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. 2016 Sep 21;2016(9):CD005001. doi: 10.1002/14651858.CD005001.pub3

Mock 2004.

Methods RCT, 2 groups
Study start and stop dates: Potential participants were identified between 1998 and 2001
 Length of intervention: 6 weeks to 6 months, depending on the duration of the adjuvant therapy
Length of follow‐up: end of intervention
Participants 119 breast cancer patients, stages 0 to III, after surgery, receiving chemotherapy or radiotherapy, sedentary
Interventions Intervention (n = 60): aerobic training (walking), self directed, 50% to 70% HRmax, 15 min per session, increased to 30 min as training progressed, 5 to 6/x week. Radiotherapy: 6 weeks exercise; chemotherapy: 3 to 6 months exercise.
Control (n = 59): usual care
Outcomes
  • fatigue: PFS

  • physical performance: 12‐minute walk test

  • physical activity: Physical Activity Questionnaire (PAQ)

  • symptoms: Symptom Assessment Scales


Outcomes measured at: baseline and end of the adjuvant therapy/intervention
Notes Funding: FIRE (Fatigue Initiative in Research and Education) multi‐institutional award from the Oncology Nursing Society Foundation
Conflict of interest: Not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomisation
Allocation concealment (selection bias) Low risk Consecutively numbered, sealed, opaque envelopes, opened after baseline testing
Blinding of participants 
 All outcomes High risk Not done
Blinding of personnel/care providers 
 All outcomes High risk Not reported
Comment: probably not done
Blinding of outcome assessment (detection bias) 
 Fitness outcomes High risk Not reported
Comment: probably not done
Blinding of outcome assessment (detection bias) 
 All outcomes except fitness outcomes High risk Self reported items
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Drop‐out:
  • Intervention group: 6/60 (10%)

  • Control group: 5/59 (8.5%)


All participants 11/119 (9.2%)
Reported both ITT and per‐protocol analysis
Selective reporting (reporting bias) Unclear risk No study protocol published
Group similarity at baseline Low risk No significant differences
Adherence High risk Not adherent: 15/54 (28%). 72% were adherent in the sense of the studies' definition (85% of minimum prescription)
Contamination High risk Contamination: 21/54 (39%) of the control group were exercising