None listed
Conditions
Brief summary
This pilot study will investigate quality of life issues related to having brain cancer, other cancers which spread to the brain or advanced cancer of other types; where the person is required to take regular dexamethasone (a corticosteroid) for disease management and/or chemotherapy. The study will enable us to follow how patients are doing during their treatment for cancer by looking at the severity and frequency of side effects that occur with dexamethasone, in particular by using a new instrument which assist patients and their caregivers to tell us about the possible side effects they might be experiencing in relation to dexamethasone treatment and their severity. The study will also look at factors that might help us decide how to improve the management of dexamethasone use.
Interventions
This is not an interventional study but a feasibility study measuring patient reported outcomes (PROs) in the evaluation of side effects and toxicities from steroid use in patients with brain tumours or brain metastases or advanced cancer. Clinician's will rate patient toxicities from steroid use at baseline using Common Terminology Criteria for Adverse Events version 4. 50 patients will be recruited to the study with at least half (25) having a primary brain tumour (and 50 associated caregive
This is not an interventional study but a feasibility study measuring patient reported outcomes (PROs) in the evaluation of side effects and toxicities from steroid use in patients with brain tumours or brain metastases or advanced cancer. Clinician's will rate patient toxicities from steroid use at baseline using Common Terminology Criteria for Adverse Events version 4. 50 patients will be recruited to the study with at least half (25) having a primary brain tumour (and 50 associated caregivers). The caregivers’ responses are collected in conjunction with those of the patients and are crucial for assessing the reliability of the measurements. The duration of observation for each patient is 8 weeks with timepoints occuring at baseline, 2, 4 and 8 weeks. At each timepoint, questionnaires are required to be completed.
Sponsors
Cooperative Trials Group for Neuro-Oncology (COGNO)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of a primary malignant brain tumour, brain metastases or advanced cancer 2. The participants need to have been taking dexamethasone continuously for at least 48 hours 3. For patients with primary brain tumour recommencement of dexamethasone or dose increase to at least 4mg in the last 2 weeks due to progressive raised intracranial pressure in patients and on a stable steroid dose for at least 48 hours with no intention of changing dose for next 48 hours 4. Greater than or equal to 18 years of age 5. Karnofsky performance status (KPS) score of greater than or equal to 40 at baseline 6. Life expectancy of greater than or equal to 8 weeks
Exclusion criteria
1. Clinically significant head injury, neurological disorder, chronic seizure disorder or CNS infection, if functional impairment that will interfere with ability to complete assessments; 2. Inability of patient (and caregiver to provide written informed consent; 3. Inability of patient (and caregiver) to complete assessments.
Outcome results
None listed