[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"caregiver-distress\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:caregiver-distress":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,42,78,105,139,164,201],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100596689","phase-2-psilocybin-assisted-existential-attachment-and-relational-pearl-therapy-for-caregivers-of-patients-with-advanced-cancer-100596689",false,"NCT07048743","Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Caregivers of Patients With Advanced Cancer","Psilocybin-assisted Existential, Attachment and Relational (PEARL) Therapy for Caregivers of Patients With Advanced Cancer: A Phase II Open-Label Trial","PEARL-C1","Inclusion Criteria:\n\n* 18 years of age or older.\n* Participant must reside in Ontario, Canada.\n* Ability to speak and read English (participant to provide written informed consent and participate in PEARL intervention, as determined by study personnel).\n* No cognitive impairment indicated in medical record or by the primary care physician.\n* Primary or significant caregiver of a patient with advanced cancer enrolled in a companion trial of PEARL for patients with advanced cancer or caregiver of a patient receiving psilocybin-therapy through the Special Access Program (SAP) at University Health Network (UHN); such patients will have been recruited from psychosocial oncology or palliative care clinics at Princess Margaret (study physicians to assess appropriateness of inclusion and whether treatment will support the family system).\n* At least mild anxiety or depression symptoms, defined as a score of \\>5 on the General Anxiety Disorder-7 (GAD-7) or \\>8 on the Patient Health Questionnaire-9 (PHQ-9).\n* Interest in and ability to participate in and complete the PEARL intervention and protocol as outlined.\n* Normal hepatic functioning as determined by prior medical history or\u002Fand screening bloodwork (international normalized ratio \\[INR\\]\\\u003C1.5, aspartate aminotransferase \\[AST\\]\u002Falanine transaminase \\[ALT\\] \\\u003C 2x upper limit of normal, normal range bilirubin, platelets ≥150).\n* Normal renal functioning as determined by prior medical history or\u002Fand screening bloodwork (estimated glomerular filtration rate \\[eGFR\\]\\>45).\n* Participants who are sexually active and could become pregnant or inseminate a partner must be using one method of highly effective contraception (hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy or tubal ligation). Alternatively, they may use a combination of two or more effective methods of contraception which include male condom, female condom, cervical cap, diaphragm, or contraceptive sponge. These acceptable methods of contraception must be used prior to study entry, during study participation, and for the duration of the study.\n* For participants of child-bearing potential, a negative serum pregnancy test result is required at screening. A urine pregnancy test will be administered on the morning of psilocybin administration for applicable participants. Participants cannot be pregnant or nursing through the duration of the study.\n* If using prescribed medications or other substances, participants must agree to refrain from taking them if instructed by study investigators. These include:\n\n  * not using any non-prescription medication, nutritional supplement, or herbal supplement except when approved by the treatment team (exceptions will be evaluated by the Sponsor-Investigator and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals).\n  * not using nicotine for at least 2 hours before psilocybin administration, and not again until approximately 7 hours after psilocybin administration.\n  * consuming approximately the same amount of caffeine-containing beverages (e.g., coffee, tea) that they consumes on a usual morning before arriving at the treatment centre for the psilocybin session day.\n  * not taking any as needed medications on the mornings of psilocybin sessions (with the exception of daily and as needed opioid pain medication).\n  * refraining from using any psychoactive drugs, including alcoholic beverages, within 24 hours of the psilocybin administration.\n* Participants must have a responsible individual to drive them after the dosing session to where they are staying (home, hotel or another location) and to accompany\u002Fattend to them because psilocybin may affect their alertness and concentration on the evening of the dosing session.\n* Participants must agree not to drive or operate machinery for at least 24 hours after dose administration.\n* The therapist involved in the participant's psilocybin dosing session and\u002For the principal investigators will provide their phone number, in advance of the session, to the participant, in case the participant needs to reach them for emergency support in the 24 hours following the psilocybin dosing session. Because the therapists will change from participant to participant, the study team cannot provide the same emergency phone number to every study participant.\n\nExclusion Criteria:\n\n* A history of past intolerability to psilocybin or other psychedelics.\n* Past\u002Fpresent psychiatric diagnoses of bipolar disorder, any psychotic disorder, active substance use disorders, or dementia.\n\n  a. Participants may have current mild alcohol or cannabis use disorder (meets 3 of 11 diagnostic criteria per The Diagnostic and Statistical Manual of Mental Illnesses \\[DSM-5\\]) or moderate alcohol or cannabis use disorder in early remission for the 3 months prior to enrollment (meets 5 of 11 diagnostic criteria per DSM-5).\n* Clinically significant suicidal ideation either currently or within the past 6 months, as judged by study clinicians.\n* Participant under the age of 30 years who has a first degree relative with a primary psychotic disorder.\n* Other personal circumstances or behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin.\n* Severe hypertension (defined as systolic blood pressure \\>140 or diastolic pressure \\>90) based on two readings on the same day. If the second reading remains over 140\u002F90 the participant can be brought in for another reading on a different day. Participants can be re-screened for participation once blood pressure is adequately controlled.\n* Hepatic dysfunction (history of cirrhosis and\u002For abnormal parameters \\[INR\\>1.5, elevated AST\u002FALT 2x upper limit, elevated bilirubin, platelets \\\u003C 150\\]) or liver failure, defined as clinical diagnosis of liver fibrosis, cirrhosis of the liver, or advanced liver disease.\n* Cardiovascular conditions including uncontrolled hypertension, heart failure (defined as class IV of the New York Heart Association classification), angina, a clinically significant electrocardiogram \\[ECG\\] abnormality (e.g., atrial fibrillation without rate control, prolonged Corrected QT Interval (QTc) defined as \\> 450ms for males or \\> 470ms for females), transient ischemic attack in the last six months, stroke, peripheral or pulmonary vascular disease (no active claudication).\n* Uncontrolled epilepsy or history of seizures.\n* Diabetes with inability to skip a meal (lunch), requiring administration of medication more than twice daily, or symptomatic hypoglycemia within the prior 30 days.\n* GI bleed in last 6 months.\n* Use of other investigational agents that would be inappropriate to take with psilocybin in the judgement of the investigator, psychoactive prescription medications (e.g., benzodiazepines, lithium, SSRIs), medications having a pharmacological effect on serotonin-2a (5-HT2A) receptors (e.g., olanzapine, mirtazapine, or trazodone), medications that are monoamine oxidase (MAO) inhibitors, any potent metabolic inducers (e.g. rifamycin, rifampin, rifabutin, rifapentine, carbamazepine, phenytoin, phenobarbital, nevirapine, efavirenz, Taxol, dexamethasone, St John's wort) or inhibitors (e.g. HIV protease inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin). Note: Inhibitors of UGT1A9 and 1A10 may increase systemic psilocin exposure (i.e., the Cmax and AUC) of psilocin and should be discontinued at least five half-lives prior to the administration of psilocybin. Similarly, aldehyde or alcohol dehydrogenase inhibitors should be discontinued at least 5 half-lives prior to the dose of psilocybin.\n\nIn suitable participants, contraindicated medications may be tapered by a study physician between study enrolment and the psilocybin session when it is deemed safe to do so and in coordination with the prescribing physician. A safe and appropriate tapering regimen will then be developed based on the particular medication, on a case-by-case basis. If taking an MAO inhibitor, the psilocybin session will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose. Participants prescribed opioids will be allowed to take their usual dose regimen for analgesia, including the use of as needed analgesic medications on psilocybin session days.",true,"ALL","18 Years",{"count":21,"type":22},15,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The PEARL-C1 trial is a phase II open-label trial. Participants will receive a single high-dose (25 mg) of psilocybin in the context of Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy.",[28],"Caregiver Distress","RECRUITING","2026-06-19",{"date":32,"type":33},"2026-06-23","ACTUAL",{"date":35,"type":33},"2025-07-16",{"date":37,"type":22},"2027-12-02",{"name":39,"class":40},"University Health Network, Toronto","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":18,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100638866","effects-of-binaural-beats-and-spatialized-music-on-behavioural-and-psychological-symptoms-of-dementia-in-assisted-living-facility-residents-100638866","NCT07626944","Effects of Binaural Beats and Spatialized Music on Behavioural and Psychological Symptoms of Dementia in Assisted Living Facility Residents","Effects of Binaural Beats and Spatialized Music on Behavioural and Psychological Symptoms of Dementia in Assisted Living Facility Residents: A Randomized Controlled Pilot Protocol","Inclusion Criteria:\n\n* (1) age 55-95 years; (2) the subject and\u002For his\u002Fher legal guardian have signed written informed consent; (3) the subject is able to complete the entire trial period; and (4) a minimum of fifty percent of the subjects will have a diagnosis of a dementia condition with a moderate to severe progression.\n\nExclusion Criteria:\n\n* (1) profound hearing loss or impairment; (2) history of seizures, epilepsy (especially sound-induced epilepsy), claustrophobia, or other conditions that put the subject at risk during the trial; (3) physical or mental conditions that may result in inability to complete and\u002For affect the efficacy of assessment.","55 Years","95 Years",{"count":52,"type":22},120,[54],"NA","The purpose of this study is to investigate the effects of Binaural Beat Music (BBM; personalized music playlist with binaural beats), Spatialized Music (SM; personalized and spatialized music playlist), their combination, and possible interaction on older adults in an assisted living community who are either living with a dementia diagnosis or are experiencing typical age-related changes. The control condition is a personalized music playlist without binaural beats and spatialization. It is hypothesized that BBM, SM, and their combination each improve aspects of BPSD compared to controls over a two-week intervention period.\n\nThe Specific Aims of the study are (1) to evaluate whether BBM, SM, and\u002For their combination is superior to control in reducing BPSD severity (primary outcome); (2) to evaluate whether BBM, SM, and\u002For their combination is superior to control in reducing caregiver distress (secondary outcomes); and (3) to evaluate the effects of BBM, SM, and\u002For their combination on improving overall well-being and mood (secondary outcomes).",[57,28,58,59],"BPSD","Well-being","Mood",[61,58,59,28,62,63,64,65,66,67],"Dementia","Personalized Music Listening","Binaural Beat Stimulation","Spatial Audio","Artificial Intelligence","Randomized Controlled Trial","Assisted Living Residences","2026-05-29",{"date":70,"type":33},"2026-06-04",{"date":72,"type":33},"2026-05-04",{"date":74,"type":22},"2026-06-27",{"name":76,"class":40},"Maharishi International University",2,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":41},"100610253","mhealth-for-early-psychosis-caregivers-in-statewide-program-outreach-100610253","NCT07225179","mHealth for Early Psychosis Caregivers in Statewide Program Outreach","Bolster-NC: A Pilot Study of the Bolster mHealth Intervention Within Early Psychosis Program Outreach in North Carolina","Bolster-NC","Inclusion Criteria:\n\n* 18 years or older\n* North Carolina resident\n* Caregiver to a young adult with early psychosis, wherein early psychosis is defined as: (1) Being between the ages of 15 and 30, and (2) Within the past five years, the young adult first experienced hallmark symptoms: (2A) Presence of psychotic symptoms represented by one or more of hallucinations, delusions, marked thought disorder, psychomotor disorder or bizarre behavior, as well as (2B) Definite change of personality or behavior manifesting as two or more of the following: serious deterioration of function, marked social withdrawal, persistent self-neglect, episodic marked anxiety.\n* A positive screen according to the Caregiver Prime Screen - Revised (endorsed two or more responses of five or six (\"somewhat\"\u002F\"definitely\" agree)\n* Own an Apple iPhone\n* Have access to the internet (e.g., via WiFi or data plan)\n* Self-identify as a caregiver of the affected person\n* Are proficient in English to the degree necessary to complete study assessments and engage meaningfully in the intervention\n\nExclusion Criteria:\n\n* Participant failed to demonstrate understanding of study details in comprehension screening process.\n* Previous enrollment in a study involving Bolster.\n* Activity on screening questionnaires that indicates suspicious or dishonest participation such that the participant is likely to be a \"malicious actor\" or \"gamer\" (i.e. an individual that attempts to enroll in online research studies solely for compensation with dishonest or illegitimate responses to study questionnaires)",{"count":87,"type":22},30,[54],"The purpose of this study is to pilot the delivery of an mHealth intervention for caregivers to young people with early psychosis within a network of early psychosis intervention programs in the state of North Carolina. The investigators will examine the feasibility of recruitment through program outreach, develop North Carolina specific outreach resources to be used with the mHealth intervention and evaluate the effectiveness of this intervention for reducing caregiver psychological morbidity and improving family communication. The investigators will also collect pilot data to inform recruitment and development of implementation strategies for delivering Bolster within a statewide early psychosis network.",[91,28,92,93],"Caregiver","Caregiver to a Young Adult With Early Psychosis","Family Caregivers",[91,95],"Caregiver Support","2026-05-26",{"date":98,"type":33},"2026-05-27",{"date":100,"type":33},"2025-12-01",{"date":102,"type":22},"2027-07-30",{"name":104,"class":40},"University of North Carolina, Chapel Hill",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":17,"sex":18,"minAge":112,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":41},"100633559","act-group-for-family-caregivers-of-stroke-survivors-100633559","NCT07528261","ACT Group for Family Caregivers of Stroke Survivors","Effects of Acceptance and Commitment Therapy (ACT) Group for Family Caregivers of Stroke Survivors","Inclusion Criteria:\n\n* Age 40 or above.\n* Taking the primary responsibility for the care of a family member suffering from stroke (i.e. spending at least 70% of the time on performing caregiving tasks).\n* The stroke patient has been discharged from hospital and is currently living with the caregiver.\n* Having cared for the stroke patient for at least six months, including at least two months after discharge.\n* CSAQ score (as determied during pre-group screening meeting) indicates a high level of distress, as evidenced by one of the following: a) participant answered \"Yes\" to either or both questions 4 and 11; b) total \"Yes\" scores = 10 or more; c) score on question 17 is 6 or higher; d) score on question 18 is 6 or higher.\n* Able to use a computer and has internet access.\n* Able to provide informed consent to participate.\n\nExclusion Criteria:\n\n* is below 40 years old.\n* has any comorbid mental disorder or disability that may impede group participation (e.g., personality disorder, learning disability).\n* does not understand English (read, write, listen, and speak).\n* has current active suicidal\u002Fhomicidal ideation.\n* is currently receiving psychological intervention (individual or group).","40 Years",{"count":87,"type":22},[54],"The goal of this study is to evaluate the efficacy of group-based ACT intervention in improving the levels of psychological distress in caregivers of stroke survivors. The main questions it aims to answer are:\n\n1. Does group-based ACT intervention improve the levels of psychological distress and QoL in family caregivers of stroke survivors?\n2. Do the levels of psychological flexibility and experiential avoidance in family caregivers of stroke survivors mediate the outcome of the ACT Group?\n\nThe researcher will compare the experimental group (i.e., participants who received group-based ACT intervention) with the control group (i.e., participants who did not receive group-based ACT intervention) to assess whether the group-based ACT intervention is effective in mitigating caregiver stress and improving caregivers' QoL.\n\nParticipants in the experimental group will:\n\n1. Receive a 5-weekly, 1.5-hour group intervention based on the ACT Model;\n2. Complete study measures at pre-treatment, immediate post-treatment, and 2-month follow-up.\n\nParticipants in the control group will not receive the group intervention but will complete the same study measures.",[117,118,119,28,120,121,122,123,124,125,126,127,128,129],"Caregiver Stress","Caregiver Stress Syndrome","Caregiver Burnout","Caregiver Exhaustion","Caregiver Health Related QOL","Caregiver Burden for Those Who Care for Adults With Impaired Functional Status","Caregiver Quality of Life","Caregiver Burden","Caregiver Mental Health","Caregiver Resilience and Stress","Caregiver Sense of Control Over Life","Caregiver Awareness","Caregiver Stress in Chronic Mental Illness","2026-04-29",{"date":132,"type":33},"2026-05-01",{"date":134,"type":33},"2025-09-01",{"date":136,"type":22},"2028-05-31",{"name":138,"class":40},"The Wright Institute",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":149,"conditions":150,"keywords":154,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":41},"100614347","assessing-and-addressing-health-related-social-needs-among-families-of-children-with-cancer-100614347","NCT07278414","Assessing and Addressing Health-Related Social Needs Among Families of Children With Cancer","Developing and Refining an Intervention to Assess and Address Health-Related Social Needs Among Families of Children With Cancer","Inclusion Criteria:\n\nCaregivers of Children with Cancer\n\n* A caregiver of a child (\\\u003C18 years old) actively receiving treatment or recently completed treatment (within the past 1 year prior to enrollment) for any type of cancer. A caregiver is defined as any individual involved in bringing the child to the clinic or providing care at home, the hospital, or other healthcare setting (e.g., parents, guardians, siblings, etc.).\n* Ability to understand IRB-approved information sheet and willingness to provide consent.\n* Age ≥ 18 years at the time of consent.\n* Ability to understand the English and\u002For Spanish language.\n\nCommunity-based Organizations\n\n* Representative of community-based organizations that provide resources for families of children with cancer\n* Ability to understand IRB-approved information sheet and willingness to provide consent.\n* Age ≥ 18 years at the time of consent.\n* Ability to understand English and\u002For Spanish language.\n\nHealthcare Professionals\n\n* Physicians, advanced practice practitioners, nurses, clinical social workers, medical assistants, clinic patient service representatives, and cancer center administrators at AHWFBC.\n* Ability to understand IRB-approved information sheet and willingness to provide consent.\n* Age ≥ 18 years at the time of consent.\n* Ability to understand English and\u002For Spanish language.\n\nExclusion Criteria:\n\n* There are no specific exclusion criteria.",{"count":147,"type":22},60,"OBSERVATIONAL","The purpose of this study is to design Community Enhancing Resources for Childhood cAncer support (CERCA) and refine intervention procedures to target Health-related Social Needs (HRSN) in families of children with cancer. CERCA will leverage existing community resources and create partnerships that will lead to sustainable outcomes. The hypothesis is that through context-driven co-design and community-engaged research methods, the study team will develop an acceptable intervention to target unmet HRSN in families of children with cancer.",[151,152,28,153],"Childhood Cancers","Caregiver Social Support","Social Needs",[153,95,155],"Childhood Cancer","2026-04-27",{"date":72,"type":33},{"date":159,"type":33},"2026-01-07",{"date":161,"type":22},"2027-06",{"name":163,"class":40},"Wake Forest University Health Sciences",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":23,"phases":174,"briefSummary":175,"conditions":176,"keywords":182,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":200},"100618415","the-coma-family-program-coma-f-a-resilience-program-for-caregivers-of-patients-with-severe-acute-brain-injury-100618415","NCT07331324","The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury","The Coma Family Program (COMA-F): A Multi-site Clinical Trial of a Resilience Program for Caregivers of Patients With Severe Acute Brain Injury","COMA-F","Inclusion Criteria:\n\n1. 18 years or older - study population\n2. English fluency and literacy - measures and intervention are in English\n3. Screens positive for emotional distress on either depression or anxiety subscales (\\>7) of the Hospital Anxiety and Depression scale - study population (caregivers must be at-risk for chronic distress via heightened acute distress)\n4. Confirmed by the clinical team as the primary caregiver of a patient who has been admitted to an intensive care unit (ICU) with a severe acute brain injury with the following characteristics:\n\n   1. 18 years or older - study population\n   2. Admitted with ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, traumatic brain injury, or hypoxic-ischemic encephalopathy - study population\n   3. Glasgow Coma Scale score below 9 (in judgement of the clinical team) while not intubated or an inability to follow meaningful commands while intubated at any point during the hospitalization for \\> 24 consecutive hours due to the brain injury itself and not a confounding factor (e.g., sedation or seizures) - study population\n   4. Still alive in ICU at the time the clinical team approaches the caregiver about possible recruitment - excludes caregivers of those that passed away as would require a different intervention (e.g., grieving intervention)\n   5. Has been committed to or has already received long-term life-sustaining treatments including tracheostomy and\u002For percutaneous endoscopic or surgical gastrostomy tube placement (trach or PEG) - study population; at time of enrollment patients can be in various early stages of cognitive\u002Ffunctional recovery from initial coma, but all were severe enough to require trach and\u002For PEG\n   6. Has a prognosis for survival of greater than 3 months and does not have a concurrent diagnosis of a terminal illness or injury as judged by the clinical team - as in \"d\"; such caregivers would require different intervention\n   7. Is still in ICU or has been transferred to a lower level of care (e.g., stepdown) for \\\u003C7 days at the time of consent - study population; we aim to begin the intervention when caregivers are acutely distressed in the context of the patient's ICU stay or shortly after the ICU stay (i.e., within 7 days of leaving)\n\nExclusion Criteria:\n\n* 1\\. Serious mental illness, substance misuse, or active suicidal intent or plan - requires higher level of care",{"count":173,"type":22},150,[54],"The purpose of this research study is to determine whether COMA-F is more efficacious at reducing emotional distress in caregivers of patients with severe acute brain injuries, compared to health education control.",[28,177,178,179,180,181],"Emotional Distress","Caregivers","Resilience","Coma","Brain Injury",[183,184,185,186,187,188,189],"caregivers","emotional distress","caregiver burden","resilience","coma","severe acute brain injury","mindfulness","NOT_YET_RECRUITING","2026-02-18",{"date":193,"type":33},"2026-02-20",{"date":195,"type":22},"2026-05",{"date":197,"type":22},"2030-12",{"name":199,"class":40},"Massachusetts General Hospital",3,{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":211,"conditions":212,"keywords":215,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":77},"100588658","assessment-of-cancer-related-post-traumatic-stress-in-patients-and-caregivers-in-the-year-following-diagnosis-and-identification-of-their-expectations-of-personalized-support---candystress-100588658","NCT06944262","Assessment of Cancer-related Post-traumatic Stress in Patients and Caregivers in the Year Following Diagnosis, and Identification of Their Expectations of Personalized Support - CANDYSTRESS","Évaluation de la détresse Post-traumatique Relative au Cancer Dans l'année Suivant le Diagnostic Chez Les Patients et Les Aidants et Identification de Leurs Attentes Envers un Accompagnement personnalisé","CANDYSTRESS","Inclusion Criteria:\n\nPart 1. Diagnosis of Ca-PTS\n\nPatient inclusion criteria:\n\n* Male or female, 18 years of age or older,\n* recently (\\\u003C4 months) diagnosed with breast, gynecological, testicular or digestive cancer at the time of the announcement visit (i.e., the announcement to the patient of the treatment plan after the initial multidisciplinary consultation meeting in the cancer center - in accordance with the Cancer Plan),\n* with cancer requiring oncological treatment,\n* starting oncology treatment at the Oscar Lambret Center,\n* with no Central Nervous System (CNS) metastases,\n* with a PRONOPALL score ≤3 (favorable prognosis group, Bourgeois et al., 2017) or expected survival greater than 6 months,\n* who have given signed consent to participate in the study and are covered by French social security,\n* able to identify a caregiver (i.e., a family member, friend or other person who has helped care for them since diagnosis).\n* equipped with a computer or tablet equipped with a webcam and an internet connection, for the online questionnaire - the webcam is only necessary if the participant wants the IGE to be present via video on the computer, if they prefer the video to be made over the phone, in which case they must also be equipped with a smartphone enabling video calls.\n\nInclusion criteria for caregivers:\n\n* Male or female, 18 years of age or older,\n* designated by the patient as their primary caregiver (i.e. \"a family member, friend or other person who has helped care for you since diagnosis\"),\n* have given their signed consent to participate in the study.\n* equipped with a computer or tablet equipped with a webcam and an internet connection, for the online questionnaire - the webcam is only necessary if the participant wishes the IGE to be present via video on the computer, if he\u002Fshe prefers the video to be made over the phone, in which case it is also necessary to be equipped with a smartphone enabling video calls.\n\nPart 2. Gathering expectations for personalized support and its components.\n\nIn addition, 3 types of focus groups will be set up remote :\n\nFocus groups with patients from local associations, as well as patient partners of the Oscar Lambret Center and patients from Part 1 if they are interested.\n\nInclusion criteria for patient focus groups:\n\n* Men or women of legal age who have or have had cancer,\n* Members of a local patient association or of the Oscar Lambret Center's \"patient partners\" committee,\n* Or have participated in part 1 (Ca-PTS screening, once the 3 steps have been completed),\n* Equipped with a computer or tablet with camera and internet connection,\n* Have given their consent to take part in the study.\n\nFocus group with caregivers from local associations as well as \"partner caregivers\" from the Oscar Lambret Center and caregivers from part 1 if they are interested.\n\nInclusion criteria for \"caregiver\" focus groups:\n\n* Men or women of full age who are, or have been, caregivers of a cancer patient,\n* members of a local caregivers' association,\n* or having participated in part 1 (Ca-PTS screening, once the 3 steps have been completed),\n* Equipped with a computer or tablet with camera and internet connection,\n* Having given their consent to take part in the study.\n\nFocus groups with hospital medical and paramedical staff as well as non-hospital caregivers involved in the medical in the medical and psychological follow-up of patients.\n\nInclusion criteria for caregiver focus groups:\n\n* Member of the medical and paramedical staff of the Oscar Lambret Center\n* Or non-hospital staff involved in the medical or psychological care of patients,\n* Professionals not involved in the present study,\n* Equipped with a computer or tablet with camera and internet connection\n* Having given their consent to participate in the study\n\nExclusion Criteria:\n\nPart 1. Diagnosis of Ca-PTS\n\nNon inclusion criteria for patients :\n\n* Patients with meningeal or cerebral metastases,\n* Patients with cancer recurrence,\n* Patients suffering from a psychiatric or neurological disorder likely to impair their ability to reason or judge (in particular psychotic disorder, autism spectrum disorder, intellectual disability),\n* Patients with a psychological or physical incapacity to answer questionnaires, certified by medical staff,\n* Patients subject to a custodial sentence, guardianship or protection of vulnerable adults,\n* Presence of CNS metastases (risk of cognitive impairment preventing completion of questionnaires).\n\nNon-inclusion criteria for caregivers:\n\n* Caregivers suffering from a psychiatric or neurological disorder likely to impair their ability to reason or exercise judgment judgment (in particular psychotic disorder, autism spectrum disorder intellectual disability), or for whom there is a suspicion (not there is a suspicion (no additional examination is prescribed to confirm this criterion, which remains self-declaratory).\n* Caregivers with a psychological or physical inability to answer questionnaires, or for whom there is a suspicion suspicion (no further tests are required to confirm this criterion which remains self-reported).\n* Caregivers subject to a custodial sentence, guardianship or protection guardianship or protection of vulnerable adults.\n\nPart 2. Collection of expectations for personalized support and its components.\n\nNon-inclusion criteria for patients and caregivers who participated in the screening part of the Ca-PTS :\n\n\\- Failure to complete all measurement times (T0, T1, T2)\n\nNon-inclusion criteria for focus groups (patients, caregivers): none",{"count":210,"type":22},350,"The impact of cancer on the lives of patients and their caregivers is undeniable. In addition to the potentially traumatic aspects (i.e., creating a very violent emotional shock) linked to the announcement of the disease and the various stages of the care pathway (effects of treatment, announcement of a cancer recurrence), even before the onset of the disease, patients and their caregivers may have been directly or indirectly confronted with traumatogenic events (e.g., childhood abuse, sudden death). They may therefore be more likely to develop a stress-related mental disorder in their lifetime. The question of the accumulation of traumatic events, the identification of groups of people at risk of developing symptoms of distress, and the management of these symptoms is therefore crucial. In addition, the mutual influence within the patient-caregiver dyad in terms of emotional adjustment, and its evolution throughout the cancer care pathway, are key elements to be considered in these issues.\n\nThe CandyStress project is based on a partnership with patients, their caregivers and carers to identify the needs of patient-caregiver dyads at risk of cancer-related post-traumatic stress disorder (Ca-PTS). Longitudinal screening for Ca-PTS in the year following cancer diagnosis will be carried out to identify the characteristics of at-risk dyads who could benefit from long-term support. The aim of this project is to identify the potential need for targeted support and the desired format of this support. This is a preliminary step in identifying needs and the context conducive to the implementation of personalized support, but in no way an evaluation of the effectiveness of an intervention.",[213,214,28,91,118],"Cancer","Healthcare Professionnals",[216,217,218,183,219,220],"cancer","trauma","patients","dyad","cancer-related post-traumatic stress disorder","2025-04-23",{"date":223,"type":33},"2025-04-25",{"date":225,"type":33},"2025-04-02",{"date":227,"type":22},"2028-02-02",{"name":229,"class":40},"Lille University"]