Chambers 2014.
Study characteristics | ||
Methods |
Setting: community‐based; 2 large and well‐established state‐based Cancer Helplines in Australia Recruitment: eligible participants were adult patients and carers who called cancer information and support Cancer Helplines in 2 Australian states (Queensland and New South Wales). Patients and carers were independent callers and, therefore, were not a dyad. Study inclusion criteria included (a) having a score of 4 or greater on the Distress Thermometer, (b) being able to read and speak English, and (c) having no previous history of head injury and/or dementia. Individuals under current psychiatric care and those who presented with grief or bereavement were excluded. The Cancer Helpline operator offered callers who met selection criteria entry into the study at the time of the call Randomisation: randomised trial. Participants were randomised following completion of baseline measures. Randomisation was stratified by participant and carer and state |
|
Participants | 354 participants with various cancer diagnoses and 336 carers | |
Interventions |
Intervention: participants and carers randomised between (a) single nurse‐delivered telephone self‐management session and (b) 5 telephone CBT sessions delivered by a psychologist Both groups were provided a self‐management resource kit comprising:
|
|
Outcomes |
Method of assessing outcome measures:
|
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was stratified by participant and carer and state (Queensland vs New South Wales) and occurred in blocks of 10, with each condition randomly generated 5 times within each block to ensure an unpredictable allocation sequence with equal numbers of participants in each group at the completion of each block |
Allocation concealment (selection bias) | Low risk | Unpredictable allocation sequence was undertaken by the project manager and was concealed from investigators |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Project staff tracking assessments were blinded to treatment allocation |
Incomplete outcome data (attrition bias) All outcomes | High risk | Loss to follow‐up over 20%; loss to follow‐up considerably higher in the 5‐session psychologist‐delivered CBT sessions intervention group |
Selective reporting (reporting bias) | Low risk | Balanced reporting for all measures |
Other bias | Unclear risk | 93% completed the single‐intervention session with the nurse; only 53% completed all 5 sessions in the psychologist arm |