Trying Activity in Kidney Cancer Survivors (TRACKS) Trial: A Randomized Controlled Trial Comparing the Effects of Supervised Physical Activity Versus Supervised Physical Activity Plus Behavioural Counselling

Background: Despite the reported benefits of physical activity (PA), the majority of cancer survivors are not meeting public health PA guidelines. Most PA intervention studies have used supervised exercise and demonstrated benefits. However, these studies have also found that PA declines significantly after the supervised intervention is completed. Consequently, interventions are needed to ensure longer term adherence after short term supervised exercise interventions. Although several of behaviour change interventions have supported positive increases in PA, no study to date has examined the effects of adding behavioural counseling to a standard supervised exercise program and no study has focused on kidney cancer survivors (KCS).

Objectives: The primary purpose of the Trying Activity in Kidney Cancer Survivors (TRACKS) Trial is to compare the effects of a supervised physical activity program plus traditional exercise counseling (SPA) versus a supervised physical activity plus motivationally-enhanced behavioural counseling (SPA+BC) on change in self-reported moderate/vigorous PA between baseline, post-intervention, and 12-week follow-up among KCS. The secondary outcomes are changes in self-reported quality of life (QoL), body composition (anthropometric measures), cardiorespiratory fitness, physical function, and motivational constructs from the Theory of Planned Behaviour (TPB) constructs.

Methods: The study will pilot a two-armed, randomized controlled trial of 50 KCS. KCS will be recruited from a previous study using the Alberta Cancer Registry. Eligibility will include: a) between 18-80 years of age, b) diagnosed with Stage I-IIIa kidney cancer, and g) interested in increasing their physical activity. Following the screening procedure and prior to randomization, participants will undergo submaximal exercise testing on a treadmill to ensure that they are able to exercise safely at a moderate-to-vigorous intensity. Randomization will occur after all baseline measurements have been completed. The goal of the intervention, based on current public health recommendations, will be to gradually increase all participants by at least 60 minutes of moderate intensity PA or 30 minutes of vigorous intensity PA to a minimum of 150 minutes of moderate intensity PA or 75 minutes of vigorous intensity PA per week. Participants in both arms will be provided with six individual supervised exercise sessions with a physical activity specialist that will taper to an unsupervised program by the end of the intervention. Participants assigned to the SPA group will be given an individualized prescription at a moderate-to-vigorous intensity. They will also receive traditional exercise counseling to teach proper PA technique, how to monitor intensity, and to progress PA safely and effectively to achieve the public health PA guidelines. For the SPA+BC group, participants will receive the same supervised PA sessions with the addition of six individual "face-to-face" behavioural counseling sessions with a physical activity specialist. These behaviour counseling sessions will include training in behavioural strategies to promote the adoption and long-term maintenance of PA. Measurements for the primary and secondary endpoints will be assessed at baseline (pre-intervention), 4 weeks (post-intervention), and 12 weeks follow-up.

Conclusion: The study results can be used to determine if a behavior change intervention for KCS based on the TPB results in potentially meaningful improvements in PA and selected health outcomes.