Improving Quality of Life Using Patient Reported Outcomes Measures Post-operative Via Text Messaging

Gynecologic Cancer Clinical Trial

Official title:

Improving Quality of Life Using Patient Reported Outcomes Measures Post-operative Via Text Messaging: a Randomized Control Trial (PROMPT Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04852471
• Other study ID #: UMCC 2020.173
• Secondary ID: HUM00190175
• Status: Completed
• Phase: N/A
• Start date: January 5, 2022
• Est. completion date: May 2, 2023

Study information

• Verified date: October 2023
• Source: University of Michigan Rogel Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: May 2, 2023
• Est. primary completion date: May 2, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

Behavioral:
• Standard Post-Operative Counseling + FACT-G
Counseling at discharge + FACT-G at enrollment, at 15-18 and at 30-32 days post-operative.
• PROM 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.

Locations

Country	Name	City	State
United States	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean total score on FACT-G	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.	30-32 days post-operative
Secondary	Proportion of patients who had non-standard clinic visits	The proportion of patients who are seen in the clinic for visits other than a scheduled post-operative visit. Data collected by chart review.	30 days post-operative
Secondary	Proportion of patients who called the care team	Data collected by chart review.	30 days post-operative
Secondary	Proportion of patients seen in urgent care clinics	Data collected by chart review.	30 days post-operative
Secondary	Proportion of patients seen in emergency room	Data collected by chart review.	30 days post-operative
Secondary	Proportion of patients readmitted to hospital	Data collected by chart review.	30 days post-operative