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

NCT ID: NCT00870233

Last Updated: 2018-10-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-24

Study Completion Date

2018-02-12

Brief Summary

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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.

Detailed Description

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Conditions

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Fallopian Tube Cancer Ovarian Cancer Peritoneal Cancer Uterine Cancer Vaginal Cancer Vulvar Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

online platform WEBCORE

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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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 Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dennis Chi, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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08-155

Identifier Type: -

Identifier Source: org_study_id

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