Carcinoma Clinical Trial
Official title:
Existential Distress in Patients With Advanced Cancer and Their Caregivers: A Longitudinal Cohort Study
Despite the potential for alleviation of existential distress through psychosocial interventions, existential concerns and their impact on health care outcomes of patients and caregivers have not yet been systematically studied. The aim of this longitudinal cohort study is to investigate the frequency, longitudinal trajectory and predictive impact of existential distress on patient- and caregiver-relevant end-of-life outcomes. Further, it aims to determine the need for and utilization of psychosocial support in patients and caregivers with regard to existential concerns.
Due to medical progress and an aging population, the number of patients and caregivers who face the profound existential challenges of advanced incurable cancer is constantly growing. Clinically significant existential distress may result from a fear of suffering and perceived lack of control, fear and uncertainty about the end of life, feelings of burdensomeness or insufficiency, grief about missed opportunities, and profound loneliness. Such distress may have a unique and independent contribution to health care outcomes at the end of life. Despite an increasing interest in existential and palliative care interventions that discuss such issues openly, a lack of systematic quantitative data on existential distress and specific support needs hampers clinicians to consequently detect and address existential needs. This longitudinal study aims to 1) systematically investigate the frequency, longitudinal trajectory and predictive impact of existential distress on patient- and caregiver-relevant end-of-life outcomes and 2) determine patients' and caregivers' specific need for and utilization of psychosocial support with respect to existential concerns. Adult patients diagnosed with advanced cancer and caregivers will be consecutively recruited from outpatient and inpatient treatment facilities of the Univer-sity Cancer Center Hamburg and affiliated clinics. Existential distress, end-of-life outcomes, and mental disorders in 1,000 participants (500 patients, 500 care-givers) will be assessed using self-report questionnaires at five points of assessment over a period of 12 months and diagnostic interviews (at baseline, after six months). To determine the prevalence of existential distress, mental disorders and palliative care outcomes descriptive statistics will be calculated. Descriptive analyses will also be used to examine the need for and utilization of psychosocial support. To investigate the predictive impact of existential distress and patient- and caregiver-relevant end-of-life outcomes multiple linear and logistic regression will be conducted. To analyze longitudinal trajectory of existential distress growth mixture models will be used. Shaping a clear and systematic knowledge about frequent and persistent existential concerns that are most relevant to the risk for unfavorable end-of-life outcomes, results will significantly contribute to the recognition and manage-ment of existential distress and provide a valuable basis for the development of targeted interventions. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05283226 -
Study to Evaluate the Safety and Efficacy of Oral NRC-2694-A in Combination With Paclitaxel in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma, Who Progressed on or After Immune Checkpoint Inhibitor Therapy
|
Phase 2 | |
Active, not recruiting |
NCT04362072 -
Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer
|
Phase 4 | |
Completed |
NCT04033991 -
Study of Patients With Metastatic and/or Advanced Renal Cell Carcinoma, Treated With Sunitinib/Axitinib.
|
||
Recruiting |
NCT02292641 -
Beyond TME Origins
|
N/A | |
Not yet recruiting |
NCT02907606 -
Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study
|
N/A | |
Completed |
NCT02507544 -
A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer
|
Phase 1 | |
Completed |
NCT01942200 -
A Non Interventional Study With Oxaliplatin Onkovis (Oxaliplatin) Utilized for the Treatment of Cancer
|
||
Completed |
NCT01061645 -
Study of MOC31-PE in Antigen Positive Carcinomas
|
Phase 1 | |
Completed |
NCT00532155 -
A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
|
Phase 3 | |
Terminated |
NCT00557596 -
A Phase 1-2, XIAP Antisense AEG35156 With Gemcitabine in Patients With Advanced Pancreatic Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT00216372 -
Efficacy and Safety of Lanreotide Microparticles as Palliative Treatment in Peritoneal Carcinomatosis
|
Phase 3 | |
Recruiting |
NCT06022757 -
Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19)
|
Phase 1/Phase 2 | |
Recruiting |
NCT05520281 -
Short-term Psychodynamic Psychotherapy in Serious Physical Illness
|
N/A | |
Recruiting |
NCT05752357 -
The Role of Pre-operative and Post-operative Circulating Tumor Cells in Gastric Cancer.
|
||
Not yet recruiting |
NCT05023928 -
Tumor Antigen-sensitized DC Vaccine as an Adjuvant Therapy for Esophagus Cancer
|
Phase 1 | |
Completed |
NCT00446446 -
PRISM (Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer)
|
Phase 2 | |
Recruiting |
NCT04566952 -
Anlotinib Combined With Dose-reduced Olaparib in Patients With Platinum-Sensitive Recurrent Ovarian Cancer
|
Phase 2 | |
Not yet recruiting |
NCT06112041 -
The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors (PRaG9.0)
|
Phase 2 | |
Completed |
NCT03562897 -
Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer
|
Phase 2 | |
Recruiting |
NCT06013111 -
An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti-CEA-CAR-T Cells Injection in Patients With CEA+ Locally Advanced and/or Metastatic Solid Tumors
|
Phase 1 |