| Methods |
Study design: single‐centre RCT Number randomised: 330; 109 to intervention tailored‐print, 110 to intervention targeted‐print, 111 to control Study start: October 2010; stop date: October 2013 Length of intervention: 3 months Length of follow‐up: at 4 and 10 months post intervention Country: Australia |
| Participants |
Age, years, mean (range):
Stage, n (%):
Intervention tailored‐print: stage 0, 3 (2,9); stage I, 27 (26.5); stage II, 32 (31.4); stage III, 23 (22.6); stage IV, 2 (1.9); stage unknown, 15 (14.7)
Intervention targeted‐print: stage 0, 3 (2,8); stage I, 22 (20.8); stage II, 45 (42.5); stage III, 20 (18.8); stage IV, 1 (0.9); stage unknown, 15 (14.5)
Control: stage 0, 1 (0.9); stage I, 25 (23.4); stage II, 36 (33.6); stage III, 26 (24.3); stage IV, 3 (2.8); stage unknown, 16 (14.9)
Inclusion criteria: • Female breast cancer survivors over the age of 18 • Finished “active” cancer treatment (defined as surgery, chemotherapy, and/or radiotherapy) • Could read and write in English Exclusion criteria: • Not reported |
| Interventions |
330 participants assigned to 2 different physical activity behavioural change interventions:
Intervention tailored‐print: Participants received 3 social cognitive theory‐based computer‐tailored A4 4‐page newsletters over a 12‐week period (6 weeks apart). Newsletters were iteratively tailored via personal physical activity and demographic, psychosocial, and health‐related information derived from individual assessments at baseline; and physical activity and goal‐setting information derived from "update cards", which were sent to participants via mail at 4 weeks and 8 weeks post baseline. If participants’ update cards were not returned within 2 weeks, newsletters were printed without iterative physical activity and goal‐setting feedback. A recommendation was provided to engage in aerobic PA of at least moderate intensity for 30 minutes or longer most days of the week. Participants were also encouraged to perform resistance training exercises 1 to 3 times per week. However, no specific instructions for resistance training exercises were provided.
IBntervention targeted‐print: Participants received a copy of the 54‐page (A5) theory of planned behavior‐based booklet Exercise for Health: An Exercise Guide for Breast Cancer Survivors, which has been evaluated in a previous study. We made minor changes to the guidebook to adapt it for an Australian audience (e.g. substituting photos and text related to snow). A recommendation was provided to engage in aerobic PA of at least moderate intensity for 30 minutes or longer most days of the week. Participants were also encouraged to perform resistance training exercises (at least 6 exercises) 1 to 3 times per week. However, no specific instructions for resistance training exercises were provided.
Adherence:
Intervention tailored‐print: change in % meeting aerobic guidelines (150 minutes/week) at 4 months vs baseline, +23.9%; mean (SD) resistance exercise score (sessions*exercise) at 4 months: 13.5 (27.0)
Intervention targeted‐print: change in % meeting aerobic guidelines (150 minutes/week) at 4 months vs baseline, +12.5%; mean (SD) resistance exercise score at 4 months: 10.9 (27.4)
111 participants assigned to control:
|
| Outcomes |
Primary outcome:
Other outcomes:
Adherence to meeting PA guidelines for aerobic (150 minutes of aerobic activity over at least 5 days of the week) and resistance‐based (1 session per week containing at least 6 exercises, based on the lower suggested threshold) activity, calculated on the basis of participants’ self‐reported PA
Mean daily steps assessed via at least 3 days of pedometry and a step count diary
Self‐reported sitting time measured with a validated 5‐item scale assessing sitting time across 5 different domains on a weekday and on a weekend day
Health‐related quality of life measured by FACT‐B version 4
Fatigue measured via the FACIT‐Fatigue scale
Numbers of participants assessed:
Intervention tailored‐print: baseline, 109; at 4 months, 98
Intervention targeted‐print: baseline, 110; at 4 months, 97
Control: baseline, 111; at 4 months, 104
Adverse events: not reported |
| Notes |
Trial registration link: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611001061921 Trial authors contacted: no Intention‐to‐treat analysis: yes, but LOCF Funding: funded by the Cancer Institute New South Wales Research Scholar Award (10/RSA/1‐27 ‐ Trial ID in Australian New Zealand) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"computer‐generated block randomisation sequence" |
| Allocation concealment (selection bias) |
Low risk |
Sequence "implemented in a blinded fashion by an administrative assistant not involved in the project" |
| 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 |
Low risk |
"All project team members were blinded to this process until allocation was complete". |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Inappropriate handling of missing data in the analyses; "primary analysis was conducted using all observed data, and sensitivity analyses using the baseline observations carried forward approach were conducted to explore the impact of missing data" |
| Selective reporting (reporting bias) |
Low risk |
No selective reporting of outcomes is apparent. |
| Other bias |
Low risk |
Trial appears to be free of other problems that could put it at high risk of bias. |