Downe‐Wamboldt 2007.
| Study characteristics | ||
| Methods |
Setting: academic cancer centre, Canada Recruitment: eligible participants were 50 years or older, had surgery within the past 3 months, were receiving care from the Academic Clinic's Oncology Program, were living within 200 km of the academic clinic, had access to a telephone, were aware of their diagnosis, understood English, and were able to provide informed consent. Women with breast cancer stage I or II who had a lumpectomy or a mastectomy were eligible, as were men with prostate cancer stage T1 or T2M0 who had had a radical prostatectomy, and individuals with small cell lung cancer stage I, II, or IIIA. Patients receiving chemotherapy were excluded. Participants were recruited from the offices of private surgical oncologists and urologists and site‐specific clinics (breast, lung, and prostate) at an academic cancer centre clinic Randomisation: RCT |
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| Participants | 175 men or women aged 50 years or older with breast, lung, or prostate cancer | |
| Interventions |
Intervention: individualised telephone problem‐solving counselling based on cognitive‐behavioural principles. A series of counselling sessions were offered at participants' convenience over 3 months. Collaborative in nature; the participant and the interventionist worked together to define participant concerns, identify solutions, and evaluate consequences of these solutions Control group: usual care, including diagnostic and follow‐up care at 3‐month intervals Interventionist: nurse counsellor |
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| Outcomes |
Methods for assessing outcomes:
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participants were randomised to groups using concealed random computer‐generated numbers that randomly blocked after every second and fourth subject to ensure equivalent numbers of subjects in both arms of the trial |
| Allocation concealment (selection bias) | Low risk | Participants were randomised to groups using concealed random computer‐generated numbers that randomly blocked after every second and fourth subject to ensure equivalent numbers of subjects in both arms of the trial |
| Blinding (performance bias and detection bias) All outcomes | High risk | Owing to the nature of the intervention, participants and personnel were not blinded to the intervention |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up < 20%; similar reasons between groups |
| Selective reporting (reporting bias) | Low risk | There appears to be no selective reporting of outcomes |
| Other bias | Low risk | The trial appears to be free of other problems that could put it at high risk of bias |