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NCT Number: NCT00870233

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

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.

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Key information

Conditions

Fallopian Tube Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Peritoneal Cancer Urogenital Diseases Urogenital Neoplasms Uterine Cancer Uterine Diseases Uterine Neoplasms Vaginal Cancer Vaginal Diseases Vaginal Neoplasms Vulvar Cancer Vulvar Diseases Vulvar Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

online platform WEBCORE

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.

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.

Primary outcomes

  1. 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

  1. 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

  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 and Patient Satisfaction With Care Delivery.

    Time frame: two years

  3. 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

    The percentage of symptoms generated by patients on protocol

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
Mar 27, 2009
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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