Fatigue in people with brain cancer Cancer
Conditions
Interventions
Patients will be randomised to one of the three study arms through minimisation to ensure balance, with the minimisation factor being recruiting site.
Group 1:
This is
Sponsors
NHS Lothian
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 and above 2. Diagnosed with any primary brain tumour 3. >3 months post-completion of chemotherapy/radiotherapy 4. Clinically and radiologically stable, as defined by no evidence of disease progression at most recent clinic appointment 5. Moderate or severe fatigue (Brief Fatigue Inventory score =4/10, indicating at least ‘moderate’ severity of fatigue over the previous week) 6. Participants can be male or female
Exclusion criteria
Exclusion criteria: 1. Patients unable to give informed consent, or are unable or unwilling to comply with interventions 2. Patients with significant cognitive or sensory impairment (e.g. severe dysphasia or severe visual impairment) 3. Patients who are clinically unstable 4. Radiological or clinical concern at most recent appointment over disease progression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of delivering Health Coaching and Patient Activation to fatigued patients with a primary brain tumour. Feasibility will be assessed by meeting a priori defined standards for recruitment and retention as follows: 1. Recruitment will be feasible if 20 fatigued brain tumour patients can be recruited per centre over 12 months 2. Retention will be feasible if total attrition at T2 (endpoint) is less than or equal to 40% | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The acceptability of the interventions to patients 2. The manageability of the interventions for professionals 3. The development of systems and piloting outcome measures for future definitive RCTs of the interventions for fatigued brain tumour patients, including determination of mean change in outcome scale scores in each arm | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed