Prognostic Understanding in ESC (ProgESC Study)

Trial Title: Prognostic Understanding in ESC (ProgESC Study)

NCT ID: NCT06067087

Condition: Advanced Cancer

Conditions: Keywords:
Prognostic understanding
Enhanced Supportive Care Team
Quality of life
Anxiety
Depression
Satisfaction

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Cross-Sectional

Summary: 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

Detailed description: 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.

Criteria for eligibility:

Study pop:
Population: Consecutive patients with advanced cancer being referred to the Enhanced Supportive Care Team Setting: UCH Macmillan Cancer Centre

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - All participants aged 18 and older with advanced cancer referred to the ESC team will be eligible for this study. Exclusion Criteria: - Younger than 18 years - Insufficient English language to complete questionnaires - cognitive impairment - Participants who, in the opinion of the member of the ESC team, would not be appropriate to participate

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: November 15, 2023

Completion date: October 31, 2024

Lead sponsor:
Agency: University College, London
Agency class: Other

Source: University College, London

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06067087