Scheduled Meditation for Improving Postoperative Outcomes in Patients Undergoing Pancreatectomy

NCT07608458 | Not Yet Recruiting DMC FDA Device

• 3 other identifiers: 25479NCI-2026-03206P30CA033572
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma; Pancreas Cancer; Biliary Tract Neoplasms

Outcome Measures

Primary Outcomes (4)

• Proportion of enrolled patients who complete the final study assessment (retention)

  Retention will be considered feasible if ≥ 70% of enrolled participants are retained. Will be estimated along with the 95% exact binomial confidence interval.

  Up to 6 months

• Proportion of prescribed meditation modules completed (compliance)

  Each participant's proportion of completed meditation modules will be calculated using usage data from the Headspace mobile application. Participants will then be classified as high (\> 60%), medium (20-60%), or low (\< 20%) compliance. Will be estimated along with the 95% exact binomial confidence interval.

  Up to 6 months

• Change in patient-reported anxiety symptoms

  Measured using the State-Trait Anxiety Inventory (STAI). Response is defined as a reduction of at least 6 points on STAI at date of surgery date relative to baseline. The proportion of participants meeting this threshold will be reported. Will be estimated along with the 95% exact binomial confidence interval. Within-group mean change in STAI will be examined using paired t-tests (comparing any two time points of interest).

  From baseline up to day 28

• Proportion of invited patients who agree to participate (recruitment)

  Recruitment will be considered feasible if ≥ 50% of eligible patients enroll. Will be estimated along with the 95% exact binomial confidence interval.

  Up to 6 months

Secondary Outcomes (4)

• Change in patient-reported pain - Numeric Rating Scale

  rom the baseline assessment conducted three weeks prior to surgery through one month after surgery.

• Change in patient-reported pain - Brief Pain Inventory

  From the baseline assessment conducted three weeks prior to surgery up to one month after surgery.

• Change in patient-reported Pittsburgh Sleep Quality Index (PSQI)

  From baseline up to one month after surgery.

• Change in patient-reported Insomnia Severity Index (ISI)

  From baseline up to one month after surgery.

Study Arms (2)

Arm I (Headspace meditation)

EXPERIMENTAL

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.

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

Arm II (Delayed access to Headspace)

EXPERIMENTAL

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.

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

Interventions

Actigraphy OTHER

Wear activity tracker

Arm I (Headspace meditation); Arm II (Delayed access to Headspace)

Online Mindfulness Meditation BEHAVIORAL

Complete mindfulness mediation

Also known as: Online MBSR, Online Mindful Meditation, Online Mindfulness Relaxation, Online Mindfulness-Based Stress Reduction, Web-Based Mindfulness Meditation

Arm I (Headspace meditation); Arm II (Delayed access to Headspace)

Smartphone Application-based Intervention BEHAVIORAL

Receive access to Headspace

Also known as: Smartphone App-based Intervention, Smartphone Intervention, Smartphone-based Intervention

Arm I (Headspace meditation); Arm II (Delayed access to Headspace)

Survey Administration OTHER

Ancillary studies

Arm I (Headspace meditation); Arm II (Delayed access to Headspace)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Pancreatic Neoplasms; Biliary Tract Neoplasms

Interventions

Actigraphy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Accelerometry; Investigative Techniques

Study Officials

• Bradford Kim

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 27, 2026
• Study Start (Estimated): June 25, 2026
• Primary Completion (Estimated): November 25, 2026
• Study Completion (Estimated): November 25, 2026
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

US (1)