Trying Activity in Kidney Cancer Survivors (TRACKS) Trial
Condition: Supervised Physical Activity Plus Exercise Counseling; Supervised Physical Activity Plus Behavioural Counseling
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Objectives: The purpose of this study is to find out if a new program can help kidney cancer
      survivors (KCS) increase their physical activity (PA) and improve their quality of life
      (QoL).

      Methods: Fifty KCS will be recruited from a previous study using the Alberta Cancer Registry.
      Participants will undergo submaximal exercise testing, a physical function test and measures
      of height and weight, which will be completed at baseline and the end of the physical
      activity program (at 12 weeks). Participants will also complete questionnaires on PA and QoL
      at the baseline, after the supervised portion of the program (at 4 weeks), and at the end of
      the entire program (at 12 weeks). Following baseline assessments, participants will be
      randomly assigned to either: (1) supervised physical activity plus traditional exercise
      counseling or (2) supervised physical activity plus behavioural counseling. Participants will
      be asked to attend six individual supervised exercise and counseling sessions over a 4-week
      period with a PA specialist that eventually tapers to a home-based program by the end of the
      program.

      Implications: The investigators hope that this PA intervention for KCS is feasible and
      results in meaningful improvements in health outcomes that can be translated to public health
      practice.
    

Detailed description: 
      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.
    

Intervention name(s): Trying Activity for Kidney Cancer Survivors (TRACKS) Trial
Intervention type(s): Behavioral
Intervention description(s): 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. Over the 4-week period, both groups will be required to attend two sessions per week for weeks 1-2, and one session per week for weeks 3-4 at the Behavioural Medicine Fitness Centre at the University of Alberta. In order to achieve the PA guidelines established by the current public health recommendations, additional unsupervised sessions will be prescribed.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Kidney cancer survivors; Randomized Controlled Trial; Physical Activity; Theory of Planned Behaviour; Quality of life