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

Allard 2007.

Study characteristics
Methods Setting: 5 regional centres in different geographic areas in Quebec, Canada
Recruitment: eligible women were over the age of 18, were French speaking, and were diagnosed with primary breast cancer or a suspected lesion. They were scheduled to undergo day surgery and had no hearing impairment and no access to a phone at home. Staff nurses identified eligible patients who were given a pamphlet describing the study and subsequently, if willing to participate, were telephoned by a member of the research team
Randomisation: randomised clinical block trial
Participants 117 women with breast cancer aged 18 years or older
Interventions Intervention: based on self‐regulation theory, which emphasises concrete objective information and regulation of emotional and functional processes to achieve optimal coping. Comprising 2 telephone sessions delivered weekly for 2 weeks during the immediate postoperative period. In each session, participants were asked to identify and describe symptoms in concrete terms. Actions taken by women to manage each symptom were rated according to their effectiveness from 1 to 5 (1 = not effective, 5 = very effective). Effective actions were encouraged; ineffective actions were explored and women encouraged to find other, potentially helpful, actions. The interventionist suggested new or additional self‐care strategies and acknowledged feelings expressed by women during the call
Control group: usual care consisting of perioperative teaching and a follow‐up phone call within 24 hours of discharge from the hospital
Interventionist: the intervention was delivered by the principal investigator, who is a trained nurse
Outcomes
  • Psychological symptoms ‐ emotional distress

  • Impact on quality of life/functioning ‐ functional status


Methods for assessing outcomes:
  • Profile of Mood States Short Form (POMS‐37) (α0.75‐0.94)

  • Symptom Impact Profile (SIP); subscales 'recreation and pastimes' and 'home management'

Notes Some participants may have already started adjuvant hormonal therapies when recruited for this study
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The research assistant randomly allocated the women with or without axillary node dissection to the experimental or control group at each site using a table of random numbers
Allocation concealment (selection bias) Unclear risk The method of concealment is not described; however, the research assistant allocated participants using a table of random numbers, and the research assistant did not perform the intervention. Detection bias may exist, as it is unclear if the intervener or the research assistant collected the data
Blinding (performance bias and detection bias)
All outcomes High risk Owing to the nature of the intervention, study participants were not blinded. It is unclear who collected the data and by what method
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Attrition rate is reported. Reasons for attrition are not reported
Selective reporting (reporting bias) Low risk There appears to be no selective reporting of outcomes
Other bias Unclear risk The process of screening was reliant on staff nurses identifying participants at the doctor's office. It is unclear if all eligible participants were approached; some bias may exist, as these staff nurses may have excluded or not approached participants for many reasons