Wakefield 2016.
Methods | Randomised controlled trial | |
Participants |
Inclusion criteria: parents of children who had finished cancer treatment were eligible if they: had a child aged ≤ 15 who had completed cancer treatment with curative intent in the past 5 years; were able to read English; were able to access the Internet in a private location. Exclusion criteria: parents could not participate if they: had insufficient English skills; were experiencing extreme anxiety or depression; endorsed current symptoms of psychosis or substance abuse; had a child who was on active treatment, had relapsed, or was in palliative care Number randomised: 56 consented and randomised (before baseline), 9 dropped out before baseline assessment. 25 intervention group; 22 control group. Follow‐up: baseline, 2 weeks, 6 months Setting: children's hospital in Australia |
|
Interventions |
Intervention group: Cascade is a manualised programme consisting of 3 weekly 120‐minute online sessions delivered by a psychologist through WebEx. Driven by the theoretical models, Cascade targets intra‐ and interpersonal psychological processes important to adaptation in the context of illness (e.g. acceptance of uncertainty; practical problem solving; mobilising social support resources). CBT strategies were used to target these core mechanisms of change. Topic areas were derived from a previous study (but not specified in paper). After each session, parents would get homework assignments to practice. Control group: waiting list control group, parents could participate in Cascade intervention after 6 months. |
|
Outcomes |
|
|
Notes | 28% neuro‐oncology (47 participants; 25 intervention group, 22 control group. In total, 13 caregivers of brain tumour patients were included). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Independent personnel used an electronic randomiser to allocate participants to Cascade or waiting list. |
Allocation concealment (selection bias) | Low risk | Independent personnel used an electronic randomiser to allocate participants to Cascade or waiting list. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible due to nature of intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The statistician remained blinded until all analyses were completed. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Only participants with all 3 assessments completed were included in analysis of psychosocial outcomes (17% dropout at 6 months in intervention group; 27% dropout in waiting list control group). Unclear what reasons were. |
Selective reporting (reporting bias) | Unclear risk | There was no published study protocol. All outcomes in the manuscript were reported on. |
BPI: Brief Psychological Intervention; CBT: cognitive behavioural therapy; COPE: Creativity, Optimism, Planning, Expert Information; EORTC BN20: European Organization for Research and Treatment of Cancer Brain Cancer Module; EQ‐5D: EuroQol; MOS: Medical Outcome Study; NEO: Neuroticism‐Extraversion‐Openness; QoL: quality of life; SF‐36: 36‐item Short Form; WHO: World Health Organization.