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Completed

NCT Number: NCT04852471

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

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.

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Key information

Conditions

Gynecologic Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard Post-Operative Counseling + FACT-G

Behavioral

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

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.

Primary outcomes

  1. Mean total score on FACT-G

    Time frame: 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 outcomes

  1. Proportion of patients who had non-standard clinic visits

    Time frame: 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.

  2. Proportion of patients who called the care team

    Time frame: 30 days post-operative

    Data collected by chart review.

  3. Proportion of patients seen in urgent care clinics

    Time frame: 30 days post-operative

    Data collected by chart review.

  4. Proportion of patients seen in emergency room

    Time frame: 30 days post-operative

    Data collected by chart review.

  5. Proportion of patients readmitted to hospital

    Time frame: 30 days post-operative

    Data collected by chart review.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2021
Registry last updated
Oct 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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