University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801, United States
NCT Number: NCT03191968
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.
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Notify Me18 year–80 year
Male
Interventional
Phase 2
Urbana, Illinois, 61801, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Change in from baseline at 12 weeks
Objective Physical activity will be measured using an activity device, accelerometry (i.e., Actigraph GTX3+)
Time frame: Change in from baseline at 12 weeks
Self-reported physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire
Time frame: Change in from baseline at 12 weeks
Mobility-related fitness parameters will be measured through the six-items of the Seniors' Fitness Test.
Time frame: Change in from baseline at 12 weeks
Self-reported quality of life measured via the Functional Assessment of Cancer Therapy (FACT-G) for general quality of life.
Time frame: Change in from baseline at 12 weeks
Self-reported quality of life measured via the FACT-Prostate for prostate-specific quality of life.
Time frame: Change in from baseline at 12 weeks
Self-reported fatigue will be assessed using the FACT-Fatigue
Time frame: Change in from baseline at 12 weeks
Self-reported Short-Form 36 will be used for assessing general well-being.
Time frame: Change in from baseline at 12 weeks
Body composition will be estimated using anthropometric measurements will be taken - height, weight and waist circumference.
Time frame: Change in from baseline at 12 weeks
Aerobic endurance capacity will be assessed by using the modified Balke sub-maximual exercise test.
Time frame: Change in from baseline at 12 weeks
The primary set of neuropsychological assessments will be assessed using the validated NIH Toolbox Cognition Battery. This battery consists of tests to assess Executive Function, Attention, Episodic Memory, Language, Processing Speed and Working Memory.
Time frame: Change in from baseline at 12 weeks
The International Index of Erectile Function (IIEF) will be used to assess sexual health including erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction.
Time frame: Change in from baseline at 12 weeks
The Perceived Relationship Quality Components (PRQC) Inventory will be used to assess relationship quality.
Time frame: Change in from baseline at 12 weeks
Masculine self-esteem will be assessed using the Masculinity in Chronic Disease Inventory (MCD-I).
Time frame: Change in from baseline at 12 weeks
multi-process action control (M-PAC) framework assessing attitudes, subjective norms, perceived behavioral control, planning, habit, and identity
Time frame: Change in from baseline at 12 weeks
sitting time as measured by via self-report using the Measuring Older Adults' Sedentary Time (MOST) questionnaire which assesses sitting while watching TV, using the computer, hobbies, socializing, transportation, doing hobbies, and other activities.
Time frame: Change in from baseline at 12 weeks
Objective measures of sitting time will be assessed using an activity device, inclinometers (i.e., ActivPALs)
University of Illinois at Urbana-Champaign
Other
A Pilot, Randomized Controlled Trial Adding Behavioral Counseling to Supervised Physical Activity in Prostate Cancer Survivors
Acronym: BOOST
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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