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

NCT ID: NCT04852471

Last Updated: 2023-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-05
• Study Completion Date: 2023-05-02

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Standard Post-Operative Counseling + FACT-G

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Standard Post-Operative Counseling + FACT-G

Intervention Type: BEHAVIORAL

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

PROM symptom tracker

Intervention Type: 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.

Interventions

Standard Post-Operative Counseling + FACT-G

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shitanshu Uppal, MBBS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00190175

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2020.173

Identifier Type: -

Identifier Source: org_study_id