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. 2017 Aug 24;2017(8):CD011152. doi: 10.1002/14651858.CD011152.pub2

Fiorentino 2008.

Methods Design: crossover‐experimental. Follow‐up: 6 and 12 weeks from baseline.
Participants Major inclusion criteria: Survivors of breast cancer who had finished their breast cancer treatment and met the DSM IV criteria for insomnia
N = 14 (E: 11, C: 10)
Mean age: 61 ± 11.6 years
Stage of breast cancer: Stage 1 (7), Stage 2 (3), stage 3 (2) and advanced stage 3 (2)
Interventions E: educational + psychology (behavioural)
Education + Psychology (behavioural): 1‐hour session per week for 6 week; educational component covered sleep stages, processes regulating sleep , sleep throughout life, sleep in cancer patients, Spielman et al.’s (1987) insomnia 3‐P model and cognitive behavioral therapy basics; psychological (behavioural) component included entailed sleep restriction, stimulus control, adhering to the sleep hygiene rules, and training in progressive muscle relaxation techniques; conducted by a graduate level therapist trained in CBT‐I, and supervised by a licensed clinical psychologist
 C: usual care
Outcomes Quality of life: SF‐36
Others: actigraphy, PSQI, ISI, Sleep Diaries, MFSI‐SF, FOSQ, CESD,BSI‐18, GCS
Notes C: comparison, E: experimental, SF‐36: Short Form (36) Health Survey ISI: Insomnia, PSQI: Pittsburgh Sleep Quality Index, ISI: Insomnia Severity Index, Severity Index, MFSI‐SF: Multidimensional Fatigue Symptom Inventory, FOSQ: Functional Outcomes of Sleep Questionnaire, BSI‐18: Brief Symptom Inventory, GCS: Greene Climacteric Scale.
Dropouts or missing data where reported:
5 in experimental and 2 in comparison lost to follow‐up
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants randomly assigned through a computer‐generated random list
Allocation concealment (selection bias) Unclear risk Study did not provide enough information to allow judgment as concealment was not described
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participants could be aware of allocated interventions since they had to go through the intervention. Study did not provide enough information to allow judgment whether personnel were blinded
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Participants could be aware of allocated interventions since they had to go through the intervention. Study did not provide enough information to allow judgment whether outcome assessors were blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 2 women dropped out, 1 reported study was too much and another realised in therapy that the root of her insomnia would be addressed with a more comprehensive psychotherapy addressing psychological events and traumas experienced in childhood
Selective reporting (reporting bias) Unclear risk Study protocol was not available. Study did not provide enough information to allow conclusion if all expected outcome measures were reported
Other bias High risk Sampling bias likely present as non‐probability sampling method used. Participation rate was about 58.3%