ADT Exercise Trial and Economic Analysis

Prostate Cancer Clinical Trial

— ADTExRCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02834416
• Other study ID #: 14-8158-CE
• Status: Completed
• Phase: Phase 3
• Start date: August 2016
• Est. completion date: March 31, 2020

Study information

• Verified date: April 2021
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• men with histologically confirmed PC who are starting or continuing on ADT for at least 6 months or who are in an androgen-deprived (or castrate) state for the duration of the intervention

• fluent in English

• able to provide consent

• close to a study centre

Exclusion Criteria:

• already meeting guidelines for moderate to vigorous physical activity (MVPA) - conditions that would interfere with ability to participate

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Supervised Group Exercise
The exercise program will be delivered in a group format (4-8 participants per group) by a certified exercise specialist.
• Home Based 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.

Locations

Country	Name	City	State
Canada	University of Calgary/Tom Baker Cancer Centre	Calgary	Alberta
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	Scarborough and Rouge Hospital	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
University Health Network, Toronto	Scarborough Rouge Hospital, Southlake Regional Health Centre, Tom Baker Cancer Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Assessment of Cancer Therapy-Fatigue (FACT-F)	The FACT-F is a questionnaire that includes 13 items measuring cancer-related fatigue.	Every 3 Months for 12 Months
Primary	6 Minute Walk Test (6MWT)	The 6MWT is a commonly used, validated measure that assesses functional endurance.	Every 3 Months for 12 Months
Secondary	Functional Assessment of Cancer Therapy-General (FACT-G)	The FACT-G is a questionnaire that is well-validated and widely used to measure quality of life (QOL).	Every 3 Months for 12 Months
Secondary	Functional Assessment of Cancer Therapy-Prostate (FACT-P)	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.	Every 3 Months for 12 Months
Secondary	5 Times Sit to Stand Test	A common, simple, and validated measure of functional lower body strength.	Every 3 Months for 12 Months
Secondary	Grip Strength	Grip strength is a measure of upper body strength and predicts long-term disability and mortality in middle-aged and older adults.	Every 3 Months for 12 Months
Secondary	Bioelectrical Impedance Analysis	Body composition will be measured using bioelectrical impedance analysis (BIA).	Every 6 Months for 12 Months
Secondary	Waist Circumference and Hip Ratio	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.	Every 6 Months for 12 Months
Secondary	Body Mass Index	Body composition will be measured using body mass index (BMI).	Every 6 Months for 12 Months
Secondary	Bone Mineral Density (BMD)	Bone mineral density will be measured at lumbar spine, hip, and distal 1/3 radius using dual x-ray absorptiometry (DXA).	Every 6 Months for 12 Months
Secondary	Biological Outcomes (blood work)	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.	Every 6 Months for 12 Months
Secondary	Sedentary Behaviour	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.	Every 6 Months for 12 Months (unless otherwise specified)
Secondary	Planning, Attitudes, & Barriers scale	The Planning, Attitudes, & Barriers scale is a validated questionnaire that will be used to assess likelihood of exercise behavior over time.	Every 6 Months for 12 Months (unless otherwise specified)
Secondary	Behavioral Regulations in Exercise Questionnaire-2 (BREQ-2)	Behavioral Regulations in Exercise Questionnaire-2 (BREQ-2) is a validated questionnaire that assess predictors of adherence.	Every 6 Months for 12 Months (unless otherwise specified)
Secondary	Psychological Need Support and Frustration Scale - Relatedness Items	Relatedness will be assessed using the Psychological Need Support and Frustration Scale - Relatedness Items.	Every 6 Months for 12 Months (unless otherwise specified)
Secondary	Health Care Climate Questionnaire (HCCQ)	The Health Care Climate Questionnaire (HCCQ short form) assess participant perceptions of their health care team.	Baseline only
Secondary	Walkability	Participant postal codes will be collected to assess neighbourhood walkability (i.e., access to a grocery store within walking distance).	Baseline only
Secondary	Disease-related Costs	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.	Every 3 Months for 12 Months
Secondary	Exercise Adherence	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.	Every 3 Months for 12 Months