Prognostic Understanding in ESC (ProgESC Study)

Sponsor

University College, London (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06067087

Collaborator

(none)

100

Enrollment

10.5

Anticipated Duration (Months)

Study Details

Study Description

Brief 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 on paper, via telephone interview or online - depending on patients' preferences.

Condition or Disease	Intervention/Treatment	Phase
Advanced Cancer

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, the research team will collect data on the reason for referral to the ESC service, sociodemographic characteristics, and baseline clinical data (e.g., diagnosis, treatment history, performance status). Participants will then 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 in a paper-based format, a telephone interview or can be completed using an online format, whichever is most convenient for the participant.

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

Prognostic Understanding in Patients Receiving Enhanced Supportive Care (ProgESC Study)

Anticipated Study Start Date :

Oct 16, 2023

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Patients with advanced cancer Patients with advanced cancer that are referred to the Enhanced Supportive Care Team at University College London Hospital

Outcome Measures

Primary Outcome Measures

Patients' prognostic understanding [within 1 week after patient assessment by the Enhanced Supportive Care Team]
Patients' prognostic understanding about their illness assessed through the Prognosis and Treatment Perception Questionnaire. This questionnaire assesses patient beliefs regarding the likelihood of cure, the preference for receiving prognostic information as well as the perceived helpfulness of knowing about prognosis

Secondary Outcome Measures

Perceived value of prognostic information [within 1 week after patient assessment by the Enhanced Supportive Care Team]
Assessed through the Prognosis and Treatment Perception Questionnaire. This questionnaire assesses patient beliefs regarding the likelihood of cure, the preference for receiving prognostic information as well as the perceived helpfulness of knowing about prognosis

Other Outcome Measures

Symptoms of anxiety [within 1 week after patient assessment by the Enhanced Supportive Care Team]
Patients' symptoms of anxiety assessed through the Generalized Anxiety Disorder 2-item. This scale has a range from 0 to 6 points with higher scores indicating more symptoms of anxiety. A score of 3 points is considered a cut-off point, in which further evaluation is recommended.
Symptoms of depression [within 1 week after patient assessment by the Enhanced Supportive Care Team]
Patients' symptoms of depression assessed through the Patient Health Questionnaire-2. This scale has a range from 0 to 6 points with higher scores indicating more depressive symptoms. A score of 3 points is considered a cut-off point, in which further evaluation is recommended.
Patients' quality of life [within 1 week after patient assessment by the Enhanced Supportive Care Team]
Patients' quality of life assessed through the European Organisation for Research and Treatment of Cancer quality of life core 15 palliative questionnaire. This 15-item questionnaire, employs a 4-point Likert scale for each question, and the resulting scores are linearly transformed to a possible range of 0 to 100, where higher scores indicate a better quality of life
Trust in the treating oncologist [within 1 week after patient assessment by the Enhanced Supportive Care Team]
Patients' trust in the treating oncologist assessed on a numeric rating scale ranging from 0-10 with higher scores indicating more trust
Satisfaction with care [within 1 week after patient assessment by the Enhanced Supportive Care Team]
Patients' satisfaction with care assessed on a numeric rating scale ranging from 0-10 with higher scores indicating greater satisfaction

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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