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. 2020 Jun 2;2020(6):CD007568. doi: 10.1002/14651858.CD007568.pub2

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
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
Outcomes
  • Psychological symptoms ‐ depression, psychological adjustment

  • Impact on quality of life/functioning ‐ service use


Methods for assessing outcomes:
  • Centre for Epidemiologic Studies Depression Scale (CES‐D) (α = 0.89 in this study)

  • Derogatis Psychosocial Adjustment to Illness Scale ‐ self‐report (PAIS‐SR) (α = 0.82 in this study)

  • Expenditures for Health and Social Service Utilisation Questionnaire

  • Jalowiec Coping Scale (JCS) (α = 0.88 and 0.94 for total scores; α = 0.70 for 7 of the subscales in this study)

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