Advanced Cancer Clinical Trial
Official title:
Prognostic Understanding in Patients Receiving Enhanced Supportive Care (ProgESC Study)
This study aims to assess how aware patients with advanced cancer are about their prognosis when they are referred to an Enhanced Supportive Care (ESC) service. Further, the study aim to assess the relationship between patients prognostic understanding and their mental health, quality of life, trust in medical professionals as well as their perception of the care they receive. The study will involve adult patients with advanced cancer who are referred to the ESC service at London University College Hospital. Patients who agree to participate will provide consent and answer a questionnaire. The questionnaire will cover their prognostic awareness, psychological symptoms, and quality of life. It takes about 20 minutes to complete and can be done online via RedCap
Background: Prognostic awareness among patients with life-limiting diseases has been shown to be associated with less depression, better quality of care and earlier referral to palliative care. Moreover, accurate understanding of their illness may support patients to make informed decisions about their future in alignment with their preferences, values or needs. Supportive care in cancer is the prevention and management of the adverse effects of cancer and its treatment. This includes management of physical and psychological symptoms and side effects. Enhanced Supportive Care (ESC) is a relatively new initiative implementing early supportive care in patients with advanced cancer. Although studies have shown that a large proportion of patients with advanced cancer remain unaware that their disease is not curable, research regarding prognostic awareness in patients referred to Enhanced Supportive Care (ESC) services is still scarce. A deeper knowledge of the factors and patient characteristics associated with prognostic awareness is an important first step to develop interventions to improve prognostic communication and thereby to facilitate delivery of high-quality ESC. General aim: The ESC team at University College London Hospital is embedded within the oncology outpatient service, providing specialist symptom control and Advanced Care Planning to patients with advanced cancer. The primary aim of this study is to better understand the prognostic awareness of patients referred to the ESC service. A secondary aim is to evaluate the relationship between patients' prognostic awareness and levels of psychological distress, quality of life, trust in medical professionals and perceived quality of care. Patient population: Consecutive adult patients with advanced cancer referred to the ESC service will be eligible to participate. Patients unable to complete questionnaires due to cognitive impairment such as dementia will be excluded. Patients who have already been referred to community palliative care services will also be excluded. Methods: This will be a cross-sectional prospective study. Potentially eligible patients will be identified by members of the ESC team and will be informed about the study. Interested patients will then discuss the study with the research team and will be invited to participate. After informed consent has been obtained, participants will complete a questionnaire which will cover their level of prognostic awareness, psychological symptoms, and quality of life). The questionnaire will take approximately 20 minutes to complete. The questionnaire can be completed online via RedCap. Endpoints: The primary endpoint of this study is the level of patients' prognostic awareness, which will be assessed by the Prognosis and Treatment Perception Questionnaire. This questionnaire has previously been successfully used in research to assess patients' information preferences, perceptions about their prognosis and the goals of therapy and communication preferences about end-of-life care. Secondary endpoints will be (a) patients' preferences for receiving prognostic information assessed through the Prognosis and Treatment Perception Questionnaire (b) symptoms of depression evaluated through the Patient Health Questionnaire-2 (PHQ-2), (c) symptoms of anxiety evaluated through the Generalized Anxiety Disorder 2-item (GAD-2), (d) quality of life and (d) patients' trust in their medical team and (e) other aspects of perceived quality of care, rated on a visual analogue scale (NRS) from 0-10. Sample size and statistics: The investigators will conduct univariable and multivariable regression analyses to evaluate associations between sociodemographic or clinical variables and outcomes. The investigators aim to include 100 patients. This will give us at least 10 degrees of freedom to assess association of potential risk factors with outcome and to evaluate confounders in a multivariable analysis. Discussion: This will be the first prospective study to assess prognostic awareness among cancer patients referred to ESC services in a British setting. Identifying covariates for prognostic unawareness and psychological burden among patients with advanced cancer will inform the future development of strategies to improve care and communication with this patient group. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03181854 -
Randomized Controlled Trial of Integrated Early Palliative Care
|
N/A | |
Completed |
NCT01197170 -
Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance
|
Phase 1 | |
Recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT05045040 -
Empathetic Communication Facilitation Program for Early Initiation of End-of-life Discussions
|
N/A | |
Active, not recruiting |
NCT03994601 -
An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
Completed |
NCT01393990 -
A Study of LY2228820 in Participants With Advanced Cancer
|
Phase 1 | |
Completed |
NCT02857270 -
A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer
|
Phase 1 | |
Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT04121676 -
Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer
|
Phase 1 | |
Active, not recruiting |
NCT03177291 -
Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC
|
Phase 1 | |
Completed |
NCT03980041 -
Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
|
Phase 2 | |
Active, not recruiting |
NCT03674567 -
Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab
|
Phase 1/Phase 2 | |
Recruiting |
NCT04823377 -
Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.
|
N/A | |
Completed |
NCT02778126 -
A Study of Prexasertib (LY2606368) in Participants With Advanced Cancer
|
Phase 1 | |
Completed |
NCT02529553 -
A Study of LY3076226 in Participants With Advanced or Metastatic Cancer
|
Phase 1 | |
Completed |
NCT02507544 -
A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer
|
Phase 1 | |
Completed |
NCT02245204 -
Phase I Studies of Chlorogenic Acid for Injection for Tolerance and Pharmacokinetic of Advanced Cancers
|
Phase 1 | |
Completed |
NCT01901237 -
Yoga for Adolescent and Young Adult Non-Curative Cancer Patients
|
N/A | |
Terminated |
NCT01929941 -
An Open-Label Study of a Novel JAK-inhibitor, INCB047986, Given in Patients With Advanced Malignancies
|
Phase 1 |