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. 2019 Jul 2;2019(7):CD012582. doi: 10.1002/14651858.CD012582.pub2

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
  • Study feedback (study‐specific Post‐Study Feedback Questionnaire)

  • QoL (Linear Analogue Self‐Assessment Scale; Caregiver QoL Index‐Cancer)

  • Distress (Profile of Mood States)


Patient outcomes:
  • Compensation techniques (The Compensation Techniques Questionnaire)

  • Study feedback (study‐specific Post‐Study Feedback Questionnaire)

  • QoL and functional capacity (Functional Assessment of Cancer Therapy – Brain; Mayo‐Portland Adaptability Inventory‐4; Linear Analogue Self‐Assessment Scale)

  • Cognitive functioning (Repeatable Battery for the Assessment of Neuropsychological Status)

  • Distress (Profile of Mood States)

  • Fatigue (Brief Fatigue Inventory)

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.