Methods | Randomised controlled trial, parallel arm, unblinded. | |
Participants |
Inclusion criteria: 18 years of age or older; mild‐to‐moderate cognitive impairment based on a combination of quantitative neuropsychological test data from the clinical assessment and the clinical judgement of the evaluation neuropsychologist; prognosis of at least 6 months of life; ability to attend sessions at our medical centre for 2 weeks; designated caregiver available to attend all sessions; receiving radiation therapy. No. randomised: Cognitive rehabilitation program: 7; standard care: 12. Follow‐up: post‐intervention and 3 months. Setting: one radiation oncology clinic in the United states. |
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Interventions | Treatment arm schedule: 1. Six 50‐minute sessions of cognitive rehabilitation carried out over 2 weeks, involving the learning and use of a calender as a compensatory aid. 2. Six 50‐minute sessions of problem‐solving carried out over 2 weeks, involving education of a model of stress and learning positive problem‐solving management techniques. Control arm: standard care. |
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Outcomes | Cognitive function (RBANS) QoL (CQOLC, LASA) Mood (POMS) Fatigue (BFI) Functional capacity (FACT‐BR, MPAI‐4) |
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Notes | No cognitive function statistical comparisons were made between groups. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | "Patients were randomized by our randomization center at the time of their enrollment. The randomization center is an entirely separate group of personnel from those recruiting and enrolling patients for the study" (obtained via correspondence). However, "Due to low accrual and anticipation of the ending of the enrolment period, the last three patient/caregiver dyads were not randomized and were enrolled directly into the intervention group." |
Allocation concealment (selection bias) | High risk | "randomization was not pre‐scheduled. That is, they were randomized patient by patient as they enrolled so I could not foresee their group because it had not been determined yet." (obtained via correspondence). However, "Due to low accrual and anticipation of the ending of the enrolment period, the last three patient/caregiver dyads were not randomized and were enrolled directly into the intervention group." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Due to the nature of the intervention, blinding of patients to the treatment or control group was not possible. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | It is unclear who carried out the assessments, and whether they were blinded, but it is likely that is was the neuropsychologist, master’s level behavioural therapist or master’s level psychology study personnel that had been involved in delivering the intervention. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Similar reasons between groups for missing data. "Most patients did not return at that time for in‐person follow‐up…so most patients did not complete the R‐BANS at follow‐up." |
Selective reporting (reporting bias) | Low risk | All outcomes reported. |
Other bias | Low risk | None. |