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

Badger 2007.

Study characteristics
Methods Setting: Arizona, USA (not specified)
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, had no physical or psychological disabilities, and had a partner who was available and willing to take part in the intervention. 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: 3‐arm RCT
Participants 96 women with breast cancer and their supportive partners
Interventions Intervention: participants and their partners were randomised to receive 1 of 3 programmes: (1) telephone interpersonal counselling (TIP‐C); (2) self‐managed exercise (SE); or (3) attention control (AC). In the TIP‐C arm, participants received 6 × weekly calls, which consisted of cancer education, social support, and awareness and management of depressive and anxiety symptoms. Partners received 3 × calls (every other week of the intervention) to discuss their well‐being and relationship. Participants in the SE arm also received 6 × weekly calls. The calls encouraged participants to exercise and recorded information about progress and intensity of exercise. The SE partners also received calls every other week to encourage exercise and to track progress
Control group: the AC group received printed information about breast cancer and 6 brief weekly calls. Their partners received 3 biweekly calls during the same period. The calls averaged 7 minutes in duration. If these participants reported any problems, they were directed to the primary physician. No counselling or encouragement to exercise was offered
Interventionist: psychiatric nurse counsellors
Outcomes
  • Psychological symptoms ‐ depression, anxiety


Methods for assessing outcomes:
  • Center for Epidemiologic Studies Depression Scale (CES‐D) (α ≥ 0.85)

  • Investigator‐designed survey devised from parts of the Positive and Negative Affect Schedule (PANAS), 1 item from the Short Form‐12 (SF‐12) Scale, and 3 items from the Index of Clinical Stress Scale (ICS) (in this study, α = 0.91, 0.89, 0.88 for breast cancer participants; and 0.89, 0.88, and 0.91 for partners at T1, T2, and T3, respectively)

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 Low risk The trial appears to be free of other problems that could put it at high risk of bias