[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06015932":3,"trial-entities:NCT06015932":122,"trial-summary:NCT06015932":127},{"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":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":46,"secondary_outcomes":51,"sex":71,"minimum_age":72,"maximum_age":73,"healthy_volunteers":74,"eligibility_criteria":75,"std_ages":86,"locations":89,"central_contacts":112,"overall_officials":115,"references":117,"see_also_links":118},"NCT06015932","17-000947","Group Cognitive Behavior Sessions (CBCSM) to Decrease Distress in Cancer Patients","A Non-Randomized Translational Trial of Cognitive Behavioral Cancer Stress Management (CBCSM) and Its Effects on Cancer Distress","RECRUITING","2029-12-31","2026-06","2026-06-09","2017-12-20","Mayo Clinic","OTHER",true,"This clinical trial tests how well cognitive behavioral cancer stress management (CBCSM) group sessions work to decrease psychological distress in cancer patients. CBCSM teaches patients how to recognize and reduce the impacts of cancer associated stress on the biological, psychological, and social life domains.","PRIMARY OBJECTIVE:\n\nI. To reduce psychological stress.\n\nSECONDARY OBJECTIVES:\n\nI. To increase post-traumatic growth (PTG). II. To increase patient self-efficacy in utilizing therapy skills. III. To estimate patient acceptability and feasibility of conducting CBCSM within the clinical setting.\n\nIV. To estimate differences of conducting CBCSM virtually during the Public Health Emergency (PHE) versus in person pre-PHE.\n\nV. To estimate differences of conducting CBCSM post PHE virtually with limitation to Minnesota patients only.\n\nVI. To explore the difference using the same therapy in patients with advanced, metastatic disease in a individual setting versus patients without the advanced, metastatic disease in a group setting.\n\nOUTLINE: Patients are assigned to 1 of 2 groups.\n\nGROUP I: Patients participate in five CBCSM group sessions on study. Patients complete questionnaires throughout the trial and during follow-up at 1, 3, 6, and 12 months.\n\nGROUP II: Patients complete questionnaires throughout the trial and during follow-up at 1, 3, 6, and 12 months.",[19,20,21],"Hematopoietic and Lymphoid System Neoplasm","Malignant Solid Neoplasm","Metastatic Malignant Solid Neoplasm",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[26],"NA",{"count":28,"type":29},400,"ESTIMATED",[31,41],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":37},"BEHAVIORAL","Cognitive Behavior Therapy","Participate in CBCSM group sessions",[36],"Group I (CBCSM)",[38,39,40],"CBT","cognitive therapy","CT",{"type":14,"name":42,"description":43,"armGroupLabels":44},"Questionnaire Administration","Complete questionnaires",[36,45],"Group II (no CBCSM)",[47],{"measure":48,"description":49,"timeFrame":50},"Change in post-traumatic stress (PTS) score","Each item on the PTS is rated on a 5-point scale (0=Not at all; 1=A little bit; 2=Moderately; 3=Quite a bit, and 4=Extremely). The total score can range from 0 to 36 with higher scores indicating greater severity of posttraumatic stress disorder.","At baseline, 1, 3, 6, and 12 months",[52,55,58,62,65,68],{"measure":53,"description":54,"timeFrame":50},"Change in post-traumatic growth (PTG) score","PTG will be assessed using the Patient-Reported Outcomes Measurement System (PROMIS®)-Psychosocial Impact Scale-Positive. The PROMIS assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain.",{"measure":56,"description":57,"timeFrame":50},"Change in self-efficacy score","Will examine predicted increase in self-efficacy associated with Cognitive Behavioral Cancer Stress Management (CBCSM) from pre-intervention to post-intervention. Scores will be assessed using the Measure of Current Status-Part A (MOCS-A), which measures participants' current self-perceived status on several skills: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, express anger effectively and appropriately, and choose appropriate coping responses as needed. Ratings are made on a scale from I cannot do this at all (0) to I can do this extremely well (4).",{"measure":59,"description":60,"timeFrame":61},"Patient acceptability and satisfaction","Will be assessed by simple percentage, based on scores from an Institute for Healthcare Improvement 10-point Likert scale (0-10, \"Would you recommend this program to your friends and family?\" A score ≥7 indicates high individual satisfaction.","Baseline to 12 months",{"measure":63,"description":64,"timeFrame":61},"Patient attendance and feasibility","Will be assessed by simple percentage. Attendance and feasibility will be determined by the number of patients attending ≥3 sessions out of five.",{"measure":66,"description":67,"timeFrame":50},"Anxiety","Will examine predicted reductions in anxiety symptoms associated with Cognitive Behavioral Cancer Stress Management (CBCSM) from pre-intervention to post-intervention. Anxiety will be measured using General Anxiety Disorder-7 (GAD-7) symptom scores, an 8-question survey. Seven questions are answered on a 0-3 scale where 0=Not at all and 3=Nearly every day. The final question is answered on a 4-point scale from Not Difficult at All to Extremely Difficult.",{"measure":69,"description":70,"timeFrame":50},"Depression","Will examine predicted reductions in depression symptoms associated with Cognitive Behavioral Cancer Stress Management (CBCSM) from pre-intervention to post-intervention. Level of depression will be determined using the Patient Health Questionnaire-8 (PHQ-8). The PHQ-8 is an 8-item questionnaire answered on a scale of 0-3 where 0=Not at all and 3=Nearly every day.","ALL","18 Years",null,false,{"inclusion":76,"exclusion":83,"raw_text":85},[77,78,79,80,81,82],"Eligible for the cognitive behavioral cancer stress management (CBCSM) clinical service","Cancer diagnosis with predicted survival \\> 1 year","Cancer treatment within past 1 year or treatment planning in progress","Age \\>= 18-years","Moderate distress screen, indicated by Impact of Event Scale-Revised (IES-R) score \\>= 14 or clinical judgment","Written informed research consent",[84],"Inability to actively participate in and learn from group therapy (e.g., psychotic symptoms, neurological condition, personality pathology) as determined by clinical judgment in clinical consultation (Individual therapy or alternative group therapy will be offered)","Inclusion Criteria:\n\n* Eligible for the cognitive behavioral cancer stress management (CBCSM) clinical service\n* Cancer diagnosis with predicted survival \\> 1 year\n* Cancer treatment within past 1 year or treatment planning in progress\n* Age \\>= 18-years\n* Moderate distress screen, indicated by Impact of Event Scale-Revised (IES-R) score \\>= 14 or clinical judgment\n* Written informed research consent\n\nExclusion Criteria:\n\n* Inability to actively participate in and learn from group therapy (e.g., psychotic symptoms, neurological condition, personality pathology) as determined by clinical judgment in clinical consultation (Individual therapy or alternative group therapy will be offered)",[87,88],"ADULT","OLDER_ADULT",[90],{"facility":91,"status":8,"city":92,"state":93,"zip":94,"country":95,"contacts":96,"geoPoint":109},"Mayo Clinic in Rochester","Rochester","Minnesota","55905","United States",[97,102,106],{"name":98,"role":99,"phone":100,"email":101},"Clinical Trials Referral Office","CONTACT","855-776-0015","mayocliniccancerstudies@mayo.edu",{"name":103,"role":99,"phone":104,"email":105},"Deanna Hofschulte","507-255-2972","Hofschulte.Deanna@mayo.edu",{"name":107,"role":108},"Shawna L. Ehlers, Ph.D., L.P.","PRINCIPAL_INVESTIGATOR",{"lat":110,"lon":111},44.02163,-92.4699,[113,114],{"name":98,"role":99,"phone":100,"email":101},{"name":103,"role":99,"phone":104,"email":105},[116],{"name":107,"affiliation":91,"role":108},[],[119],{"label":120,"url":121},"Mayo Clinic Clinical Trials","https:\u002F\u002Fwww.mayo.edu\u002Fresearch\u002Fclinical-trials",{"nct_id":4,"conditions":123,"biomarkers":126},[124,125],"Hematologic Neoplasm","Solid Neoplasm",[],{"nct_id":4,"found":15,"summary":128,"prompt_version":138},{"design":129,"status":130,"heading":131,"summary":132,"follow_up":133,"word_count":134,"commitments":135,"compensation":136,"drugs_mentioned":137},"This interventional study plans to enroll 400 participants and assigns them to one of two groups. One group participates in CBCSM group sessions, while the other group completes questionnaires only.","completed","Group Cognitive Behavior Sessions to Decrease Distress in Cancer Patients","This study is testing how well group Cognitive Behavioral Cancer Stress Management (CBCSM) sessions can help reduce psychological distress in people with cancer. CBCSM teaches you ways to manage the stress that comes with a cancer diagnosis and treatment. You might be able to join if you are 18 or older, have a cancer diagnosis (hematopoietic and lymphoid system neoplasm, malignant solid neoplasm, or metastatic malignant solid neoplasm) with a predicted survival of more than one year, and have experienced cancer treatment within the last year or are planning treatment. The study aims to see if these sessions can lower your post-traumatic stress (PTS) scores over 12 months. The study plans to enroll 400 participants, but its current status is unclear.","Participants are followed for 12 months after the start of the study.",121,"If you are in Group I, you will participate in five CBCSM group sessions and complete questionnaires throughout the trial and during follow-up at 1, 3, 6, and 12 months. If you are in Group II, you will complete questionnaires throughout the trial and during follow-up at 1, 3, 6, and 12 months.","Not stated in the trial record.",[],"v2"]