Locke 2008.
Methods | Quasi‐randomised controlled trial | |
Participants |
Inclusion criteria: people with newly diagnosed primary brain tumour eligible for radiotherapy and aged > 18 years; have mild‐to‐moderate cognitive impairment; have a prognosis of ≥ 6 months and ability to attend sessions at the medical centre for 2 weeks. All patients were required to have a designated caregiver available to attend all sessions. Exclusion criteria: none specified. Number randomised: 16 (9 intervention group, 7 control group). 3 more were not randomised but allocated to the intervention group. Follow‐up: baseline, 2 weeks, 3 months Setting: tertiary medical centre in US |
|
Interventions |
Intervention group: received cognitive rehabilitation and problem solving. Cognitive rehabilitation: dyads were taught to use a calendar that had a specific format as an external aid to compensate for cognitive symptoms. 6 × 50‐minute sessions over 2‐week period. Specific goals were developed for each session. Problem solving: teaching dyads a model of stress and a specific problem‐solving technique for its management. 6 × 50‐minute sessions over 2‐week period, delivered concurrently with the cognitive rehabilitation intervention. Control group: standard medical care |
|
Outcomes |
Caregiver outcomes
Patient outcomes:
|
|
Notes | 100% neuro‐oncology (16 participants, 9 intervention group, 7 control group). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Method of randomisation not described. Last 3 participants enrolled were not randomly allocated. |
Allocation concealment (selection bias) | High risk | Last 3 participants enrolled were not randomly allocated. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not described in the report, but blinding was likely not possible due to nature of the intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described in the report. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Dropout rates: 26% at postintervention; increased to 32% at 3 months' follow‐up. 33% did not complete the intervention. Not clear how missing data were handled, presumably not included in analysis. |
Selective reporting (reporting bias) | Unclear risk | There was no published study protocol. All outcomes in the manuscript were reported on. |