Plain English Summary
Background and Study Aims:
Brain tumours are the leading cause of cancer death in the under-40s. Even with all the current treatment opportunities available, survival from this illness is still poor. With this in mind, a patient's quality of life - their overall function and well-being - should be a focus in treatment decision making, as quality of life has been shown to play an important role in overall outcome. There are specific 'tools' in the form of questionnaires to measure quality of life, however, those currently available are time consuming and burdensome. Moreover, "quality of life" is a difficult concept to measure as its meaning may be different to different people. Furthermore, the impact on caregivers' quality of life - notably in time, financial concerns and personal health consequences should not be forgotten about.
The purpose of this study is to identify whether the patient generated index (PGI) - a tool designed to document quality of life concerns in a more personalised manner as they are stated by the individual - is feasible in the brain tumour population (patients and caregivers). We will ask patients to complete both standard validated questionnaires as well as the patient generated index (PGI) and we will use the same process to assess quality of life of their main caregiver - a method we are terming the Caregiver Generated Index (CaGI). The intention is then to compare the results of PGI and CaGI to the existing standard quality of life questionnaires to get an understanding of how well they capture the impact of living with this new diagnosis.
Who can participate?
Adults who have been diagnosed with a brain tumour and are undergoing active treatment and/or their caregiver.
What does the study involve?
Participants will be required to visit the hospital and complete some questionnaires on 6 occasions over 6 months.
What are the possible benefits and risks of participating?
There will be no direct benefit but ultimately, we hope that we will be able to validate the Patient Generated Index so that it can be utilised in routine clinical practice to help deliver more personalised care. We anticipate that the process of using the PGI and other questionnaires may highlight some areas of concern which may not have been discussed in normal clinic visits. We would anticipate that this process would itself be beneficial; however, if required, we will be able (with the participants' permission) to discuss these areas of concern with their wider treating team and access other support services if necessary.
Where is the study run from?
1. Imperial College Healthcare NHS Trust
2. Barts Health NHS Trust
3. Guys & St Thomas NHS Foundation Trust
When is the study starting and how long is it expected to run for?
October 2019 to March 2022
Who is funding the study?
1. Imperial Health Charity
2. NIHR Imperial Biomedical Research Centre
3. Royal Marsden Cancer Charity (RM Partners)
Who is the main contact?
Lillie Pakzad-Shahabi (public), lillie.shahabi@nhs.net
Dr Matt Williams (scientific), matt.williams3@nhs.net
Trial website
Contact information
Type
Public
Primary contact
Miss Lillie Pakzad-Shahabi
ORCID ID
http://orcid.org/0000-0001-5268-0771
Contact details
Imperial College London
John Fulcher Neuro-oncology Lab
5th Floor Burlington Danes
London
W6 8RF
United Kingdom
+44 (0)7894 790450
lillie.shahabi@nhs.net
Type
Scientific
Additional contact
Dr Matt Williams
ORCID ID
http://orcid.org/0000-0001-7096-0718
Contact details
Radiotherapy Department
Charing Cross Hospital
Fulham Palace Rd
Hammersmith
London
W6 8RF
United Kingdom
+44 (0)20 3311 8427
matt.williams3@nhs.net
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
IRAS 266261, CPMS 45067
Study information
Scientific title
CaPaBLE: Caregiver and Patient less-Burden Life Evaluation - A Phase II observational study comparing the Patient Generated Index (Quality of life tool) in patients and caregivers to conventional QoL measures in the high-grade brain tumour population
Acronym
CaPaBLE
Study hypothesis
The CaPaBLE study intends to assess the feasibility of using the PGI process with patients diagnosed with brain tumours, additionally we will use the same process to assess QoL of their main caregiver - a method we are terming the Caregiver Generated Index (CaGI). The results of PGI and CaGI will be compared to existing standard QoL questionnaires to get an understanding how well they capture the impact of living with this new diagnosis.
Ethics approval
Approved 22/04/2020, London - Bloomsbury Research Ethics Committee (3rd Floor 4 Minshull Street Manchester M1 3DZ, UK; +44 (0)207 104 8375; bloomsbury.rec@hra.nhs.uk), ref: 20/LO/0338
Study design
Phase II non-randomized pragmatic cohort study of patients and caregivers
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
See additional files
Condition
Quality of life in newly diagnosed/ recurrent high-grade primary brain tumour patients and their caregivers
Intervention
This is an observational study; patients will therefore receive treatment as clinically indicated, in line with standard guidelines. Potential participants will include any patient that is referred to the Brain Tumour MDT and/or neuro-oncology clinic with a suspected new, or recurrent, high grade brain tumour and plan is for:
• neurosurgical biopsy or resection
• start a course of radical radiotherapy (≥45 Gy)
• course of chemoradiotherapy
• stereotactic radiotherapy
• or for re-treat for relapsed disease
Participants will be divided into three cohorts for eligibility/ recruitment into the study:
1. Patient and caregiver both consent for study
2. Patient consents for study and the caregiver does not consent to take part in study
3. Patient does not consent to being part of study but gives consent for research team to have access to medical records. Caregiver consents to being enrolled into study.
Participants will then take part in an observational, longitudinal study of HRQoL from diagnosis to six months or discontinuation of treatment or death. Patients will undergo standard follow up procedures (both clinical and imaging assessment) as part of their routine clinical care (monthly if on chemo-radiotherapy and 3-6 monthly during the follow up), and for this study will be followed from enrolment until 6 months. We intend to complete both patient and caregiver assessments at the same clinic visits. At all visits, the PGI/CaGI will be completed prior to any other assessment (EORTC QLQ30, BN20, CarGOQoL and EQ-5D-5L). At each visit the PGI/CaGI is completed anew, this will allow assessment of change in domains highlighted and the weighting ascribed to them. To assess their previous medical history and concurrent medical conditions, the attending medical professional or researcher will complete the Adult Co-Morbidity Evaluation 27 with the patient and caregiver at enrolment.
The initial assessment for patients consists of taking a full medical history and gathering background information (gender, age, ethnicity etc) and a brief assessment of your memory and concentration (MoCA)which normally takes 5-10 minutes. Once this is completed, the Patient Generated Index will be completed which is a three step process. After this two standard questionnaires, totaling 50 questions, (QLQ-C30 and BN20) will need to be completed. This typically takes less than 15 minutes. Further assessments will take place at 2 and 6 weeks and then at 3, 4, and 6 months (end of study). At study visits 3 and 5 we will also ask participants to do an additional questionnaire which consists of 5 questions (EQ-5D) - which is the same for caregivers.
This initial assessment for caregivers consists of gathering information about their background (gender, age, ethnicity etc) and any underlying health condition which they feel is relevant for us to know about. Once this is completed, the Caregiver Generated Index will be completed which is a three-step process. After this participants will be asked to complete a standard questionnaire totalling 41 questions (CarGoQoL). This should take approximately 5 to 10 minutes. Further assessments will take place at 2 and 6 weeks and then at 3, 4, and 6 months (end of study). At study visits 3 and 5 we will also ask for you to do an additional questionnaire which consists of 5 questions (EQ-5D) - which is the same for patients.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Feasibility and acceptability of novel, personalised measures of HRQoL in patients with brain tumours and their caregivers, which will be assessed using completion rates at the end of the study
2. Patient quality of life measured at baseline, 2 weeks, 6 weeks, 3 months, 4 months, 6 months using the following:
2.1. Patient Generated Index
2.2. Cancer quality of life questionnaire (QLQ-C30)
2.3. Quality of Life Questionnaire - Brain Cancer Module (BN20)
2.4. EQ-5D (at 6 weeks and 4 months only)
3. Caregiver quality of life measured at baseline, 2 weeks, 6 weeks, 3 months, 4 months, 6 months using the following:
3.1. Caregiver Generated Index
3.2. CareGiver Oncology Quality of Life questionnaire (CarGoQoL)
3.3. EQ-5D (at 6 weeks and 4 months only)
Secondary outcome measures
Patient, caregiver and professional views on the comparative benefits and drawbacks of standard approaches and PGI/CaGI measured using two focus groups (midway through and end of study) where patients, caregivers and multi-disciplinary staff will be invited to have open discussions in regards to the PGI/ CaGI vs standard methods. In each session we will ask participants to express their views and thoughts, and then reflect emerging themes to the group to stimulate further discussion.
Overall trial start date
01/10/2019
Overall trial end date
07/03/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patient
1. Newly diagnosed, or recurrent, high-grade primary brain tumour. We define a high-grade tumour as any grade 3 or 4 primary brain tumour (including meningioma)
2. Newly diagnosed patients intending to undergo neurosurgical biopsy or resection, or to start a course of radical (>=45Gy) radiotherapy or a course of chemoradiotherapy or stereotactic radiotherapy.
3. Recurrent brain tumours patients undergoing further treatment including surgery, chemotherapy or re-irradiation.
4. Performance status 0, 1, or 2
5. Able to provide written informed consent
6. Intention to attend at least 5 clinic visits over a six-month period to the study site
7. Age 18 years and above
8. Willing to undertake study-specific measures
Caregiver
1. Main caregiver of patient with newly diagnosed or recurrent high-grade primary brain tumour
2. Caregiver of patient receiving treatment (surgery and/or radiotherapy/ chemotherapy) expected to last >=3 weeks in total
3. Aged 18 and above
4. Intention to attend at least 5 clinic visits over a six-month period to the study site
5. Willing to undertake study-specific measures
6. Able to provide written informed consent
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
130
Participant exclusion criteria
Patient
1. Diagnosed with a low-grade brain tumour (including grade 1 and 2 meningiomas)
2. Poor performance status (PS 3,4) or rapidly deteriorating fitness and for best supportive care and/or symptom control only
3. Diagnosed with a high-grade brain tumour but not planned for any intervention
4. Language barriers
5. Poor cognition status based on clinical assessment/ Montreal Cognitive Assessment (MoCA)/ MDT)
6. Refusal to participate
Caregiver
1. Severe cognitive problems based on the doctor’s opinion
2. Language barrier
3. Ongoing active treatment for own medical condition expected to significantly limit attendance for study assessments (missing 2 or more clinic visits). To be assessed by attending clinical or research team
Recruitment start date
15/06/2020
Recruitment end date
31/07/2021
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Charing Cross Hospital
Imperial College Healthcare NHS Trust
Fulham Palace Rd
Hammersmith
London
W6 8RF
United Kingdom
Trial participating centre
The Royal London Hospital
Barts Health NHS Trust
Whitechapel
London
E1 1BB
United Kingdom
Trial participating centre
Guy's Hospital
Guys and St Thomas' NHS Foundation Trust
Great Maze Pond
London
SE1 9RT
United Kingdom
Sponsor information
Organisation
Imperial College London
Sponsor details
Room 215 Level 2
Medical School Building
Norfolk Place
London
W2 1PG
United Kingdom
+44 (0)207 5949459
becky.ward@imperial.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Imperial Health Charity
Alternative name(s)
Imperial Charity, IHC
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Funder name
NIHR Imperial Biomedical Research Centre
Alternative name(s)
Imperial Biomedical Research Centre, NIHR Imperial BRC, BRC
Funding Body Type
private sector organisation
Funding Body Subtype
Research institutes and centers
Location
United Kingdom
Funder name
Royal Marsden Cancer Charity (RM Partners)
Alternative name(s)
The Royal Marsden Cancer Charity
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
We intend to publish and disseminate our finding through peer reviewed scientific journals , conference presentations and updates/ publication on websites (i.e Brain Tumour Research; Imperial College London)
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.
Intention to publish date
01/10/2021
Participant level data
Other
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN45555598_PIS_(caregiver info)_v1.5.pdf Uploaded 04/01/2021
- ISRCTN45555598_PIS_v1.5.pdf Uploaded 04/01/2021
- ISRCTN45555598_PROTOCOL_v3.3_14April2020.pdf Uploaded 04/01/2021