Prostate Cancer Survivors and Exercise and Behavioral Counseling

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot, Randomized Controlled Trial Adding Behavioral Counseling to Supervised Physical Activity in Prostate Cancer Survivors

Conditions
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Physical Activity, Cancer of the Prostate, Cognitive Impairment, Quality of Life

Intervention / Treatment
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* Behavioral: Supervised Physical Activity Plus Behavioral Counseling
* Behavioral: Supervised Physical Activity Plus Exercise Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years and older Histologically confirmed prostate cancer (Stage I-IIIa) but now cured or in remission Ability and willingness to effectively communicate in English Not meeting physical activity guidelines of ≥150 minutes of vigorous physical activity Exclusion Criteria: Severe coronary artery disease (Canadian Cardiovascular Society class III or greater) Significant congestive heart failure (New York Heart Association class III or greater) Uncontrolled pain Neurological or musculoskeletal co-morbidity inhibiting exercise Diagnosed psychotic, addictive or major cognitive disorders Absent for more than 3 consecutive days during the 12-week intervention High risk individuals (i.e., men who have symptomatic and known cardiovascular, pulmonary and/or metabolic disease) as determined by the risk stratification questionnaire

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised PA Plus Behavioral Counseling<br>25 prostate cancer survivors will receive supervised physical activity and behavioral counseling (SPA+BC) based on the M-PAC. 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 | Behavioral: Supervised Physical Activity Plus Behavioral Counseling<br>* 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<br>|
| Active Comparator: Supervised PA Plus Exercise Counseling<br>25 prostate cancer survivors will supervised physical activity and exercise counseling (SPA+EC).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. | Behavioral: Supervised Physical Activity Plus Exercise Counseling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objectively assessed physical activity | Objective Physical activity will be measured using an activity device, accelerometry (i.e., Actigraph GTX3+) | Change in from baseline at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported physical activity | Self-reported physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire | Change in from baseline at 12 weeks | 
| Physical Function | Mobility-related fitness parameters will be measured through the six-items of the Seniors' Fitness Test. | Change in from baseline at 12 weeks | 
| General quality of life | Self-reported quality of life measured via the Functional Assessment of Cancer Therapy (FACT-G) for general quality of life. | Change in from baseline at 12 weeks | 
| Prostate-specific quality of life | Self-reported quality of life measured via the FACT-Prostate for prostate-specific quality of life. | Change in from baseline at 12 weeks | 
| Cancer-related fatigue | Self-reported fatigue will be assessed using the FACT-Fatigue | Change in from baseline at 12 weeks | 
| General well-being | Self-reported Short-Form 36 will be used for assessing general well-being. | Change in from baseline at 12 weeks | 
| Body composition | Body composition will be estimated using anthropometric measurements will be taken - height, weight and waist circumference. | Change in from baseline at 12 weeks | 
| Cardiorespiratory fitness | Aerobic endurance capacity will be assessed by using the modified Balke sub-maximual exercise test. | Change in from baseline at 12 weeks | 
| Cognitive function | 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. | Change in from baseline at 12 weeks | 
| Sexual Health | 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. | Change in from baseline at 12 weeks | 
| Relationship quality | The Perceived Relationship Quality Components (PRQC) Inventory will be used to assess relationship quality. | Change in from baseline at 12 weeks | 
| Masculine self-esteem | Masculine self-esteem will be assessed using the Masculinity in Chronic Disease Inventory (MCD-I). | Change in from baseline at 12 weeks | 
| Motivational outcomes | multi-process action control (M-PAC) framework assessing attitudes, subjective norms, perceived behavioral control, planning, habit, and identity | Change in from baseline at 12 weeks | 
| Self-reported sedentary behavior | 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. | Change in from baseline at 12 weeks | 
| Objectively assessed sedentary behavior | Objective measures of sitting time will be assessed using an activity device, inclinometers (i.e., ActivPALs) | Change in from baseline at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavior change, Prostate cancer, Behavioral counseling, Physical Activity, Randomized controlled trial