Gynecologic Cancer
Conditions
Keywords
laparotomy
Brief summary
This study is investigating a new way to monitor patients who are recovering at home after surgery. This study uses text messages to ask patients to review their own symptoms and then reply with the level of severity of specific symptoms. Based on each patient's specific response to the text message survey, a pre-programmed, automated response will be sent from the study prompting the patient to take specific actions (or no action if no symptoms). Investigators will assess whether this method improves patients' well-being as compared to the current standard of care for patients. Currently, after surgery, patients are provided counseling and written instructions when they leave the hospital on how to care for themselves at home. If the patient has questions or concerns, they contact their care team. The optimal way to help patients assess their own symptoms at home remains unknown. Investigators are also assessing if using the symptom survey reduces readmissions to the hospital.
Interventions
BEHAVIORALStandard Post-Operative Counseling + FACT-G
Counseling at discharge + FACT-G at enrollment, at 15-18 and at 30-32 days post-operative.
BEHAVIORALPROM symptom tracker
A 12-item symptom tracker adopted from the Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE), delivered via text, on days 4, 6, 8, 12, 18, 24, and 30 post surgery.
Sponsors
University of Michigan Rogel Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years of age or greater. * Planning to undergo a surgical procedure via a laparotomy incision for a suspected or known gynecologic malignancy. There is no restriction on the spectrum of pathology or disease. * The ability and willingness to send and receive short messaging service (SMS) text messages. * Able to read and understand English. * Willing and able to provide informed consent
Exclusion criteria
* Persons who are planning to undergo a minimally invasive procedure without laparotomy. * Persons unable to be contacted by SMS text message or choose to opt-out of the study. * Patients who do not have access to the internet via a home computer or a smart phone.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean total score on FACT-G | 30-32 days post-operative | The mean total score on the FACT-G will be compared between the two arms. The FACT-G is a 27-item questionnaire that covers four HR-QOL sub-domains: physical, social, emotional, and functional well-being. Each of the questions will be scored on a scale from 0 (Not at all) to 4 (Very much) using a manual scoring template in which some items are reverse scored. The minimally important difference (MID) is 5 points for the FACT-G questionnaire. In other words, five points is the most minimal difference between the control group and treatment group scores that would indicate a clinically meaningful change. A positive change in points indicates better QOL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who had non-standard clinic visits | 30 days post-operative | The proportion of patients who are seen in the clinic for visits other than a scheduled post-operative visit. Data collected by chart review. |
| Proportion of patients who called the care team | 30 days post-operative | Data collected by chart review. |
| Proportion of patients seen in urgent care clinics | 30 days post-operative | Data collected by chart review. |
| Proportion of patients seen in emergency room | 30 days post-operative | Data collected by chart review. |
| Proportion of patients readmitted to hospital | 30 days post-operative | Data collected by chart review. |
Countries
United States
Outcome results
None listed