An Early Phase 1 interventional study of Survey Administration and Interview in Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-14.
Sponsored by Emory University · Early Phase 1, Interventional, and Supportive care
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 73 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
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Exclusion Criteria:
Patients complete pain survey via text message daily for 10 days after surgery. Patients also complete telephone interview 2 weeks after surgery.
Other: Survey Administration · Other: Interview
Patients complete mindfulness intervention via text message daily for 10 days after surgery. Patients also complete telephone interview 2 weeks after surgery.
Other: Text Message-Based Navigation Intervention · Other: Interview
Complete Survey
Complete Interview
Complete mindfulness intervention
Also known as: Automated Text Message-Based Navigation, Text Message-Based Navigation
Complete interview
Incidence of adverse events
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 of intervention and mode of delivery
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
Intervention and mode of delivery utilizing the Client Satisfaction Survey (CSQ-8)
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: 1. the overall quality 2. perception of the program's ability to meet their needs 3. amount of help received 4. the extent to which this program helped them deal with recovery after surgery. The CSQ-8 has demonstrated good internal consistency, test-retest reliability, and sensitivity10.
Time frame: Up to 12 months
Intervention and mode of delivery utilizing the System Usability Scale (SUS)
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.
Time frame: Up to 12 months
Plan to share: No
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Emory University