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  • br Methods br This was a two arm waiting list

    2019-11-12


    Methods
    This was a two-arm waiting list randomised control trial and cost-consequence analysis conducted in accordance with the Consolidated Standards of Reporting Trials.24 The trial ran in accordance with the study protocol which has been published previously.25 This study also included an embedded process evaluation, the results of which are reported separately.
    The Move More Pack
    UK charity Macmillan Cancer Support (Macmillan) developed a printed resource in 2011 called the Move More Pack that Pimozide aimed to effect change in the physical activity of UK cancer survivors regardless of tumour site or cancer status. The principal investigator led the redevelopment of the Move More Pack in 2016 using guidance from the UK Medical Research Council on developing and evaluating complex interventions.26
    The original Move More Pack was reviewed using the constructs of the Theory of Planned Behaviour (TPB),27 the Social Cognitive Theory (SCT)28 (as the most used causal the-ories of behaviour change)29,30 and the Behaviour Change Technique Taxonomy, version 1 (BCTTv1)31 to highlight areas for improvement. A group of six subject experts, representa-tives from Macmillan, and four cancer survivors developed the intervention content, which was awarded the National Health Service (NHS) England Information Standard.32
    The resulting intervention consisted of a series of printed components and Internet tools (the Internet tools are avail-able at www.macmillan.org.uk/BeActive; examples of the
    printed components have been published previously)25 and e-newsletters influenced by the stage of physical activity behaviour change model33 with content tailored by prediag-nosis levels of physical activity, age and gender. Supplementary file 1 presents detail of the Move More Pack (printed components and Internet tools) including the asso-ciated constructs of the SCT, the TPB and the BCTs used. Supplementary file 2 presents the components of the e-newsletters including the associated stage of physical activity behaviour change and the BCTs used.
    Recruitment and randomisation
    Participants were recruited by email invitation sent to 8910 UK cancer survivors on the 29th of March 2017, contacts held by Macmillan who had engaged with the charity within the previous six months. A separate invitation was also posted on the charity's Facebook page on the 3rd and 24th of April 2017 (it was not possible to assess the number of cancer survivors who viewed these Facebook posts).
    In total, 1019 cancer survivors expressed an interest in the study and were informed that the study was investigating the impact of health promotion information on lifestyle behav-iours; no specific reference was made to physical activity.
    Participants were randomised by the principal investi-gator using simple randomisation to receive a standard letter recommendation in the mail (control) (supplementary file 3), or a letter (supplementary file 4) plus the Move More Pack (intervention) in the mail with signposting to the Internet tools. The study aimed to recruit 99 participants to each arm of the study; the sample size calculation is published elsewhere.25
    Adult participants (aged 18 years and above) who could read English, provide consent and were computer and Internet literate with a working email account were included regardless of cancer status or type. Digital consent was ob-tained after guidance from the British Psychological Society ethics guidance for Internet-mediated research.34
    The Move More Pack did not prescribe physical activity rather Unequal crossing-over aimed to empower cancer survivors to increase control over their physical activity behaviour and to be active on their own terms. The relevant safety information was sent as part of the standard letter recommendation and the Move More Pack in the mail to participants at the start of the study. The safety information had received the NHS Infor-mation Standard.32 However, some cancer survivors require medical advice and approval before becoming more physi-cally active. A screening questionnaire, based on guidance for exercise and cancer survivorship from the American College of Sports Medicine35 and reviewed and approved by subject experts from Macmillan's physical activity team, identified and screened out those requiring medical guid-ance and approval before becoming physically active; the questions included within the screening questionnaire are published elsewhere.25