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

Sponsor

University of Michigan Rogel Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04852471

Collaborator

(none)

162

Enrollment

Location

Arms

17.8

Anticipated Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gynecologic Cancer	Behavioral: Standard Post-Operative Counseling + FACT-G Behavioral: PROM symptom tracker	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

162 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jan 5, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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 who called the care team [30 days post-operative]
Data collected by chart review.
Proportion of patients seen in urgent care clinics [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

University of Michigan Rogel Cancer Center

Investigators

Principal Investigator: Shitanshu Uppal, MBBS, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Michigan Rogel Cancer Center

ClinicalTrials.gov Identifier:

NCT04852471

Other Study ID Numbers:

UMCC 2020.173
HUM00190175

First Posted:

Apr 21, 2021

Last Update Posted:

Jul 12, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Michigan Rogel Cancer Center

laparotomy

Study Results

No Results Posted as of Jul 12, 2022