[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04512144":3,"trial-entities:NCT04512144":110,"trial-summary:NCT04512144":115},{"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":24,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":39,"secondary_outcomes":48,"sex":65,"minimum_age":66,"maximum_age":67,"healthy_volunteers":68,"eligibility_criteria":69,"std_ages":78,"locations":81,"central_contacts":98,"overall_officials":105,"references":108,"see_also_links":109},"NCT04512144","30780","Mindfulness in Endometrial and Cervical Cancer","Mindfulness Practice in Endometrial and Cervical Cancers With Smartphone Applications (MECCA)","RECRUITING","2026-07-30","2025-09","2025-09-30","2020-07-25","St. Louis University","OTHER",false,"Patients with endometrial cancer who will be undergoing surgery or patients with cervical cancer who will be treated with chemoradiation will be randomized to utilize the Headspace smartphone application or not prior to their anticipated treatment.","A diagnosis of cancer can be a major stress-inducing event. The prevalence of depression in patients diagnosed with cancer is estimated up to 16%. Practicing mindfulness is a cost-effective treatment which can also help manage treatment adverse effects and cancer-related symptoms.\n\nEven short exposure and practice of mindfulness exercises have demonstrated improved subjective and objective measurements of stress and anxiety with breast biopsies. Patients with breast cancer also have improved quality of life with mindfulness training. Self-guided mindfulness with smartphone applications, specifically the app Headspace, has been associated with positive benefits and ease of use in the general population and among cancer patients.\n\nA patient's inherent level of baseline mindfulness has been associated with lower pain scores following minimally invasive hysterectomy. This study did not specifically encourage practice of mindfulness exercises. Our own study of post-operative opiate usage in women following minimally invasive hysterectomy contains self-reported data of women using opiates to relax or help sleep. This suggests that mindfulness exercises may improve quality of life in these areas and thus reduce opiate usage. Patients undergoing minimally invasive hysterectomy for treatment of endometrial cancer were specifically chosen as a study cohort to build on our own data and that currently reported in the literature as well as the highest incidence of this cancer as a gynecologic malignancy. The second study cohort chosen was women with cervical cancer undergoing definitive treatment with chemo-sensitizing radiation given the significant endeavor required for complete treatment. Additionally, these women are often younger with the diagnosis of cervical cancer often being their first major medical diagnosis.",[19,20,21,22,23],"Gynecologic Cancer","Endometrial Cancer","Cervical Cancer","Quality of Life","Opioid Use",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[28],"NA",{"count":30,"type":31},120,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"BEHAVIORAL","Headspace Smartphone Application","Headspace is a smartphone application used for mindfulness, meditation, and stress reduction. It has been utilized in other behavioral and quality of life studies.",[38],"Intervention",[40,44],{"measure":41,"description":42,"timeFrame":43},"Opiate Usage-Endometrial cancer","The amount of opiates used during the acute (30 day) recovery after surgery for endometrial cancer or acute treatment with chemoradiation for cervical cancer will be recorded.","Enrollment to 30 days post op for endometrial cancer.",{"measure":45,"description":46,"timeFrame":47},"Opiate Usage-Cervical Cancer","The amount of opiates used during the acute treatment with chemoradiation for cervical cancer will be recorded.","Enrollment to 6 weeks post treatment for cervical cancer.",[49,53,56,59,62],{"measure":50,"description":51,"timeFrame":52},"Five Facet Mindfulness Questionnaire","Patients will be asked to complete a Five Facet Mindfulness Questionnaire form at enrollment, on the day of surgery (endometrial cancer) or first brachytherapy (cervical cancer), and at their post-treatment visit.","Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.",{"measure":54,"description":55,"timeFrame":52},"Functional Assessment of Cancer Therapy-General","Patients will be asked to complete a Functional Assessment of Cancer Therapy-General form at enrollment, on the day of surgery (endometrial cancer) or first brachytherapy (cervical cancer), and at their post-treatment visit.",{"measure":57,"description":58,"timeFrame":52},"Complication Rates","Surgical or treatment complications will be monitored in each group.",{"measure":60,"description":61,"timeFrame":52},"Patient satisfaction","Patients from each group will be asked to complete an anonymous study-specific survey evaluating their satisfaction with the program.",{"measure":63,"description":64,"timeFrame":52},"Compliance","The number of Headspace sessions utilized by patients in the intervention group will be recorded.","FEMALE","18 Years","90 Years",true,{"inclusion":70,"exclusion":73,"raw_text":77},[71,72],"New diagnosis of either 1) endometrial cancer undergoing surgery or 2) cervical cancer undergoing chemo-sensitizing radiation","Access to a smartphone",[74,75,76],"Non-English speaking","No access to smartphone","Current use of Headspace application","Inclusion Criteria:\n\n* New diagnosis of either 1) endometrial cancer undergoing surgery or 2) cervical cancer undergoing chemo-sensitizing radiation\n* Access to a smartphone\n\nExclusion Criteria:\n\n* Non-English speaking\n* No access to smartphone\n* Current use of Headspace application",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":83,"status":8,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":95},"Saint Louis University","St Louis","Missouri","63104","United States",[89],{"name":90,"role":91,"phone":92,"phoneExt":93,"email":94},"Shannon Grabosch, MD","CONTACT","314-781-8605","1","shannon.grabosch@health.slu.edu",{"lat":96,"lon":97},38.62727,-90.19789,[99,101],{"name":90,"role":91,"phone":100,"phoneExt":93,"email":94},"3147818605",{"name":102,"role":91,"phone":103,"email":104},"Shohreh Jamalabadi-Majidi, DMD, MPH","3149777482","shohreh.jamalabadimajidi@health.slu.edu",[106],{"name":90,"affiliation":13,"role":107},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":111,"biomarkers":114},[112,113],"Cervical Carcinoma","Endometrial Carcinoma",[],{"nct_id":4,"found":68,"summary":116,"prompt_version":126},{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This interventional study plans to enroll 120 participants. Participants will be randomly assigned to either use the Headspace app or not.","completed","Mindfulness with Headspace for Endometrial and Cervical Cancer","This study is exploring if using the Headspace smartphone app can help women with endometrial or cervical cancer manage pain and reduce their need for opioid medication. You might be able to join if you are a woman aged 18 to 90, have a new diagnosis of endometrial cancer and are having surgery, or have cervical cancer and are having chemoradiation. You also need to have a smartphone and speak English. The study will look at how much opioid medication you use after surgery for endometrial cancer (up to 30 days) or after treatment for cervical cancer (up to 6 weeks). The current status of this study is unclear.","Opioid use will be measured up to 30 days after surgery for endometrial cancer, or up to 6 weeks after treatment for cervical cancer.",109,"Participants will use the Headspace smartphone application or not, prior to their anticipated cancer treatment.","Not stated in the trial record.",[],"v2"]