Scheduled Meditation for Improving Postoperative Outcomes in Patients Undergoing Pancreatectomy

City of Hope

Status: Begins enrollment this month

Conditions: Biliary Tract Neoplasms; Pancreas Cancer; Hepatocellular Carcinoma

Treatments: Behavioral: Online Mindfulness Meditation; Other: Actigraphy; Other: Survey Administration; Behavioral: Smartphone Application-based Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07608458

NCI-2026-03206 (Registry Identifier)

P30CA033572 (U.S. NIH Grant/Contract)

25479 (Other Identifier)

Details and patient eligibility

About

This clinical trial tests the feasibility and how well a scheduled meditation intervention works to improve postoperative outcomes such as pain, anxiety, insomnia, stress and mobility for patients undergoing pancreatectomy. Many patients undergoing pancreatectomy surgery report clinically important fatigue, pain, and/or reduction in quality of life. Meditation is a behavioral intervention that has been studied in a variety of medical and surgical settings, where it has been associated with reductions in pain, anxiety, blood pressure, and lack of sleep, and in some cases with decreased pain and shorter length of stay. The meditation intervention using Headspace is an easily accessible and interactive way to complete scheduled meditation. This may improve postoperative outcomes for patients undergoing pancreatectomy.

Full description

PRIMARY OBJECTIVES:

I. Evaluate the feasibility of implementing a meditation-based intervention in patients undergoing pancreatectomy, as measured by recruitment, retention, and participant compliance with the prescribed modules II. Evaluate the effect of a perioperative meditation intervention on anxiety, as measured by changes in State-Trait Anxiety Inventory (STAI) scores from baseline to one month postoperatively.

SECONDARY OBJECTIVE:

I. To observe the relationship of meditation intervention on change in health-related quality of life (HRQOL) outcomes for pain and sleep quality from baseline through one month postoperatively.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive access to the Headspace application. Patients complete mindfulness meditation including focused breathing, awareness of thought patterns, and management of mind-wandering for 10 minutes once daily (QD) for 3 weeks prior to surgery and twice daily (BID) for 1 month after surgery. Patients wear a Garmin activity tracker throughout the study.

ARM II: Patients receive access to the Headspace application at the time of hospital discharge and will be informed of the availability of the "Basics" meditation pack. Patients wear a Garmin activity tracker throughout the study.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented informed consent of the participant and/or legally authorized representative
• Willing to install required apps on personal smartphone
• Willing to wear a Garmin wearable device throughout the study
• Age: ≥ 18 years
• Ability to read and understand English for questionnaires
• Owns a smartphone
• Comfortable with routine smartphone use
• Scheduled to undergo pancreatectomy

Exclusion criteria

• Participants with prior formal training in meditation or mindfulness (e.g., completion of structured courses, workshops, or certification programs)
• Participants who currently engage in a structured meditation or mindfulness practice, including regular use of mobile applications (e.g., Headspace, Calm, or similar platforms) or other formalized routines

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Arm I (Headspace meditation)

Experimental group

Description:

Patients receive access to the Headspace application. Patients complete mindfulness meditation including focused breathing, awareness of thought patterns, and management of mind-wandering, for 10 minutes QD for 3 weeks prior to surgery and BID for 1 month after surgery. Patients wear a Garmin activity tracker throughout the study.

Treatment:

Behavioral: Smartphone Application-based Intervention

Other: Survey Administration

Other: Actigraphy

Behavioral: Online Mindfulness Meditation

Arm II (Delayed access to Headspace)

Experimental group

Description:

Patients receive access to the Headspace application at the time of hospital discharge and will be informed of the availability of the "Basics" meditation pack. Patients wear a Garmin activity tracker throughout the study.

Treatment:

Behavioral: Smartphone Application-based Intervention

Other: Survey Administration

Other: Actigraphy

Behavioral: Online Mindfulness Meditation