[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"palliative-treatment\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:palliative-treatment":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100555394","cognitive-behavioral-therapy-for-cancer-related-fatigue-in-patients-with-cancer-receiving-palliative-systemic-treatment-100555394",false,"NCT06511518","Cognitive Behavioral Therapy for Cancer-related Fatigue in Patients With Cancer Receiving Palliative Systemic Treatment","Making Cognitive Behavioral Therapy for Cancer-related Fatigue Fit for Implementation in Patients With Cancer Receiving Palliative Systemic Treatment","TIRELESS","Solid (non-brain) tumor patients\n\nInclusion Criteria:\n\n* Receive systemic treatment with palliative intent for a solid (non-brain) tumor\n* Are ≥18 years old\n* Are proficient in Dutch\n* Report severe fatigue (Checklist Individual Strength, fatigue severity subscale \\[CIS-fatigue\\] score ≥35)\n* A life expectancy of ≥6 months according to their oncologist\n* Access to a device with internet\n\nExclusion Criteria:\n\n* Symptomatic brain metastases\n* Dual immunotherapy\n* Have a poor performance status (Karnofsky \\\u003C70)\n* Are currently receiving treatment for a mental disorder.\n* Treatable somatic cause that could explain the presence of severe fatigue (other than the underlying disease and the cancer treatment itself)\n* Severe cognitive deficits\n\nGlioma patients\n\nInclusion Criteria:\n\n* Histologically confirmed diffuse glioma WHO grade 2, 3, or 4\n* No oncological treatment for at least two months prior to inclusion\n* Are ≥18 years old\n* Are proficient in Dutch\n* Report severe fatigue (Checklist Individual Strength, fatigue severity subscale \\[CIS-fatigue\\] score ≥35)\n* A life expectancy of ≥3 months according to their oncologist\n* Access to a device with internet\n\nExclusion Criteria:\n\n* Signs of radiological or clinical tumor progression at the time of inclusion\n* Corticosteroid use\n* Have a poor performance status (Karnofsky \\\u003C70)\n* Are currently receiving treatment for a mental disorder\n* Treatable somatic cause that could explain the presence of severe fatigue (other than the underlying disease and the cancer treatment itself).\n* Severe cognitive deficits","ALL","18 Years",{"count":20,"type":21},56,"ESTIMATED","INTERVENTIONAL",[24],"NA","Cancer-related fatigue is highly prevalent in patients receiving treatment for gliomas or palliative systemic treatment for cancer and is experienced as one of the most burdensome symptoms affecting patients' daily functioning and quality of life. From the KWF-sponsored TIRED trial, we concluded that cognitive behavioral therapy (CBT) is effective in reducing fatigue in cancer patients with severe fatigue during palliative systemic treatment and in glioma patients. However, in its current form, integration in routine medical care is difficult and scalability is a problem, as the intervention is time-intensive, requires face-to-face consults with a psychologists, and the availability of trained psychologists is limited.\n\nThe investigators expect that inter-CBT will integrate well into clinical practice and prove non-inferior in achieving a reduction in fatigue compared to face-to-face CBT as investigated in the TIRED and GRIP study. It is further expected that the interviews will provide useful information to implement this intervention.\n\nThe main aims to answer are:\n\n* To determine the non-inferiority of CBT primarily led by nurese, compared with benchmark studies in which CBT was provided by psychologists, in its effect on reduction in cancer-related fatigue\n* To adapt CBT delivery to the needs of patients treated with palliative intent and glioma (interdisciplinary web-based CBT for cancer-related fatigue.\n* To investigate its feasibility by evaluating the practical workability, acceptability, and burden for patients and health care providers.\n\nParticipants will follow the 12 weeks CBT intervention online, mainly guided by their nurse. Participants will start with a face-to-face session with the psychologists, partly together with their nurse, to start with setting their treatment goals. Then, they will work on the modules that are applicable to them. During the CBT intervention there will be a face-to-face session with their nurse to discuss the progress of their goals. Finally, all participants will complete the therapy by realizing their treatment goals. The outcomes with respect to fatigue severity and participants' goals will be discussed by the nurse with the participant in the final, face-to-face sessions. The face-to-face sessions will take 30 to max. 45 minutes, except for the first session, which will take one hour of which the nurse will be present during 15 minutes.\n\nResearchers will compare the outcomes of the study to a benchmark study where CBT was provided by psychologists in its effect on reduction in cancer-related fatigue.",[27,28],"Cancer","Palliative Treatment","RECRUITING","2026-06-11",{"date":32,"type":33},"2026-06-15","ACTUAL",{"date":35,"type":33},"2024-06-03",{"date":37,"type":21},"2028-02-01",{"name":39,"class":40},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":41},"100544843","exercise-in-patients-with-advanced-non-small-cell-lung-cancer-100544843","NCT06374160","Exercise in Patients With Advanced Non-small Cell Lung Cancer","Better Symptom Control With Exercise in Patients With Advanced Non-small Cell Lung Cancer","BREATH","Inclusion Criteria\n\n* Patients with histologically confirmed non-small cell lung carcinoma in UICC stages IIIB and IV\n* First- or second-line therapy (inclusion up to 28 days after the first cycle) in palliative intention\n* Age ≥ 18 years\n* Signed informed consent\n\nExclusion Criteria\n\n* Severe cardiopulmonary disease (EF\\\u003C30%)\n* Newly occurring or progressive uncontrolled CNS (central nervous system) metastases\n* Expected life expectancy \\\u003C 3 months\n* Bone metastases with acute risk of fracture\n* ECOG (Eastern Cooperative Oncology Group) performance status \\> 2\n* Acute pulmonary embolism\n* Acute myocardial infarction\n* Requiring surgery for aortic aneurysm\n* Tension pneumothorax\n* Lack of proficiency in the German language\n* Active infection",{"count":51,"type":21},104,[24],"Lung cancer is one of the most common types of cancer in Germany, with 56,839 new cases and 45,072 deaths annually. Approximately 70% of patients with non-small cell lung cancer (NSCLC) are diagnosed at an advanced stage and suffer from comorbidities and symptoms such as fatigue, tiredness, and loss of strength. The standard first-line treatment for metastatic NSCLC includes platinum-based chemoimmunotherapy followed by immunotherapy maintenance. Exercise can have positive effects on symptoms such as shortness of breath, fatigue, quality of life, and physical fitness. However, there is a lack of current scientific evidence for the effectiveness of exercise in advanced lung cancer patients. No current trial investigated exercise in advanced NSCLC receiving immunotherapy so far.\n\nThe BREATH-study is a prospective 3-arm randomized controlled trial (RCT). In total, the investigators plan to recruit 104 patients. A 2:1:1 randomization will be performed with three study groups: a control group and two exercise therapy groups (strength+endurance exercise\u002Fonly endurance exercise). One group receives individual endurance training and the other group a combination of individual endurance and strength training. Both treatment groups will be treated twice a week for 12 weeks. The control group will initially receive standard treatment without exercise for 12 weeks and will then be randomized into one of the other two study groups with exercise twice a week for 12 weeks. This approach allows for a sufficiently large sample for comparisons between exercise therapy and the control group, as well as between the two exercise therapy approaches.\n\nThe primary aim is to investigate the impact of exercise on V02peak. Secondarily endpoints aim to investigate changes in physical function, patient related outcomes and cardiac function before and after exercise.",[55,56,57,58,59,28,60],"Advanced Lung Carcinoma","First Line Treatment","Second Line Treatment","NSCLC Stage IV","NSCLC Stage IIIB","NSCLC Stage IIIC","NOT_YET_RECRUITING","2024-04-15",{"date":64,"type":33},"2024-04-18",{"date":66,"type":21},"2024-05-01",{"date":68,"type":21},"2026-08-31",{"name":70,"class":40},"University Hospital, Essen"]