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

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)
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)
Outcomes
  • Psychological symptoms ‐ depression

  • Fatigue

  • Impact on quality of life/functioning ‐ stress, positive and negative effects


Methods for assessing outcomes:
  • Center for Epidemiologic Studies Depression Scale (CES‐D)

  • Multi‐dimensional Fatigue Inventory (MFI)

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