Clinical trial NCT05346692: Digital Meditation for Postoperative Pain Control After Abdominal Surgery for Cancer
Official title: A Prospective, Double-Arm Pilot Study to Investigate the Safety, Feasibility and Acceptability of a Digital Mindfulness Intervention Following Open Abdominal Surgery for Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-04-26
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients \>= 18 years of age
* Open abdominal surgery for cancer
* Ownership of smartphone (iOS or Android operating systems) with SMS texting capabilities
* Ability to read
* Ability to understand the purposes and risk of the study and willingly give standard written informed consent for treatment established by each participating institution.

Exclusion Criteria:

* Patients with contraindications to abdominal surgery and/or general anesthesia

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 12 months
measure: Feasibility of intervention and mode of delivery
timeFrame: Up to 12 months
Secondary outcomes:
measure: Intervention and mode of delivery utilizing the Client Satisfaction Survey (CSQ-8)
timeFrame: Up to 12 months
measure: Intervention and mode of delivery utilizing the System Usability Scale (SUS)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University/Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University/Winship Cancer Institute
name: Maggie Diller, MD
role: PRINCIPAL_INVESTIGATOR
References: