Prostate Cancer Survivors and Exercise and Behavioral Counseling
Condition: Physical Activity; Cancer of the Prostate; Cognitive Impairment; Quality of Life
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the feasibility of delivering a supervised physical activity program
      plus standard exercise counseling (SPA+EC) versus a supervised physical activity plus
      motivationally-enhanced behavioral counseling (SPA+BC) in prostate cancer survivors (PCS).
      Fifty participants (n=25) will be randomized to receiving SPA+EC or SPA+BC (n=25). We
      hypothesize that PCS receiving the SPA+BC intervention will result in greater increases in
      objectively-assessed physical activity compared with PCS receiving the SPA+EC intervention.
    

Detailed description: 
      Physical activity (PA) has a positive impact on clinical outcomes such as improvement in
      overall QoL, cancer-specific mortality, reducing treatment-related toxicities, and reducing
      fatigue across many cancer survivor groups including PCS. Despite these benefits of regular
      PA, the majority of PCS are still not meeting public health PA guidelines.

      Short-term supervised PA programs have been shown to improve health-related fitness and
      patient-reported outcomes in PCS, but PA declines significantly after the supervised
      intervention has been completed. Research examining the effect of short- term supervised
      exercise programs on motivational outcomes and longer term PA among cancer survivors is
      limited, especially theoretical approaches to identify key motivational outcomes for behavior
      change.

      This study will pilot a two-armed, single blind, RCT comparing SPA+EC to SPA+BC. The proposed
      RCT in PCS is noteworthy given that it differs from standard approaches to supervised PA with
      the addition of a behavioral counseling component. This rigorous comparison condition will
      provide further evidence that theoretically-informed interventions are needed to adopt
      long-term PA maintenance.

      The program's supervised exercise length will be 6 weeks, followed by a tapered contact
      throughout the a 6-week home-based component through 'booster' behavioral counseling
      delivered via telephone. In terms of study measures, objective measures of PA will be used
      (i.e.,accelerometry, inclinometers), and cardiorespiratory fitness will be evaluated using
      maximal graded exercise testing via treadmill. Additional secondary outcomes include
      cognitive function, quality of life, physical function, body composition, motivational
      outcomes, sexual functioning, masculinity, sedentary behavior, and cardiorespiratory fitness.
    

Intervention name(s): Supervised Physical Activity Plus Behavioral Counseling; Supervised Physical Activity Plus Exercise Counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): In addition to supervised physical activity, behavioral counseling sessions will be delivered with a PA specialist based on the Multi-process Action Control (M-PAC) framework and include behavior change techniques addressing information regarding the consequences, social support, goal setting, self-monitoring, cues and prompts, barrier identification, intention formation, planning, and habit and identity formation; In addition to the supervised exercise sessions, standard exercise counseling will be delivered by a PA specialist to teach proper PA and resistance training techniques, how to monitor intensity, and to progress PA safely and effectively to achieve the public health PA guideline.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Behavior change; Prostate cancer; Behavioral counseling; Physical Activity; Randomized controlled trial