Scheduled Meditation for Improving Postoperative Outcomes in Patients Undergoing Pancreatectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Actigraphy, Online Mindfulness Meditation, Smartphone Application-based Intervention, Survey Administration.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma, Pancreas Cancer, Biliary Tract Neoplasms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Scheduled Meditation for Perioperative Optimization: A Randomized Controlled Trial on Postoperative Outcomes, Pain, Anxiety, Insomnia, Stress, and Mobility in Pancreatectomy Patients
Overview
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.
Detailed 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.
Interventions
- Other Actigraphy
Wear activity tracker - Behavioral Online Mindfulness Meditation
Complete mindfulness mediation - Behavioral Smartphone Application-based Intervention
Receive access to Headspace - Other Survey Administration
Ancillary studies
Primary outcome measures
- Proportion of enrolled patients who complete the final study assessment (retention) [Time frame: Up to 6 months]
- Proportion of prescribed meditation modules completed (compliance) [Time frame: Up to 6 months]
- Change in patient-reported anxiety symptoms [Time frame: From baseline up to day 28]
- Proportion of invited patients who agree to participate (recruitment) [Time frame: Up to 6 months]
Secondary outcome measures (4)
- Change in patient-reported pain - Numeric Rating Scale [Time frame: rom the baseline assessment conducted three weeks prior to surgery through one month after surgery.]
- Change in patient-reported pain - Brief Pain Inventory [Time frame: 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) [Time frame: From baseline up to one month after surgery.]
- Change in patient-reported Insomnia Severity Index (ISI) [Time frame: From baseline up to one month after surgery.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- City of Hope Medical Center — Duarte
Identifiers
NCT: NCT07608458 · 25479 · NCI-2026-03206 · 25479 · P30CA033572