Badger 2005.
| Study characteristics | ||
| Methods |
Setting: academic cancer centres and urban private oncology offices in Arizona, USA Recruitment: eligible women had a diagnosis of stage I‐III breast cancer, were receiving adjuvant treatment, were able to speak English and talk on the telephone, were married, and had a partner, who were also willing to take part in the intervention and were employed at the time of the study. Participants were recruited from a local cancer centre, oncologists' offices, and support groups, and through self‐referral after reading brochures displayed in the various settings Randomisation: pilot quasi‐randomised controlled trial (experimental with repeated measures) |
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| Participants | 48 women in their mid‐50s with breast cancer | |
| Interventions |
Intervention: telephone interpersonal counselling (TIP‐C). Based on theories of interpersonal therapy and cancer education. Participants received 6 weekly telephone calls × 30 minutes (approximately) while they were undergoing treatment for breast cancer. Sessions focused on cancer education, interpersonal role disputes, social support, awareness, management of depressive symptoms, and role transitions. Partners of participants received 3 telephone‐delivered TIP‐C sessions (weeks 1, 3, and 5) during the same 6‐week period as the women. These sessions also focused on issues such as cancer education, role disputes, role transitions, and social support
Control group: participants in the usual care arm received a resource list about cancer and brief, focused telephone calls (6 for women and 3 for their partners × 5 to 10 minutes) to inquire about general well‐being and to answer general questions (no counselling) Interventionist: nurse counsellors (master's prepared clinical nurse specialists in psychiatric/mental health nursing who had additional oncology training) |
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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) | High risk | Pilot study, quasi‐randomised sample |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding (performance bias and detection bias) All outcomes | High risk | It is unclear if study participants were blinded. Interveners were not blinded. It is unclear who collected the data and by what method |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attrition is not reported |
| 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 |