Clinical trial NCT04852471: Improving Quality of Life Using Patient Reported Outcomes Measures Post-operative Via Text Messaging
Official title: Improving Quality of Life Using Patient Reported Outcomes Measures Post-operative Via Text Messaging: a Randomized Control Trial (PROMPT Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Cancer
Keywords: laparotomy
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean total score on FACT-G
timeFrame: 30-32 days post-operative
Secondary outcomes:
measure: Proportion of patients who had non-standard clinic visits
timeFrame: 30 days post-operative
measure: Proportion of patients who called the care team
timeFrame: 30 days post-operative
measure: Proportion of patients seen in urgent care clinics
timeFrame: 30 days post-operative
measure: Proportion of patients seen in emergency room
timeFrame: 30 days post-operative
measure: Proportion of patients readmitted to hospital
timeFrame: 30 days post-operative
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Shitanshu Uppal, MBBS
role: PRINCIPAL_INVESTIGATOR
References: