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

Yates 2005.

Study characteristics
Methods Setting: Melbourne and Brisbane, Australia
Recruitment: eligible patients were aged 18 years or older, had stage I or II breast cancer, were commencing adjuvant chemotherapy, and had an Eastern Cooperative Oncology Group performance rating of 1or 2; their haemoglobin level was at least 11.6 g/mL. Participants were recruited from 5 outpatient clinics at 3 major metropolitan hospitals
Randomisation: RCT
Participants 109 women aged 18 years or older with breast cancer
Interventions Intervention: psycho‐educational intervention aiming to improve participants' knowledge and skills to enable them to perform self‐care behaviours designed to minimise fatigue. Consisted of 3 sessions tailored to participants' individual needs and circumstances. The first session consisted of a 20‐minute face‐to‐face meeting in the clinic at the participant's second chemotherapy course, and focused on techniques of information‐giving, problem‐solving, rehearsal, and reinforcement. The second and third sessions were delivered by telephone, were conducted a week apart, and lasted 10 minutes each. In these sessions, participants' fatigue management strategies were reviewed. Printed information supplemented the face‐to‐face/telephone interactions
Control group: participants received general cancer education in the form of verbal and printed information about cancer in sessions equivalent in number and timing to the sessions provided to the intervention group
Interventionist: oncology nurses trained in the research programme and in the fatigue management or control intervention
Outcomes
  • Psychological symptoms ‐ anxiety, depression, self‐efficacy with coping with cancer

  • Fatigue ‐ use of fatigue‐management behaviours, confidence with managing fatigue, fatigue intensity, and impact

  • Impact on quality of life/functioning ‐ quality of life


Methods for assessing outcomes:
  • Investigator‐designed questionnaire based on elements from the Revised Piper Fatigue Scale (RPFS)

  • Functional Assessment of Cancer Therapy ‐ Fatigue (FACT‐F)

  • 30‐item European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (version 3)

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomly assigned to intervention or control conditions through a central telephone system via computer‐generated random numbers
Allocation concealment (selection bias) Low risk Group allocation was concealed from research assistants involved in recruitment and in baseline and follow‐up assessments
Blinding (performance bias and detection bias)
All outcomes Unclear risk Not stated
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
Other bias Low risk The trial appears to be free of other problems that could put it at high risk of bias

CBT: cognitive‐behavioural therapy.

ECOG: Eastern Cooperative Oncology Group.

GP: general practitioner.

RCT: randomised controlled trial.

SIGN: Scottish Intercollegiate Guidelines Network.

TAU: treatment as usual.