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

NCT04852471 | Completed

• 2 other identifiers: UMCC 2020.173HUM00190175
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer

Keywords

laparotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Proportion of patients who had non-standard clinic visits

  30 days post-operative

• Proportion of patients who called the care team

  30 days post-operative

• Proportion of patients seen in urgent care clinics

  30 days post-operative

• Proportion of patients seen in emergency room

  30 days post-operative

• Proportion of patients readmitted to hospital

  30 days post-operative

Study Arms (2)

Standard Post-Operative Counseling + FACT-G (Control Arm)

ACTIVE COMPARATOR

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

Standard Post-Operative Counseling + PROM survey + FACT-G (Intervention Arm)

EXPERIMENTAL

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; Behavioral: PROM symptom tracker

Interventions

Standard Post-Operative Counseling + FACT-G BEHAVIORAL

Counseling at discharge + FACT-G at enrollment, at 15-18 and at 30-32 days post-operative.

Standard Post-Operative Counseling + FACT-G (Control Arm); Standard Post-Operative Counseling + PROM survey + FACT-G (Intervention Arm)

PROM symptom tracker BEHAVIORAL

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.

Standard Post-Operative Counseling + PROM survey + FACT-G (Intervention Arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• Shitanshu Uppal, MBBS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 21, 2021
• Study Start: January 5, 2022
• Primary Completion: May 2, 2023
• Study Completion: May 2, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)