[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07608458":3,"trial-entities:NCT07608458":134,"trial-summary:NCT07608458":139},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":60,"secondary_outcomes":75,"sex":91,"minimum_age":92,"maximum_age":93,"healthy_volunteers":94,"eligibility_criteria":95,"std_ages":109,"locations":112,"central_contacts":129,"overall_officials":130,"references":132,"see_also_links":133},"NCT07608458","25479","Scheduled Meditation for Improving Postoperative Outcomes in Patients Undergoing Pancreatectomy","Scheduled Meditation for Perioperative Optimization: A Randomized Controlled Trial on Postoperative Outcomes, Pain, Anxiety, Insomnia, Stress, and Mobility in Pancreatectomy Patients","NOT_YET_RECRUITING","2026-11-25","2026-08","2026-08-20","2026-10-01","City of Hope Medical Center","OTHER",true,"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\u002For 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:\n\nI. 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.\n\nSECONDARY OBJECTIVE:\n\nI. 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.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM 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.\n\nARM 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.",[19,20,21],"Hepatocellular Carcinoma","Pancreas Cancer","Biliary Tract Neoplasms",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[26],"NA",{"count":28,"type":29},70,"ESTIMATED",[31,37,48,56],{"type":14,"name":32,"description":33,"armGroupLabels":34},"Actigraphy","Wear activity tracker",[35,36],"Arm I (Headspace meditation)","Arm II (Delayed access to Headspace)",{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"BEHAVIORAL","Online Mindfulness Meditation","Complete mindfulness mediation",[35,36],[43,44,45,46,47],"Online MBSR","Online Mindful Meditation","Online Mindfulness Relaxation","Online Mindfulness-Based Stress Reduction","Web-Based Mindfulness Meditation",{"type":38,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Smartphone Application-based Intervention","Receive access to Headspace",[35,36],[53,54,55],"Smartphone App-based Intervention","Smartphone Intervention","Smartphone-based Intervention",{"type":14,"name":57,"description":58,"armGroupLabels":59},"Survey Administration","Ancillary studies",[35,36],[61,65,68,72],{"measure":62,"description":63,"timeFrame":64},"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",{"measure":66,"description":67,"timeFrame":64},"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 (\\\u003C 20%) compliance. Will be estimated along with the 95% exact binomial confidence interval.",{"measure":69,"description":70,"timeFrame":71},"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",{"measure":73,"description":74,"timeFrame":64},"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.",[76,80,84,88],{"measure":77,"description":78,"timeFrame":79},"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.","rom the baseline assessment conducted three weeks prior to surgery through one month after surgery.",{"measure":81,"description":82,"timeFrame":83},"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.","From the baseline assessment conducted three weeks prior to surgery up to one month after surgery.",{"measure":85,"description":86,"timeFrame":87},"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.","From baseline up to one month after surgery.",{"measure":89,"description":90,"timeFrame":87},"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.","ALL","18 Years",null,false,{"inclusion":96,"exclusion":105,"raw_text":108},[97,98,99,100,101,102,103,104],"Documented informed consent of the participant and\u002For 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",[106,107],"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","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Willing to install required apps on personal smartphone\n* Willing to wear a Garmin wearable device throughout the study\n* Age: ≥ 18 years\n* Ability to read and understand English for questionnaires\n* Owns a smartphone\n* Comfortable with routine smartphone use\n* Scheduled to undergo pancreatectomy\n\nExclusion Criteria:\n\n* Participants with prior formal training in meditation or mindfulness (e.g., completion of structured courses, workshops, or certification programs)\n* 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",[110,111],"ADULT","OLDER_ADULT",[113],{"facility":13,"city":114,"state":115,"zip":116,"country":117,"contacts":118,"geoPoint":126},"Duarte","California","91010","United States",[119,124],{"name":120,"role":121,"phone":122,"email":123},"Bradford Kim","CONTACT","626-218-1840","brakim@coh.org",{"name":120,"role":125},"PRINCIPAL_INVESTIGATOR",{"lat":127,"lon":128},34.13945,-117.97729,[],[131],{"name":120,"affiliation":13,"role":125},[],[],{"nct_id":4,"conditions":135,"biomarkers":138},[19,136,137],"Malignant Pancreatic Neoplasm","Neoplasm of biliary tract",[],{"nct_id":4,"found":15,"summary":140,"prompt_version":149},{"design":141,"status":142,"heading":6,"summary":143,"follow_up":144,"word_count":145,"commitments":146,"compensation":147,"drugs_mentioned":148},"This interventional study plans to enroll 70 participants and will compare two groups: one receiving early access to Headspace meditation and another receiving it later.","completed","This study is exploring if a scheduled meditation program can help patients who are having a pancreatectomy (surgery to remove part or all of the pancreas) feel better after their operation. Many patients experience pain, anxiety, and fatigue after this surgery. This study uses the Headspace app for mindfulness meditation and asks participants to wear an activity tracker. We want to see if this approach is practical and if it can reduce anxiety. We're also looking at how it might affect pain and sleep quality. You might be able to join if you are 18 or older, have a smartphone you're comfortable using, and are scheduled for a pancreatectomy. The study aims to enroll 70 participants.","You would be followed for up to 6 months to assess retention and compliance, and anxiety symptoms are measured up to day 28.",116,"You would install required apps on your smartphone, wear a Garmin activity tracker throughout the study, and complete mindfulness meditation sessions daily for several weeks before and after surgery. You will also complete surveys.","Not stated in the trial record.",[],"v2"]