Barsevick 2010.

Study characteristics
Methods	Setting: 2 university health centres, a community cancer centre, and a comprehensive cancer centre in Philadelphia, USA Recruitment: eligible patients were 18 years of age or older and were beginning a new chemotherapy regimen with at least 2 drugs administered intravenously in a cyclical manner for breast, lung, colorectal, prostate, gynaecological, bladder, or testicular cancer or lymphoma. Prior treatment other than surgery had to be completed at least 1 month previously, and the individual could receive concurrent radiotherapy. Participants had to be able to read and write English. Individuals were excluded if they were having marrow or stem cell transplantation, interleukins, interferons, or tumour necrosis factor; had chronic fatigue syndrome; were being treated for diagnosed sleep disorder; were enrolled in another study involving a psycho‐educational intervention; had a communication impairment; had overt evidence of psychiatric disorder; or had initiated treatment for anaemia or depression in the past 3 weeks. Potential participants were approached by telephone or in the clinic, and the study was explained Randomisation: RCT. Participants were stratified by diagnosis (breast cancer vs non‐breast cancer) at each site and then were randomly assigned to intervention or control group
Participants	292 men and women aged 18 years or older with various cancers
Interventions	Intervention: The EASE intervention is based on the Common Sense Model and includes providing information about fatigue and sleep disturbance, coping skills training, and appraisal of used coping strategies. Participants received 3 telephone sessions during the second, third, and fourth weeks after the first chemotherapy treatment. Participants also received a handbook with information about symptoms and examples of energy conservation and sleep management strategies. Between sessions 1 and 2, participants completed a daily diary of their symptoms and sleep patterns, as well as a priority list of usual activities Control group: attention control consisting of information about nutrition and a healthy diet. Participants kept a dietary record for 24 hours in preparation for session 2. The 3 control sessions were equivalent to the intervention session in terms of the amount of time spent with the individual Interventionist: research nurse
Outcomes	Psychological symptoms ‐ depression Fatigue Physical symptoms ‐ pain, sleep disturbance Impact on quality of life/functioning ‐ functional status Method of assessing outcome measures: General Fatigue Scale (GFS) (α = 0.92 for this sample) Profile of Mood States (POMS) ‐ fatigue subscale (α = 0.94 for this sample) Pittsburgh Sleep Quality Index (PSQI) (α = 0.75 for this sample) Octagonal Basic Motion Logger Actigraph (measures sleep‐wake and activity‐rest patterns) Morin Sleep Diary (α = 0.83 to 0.99 for this sample) Brief Pain Inventory (BPI) (α = 0.92 for this sample) Profile of Mood States (POMS) ‐ depression subscale (α = 0.90 for this sample) Side Effect Checklist (SCL) (α = 0.87 for this sample) Brief Pain Inventory (BPI) ‐ adapted to apply to symptoms rather than to pain only SF‐12 Eastern Cooperative Oncology Group Performance Status
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random assignments were generated by the statistician
Allocation concealment (selection bias)	Low risk	Random assignments were generated by the statistician and placed in sealed envelopes that were numbered and selected sequentially for each stratification group
Blinding (performance bias and detection bias) All outcomes	High risk	It is unclear 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