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Scheduled Meditation for Improving Postoperative Outcomes in Patients Undergoing Pancreatectomy

ConditionsHepatocellular CarcinomaPancreas CancerBiliary Tract Neoplasms
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Actigraphy

    Other intervention

    Wear activity tracker

  • Online Mindfulness Meditation

    Behavioral

    Complete mindfulness mediation

  • Smartphone Application-based Intervention

    Behavioral

    Receive access to Headspace

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Arm I (Headspace meditation)Experimental treatment 4 interventions
Group B: Arm II (Delayed access to Headspace)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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.
2

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.
3

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.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: