Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
NCT Number: NCT05346692
This phase I trial tests a digital meditation for postoperative pain control after abdominal surgery for cancer. Mindfulness interventions such as guided meditation may improve pain control and decrease stress. Including a brief mindfulness intervention administered via test messages as part of postoperative care may improve pain severity, decrease opioid use, and improve patient responses to non-surgical treatments.
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Notify Me18 year and older
All sexes
Interventional
Early Phase 1
Atlanta, Georgia, 30322, United States
PRIMARY OBJECTIVES:
I. To investigate and define anticipated and unanticipated adverse events (AEs) related to a daily virtual mindfulness intervention delivered via short message service (SMS) text messaging and to test its safety in the postoperative period amongst patients with cancer.
II. To determine the feasibility and acceptability of a novel, brief mindfulness intervention delivered via SMS text messaging in the postoperative period amongst patients undergoing surgery for cancer.
III. To determine the feasibility and acceptability of an artificial intelligence platform to deliver and receive SMS text messages for the purpose of delivering pain assessment tools and collecting and storing pain-specific and patient reported outcomes.
OUTLINE: Patients are assigned to 1 of 2 arms. ARM I: Patients complete pain survey via text message daily for 10 days after surgery. Patients also complete telephone interview 2 weeks after surgery.
ARM II: Patients complete mindfulness intervention via text message daily for 10 days after surgery. Patients also complete telephone interview 2 weeks after surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Complete Survey
Complete Interview
Complete mindfulness intervention
Other names: Automated Text Message-Based Navigation, Text Message-Based Navigation
Time frame: Up to 12 months
Adverse events (AEs) will be reported, and summarized using frequencies and percentages. An AE will be considered unexpected if the nature, severity, or frequency of the event is not consistent with the risk information previously described for the study intervention. Unexpected AEs will be summarized descriptively. The most common adverse events reported within the mindfulness literature anxiety, depression, and cognitive anomalies. The overall prevalence of meditation adverse events is 8%, which is similar to those reported for psychotherapy practice in general.
Time frame: Up to 12 months
Feasibility for each arm is defined as completion of at least 50% of the program.The proportion completing at least 50% of the program will be compared to a null proportion of 20% completing at least 50% of the program using a one-sample Z-test.
Time frame: Up to 12 months
Acceptability of intervention and mode of delivery will include quantitative and qualitative analyses. Quantitative analysis will include the Client Satisfaction Survey (CSQ-8). The CSQ-8 focuses on participant satisfaction with the intervention received, including:
Time frame: Up to 12 months
Acceptability of intervention and mode of delivery will include quantitative and qualitative analyses. Quantitative analysis will include the System Usability Scale (SUS) administered to all participants at study completion of the study to all participants.
The SUS is a 10-item scale that examines the perceived usability of a technology and is commonly used in evaluating mobile apps. The SUS has demonstrated good reliability in other studies.
Emory University
Other
A Prospective, Double-Arm Pilot Study to Investigate the Safety, Feasibility and Acceptability of a Digital Mindfulness Intervention Following Open Abdominal Surgery for Cancer
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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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