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

University of Michigan Rogel Cancer Center

Status: Completed

Conditions: Gynecologic Cancer

Treatments: Behavioral: PROM symptom tracker; Behavioral: Standard Post-Operative Counseling + FACT-G

Study type: Interventional

Funder types: Other

Identifiers

NCT04852471

UMCC 2020.173

HUM00190175 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

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

Active Comparator group

Description:

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).

Treatment:

Behavioral: Standard Post-Operative Counseling + FACT-G

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

Experimental group

Description:

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.

Treatment:

Behavioral: Standard Post-Operative Counseling + FACT-G

Behavioral: PROM symptom tracker