NCT00870233 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: Not reported
Status at capture: COMPLETED
Registry last update: 2018-10-15

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery

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outcome · POSTED

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.

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outcome · POSTED

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.

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outcome · POSTED

Most Commonly Reported and Most Distressing Symptoms Reported by Patients After Gynecologic Cancer Surgery Using the STAR System

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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).
healthy Volunteers: false
minimum Age: 18 Years
sampling Method: NON_PROBABILITY_SAMPLE
sex: FEMALE
std Ages: ADULT
OLDER_ADULT
study Population: Patients undergoing laparotomy for presumed or confirmed gynecologic malignancy at MSKCC.

Treatment arms and interventions

arm Groups

description
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).
intervention Names
Behavioral: online platform WEBCORE
label
GYN pts undergoing surgery

interventions

arm Group Labels
GYN pts undergoing surgery
description
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.
name
online platform WEBCORE
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.
type
BEHAVIORAL

Study design

observational Model: COHORT
time Perspective: PROSPECTIVE

Enrollment

count: 120
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery
time Frame
once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.

secondary Outcomes

measure
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
measure
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
description
The percentage of symptoms generated by patients on protocol
measure
Most Commonly Reported and Most Distressing Symptoms Reported by Patients After Gynecologic Cancer Surgery Using the STAR System
time Frame
weekly starting 7 days after surgery until the 6-week post-operative period

Full study description

brief Summary: 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.

Source references