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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
70
Wear activity tracker
Complete mindfulness mediation
Receive access to Headspace
Ancillary studies
City of Hope Medical Center
Duarte, California, United States
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Up to 6 months
Change in patient-reported pain - Numeric Rating Scale
Change in patient-reported pain from baseline three weeks prior to surgery through one month postoperatively, measured using the Numeric Rating Scale (NRS, 0 -10 ). 0 means no pain to 10 means worst pain possible.
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
Change in patient-reported pain from baseline three weeks prior to surgery through one month postoperatively, measured using the Brief Pain Inventory.(BPI). 0 means no pain to 10 means worst pain possible.
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)
Self-reported questionnaire will be used to measure sleep quality and sleep patterns over the past month. PSQI will be interpreted by totaling the component scores into a global score ranging from 0 to 21, where higher scores indicate poorer sleep quality; a score greater than 5 generally suggests significant sleep disturbance or poor sleep quality.
Time frame: From baseline up to one month after surgery.
Change in patient-reported Insomnia Severity Index (ISI)
Self-reported questionnaire will be used to assess the severity and impact of insomnia symptoms, including difficulty falling asleep, staying asleep, and the effect of sleep problems on daily functioning. The ISI is interpreted using a total score from 0 to 28: 0-7 indicates no clinically significant insomnia, 8-14 indicates subthreshold insomnia, 15-21 indicates moderate insomnia, and 22-28 indicates severe insomnia.
Time frame: From baseline up to one month after surgery.
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