Improving Quality of Life Using Patient Reported Outcomes Measures Post-operative Via Text Messaging
- Conditions
- Gynecologic Cancer
- Interventions
- Behavioral: Standard Post-Operative Counseling + FACT-GBehavioral: PROM symptom tracker
- Registration Number
- NCT04852471
- Lead Sponsor
- University of Michigan Rogel Cancer Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 102
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Post-Operative Counseling + FACT-G (Control Arm) Standard Post-Operative Counseling + FACT-G Patients will receive the standard postoperative counseling at discharge, discharge instructions, and the link to website with postoperative instructions. Patients will complete the Functional Assessment of Cancer Therapy - General (FACT-G). Standard Post-Operative Counseling + PROM survey + FACT-G (Intervention Arm) Standard Post-Operative Counseling + FACT-G Patients will receive the standard postoperative counseling at discharge, discharge instructions, and the link to website with postoperative instructions. The intervention arm will receive and complete the Patient-Reported Outcome Measure (PROM) survey via the SMS text messaging service on a set schedule. Patients will complete the FACT-G. Standard Post-Operative Counseling + PROM survey + FACT-G (Intervention Arm) PROM symptom tracker Patients will receive the standard postoperative counseling at discharge, discharge instructions, and the link to website with postoperative instructions. The intervention arm will receive and complete the Patient-Reported Outcome Measure (PROM) survey via the SMS text messaging service on a set schedule. Patients will complete the FACT-G.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Proportion of patients who called the care team 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.
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 seen in urgent care clinics 30 days post-operative Data collected by chart review.
Trial Locations
- Locations (1)
University of Michigan Rogel Cancer Center
🇺🇸Ann Arbor, Michigan, United States