Nctid:
NCT06233253
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000015179", "term"=>"Colorectal Neoplasms"}], "ancestors"=>[{"id"=>"D000007414", "term"=>"Intestinal Neoplasms"}, {"id"=>"D000005770", "term"=>"Gastrointestinal Neoplasms"}, {"id"=>"D000004067", "term"=>"Digestive System Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D000003108", "term"=>"Colonic Diseases"}, {"id"=>"D000007410", "term"=>"Intestinal Diseases"}, {"id"=>"D000012002", "term"=>"Rectal Diseases"}], "browseLeaves"=>[{"id"=>"M4324", "name"=>"Anxiety Disorders", "relevance"=>"LOW"}, {"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M17890", "name"=>"Colorectal Neoplasms", "asFound"=>"Colorectal Carcinoma", "relevance"=>"HIGH"}, {"id"=>"M10448", "name"=>"Intestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8886", "name"=>"Gastrointestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M7256", "name"=>"Digestive System Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M6336", "name"=>"Colonic Diseases", "relevance"=>"LOW"}, {"id"=>"M10444", "name"=>"Intestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M14844", "name"=>"Rectal Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>100}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-09-29", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-22", "studyFirstSubmitDate"=>"2024-01-08", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Retention rate (Feasibility)", "timeFrame"=>"Up to 4 weeks", "description"=>"Feasibility will be assessed by the number of patients referred, number of participants recruited, and missing data from surveys and medical records. Feasibility will be achieved with a retention rate of 90% throughout the intervention. An independent samples t-test will be conducted to compare State-Trait Anxiety Inventory: State-Subscale (STAI-S) scores. Linear regression will be conducted to assess the difference when controlling for potential confounding variables of interest."}, {"measure"=>"Satisfaction with the intervention (Acceptability)", "timeFrame"=>"At follow-up (1-2 days after the colonoscopy)", "description"=>"Acceptability will be assessed by the number of intervention materials accessed and time to complete study activities (infographics, meditations, and surveys) via embedded REDCap metrics. Participants within the MBI group will also report meditation satisfaction and state mindfulness immediately after each meditation in addition to intervention satisfaction during the follow-up survey. Will report an average satisfaction score with the intervention \\>= 6.0, measured using a 7-point Likert scale. An independent samples t-test will be conducted to compare STAI-S scores. Linear regression will be conducted to assess the difference when controlling for potential confounding variables of interest."}], "secondaryOutcomes"=>[{"measure"=>"Colonoscopy nervousness", "timeFrame"=>"At pre-colonoscopy assessment", "description"=>"Anxiety specific to the bowel prep and colonoscopy will be assessed using a visual analogue scale. Will be analyzed using t-test."}, {"measure"=>"Mindfulness", "timeFrame"=>"At follow-up (1-2 days after the colonoscopy)", "description"=>"Will measure the trait mindfulness using The Philadelphia Mindfulness Scale, a 20-item self-report with subscales of awareness and acceptance. Will be analyzed using t-test."}, {"measure"=>"Mindfulness knowledge", "timeFrame"=>"At follow up (1-2 days after the colonoscopy)", "description"=>"Will be assessed using a 5-item score about mindfulness. An independent samples t-test will be conducted to compare STAI-S scores."}, {"measure"=>"Colorectal screening knowledge", "timeFrame"=>"At follow up (1-2 days after the colonoscopy)", "description"=>"Will be assessed using a 5-item score about colorectal (CRC) screening. Will be analyzed using t-test."}, {"measure"=>"Attitudes about CRC and CRC screening", "timeFrame"=>"At follow up (1-2 days after the colonoscopy)", "description"=>"Will be self-reported and measured on a 5-point Likert scale. Will be analyzed using t-test."}, {"measure"=>"Bowel prep adherence", "timeFrame"=>"At pre-colonoscopy assessment", "description"=>"Will be self-reported and measured on a 5-point Likert scale. Will be analyzed using chi-square test."}, {"measure"=>"Bowel prep difficulty", "timeFrame"=>"At pre-colonoscopy assessment", "description"=>"Will be self-reported and measured on a 5-point Likert scale. Will be analyzed using t-test."}, {"measure"=>"Bowel prep quality", "timeFrame"=>"Up to 4 weeks", "description"=>"Will be measured using the Boston Bowel Preparation Scale or 5-point Likert scale and medical chart review. Will be analyzed using t-test."}, {"measure"=>"Cancellation/no-show", "timeFrame"=>"At pre-colonoscopy assessment", "description"=>"Will be measured by attendance. Will be analyzed using chi-square test."}, {"measure"=>"Heart rate", "timeFrame"=>"Up to 4 weeks", "description"=>"Will be measured in beats per minute using medical chart review. Will be analyzed using t-test."}, {"measure"=>"Blood pressure", "timeFrame"=>"Up to 4 weeks", "description"=>"Will be measured in millimeter of mercury using chart review at time of check-in (the first recorded) to the endoscopy suite holding area. Will be analyzed using t-test."}, {"measure"=>"Sedative dose", "timeFrame"=>"Up to 4 weeks", "description"=>"Will be measured in milligrams using chart review. Will be analyzed using t-test."}, {"measure"=>"Procedural time", "timeFrame"=>"Up to 4 weeks", "description"=>"Will be measured in minutes using medical chart review. Will be analyzed using t-test."}, {"measure"=>"Cecal intubation time", "timeFrame"=>"At post-colonoscopy", "description"=>"Will be measured in minutes using medical chart review. Will be analyzed using t-test."}, {"measure"=>"Endoscopy suite time", "timeFrame"=>"Up to 4 weeks", "description"=>"Will be measured in minutes using medical chart review. Will be analyzed using t-test."}, {"measure"=>"Procedure satisfaction", "timeFrame"=>"At follow up (1-2 days after the colonoscopy)", "description"=>"Will be self-reported and measured on a 5-point Likert scale. Will be analyzed using t-test."}, {"measure"=>"Intent for future CRC screening", "timeFrame"=>"At follow up (1-2 days after the colonoscopy)", "description"=>"Will be self-reported and measured on a 5-point Likert scale. Will be analyzed using t-test."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Colorectal Carcinoma"]}, "referencesModule"=>{"seeAlsoLinks"=>[{"url"=>"http://cancer.osu.edu", "label"=>"The Jamesline"}]}, "descriptionModule"=>{"briefSummary"=>"This clinical trial tests how well an online mindfulness-based intervention (MBI) works to decrease anxiety in patients before a first-time screening colonoscopy. Elevated pre-procedural anxiety can affect patient outcomes including bowel preparation adherence and quality, the amount of sedation required, procedure time, patient satisfaction, cancellation or no-shows, and intention for future cancer screening. Mindfulness is a form of meditation that focuses on staying within the present moment to reduce anxiety. Previous research supports mindfulness practice among cancer survivors to decrease anxiety, fear of cancer re-occurrence, and to improve quality of life. Online MBIs have the potential to include targeted meditations and educational information designed to promote behavior change. This study may help researchers learn whether a mindfulness intervention works to decrease anxiety in patients before a first-time screening colonoscopy.", "detailedDescription"=>"PRIMARY OBJECTIVE:\n\nI. To establish intervention feasibility and acceptability, and to collect preliminary efficacy data on a developed online mindfulness-based intervention (MBI) to reduce pre-procedural anxiety before a first-time screening colonoscopy compared to usual care.\n\nOUTLINE: Patients are randomized to 1 of 2 groups.\n\nGROUP I: Patients receive usual care prior to their scheduled screening colonoscopy.\n\nGROUP II: Patients receive an online mindfulness intervention including infographics and 5-minute meditations once daily (QD) for 5 days prior to their scheduled screening colonoscopy.\n\nAfter completion of study intervention, patients are followed up 1-2 days post-colonoscopy."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"45 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients must be ages 45-75\n* Patients must be at average risk for colorectal cancer (CRC)\n* Patients must have scheduled their first-time screening colonoscopy as an outpatient at Ohio State University (OSU) at least 14 days in advance\n* Patients must be able to speak and read English\n* Patients must have daily access to a working telephone, email address, and internet connection\n* Patients must provide consent\n\nExclusion Criteria:\n\n* Previous colonoscopy\n* Colonoscopy for diagnostic purposes\n* Auditory or visual impairment that prevents internet use\n* Previous cancer diagnosis (other than skin cancer)\n* Previous diagnosis of a mental health disorder\n* Current mental health treatment\n* Family history of CRC\n* Personal history of inflammatory bowel disease (ulcerative colitis or Crohn's disease)\n* Confirmed or suspected hereditary CRC syndrome, such as familial adenomatous polyposis or Lynch syndrome"}, "identificationModule"=>{"nctId"=>"NCT06233253", "briefTitle"=>"Online Mindfulness-Based Intervention to Decrease Pre-Procedural Anxiety Before a First-Time Screening Colonoscopy", "organization"=>{"class"=>"OTHER", "fullName"=>"Ohio State University Comprehensive Cancer Center"}, "officialTitle"=>"A Brief Online Mindfulness-Based Intervention to Decrease Pre-Procedural Anxiety Before a First-Time Screening Colonoscopy: A Pilot Randomized Controlled Trial", "orgStudyIdInfo"=>{"id"=>"OSU-23136"}, "secondaryIdInfos"=>[{"id"=>"NCI-2023-10496", "type"=>"REGISTRY", "domain"=>"CTRP (Clinical Trial Reporting Program)"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Group I (usual care)", "description"=>"Patients receive usual care prior to their scheduled screening colonoscopy.", "interventionNames"=>["Other: Best Practice", "Other: Medical Chart Review", "Other: Survey Administration"]}, {"type"=>"EXPERIMENTAL", "label"=>"Group II (online mindfulness intervention)", "description"=>"Patients receive an online mindfulness intervention including infographics and 5-minute meditations QD for 5 days prior to their scheduled screening colonoscopy.", "interventionNames"=>["Other: Medical Chart Review", "Behavioral: Online Mindfulness Meditation", "Other: Survey Administration"]}], "interventions"=>[{"name"=>"Best Practice", "type"=>"OTHER", "otherNames"=>["standard of care", "standard therapy"], "description"=>"Receive usual care", "armGroupLabels"=>["Group I (usual care)"]}, {"name"=>"Medical Chart Review", "type"=>"OTHER", "otherNames"=>["Chart Review"], "description"=>"Ancillary studies", "armGroupLabels"=>["Group I (usual care)", "Group II (online mindfulness intervention)"]}, {"name"=>"Online Mindfulness Meditation", "type"=>"BEHAVIORAL", "otherNames"=>["Online MBSR", "Online Mindful Meditation", "Online Mindfulness Relaxation", "Online Mindfulness-Based Stress Reduction", "Web-Based Mindfulness Meditation"], "description"=>"Receive an online mindfulness intervention", "armGroupLabels"=>["Group II (online mindfulness intervention)"]}, {"name"=>"Survey Administration", "type"=>"OTHER", "description"=>"Ancillary studies", "armGroupLabels"=>["Group I (usual care)", "Group II (online mindfulness intervention)"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"43210", "city"=>"Columbus", "state"=>"Ohio", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Mira Katz", "role"=>"CONTACT", "email"=>"mira.katz@osumc.edu", "phone"=>"614-293-6603"}, {"name"=>"Mira Katz", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Ohio State University Comprehensive Cancer Center", "geoPoint"=>{"lat"=>39.96118, "lon"=>-82.99879}}], "overallOfficials"=>[{"name"=>"Mira Katz", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Ohio State University Comprehensive Cancer Center"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Ohio State University Comprehensive Cancer Center", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Mira Katz", "investigatorAffiliation"=>"Ohio State University Comprehensive Cancer Center"}}}}
