[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07305740":3,"trial-entities:NCT07305740":134,"trial-summary:NCT07305740":138},{"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":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":45,"secondary_outcomes":74,"sex":75,"minimum_age":76,"maximum_age":77,"healthy_volunteers":15,"eligibility_criteria":78,"std_ages":99,"locations":102,"central_contacts":120,"overall_officials":129,"references":132,"see_also_links":133},"NCT07305740","25-521","On-Trac: An Online Intervention for Cancer Survivors Managing Anxiety","Online Training After Cancer (On-Trac): Developing An Online Intervention for Cancer Survivors Managing Anxiety","RECRUITING","2027-12-31","2026-05","2026-05-13","2026-03-11","Dana-Farber Cancer Institute","OTHER",false,"This study is evaluating On-Trac (Online Training After Cancer), an online educational intervention to teach adult cancer survivors strategies to address anxiety based on Cognitive-Behavioral Therapy (CBT) and Acceptance Commitment Therapy (ACT)\n\nThe name of the study intervention is Online Training After Cancer (On-Trac)","This is a minimal-risk behavioral optimization trial to optimize and refine On-Trac (Online Training After Cancer), an online educational intervention designed to help adult cancer survivors.\n\nThe research study procedures include screening for eligibility, questionnaires and interviews.\n\nParticipation in the study involves:\n\n* Completing online survey using using a web-based survey platform for baseline assessment\n* Taking part in an online, 120 minute, group session via video conference platform and completing an online questionnaire.\n* Completing 1-2, 30-40 minute, individual coaching sessions 1-7 days after group educational video session.\n* Completing follow-up questionnaire using a web-based survey platform and telephone interview at 4, and 8 weeks after the group education session.\n* Participants will receive gift card incentives for completing the brief post-session evaluation and the longer follow-up questionnaires and interview, with a maximum total of $90.\n\nIt is expected about 80 people will participate in this research study and will be grouped in four aged based cohorts of 15-20 participants.",[19,20,21],"Cancer","Survivorship","Anxiety",[23,21],"Cancer Survivorship","INTERVENTIONAL","SUPPORTIVE_CARE",[27],"NA",{"count":29,"type":30},80,"ESTIMATED",[32,41],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","ON-TRAC Education session","120 minute educational session on strategies for anxiety delivered via synchronous videoconference session",[37,38,39,40],"Cohort 1: CANCER SURVIVORS AGE 18-39 ON-TRAC SMALL GROUP","Cohort 2: CANCER SURVIVORS AGE 18-39 ON-TRAC INDIVIDUAL SESSIONS","Cohort 3: CANCER SURVIVORS AGE 40+ ON-TRAC SMALL GROUP","Cohort 4: CANCER SURVIVORS AGE 40+ ON-TRAC INDIVIDUAL SESSIONS",{"type":33,"name":42,"description":43,"armGroupLabels":44},"ON-TRAC Coaching","30-40 minute individual coaching sessions on implementation of strategies for anxiety",[37,38,39,40],[46,50,52,55,57,60,63,66,68,71],{"measure":47,"description":48,"timeFrame":49},"Change in OASIS (Overall Anxiety Severity and Impairment Scale) from baseline to 4 weeks","OASIS is a 5-item self-report measure, where the total score is obtained as a sum of the individual items. Higher scores are indicative of more severe and impairing anxiety symptoms.","Anxiety measures will be collected once at baseline prior to receiving On-Trac intervention, and at follow-up 4 and 8 weeks post-baseline.",{"measure":51,"description":48,"timeFrame":49},"Change in OASIS (Overall Anxiety Severity and Impairment Scale) from baseline to 8 weeks",{"measure":53,"description":54,"timeFrame":49},"Change in AAQ-2 (Acceptance and Action Questionnaire - Version 2) from baseline to 4 weeks","AAQ-2 is a 7-item self report measure, where the total score is obtained as a sum of the individual items. Higher scores are indicative of higher psychological inflexibility.",{"measure":56,"description":54,"timeFrame":49},"Change in AAQ-2 (Acceptance and Action Questionnaire - Version 2) from baseline to 8 weeks",{"measure":58,"description":59,"timeFrame":49},"Change in PROMIS-Anxiety from baseline to 4 weeks","PROMIS-Anxiety is a 7-item self report measure, where the total score is obtained as a sum of the individual items. Higher scores are indicative of greater severity of anxiety symptoms.",{"measure":61,"description":62,"timeFrame":49},"Change in PROMIS-Anxiety Short Form 7a (SF-7a) from baseline to 8 weeks","PROMIS-Anxiety SF-7 is a 7-item self report measure, where the total score is obtained as a sum of the individual items. Higher scores are indicative of greater severity of anxiety symptoms.",{"measure":64,"description":65,"timeFrame":49},"Change in IAQ (Illness Anxiety Questionnaire) from baseline to 4 weeks","IAQ is a 7-item self report measure, with all items adapted from the Short Health Anxiety Inventory (SHAI). The total score is obtained as a sum of the individual items.",{"measure":67,"description":65,"timeFrame":49},"Change in IAQ ( Illness Anxiety Questionnaire) from baseline to 8 weeks",{"measure":69,"description":70,"timeFrame":49},"Change in PROMIS-Self Efficacy from baseline to 4 weeks","SIx PROMIS-Self Efficacy items were selected from the PROMIS item bank for managing chronic conditions - managing emotions. A total score is obtained as a sum of the individual items. Higher scores are indicative of greater self-efficacy for managing emotions.",{"measure":72,"description":73,"timeFrame":49},"Change in PROMIS-Self Efficacy from baseline to 8 weeks","Six PROMIS-Self Efficacy items were selected from the PROMIS item bank for managing chronic conditions - managing emotions. A total score is obtained as a sum of the individual items. Higher scores are indicative of greater self-efficacy for managing emotions.",[],"ALL","18 Years",null,{"inclusion":79,"exclusion":88,"raw_text":98},[80,81,82,83,84,85,86,87],"Age ≥ 18","A diagnosis of cancer (except non-melanoma skin cancer) ≥ 12 months prior.","No active cancer therapy (excluding chemoprevention) in the past 4 months, and no further therapy planned.","Significant anxiety as evidenced by both of the following","Endorsement of the SCID ( Structured Clinical Interview for the DSM-5) Screener Items for Social Anxiety Disorder, Generalized Anxiety Disorder, Agoraphobia, Specific Phobia, or Illness Anxiety Disorder.","A score ≥ 6 on the Overall Anxiety Severity and Impairment Scale (OASIS).","Regular access to the internet.","Ability to read and write in English.",[89,90,91,92,93,94,95,96,97],"Significant symptoms of Panic Disorder in the prior month, including anticipatory anxiety of having a future panic attack or avoidance symptoms associated with panic attacks, as assessed by three SCID-5 items from the panic attack disorder module.","Significant symptoms of Obsessive Compulsive Disorder, as evidenced by any obsessions over the past 3 months, as assessed by three SCID items from the Obsessive Compulsive Disorder module.","Psychiatric hospitalizations or emergency room visits for psychiatric care in the prior 2 years.","In the next two months, intention to use or likelihood of using emergent or \"rescue\" anxiety medication (e.g., Ativan, Xanax, Valium) or self-prescribed substances (i.e., marijuana) at the onset of anxiety symptoms or when entering a situation where they expect to experience anxiety.","Any significant marijuana use which could impact anxiety symptoms, as evidenced by one of the following:","4 days of marijuana use in any week in the last month","20 milligrams of THC (Tetrahydrocannabinol) products in any week in the last month.","Participation in any CBT or ACT-based behavioral or education intervention for anxiety in the past 2 years. This includes in-person, asynchronous, and synchronous online anxiety programs, and therapy that includes these skills. This does not include independent use of any self-help materials (i.e., workbooks, books).","Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all parts of the study independently.","Inclusion Criteria:\n\n* Age ≥ 18\n* A diagnosis of cancer (except non-melanoma skin cancer) ≥ 12 months prior.\n* No active cancer therapy (excluding chemoprevention) in the past 4 months, and no further therapy planned.\n* Significant anxiety as evidenced by both of the following\n\n  * Endorsement of the SCID ( Structured Clinical Interview for the DSM-5) Screener Items for Social Anxiety Disorder, Generalized Anxiety Disorder, Agoraphobia, Specific Phobia, or Illness Anxiety Disorder.\n  * A score ≥ 6 on the Overall Anxiety Severity and Impairment Scale (OASIS).\n* Regular access to the internet.\n* Ability to read and write in English.\n\nExclusion Criteria:\n\n* Significant symptoms of Panic Disorder in the prior month, including anticipatory anxiety of having a future panic attack or avoidance symptoms associated with panic attacks, as assessed by three SCID-5 items from the panic attack disorder module.\n* Significant symptoms of Obsessive Compulsive Disorder, as evidenced by any obsessions over the past 3 months, as assessed by three SCID items from the Obsessive Compulsive Disorder module.\n* Psychiatric hospitalizations or emergency room visits for psychiatric care in the prior 2 years.\n* In the next two months, intention to use or likelihood of using emergent or \"rescue\" anxiety medication (e.g., Ativan, Xanax, Valium) or self-prescribed substances (i.e., marijuana) at the onset of anxiety symptoms or when entering a situation where they expect to experience anxiety.\n* Any significant marijuana use which could impact anxiety symptoms, as evidenced by one of the following:\n\n  * 4 days of marijuana use in any week in the last month\n  * 20 milligrams of THC (Tetrahydrocannabinol) products in any week in the last month.\n* Participation in any CBT or ACT-based behavioral or education intervention for anxiety in the past 2 years. This includes in-person, asynchronous, and synchronous online anxiety programs, and therapy that includes these skills. This does not include independent use of any self-help materials (i.e., workbooks, books).\n* Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all parts of the study independently.",[100,101],"ADULT","OLDER_ADULT",[103],{"facility":104,"status":8,"city":105,"state":106,"zip":107,"country":108,"contacts":109,"geoPoint":117},"Dana Farber Cancer Institute","Boston","Massachusetts","02115","United States",[110,115],{"name":111,"role":112,"phone":113,"email":114},"Christopher J Recklitis, Phd, MPH","CONTACT","617-632-3839","christopher_recklitis@dfci.harvard.edu",{"name":111,"role":116},"PRINCIPAL_INVESTIGATOR",{"lat":118,"lon":119},42.35843,-71.05977,[121,125],{"name":122,"role":112,"phone":123,"email":124},"On-Trac Study Coordinator","617-582-8260","ontrac@dfci.harvard.edu",{"name":126,"role":112,"phone":127,"email":128},"Cheryl Medeiros-Nancarrow","617-632-5798","cheryl_nancarrow@dfci.harvard.edu",[130],{"name":131,"affiliation":13,"role":116},"Christopher J Recklitis, PhD, MPH",[],[],{"nct_id":4,"conditions":135,"biomarkers":137},[21,23,136],"Malignant Neoplasm",[],{"nct_id":4,"found":139,"summary":140,"prompt_version":150},true,{"design":141,"status":142,"heading":143,"summary":144,"follow_up":145,"word_count":146,"commitments":147,"compensation":148,"drugs_mentioned":149},"This is an interventional study designed to refine the On-Trac program. It plans to enroll about 80 participants, grouped into four age-based cohorts.","completed","On-Trac: Online Intervention for Cancer Survivors Managing Anxiety","This study is testing an online program called On-Trac (Online Training After Cancer) for adult cancer survivors who are experiencing anxiety. On-Trac uses strategies from Cognitive-Behavioral Therapy (CBT) and Acceptance Commitment Therapy (ACT) to help manage anxiety. You might be able to join if you are at least 18 years old, had a cancer diagnosis (not including non-melanoma skin cancer) at least 12 months ago, and have not had active cancer therapy in the past 4 months. The study will measure how much your anxiety changes after using On-Trac. The current status of this study is unclear, but it plans to enroll about 80 people.","Participants will be followed for 8 weeks after the group education session, with assessments at 4 and 8 weeks.",105,"You would complete an online survey, participate in a 120-minute online group session, and have 1-2 individual coaching sessions. You would also complete follow-up questionnaires and a telephone interview at 4 and 8 weeks.","Participants will receive gift card incentives for completing evaluations and follow-up questionnaires\u002Finterviews, with a maximum total of $90.",[],"v2"]