[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651421":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":44,"responsibleParty":63,"collaborators":65,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":42,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":42,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":47,"whyStopped":42,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mindful PaCT","EXPERIMENTAL","Patient-partner dyads assigned to this arm receive Mindful PaCT, a couple-based mindfulness program delivered through four weekly, 60- to 75-minute sessions via secure videoconferencing. Sessions are facilitated by a trained interventionist. Couples also receive a program workbook and access to supplemental audio and video mindfulness practices for use between sessions.",[13],"Behavioral: Couple-based Mindfulness Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Wellness PACT","PLACEBO_COMPARATOR","Patient-partner dyads assigned to this arm receive Wellness PaCT, a couple-based educational program delivered through four weekly, 60- to 75-minute sessions via secure videoconferencing. Sessions are facilitated by a trained interventionist and address general wellness, sleep and fatigue, diet and nutrition, and exercise and physical activity. Couples also receive a program workbook and supplemental educational resources for use between sessions.",[19],"Behavioral: Health and Wellness Education Control Condition",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Couple-based Mindfulness Intervention","Mindful PaCT is a manualized, couple-based mindfulness intervention designed to reduce distress and strengthen coping among patients with metastatic colorectal cancer and their partners. The intervention includes four weekly, 60- to 75-minute sessions delivered to each patient-partner dyad via secure videoconferencing by a trained interventionist. Sessions address four core mindfulness competencies: awareness, acceptance, compassion, and connection. Intervention content includes mindfulness-based education, guided experiential exercises, and skill-building activities designed to support individual and relational coping and adjustment in the context of advanced cancer. Couples receive a workbook containing session materials and access to supplemental audio and video recordings of guided mindfulness practices to support between-session practice and continued skill development.",[9],[9],{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Health and Wellness Education Control Condition","Wellness PaCT is a manualized, couple-based educational intervention designed as an active, attention-matched control condition for patients with metastatic colorectal cancer and their partners. The intervention includes four weekly, 60- to 75-minute sessions delivered to each patient-partner dyad via secure videoconferencing by a trained interventionist. Each session focuses on a wellness topic relevant to coping with metastatic colorectal cancer: general wellness, sleep and fatigue, diet and nutrition, and exercise and physical activity. Intervention content includes health education and structured activities intended to support healthy lifestyle behaviors in the context of advanced cancer. Couples receive a workbook containing session materials and access to supplemental educational resources to support continued learning between sessions.",[15],[32],"Wellness PaCT",[34],{"name":35,"affiliation":5,"role":36},"Lauren Zimmaro, PhD","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Kaylee Ortega","CONTACT","3037248895",null,"kaylee.ortega@cuanschutz.edu",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"University of Colorado Hospital","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-104.83192,39.72943,{"lat":57,"lon":56},[60,62],{"name":39,"role":40,"phone":61,"phoneExt":42,"email":43},"303-724-8895",{"name":35,"role":36,"phone":42,"phoneExt":42,"email":42},{"type":64,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[66],{"name":67,"class":68},"National Cancer Institute (NCI)","NIH","100651421","novel-couple-based-mindfulness-intervention-for-metastatic-colorectal-cancer-100651421",false,"NCT07759921","Novel Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer","Feasibility and Acceptability of a Novel Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Provision to sign and date the consent form.\n* Stated willingness to comply with all study procedures and be available for the duration of the study.\n* Be aged \\> 18 years to 85.\n* Fluent in English language. All study materials, including the informed consent form, participant workbooks, and questionnaires, are currently available only in English. Participation requires the ability to independently read and engage with written study materials (including the participant workbook), which are integral to the intervention session content and home practices. Therefore, individuals who are unable to read study materials in English are not eligible to participate. At this time, the intervention has not been translated or validated in other languages, therefore participation is limited to individuals who can read, speak, and understand English to ensure that participants are able to fully engage with study activities.\n* Be a person (i.e., patient) diagnosed with metastatic colorectal cancer (mCRC) or a partner (e.g., spouse) of someone diagnosed with mCRC.\n* Indicates a score \\>0 on the Distress Thermometer\n* Has access to computer\u002Finternet through with video-conferencing (phone, laptop, tablet, desktop computer)\n\nAdditional eligibility criteria include:\n\nAdditional patient participant inclusion criteria:\n\n* Has a current diagnosis of metastatic (Stage IV, recurrent) colorectal cancer\n* Has an ECOG status \\\u003C2 or otherwise deemed appropriate for study participation by a clinician\n* Is in a committed relationship with a romantic partner for \\>6 months. Monogamy is not required for eligibility; however, in cases of polyamorous relationships, the patient will designate a primary partner for participation in the study.\n\nAdditional partner participant inclusion criteria:\n\n• Has been in a committed relationship \\>6 months with a patient who meets the above eligibility criteria\n\nEligibility for relationship status will be self-reported by participants during recruitment.\n\nExclusion Criteria:\n\n* One or both members of the couple has an active or poorly controlled serious mental illness (e.g., psychotic disorder), cognitive impairment (e.g., dementia), or medical condition (e.g., significant impaired sight\u002Fhearing) that would compromise participation.\n* The couple is currently in active couples (e.g., marital) therapy together.\n\nParticipants who are physically or mentally too ill to participate or those with major cognitive impairments are excluded because they may not be able to engage with intervention sessions, surveys. No exclusions will be made based on sexual orientation, race, gender, or other sociodemographic features. Because patients with mCRC are living longer, and patients and partners can experience distress at various times since their diagnosis, we do not limit participation by time since diagnosis.",true,"ALL","18 Years","85 Years",{"count":81,"type":82},90,"ESTIMATED","INTERVENTIONAL",[85],"NA","The overall objective of this study is to learn whether a newly developed couple-based mindfulness program (Mindful PaCT) is practical to complete (feasible), helpful and well-received (acceptable), and relevant for patients with metastatic colorectal cancer (mCRC) and their partners.",[88,89],"Colorectal Cancer","Metastatic Colorectal Cancer (CRC)",[91,92,93],"Couple","Partner","Caregiver","2026-08-12",{"date":96,"type":97},"2026-08-14","ACTUAL",{"date":99,"type":82},"2026-12",{"date":101,"type":82},"2030-12",{"name":5,"class":6},1]