Quality of life in newly diagnosed/ recurrent high-grade primary brain tumour patients and their caregivers Not Applicable
Conditions
Interventions
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 neu
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
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 (>=45 Gy) 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 6-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 years and above 4. Intention to attend at least 5 clinic visits over a 6-month period to the study site 5. Willing to undertake study-specific measures 6. Able to provide written informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
England, United Kingdom
Contacts
Public ContactLillie Pakzad-Shahabi
Outcome results
None listed