Nctid:
NCT06234267
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>42}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-05-14", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-05", "completionDateStruct"=>{"date"=>"2025-06-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-05-21", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-05-23", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-04-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Successful receipt of 95% of text messages sent", "timeFrame"=>"4 weeks"}, {"measure"=>"Acceptability of text messages measured by self-report 0-4 likert scale of acceptability of each text message, where 5 is greater acceptability", "timeFrame"=>"4 weeks"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Cancer Survivors", "Neoplasms"]}, "descriptionModule"=>{"briefSummary"=>"Health behavior text message content will be delivered daily over 4-weeks to cancer survivor/caregiver dyads."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria (survivors and caregivers):\n\n1. ≥18 years old\n2. have access to a mobile phone with the ability to receive and send text messages\n3. English- or Spanish-speaking\n4. free of psychiatric or physical disorders that could interfere with participation (e.g., psychosis, delirium)\n5. able to give informed consent in English or Spanish\n\nSurvivors must also:\n\n1. have been diagnosed with any solid tumor cancer\n2. have completed primary curative treatment at least one month prior to enrollment\n3. be able to identify a caregiver to enroll in the study with them\n4. report difficulty engaging in dietary quality, physical activity, and/or sleep hygiene behaviors at screening.\n\nExclusion Criteria:\n\n* Does not meet any of the above criteria"}, "identificationModule"=>{"nctId"=>"NCT06234267", "briefTitle"=>"Eat, Play, Sleep: A Text Message Approach to Promoting Health Behaviors for Cancer Survivors and Their Caregivers", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Arizona"}, "officialTitle"=>"Eat, Play, Sleep: A Text Message Approach to Promoting Multiple Health Behaviors for Cancer Survivors and Their Informal Caregivers", "orgStudyIdInfo"=>{"id"=>"STUDY00004084"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Dietary Quality", "description"=>"Receive daily text messages for promoting dietary quality.", "interventionNames"=>["Behavioral: Eat, Play, Sleep"]}, {"type"=>"EXPERIMENTAL", "label"=>"Physical Activity", "description"=>"Receive daily text messages for promoting physical activity.", "interventionNames"=>["Behavioral: Eat, Play, Sleep"]}, {"type"=>"EXPERIMENTAL", "label"=>"Sleep Hygiene", "description"=>"Receive daily text messages for promoting sleep hygiene.", "interventionNames"=>["Behavioral: Eat, Play, Sleep"]}], "interventions"=>[{"name"=>"Eat, Play, Sleep", "type"=>"BEHAVIORAL", "description"=>"The Eat, Play, Sleep study will test health promotion text messages developed following guidelines for text message program development, aligned with established recommendations for diet, physical activity, and sleep in cancer survivorship and prevention. Feasibility of text message delivery and acceptability of the text message content related to dietary quality, physical activity, and sleep hygiene health behaviors will be tested in delivery to participants (cancer survivor/caregiver dyads) who indicate difficulty engaging in dietary quality, physical activity, or sleep hygiene behaviors.", "armGroupLabels"=>["Dietary Quality", "Physical Activity", "Sleep Hygiene"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"85719", "city"=>"Tucson", "state"=>"Arizona", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Meghan B Skiba, PhD, MS, MPH, RDN", "role"=>"CONTACT", "email"=>"mbskiba@arizona.edu", "phone"=>"520-621-9036"}, {"name"=>"Bianca SantaMaria", "role"=>"CONTACT", "email"=>"biancas@arizona.edu"}, {"name"=>"Rina S Fox, PhD, MPH", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"Meghan B Skiba, PhD, MS, MPH, RDN", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"University of Arizona Cancer Center", "geoPoint"=>{"lat"=>32.22174, "lon"=>-110.92648}}], "centralContacts"=>[{"name"=>"Rachel EB Jarrett, MPH", "role"=>"CONTACT", "email"=>"rjarrett@email.arizona.edu", "phone"=>"5206260375"}, {"name"=>"Bianca SantaMaria, MPH", "role"=>"CONTACT", "email"=>"biancas@arizona.edu"}], "overallOfficials"=>[{"name"=>"Meghan B Skiba, PhD, MS, MPH, RDN", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Arizona"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Arizona", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
