Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

This intervention arm will include 3 group, supervised sessions per week for 6 months with a certified exercise specialist. Supervised sessions will be delivered in a group format with 4-8 participants per group. Flexibility training will include stretching for 5-10 minutes at the beginning and end of each session. Aerobic training will involve 30 minutes of low-impact step aerobics. Resistance training will be conducted using resistance bands, a stability ball, and an exercise mat with 8 prescribed exercises that target the major muscle groups. Participants will be encouraged to perform exercises independently on additional days, for a total of 4-5 days per week of exercise.

The same protocol and training frequency as the supervised programs described above will be followed. However, all exercises will be completed independently by participants. Specific exercises in the aerobic program may be modified to accommodate patient preference (same target heart rate range as the supervised group). Participants will be supported with smartphone technology and remote 'health coaches' during the intervention phase. This will help to ensure participant adherence, appropriate progression, and safety.

The exercise program will be delivered in a group format (4-8 participants per group) by a certified exercise specialist.

Supervised Group Exercise

The exercise program will be executed independently by participants in a home-based setting. Home-based participants will be supported with remote health coaching and smartphone technology.

Home Based Exercise

Prostate Cancer (PC) affects 1 in 7 men. Nearly half of those diagnosed with PC will receive androgen deprivation therapy (ADT) as part of their treatment. ADT is good at managing PC but has many side effects. Researchers have shown that exercise, specifically one-on-one supervised exercise improves many of the side effects of ADT. However, exercise programs for men on ADT are not widely available. More questions need to be answered in order for exercise programs to become part of PC treatment. First, can programs that require fewer resources, such as group-exercise or home-based exercise, also improve ADT side-effects? Second, do exercise-related benefits continue beyond the structured exercise program? And what makes people continue exercising? Third, which exercise program is most cost-effective?

In this study, the investigators will compare: (a) group supervised in-centre and (b) home-based supported exercise programs to see which program is most effective for men with PC on ADT. The investigators will also look at what motivates people to continue to exercise both during a structured program and after the program is complete and will examine which exercise program is most cost-effective.

Participants (men with PC on ADT) will be recruited from one of the following cancer centres: Princess Margaret Cancer Centre in Toronto, the Tom Baker Cancer Centre in Calgary, the Southlake Regional Health Centre in Newmarket, and Scarborough and Rouge Hospital - Centenary Site in Scarborough. When a patient agrees to participate, patient will be randomly placed in 1 of 2 exercise programs. All programs will include the same type of exercises (aerobic, resistance and flexibility) and all participants will exercise 4-5 days per week for 30 minutes per day (as tolerated) for the length of the program (6 months). The investigators will look at how men with PC on ADT respond to the exercise program by measuring quality of life (QOL), fatigue and different physical measures before, during, and after the exercise program.

Although the investigators know that supervised one-on-one exercise is most effective at improving ADT side-effects, it is unknown if other forms of exercise are just as beneficial and more financially responsible. This study will allow the investigators to begin to answer these questions so that structured exercise programs become a regular part of PC treatment.

An a priori decision was made to not include additional covariates in the ANCOVA model due to a smaller than anticipated sample size. Only trial centre, length of ADT, and baseline 6MWT will be included in the model.

In addition, we have modified the wear time criteria for accelerometry from 600 minutes of wear time to 500 minutes of wear time. This allows for the inclusion of more participant data and more accurately reflects the clinical nature of this population.

Amendment date: 17-Sep-20

ADT Exercise Trial and Economic Analysis

A Randomized Control Trial (RCT) and Economic Analysis of Two Exercise Delivery Methods in Men With Prostate Cancer on ADT

The FACT-F is a questionnaire that includes 13 items measuring cancer-related fatigue.

The 6MWT is a commonly used, validated measure that assesses functional endurance.

The FACT-G is a questionnaire that is well-validated and widely used to measure quality of life (QOL).

The FACT-P is a questionnaire that supplements the FACT-G with 12 prostate-specific items covering domains of urinary function, sexual function, pain, and related symptoms.

A common, simple, and validated measure of functional lower body strength.

Grip strength is a measure of upper body strength and predicts long-term disability and mortality in middle-aged and older adults.

Body composition will be measured using bioelectrical impedance analysis (BIA).

Body composition will be measured using waist circumference(WC) and WC:hip ratio, following the standardized Canadian Society for Exercise Physiology - Physical Activity Training for Health (CSEP-PATH) protocol.

Body composition will be measured using body mass index (BMI).

Bone mineral density will be measured at lumbar spine, hip, and distal 1/3 radius using dual x-ray absorptiometry (DXA).

Fasting lipids, blood glucose, glycated hemoglobin, hemoglobin, prostate-specific antigen (PSA), and testosterone will be measured. Serum banking will also be done for use in future studies.

Time spent in activities that are characterized by an energy expenditure ≤ 1.5 metabolic equivalents and a sitting or reclining posture (sedentary behavior) will be assessed using the Sedentary Behaviour Questionnaire that is used in large cohort studies and has demonstrated evidence of reliability and validity.

The Planning, Attitudes, \& Barriers scale is a validated questionnaire that will be used to assess likelihood of exercise behavior over time.

Behavioral Regulations in Exercise Questionnaire-2 (BREQ-2) is a validated questionnaire that assess predictors of adherence.

Relatedness will be assessed using the Psychological Need Support and Frustration Scale - Relatedness Items.

The Health Care Climate Questionnaire (HCCQ short form) assess participant perceptions of their health care team.

Participant postal codes will be collected to assess neighbourhood walkability (i.e., access to a grocery store within walking distance).

The investigators will collect economically relevant data about health status using preference-based (utility) instruments (European Quality of Life Five Dimensions Questionnaire, EQ-5D). Productivity losses and out-of-pocket expenditures, in addition to hospitalization, drug co-pay, and health visit data will be gathered using a patient questionnaire.

Both accelerometry and the Godin Leisure Time Exercise Questionnaire will be used as a measure of adherence at each time point. Both measures will provide a validated measure of physical activity.

Tom Baker Cancer Centre

Southlake Regional Health Centre

Scarborough Rouge Hospital

University Health Network, Toronto

Symptoms and General Pathology

Behaviors and Mental Disorders

Fatigue

Quality of Life

This intervention arm will include 3 one-on-one, supervised sessions per week for 6 months with a certified exercise specialist. Flexibility training will include stretching for 5-10 minutes at the beginning and end of each session. Aerobic training will involve 30 minutes of low-impact step aerobics. Resistance training will be conducted using resistance bands, a stability ball, and an exercise mat with 8 prescribed exercises that target the major muscle groups. Participants will be encouraged to perform exercises independently on additional days, for a total of 4-5 days per week of exercise.

The same protocol and training frequency as the supervised programs described above will be followed. However, all exercises will be completed independently by participants. Specific exercises in the aerobic program may be modified to accommodate patient preference (same target heart rate range as supervised groups). Participants will be supported with smartphone technology and remote 'health coaches' during the intervention phase. This will help to ensure participant adherence, appropriate progression, and safety.

The exercise program will be delivered in a personal training (1:1) format by a certified exercise specialist.

Supervised 1:1 exercise

Supervised group exercise

Home-based exercise

Shabbir MH Alibhai, MD, MSc

Prostate Cancer (PC) affects 1 in 7 men. Nearly half of those diagnosed with PC will receive androgen deprivation therapy (ADT) as part of their treatment. ADT is good at managing PC but has many side effects. Researchers have shown that exercise, specifically one-on-one supervised exercise improves many of the side effects of ADT. However, exercise programs for men on ADT are not widely available. More questions need to be answered in order for exercise programs to become part of PC treatment. First, can programs that require fewer resources, such as group-exercise or home-based exercise, also improve ADT side-effects? Second, do exercise-related benefits continue beyond the structured exercise program? And what makes people continue exercising? Third, which exercise program is most cost-effective?

In this study, the investigators will compare: (a) group supervised in-centre; (b) home-based supported; and (c) 1:1 supervised in-centre exercise programs to see which program is most effective for men with PC on ADT. The investigators will also look at what motivates people to continue to exercise both during a structured program and after the program is complete and will examine which exercise program is most cost-effective.

The investigators will ask men with PC on ADT that are being treated at either Princess Margaret Cancer Centre in Toronto or the Tom Baker Cancer Centre in Calgary to participate in the study. When a patient agrees to participate, he will be randomly placed in 1 of the 3 exercise programs. All programs will include the same type of exercises (aerobic, resistance and flexibility) and all participants will exercise 4-5 days per week for 30 minutes per day (as tolerated) for the length of the program (6 months). The investigators will look at how men with PC on ADT respond to the exercise program by measuring quality of life (QOL), fatigue and different physical measures before, during, and after the exercise program.

Although the investigators know that supervised one-on-one exercise is most effective at improving ADT side-effects, it is unknown if other forms of exercise are just as beneficial and more financially responsible. This study will allow the investigators to begin to answer these questions so that structured exercise programs become a regular part of PC treatment.

An Exercise Trial and Economic Analysis in Men With Prostate Cancer

A Pilot RCT and Economic Analysis of Three Exercise Delivery Methods in Men With Prostate Cancer on ADT

Measured by the Functional Assessment of Cancer Therapy-General (FACT-G), health-related QOL refers to those aspects of QOL that relate a person's health to their physical, functional, psychological, and social well-being. The FACT-G is a well-validated and widely used QOL measure. It can be completed in 8-10 minutes and has published normative data.

Supplementing the assessment of health-related QOL, prostate-specific QOL will be measured with the FACT-P. The FACT-P contains 12 prostate-specific items covering domains of urinary function, sexual function, pain, and related symptoms. It is well-validated and used in multiple prior exercise trials.

The FACT-Fatigue (FACT-F), includes 13 items measuring cancer-related fatigue. It has excellent reliability and validity. Fatigue is a common symptom in men on ADT and has been shown to benefit from exercise.

Aerobic fitness will be assessed using a treadmill-based graded exercise test (modified Bruce protocol) to maximal exertion. Standard test termination criteria apply.

Musculoskeletal fitness will be assessed using a sit-to-stand test, a common, simple, and validated measure of functional lower body strength.

Grip strength is a measure of upper body strength and is responsive to ADT use. It predicts long-term disability and mortality in middle-aged and older adults.

Body composition will be assessed via bioelectrical impedance analysis (BIA), waist circumference (WC), WC:hip ratio, and BMI, following the standardized Canadian Society for Exercise Physiology protocol.

Bone mineral density (lumbar spine, hip, femoral neck, and distal 1/3 radius) will be assessed using dual x-ray absorptiometry (DXA).

Insulin sensitivity and blood lipid profiles have been shown to be negatively affected by ADT. To examine the effect of exercise on these metabolic outcomes, fasting lipids and blood glucose, in addition to PSA level, will be assessed. Serum banking will also be done for use in future studies.

We will use a social ecological approach to assess factors at three related levels using the following validated measures: Exosystem Measures: Neighborhood Environment Walkability Scale: Short Form (NEWS-A); Mesosystem Measures: Health Care Climate Questionnaire (HCCQ short form) and Relatedness to Others in Physical Activity scale; Microsystem Measures: Behavioral Regulations in Exercise Questionnaire-2 (BREQ-2) and a Planning, Attitudes, \& Barriers scale. Time spent in activities that are characterized by an energy expenditure ≤ 1.5 metabolic equivalents and a sitting or reclining posture will be assessed using the Sedentary Behaviour Questionnaire that is used in large cohort studies and has demonstrated evidence of reliability and validity.

We will collect economically relevant data about health status using preference-based (utility) instruments (EQ-5D). Productivity losses and out-of-pocket expenditures, in addition to hospitalization, drug co-pay, and health visit data will be gathered using a patient questionnaire.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ADT Exercise Trial and Economic Analysis	NCT02834416	Prostate Cancer	Supervised Grou... Home Based Exer...	-	University Health Network, Toronto
ADT Exercise Trial and Economic Analysis	NCT02834416	Prostate Cancer	Supervised Grou... Home Based Exer...	-	University Health Network, Toronto
An Exercise Trial and Economic Analysis in Men With Prostate Cancer	NCT02046837	Prostate Cancer	Supervised 1:1 ... Supervised grou... Home-based exer...	-	University Health Network, Toronto
An Exercise Trial and Economic Analysis in Men With Prostate Cancer	NCT02046837	Prostate Cancer	Supervised 1:1 ... Supervised grou... Home-based exer...	-	University Health Network, Toronto

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