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

Barsevick 2004.

Study characteristics
Methods Setting: a university health science centre in Utah and a comprehensive cancer centre in Philadelphia, USA
Recruitment: eligible participants spoke English; were beginning curative or local control treatment for breast, lung, colorectal, advanced prostate, gynaecological, or testicular cancer; and planned to receive at least 3 cycles of chemotherapy, 6 weeks of radiotherapy, or concurrent chemotherapy and radiotherapy. Prior treatment other than surgery had to be completed at least 1 month previously. Participants were excluded if they were having stem cell transplantation, interleukins, interferons, or tumour necrosis factor; had chronic fatigue syndrome; were enrolled in another study involving a psycho‐educational intervention; had overt evidence of psychiatric disorder; or had initiated treatment for anaemia or depression in the past 3 weeks
Randomisation: RCT
Participants 396 men and women with various cancer diagnoses
Interventions Intervention: the Telephone Energy Conservation and Activity Management (ECAM) intervention was based on the Common Sense Model, which guided participants through 3 stages of information‐processing to help them manage cancer‐related fatigue. The intervention consisted of 3 weekly telephone sessions commencing at the beginning of chemotherapy treatment or at week 3 to 5 during radiation therapy. Session 1 consisted of coping skills training. Participants kept a journal and prioritised their usual activities. During session 2, participants were assisted to develop a care plan to minimise the interference of fatigue. In session 3, participants appraised and revised the plan. Sessions 1 and 2 each lasted 30 minutes, and session 3 lasted 15 minutes
Control group: attention control consisting of information about nutrition and a healthy diet. Participants kept a dietary record for 24 hours
Interventionist: research nurse
Outcomes
  • Psychological symptoms ‐ psychosocial well‐being

  • Fatigue

  • Impact on quality of life/functioning ‐ physical functioning


Methods for assessing outcomes:
  • Short Form of the Profile of Mood States Fatigue Scale (POMS‐SF) (α = 0.89 for this sample)

  • Schwartz Cancer Scale (SCFS) ‐ Physical Fatigue subscale (α = 0.97)

  • General Fatigue Scale (GFS) (α = 0.95)

  • Functional Performance Inventory (FPI) (α = 0.91 for this sample)

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 whether participants were blinded to group. Interveners were not blinded
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Loss to follow‐up and between‐group differences regarding reasons for it are unclear
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