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

Badger 2013b.

Study characteristics
Methods Setting: Arizona, USA (not specified)
Recruitment: eligible women had a diagnosis of stage I‐III breast cancer, were receiving adjuvant treatment, spoke Spanish or English, had no physical or psychological disabilities, had access to a telephone, and had a supportive partner (SP) who was available and willing to take part in the intervention. Eligible SPs were 21 years of age or older, spoke Spanish or English, had no physical or psychological disabilities, and had access to a telephone. Participants were recruited from a local cancer centre, oncologists' offices, and support groups, and through self‐referral
Randomisation: RCT (3‐wave repeated measure with a between‐subjects factor)
Participants 90 Latina women with breast cancer and their supportive partners
Interventions Intervention: women and their supportive partners were randomly assigned to 1 of 2 interventions: (1) telephone interpersonal counselling (TIP‐C), or (2) telephone health education (THE). The TIP‐C intervention addressed mood and affect management, emotional expression, interpersonal communication and relationships, social support, and cancer information. Participants received 8 weekly phone calls × 30 minutes (approximately) in their preferred language (Spanish or English), and their SPs received 4 sessions every other week. Interventions were tailored to the cultural values and beliefs of participants
Control group: participants in the THE group also received 8 weekly phone calls in their preferred language (Spanish or English), and their SPs received 4 biweekly sessions. The THE focused on normal breast health and breast cancer, routine tests for diagnosis and prevention and associated terminology, treatment, side effects of treatment and strategies to combat these side effects, lifestyle interventions such as nutrition and physical activity, and referrals and resources
Interventionist: bilingual, bicultural master’s‐prepared social workers
Outcomes
  • Psychological symptoms ‐ depression, anxiety

  • Fatigue

  • Physical symptoms ‐ symptom distress

  • Impact on quality of life/functioning ‐ social well‐being, spiritual well‐being, psychosocial resources of cancer knowledge, and social support


Methods for assessing outcomes:
  • Center for Epidemiologic Studies Depression Scale (CES‐D) (α ≥ 0.86 for participants and SPs at all 3 time points)

  • Multi‐dimensional Fatigue Inventory (α ≥ 0.82 for participants and SPs)

  • General Symptom Distress Scale (α ≥ 0.66 for participants and SPs)

  • State version of the State‐Trait Anxiety Inventory (α ≥ 0.86 for participants and SPs)

  • Quality of Life Breast Cancer Instrument; 8‐item social well‐being subscale (α ≥ 0.65 for participants and SPs) and 8‐item spiritual well‐being subscale (α ≥ 0.55 for participants and α ≥ 0.77 for SPs)

  • Investigator‐designed cancer knowledge instrument

  • Perceived social support ‐ family (α ≥ 0.89 for participants and SPs)

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 not clear whether participants were blinded to group. Interveners were not blinded. It is unclear who collected the data and by what method
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 Unclear risk Participants received $20 for completing assessments