Hepatocellular CarcinomaNCT07608458
Scheduled Meditation for Improving Postoperative Outcomes in Patients Undergoing Pancreatectomy
A study testing Actigraphy, Online Mindfulness Meditation and Smartphone Application-based Intervention in people with Hepatocellular Carcinoma and Pancreas Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Pancreas Cancer, Biliary Tract Neoplasms
- What is being tested?
- Actigraphy, Online Mindfulness Meditation and Smartphone Application-based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 25 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
Bradford Kim, 626-218-1840, brakim@coh.org
Bradford Kim
About this study
Official title: Scheduled Meditation for Perioperative Optimization: A Randomized Controlled Trial on Postoperative Outcomes, Pain, Anxiety, Insomnia, Stress, and Mobility in Pancreatectomy Patients
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Being tested
- Actigraphy, Online Mindfulness Meditation, Smartphone Application-based Intervention, Survey Administration
- Medical subject headings
- Carcinoma, Hepatocellular, Pancreatic Neoplasms, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActigraphyOther
Wear activity tracker
Online Mindfulness MeditationBehavioural
Also called Online MBSR, Online Mindful Meditation, Online Mindfulness Relaxation, Online Mindfulness-Based Stress Reduction
Complete mindfulness mediation
Smartphone Application-based InterventionBehavioural
Also called Smartphone App-based Intervention, Smartphone Intervention, Smartphone-based Intervention
Receive access to Headspace
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Actigraphy; Behavioral: Online Mindfulness Meditation; Behavioral: Smartphone Application-based Intervention; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Up to 6 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline up to one month after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start1 Oct 2026 (estimated)
- Primary completion25 Nov 2026 (estimated)
- Study completion25 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Bradford Kim, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608458
- Sponsor's protocol ID
- 25479
- Other IDs
- NCI-2026-03206, 25479, P30CA033572
- Status last verified
- Aug 2026
- First submitted
- 13 May 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scheduled Meditation for Perioperative Optimization: A Randomized Controlled Trial on Postoperative Outcomes, Pain, Anxiety, Insomnia, Stress, and Mobility in Pancreatectomy Patients
- ClinicalTrials.gov ID
- NCT07608458
- Acronym / sponsor ID
- 25479
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 25 Nov 2026 (estimated)
- Study completion
- 25 Nov 2026 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Headspace meditation) | Experimental | Other: Actigraphy, Behavioral: Online Mindfulness Meditation, Behavioral: Smartphone Application-based Intervention, Other: Survey AdministrationPatients 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. |
| Arm II (Delayed access to Headspace) | Experimental | Other: Actigraphy, Behavioral: Online Mindfulness Meditation, Behavioral: Smartphone Application-based Intervention, Other: Survey AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActigraphyWear activity tracker | Other | Arm I (Headspace meditation), Arm II (Delayed access to Headspace) |
| Online Mindfulness MeditationAlso: Online MBSR, Online Mindful Meditation, Online Mindfulness Relaxation, Online Mindfulness-Based Stress ReductionComplete mindfulness mediation | Behavioural | Arm I (Headspace meditation), Arm II (Delayed access to Headspace) |
| Smartphone Application-based InterventionAlso: Smartphone App-based Intervention, Smartphone Intervention, Smartphone-based InterventionReceive access to Headspace | Behavioural | Arm I (Headspace meditation), Arm II (Delayed access to Headspace) |
| Survey AdministrationAncillary studies | Other | Arm I (Headspace meditation), Arm II (Delayed access to Headspace) |
Primary outcome
Proportion of enrolled patients who complete the final study assessment (retention)
Time frame: Up to 6 months
Retention will be considered feasible if ≥ 70% of enrolled participants are retained. Will be estimated along with the 95% exact binomial confidence interval.
Proportion of prescribed meditation modules completed (compliance)
Time frame: Up to 6 months
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.
Change in patient-reported anxiety symptoms
Time frame: From baseline up to day 28
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).
Proportion of invited patients who agree to participate (recruitment)
Time frame: Up to 6 months
Recruitment will be considered feasible if ≥ 50% of eligible patients enroll. Will be estimated along with the 95% exact binomial confidence interval.
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bradford Kim principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actigraphy, Online Mindfulness Meditation and Smartphone Application-based Intervention in people with Hepatocellular Carcinoma and Pancreas Cancer, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of enrolled patients who complete the final study assessment (retention) (time frame: Up to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.