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. 2018 Jan 29;2018(1):CD011292. doi: 10.1002/14651858.CD011292.pub2

Baruth 2013.

Methods Study design: single‐centre RCT
Number randomised: 32; 20 to intervention, 12 to control
Study start: not reported; stop date: not reported
Length of intervention: 12 weeks
Length of follow‐up: to end of intervention
Country: USA
Participants Age, years (mean SD):
  • Intervention: 57.4 (6.1)

  • Control: 54.9 (6.5)


Stage, n (%):
  • Intervention: stage 0, 1 (7.1%); stage I, 5 (35.7%); stage II, 7 (50.0%); stage III, 1 (7.1%); missing, 6

  • Control: stage 0, 0 (0.0%); stage I, 5 (41.7%); stage II, 5 (41.7%); stage III, 0 (0.0%); missing, 2


Inclusion criteria:
• Given a diagnosis of stage I‐III cancer, had completed adjuvant treatment within the previous 12 months, and were postmenopausal
• Free of cardiovascular disease and major orthopaedic limitations
• Not regularly active (< 5 days/week)
Interventions 20 participants assigned to exercise intervention:
  • 12‐Week home‐based walking programme (3 to 5 days per week of 20 to 30 to 40 minutes at RPE 10 to 11 to 12 to 15 by week 8) using the Active Choices model developed and refined by King and colleagues. Primary purpose of the intervention was to increase walking. Participants received a brief (˜30 minutes) in‐person counselling session, followed by 5 short (10 to 15 minutes each) telephone counselling calls during weeks 1, 2, 4, 7, and 10.

  • Initial one‐on‐one counselling session focussed on goal setting and exercise safety. Subsequent counselling calls applied key constructs of the social cognitive theory, whereby the counsellor and participants discussed a specific behaviour change principle (e.g. social support, rewards) that participants could use to increase their walking.


Adherence:
  • On average, participants completed 86.2 ± 11.9% (range 62.1% to 100%) of prescribed walking sessions each week (missing logs were assigned zeros for the number of walking sessions completed during those particular weeks; data not shown).


12 participants assigned to control:
  • Usual care control group asked to maintain usual physical activity levels throughout the 12‐week study period. Study staff had contact with this group only at follow‐up appointments. Upon completion of the study, women in the usual care control group received baseline intervention counselling session, materials, and pedometer.


Contamination of control group: not reported
Outcomes Outcomes:
  • QoL assessed via 2 measures:

    • Medical Outcomes 36‐Item Short Form Health Survey (MOS SF‐36)

    • International Breast Cancer Study Group (IBCSG) QoL Core Questionnaire, breast cancer‐specific questionnaire, developed to measure the impact of adjuvant therapy on QoL. Questionnaire consists of 10 single‐item visual analogue scales, anchored at both ends with words describing highest and lowest extremes of item content.

  • 13‐Item subscale of the Functional Assessment of Cancer Therapy: Fatigue (FACT‐Fatigue) questionnaire used to assess fatigue

  • Completed 41‐item validated Community Health Activities Model Program for Seniors (CHAMPS) questionnaire


Numbers of participants assessed:
  • Intervention: baseline, 20; at 12 weeks, 18

  • Control: baseline, 12; at 12 weeks, 12


Adverse events: none reported
Notes Trial registration link: none available
Trial authors contacted: yes, for additional data (means and SDs for outcomes), but trial authors did not reply
Intention‐to‐treat analysis: no
Funding: supported by the US Army, Grant # DAMD17‐01‐1‐0628
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Participants were randomized 2:1 (intervention: control)".
It is unclear how the allocation sequence was generated.
Allocation concealment (selection bias) Unclear risk Whether treatment assignment was concealed from study personnel and participants was not described.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Owing to the nature of the intervention, it was not possible to conceal allocation to the intervention from participants.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Blinding of outcome assessments was not described.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Post‐test data at 12 weeks were collected on 94% of participants; only completers were analysed.
Selective reporting (reporting bias) High risk Physical activity data post intervention were not reported.
Other bias Low risk Trial appears to be free of other problems that could put it at high risk of bias.