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

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

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.

Study Overview

• Status: Completed
• Conditions: Gynecologic Cancer
• Intervention / Treatment: Behavioral: Standard Post-Operative Counseling + FACT-G; Behavioral: PROM symptom tracker

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Rogel Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Post-Operative Counseling + FACT-G (Control Arm); 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).	Behavioral: Standard Post-Operative Counseling + FACT-G; Counseling at discharge + FACT-G at enrollment, at 15-18 and at 30-32 days post-operative.
Experimental: Standard Post-Operative Counseling + PROM survey + FACT-G (Intervention Arm); 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.	Behavioral: Standard Post-Operative Counseling + FACT-G; Counseling at discharge + FACT-G at enrollment, at 15-18 and at 30-32 days post-operative.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Proportion of patients who called the care team	Data collected by chart review.	30 days post-operative
Proportion of patients seen in urgent care clinics	Data collected by chart review.	30 days post-operative
Proportion of patients seen in emergency room	Data collected by chart review.	30 days post-operative
Proportion of patients readmitted to hospital	Data collected by chart review.	30 days post-operative

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Investigators: Principal Investigator: Shitanshu Uppal, MBBS, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Actual): May 2, 2023
• Study Completion (Actual): May 2, 2023

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: laparotomy
• Other Study ID Numbers: UMCC 2020.173; HUM00190175 (Other Identifier: University of Michigan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No