
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
GYN pts undergoing surgery
This 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).
Behavioral: online platform WEBCORE
Enrollees will be sent weekly email reminders to login to WEBCORE from home. 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.
Other Names:
  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing laparotomy for presumed or confirmed gynecologic malignancy at MSKCC.

Criteria

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

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870233

Contacts
Contact: Dennis Chi, MD 212-639-5016
Contact: Ethan Basch, MD 646-422-4426

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Dennis Chi, MD    212-639-5016      
Contact: Ethan Basch, MD    646-422-4426      
Principal Investigator: Dennis Chi, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Dennis Chi, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00870233     History of Changes
Other Study ID Numbers: 08-155
Study First Received: March 26, 2009
Last Updated: February 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Gynecologic cancers
Quality of Life
08-155
Surgery

Additional relevant MeSH terms:
Vaginal Diseases
Ovarian Neoplasms
Uterine Neoplasms
Vaginal Neoplasms
Vulvar Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Diseases
Vulvar Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases

ClinicalTrials.gov processed this record on July 24, 2014