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

Hayes 2013 Tel.

Methods RCT, 3 groups
Study start and stop dates: recruitment between October 2006 and June 2008
 Length of intervention: 8 months
 Length of follow‐up: 8 weeks after end of the intervention
Participants 194 breast cancer patients, of which 142 underwent adjuvant therapy concurrently with the exercise intervention (unpublished data for these patients used in the analyses of this review)
Interventions Intervention group 1: 'Hayes 2013Tel' Telephone (n = 50) ‐ incorporating both aerobic and strength‐based exercises
Intervention group 2: 'Hayes 2013 FtF' Face to face (n = 51) ‐ incorporating both aerobic and strength‐based exercises
Control group (n = 41): usual care
Outcomes Primary outcome:
  • Cancer site‐specific QoL: Functional Assessment of Cancer Therapy‐Breast (FACT‐B+4) ‐ for patients with breast cancer and lymphoedema


Secondary outcomes:
  • Subjective upper body function: DASH

  • Upper body function, clinically measured: strength and endurance test

  • Fatigue: FACIT‐F

  • Menopausal symptoms: Greene Climacteric Scale

  • Neuropathic pain: Neuropathic Pain Scale

  • Cardiorespiratory fitness: 3‐min step test

  • Lymphoedema status: bioimpedance spectroscopy (L‐Dex score)

  • Minutes of physical activity per week (Active Australia Survey)

  • Body composition: BMI


Outcomes measured at: 6 months, 12 months
Notes Funding: This research project was supported by the National Breast Cancer Foundation. The research positions of SH and EE are supported via an NBCF Early Career Research Fellowship and an NHMRC Senior Research Fellowship, respectively.
Conflict of interest: Authors declare that they have no conflict of interest.
Registered at ACTRN: 012606000233527
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Individually computer‐generated non‐blocked
Allocation concealment (selection bias) Unclear risk Not reported
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 Low risk "assessors blinded to group allocation"
Blinding of outcome assessment (detection bias) 
 All outcomes except fitness outcomes High risk All outcomes except outcomes with clinical assessment: self reported items
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Drop‐out: all participants
  • Face‐to‐face intervention group: 6

  • Telephone intervention group: 4

  • Usual‐care group: 4


All participants: 14/194 (7.2%)
Comment:
For the 142 participants undergoing adjuvant therapy:
More than 20% drop‐out for 3‐min step test (cardiorespiratory fitness)
High risk for cardiorespiratory fitness
ITT analysis, no imputation of data
Selective reporting (reporting bias) Low risk Registered prospectively
Group similarity at baseline High risk Slight imbalance in numbers, place of treatment (public vs private hospital), and rates of mastectomy between groups following randomisation. Rate of mastectomies higher in telephone group. This group has the biggest difference in QoL
Adherence High risk 25% did not meet the intervention goal at mid‐ or postintervention and did not increase their total physical activity by 30+ min (a priori deemed clinically relevant) between baseline and mid‐ or postintervention
Contamination High risk The Active Australia Survey showed that the usual‐care group was more active (more minutes per week) than the FtF group and as active as the Tel group at 6 months. At 12 months, the usual‐care group was more active than the FtF group and less active than the Tel group