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

Badger 2013a.

Study characteristics
Methods Setting: Arizona, USA (not specified)
Recruitment: eligible women had a diagnosis of breast cancer, were currently receiving treatment, were at least 21 years of age, had access to a telephone, and had a supportive partner (SP) who was available and willing to take part in the intervention. SPs were not restricted to spouses. Participants were recruited from a local cancer centre, oncologists' offices, and support groups, and through self‐referral
Participants 52 women with breast cancer and their supportive partners
Interventions Interventions: women and their supportive partners were randomly assigned to 1 of 3 interventions: (1) telephone health education (THE), (2) telephone interpersonal counselling (TIC), or (3) videophone interpersonal counselling (VIC). All participants received 8 weekly telephone calls of 30 minutes in their preferred language (English or Spanish), and their SP received 4 biweekly sessions. Participants in THE received leaflets on breast cancer terminology, treatments, side effect management, nutrition, physical activity, and resources. These materials were reviewed with participants and SPs over the telephone. Participants in the TIC and VIC arms received counselling via video or telephone, which addressed mood and affect management, emotional expression, interpersonal communication, relationships with family and providers, social support, and referral to support service as required
Interventionist: an information specialist provided THE; TIC and VIC were provided by a social worker
Outcomes
  • Depression

  • Symptom distress

  • Social well‐being

  • Spiritual well‐being


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

  • General Symptom Distress Scale (GSDS)

  • Social Well‐Being Scale

  • Spiritual Well‐Being Scale

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The generation of random sequence is not described
Allocation concealment (selection bias) Unclear risk Not stated
Blinding (performance bias and detection bias)
All outcomes High risk It is unclear if participants were blinded to group. Interveners were not blinded
Incomplete outcome data (attrition bias)
All outcomes High risk Over 20% loss to follow‐up; significantly higher attrition in the THE group compared to the TIC or VIC group
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