Prostate Cancer Survivors Moving Toward Exercise (PROMOTE) Trial
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The primary purpose of the study is to determine the effects of an implementation intention
      intervention on physical activity (PA) behaviour in prostate cancer survivors. Secondary aims
      are to (a) compare the effects of a telephone-assisted implementation intention intervention
      against a self-administered implementation intention intervention and a standard
      recommendation group on physical activity behaviour and (b) document the effects of these
      interventions on quality of life (QoL), fatigue, symptom management, and physical
      functioning.

      Hypotheses: Evidence exists that an implementation intention intervention can lead to
      significant improvements in PA levels and that regular PA has been shown to improve QoL,
      fatigue levels, manage symptoms and improve physical functioning in cancer survivors'. As
      such, the following hypotheses were generated: (1) prostate cancer survivors exposed to the
      researcher-assisted implementation intention intervention will have higher PA levels at the
      1- and 3-month follow-ups compared to the self-completed implementation intention
      intervention and the standard recommendation group; (2) prostate cancer survivors in the
      researcher-assisted implementation intention intervention will show significant improvements
      in QoL, fatigue levels, symptom management, and physical functioning compared to the
      self-completed implementation intention intervention and the standard recommendation group at
      the 1- and 3-month follow-up; and (3) prostate cancer survivors in the self-completed
      implementation intention intervention will have higher PA levels, and better improvements in
      QoL, fatigue levels, symptom management, and physical functioning compared to the standard
      recommendation group at the 1- and 3-month follow-ups.
    

Detailed description: 
      BACKGROUND:

      Prostate cancer remains the most frequently diagnosed cancer among Canadian men, with an
      estimated 24,600 men being diagnosed in 2010. In Alberta specifically, roughly 2,500 men will
      be diagnosed with prostate cancer, and 440 men will die of the disease in 2010 (Canadian
      Cancer Society, 2011). Improvements in the treatment of prostate cancer has reduced tumour
      growth and improved survival rates, however, it has also been associated with significant
      negative changes in cancer survivors' quality of life, physical functioning, body fat
      percentage and fatigue levels that may persist for years following treatment. One behavioural
      strategy that has been consistently shown to combat these negative side effects and enhance
      psychosocial and physical well-being in prostate cancer survivors is physical activity.
      Unfortunately it has been established that physical activity levels decline significantly
      from pre-diagnosis to during treatment and may never regain pre-diagnosis levels; thus it is
      important to test novel, innovative and inexpensive ways to increase physical activity
      patterns in prostate cancer survivors.

      PURPOSE:

      The primary purpose of the study is to determine the effects of an implementation intention
      intervention on physical activity behaviour in prostate cancer survivors. Secondary aims are
      to (a) compare the effects of a telephone-assisted implementation intention intervention
      against a self-administered implementation intention intervention and a standard
      recommendation group on physical activity behaviour and (b) document the effects of these
      interventions on quality of life, fatigue, symptom management, and physical functioning.

      METHODS:

      A three-arm randomized controlled trial for prostate cancer survivors will be performed
      through the Alberta Cancer Registry. To obtain a sample of at least 300 participants, 1500
      prostate cancer survivors will be contacted in the initial mail-out. Following the initial
      mail-out prostate cancer survivors agreeing to participate in the study will be randomized to
      one of the three conditions. All groups will receive a written physical activity
      recommendation, as well as the 2008 Physical Activity Guidelines. In addition to the physical
      activity materials, participants in the telephone-assisted and self-administered groups will
      be asked to complete an implementation intention intervention. Finally, the
      telephone-assisted group will receive a 10-20 minute telephone call to assist them with the
      completion of implementation intention intervention. Measures at baseline (i.e., initial
      mail-out) will include self-reported physical activity, demographic, health and medical
      factors, quality of life, fatigue, physical functioning. Follow-up at month 1 and 3 following
      the intervention will include self-reported physical activity, quality of life, fatigue and
      physical function measures.

      SUMMARY:

      This mail-out study will offer insight into the effects of an implementation intention
      intervention on physical activity levels in an understudied cancer population, and further
      explore the effect of physical activity as part of the usual care recommended for the
      treatment of prostate cancer on quality of life, fatigue and symptom management.
    

Intervention name(s): Telephone Implementation Intention; Self-completed implementation intention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Telephone implementation intention counseling; Self-administered implementation intention intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Survivors