Prostate Cancer Clinical Trial
— PBExRCTOfficial title:
A Preference-Based Trial of Two Exercise Delivery Methods in Men With PC on ADT
NCT number | NCT03335631 |
Other study ID # | 17-5506 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 19, 2017 |
Est. completion date | April 30, 2020 |
Verified date | August 2021 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prostate cancer affects 1 in 7 men. Half of these men are treated with androgen deprivation therapy (ADT). ADT slows disease progression and prolongs survival, but it also leads to worse quality of life (QOL), fatigue, loss of strength and fitness, osteoporosis, and diabetes. The investigators' recent research has shown that individually supervised exercise, supervised group exercise and home-based exercise are equally good at improving these side effects. Now the investigators are doing a larger trial with multiple centres to see whether supervised group or home-based exercise is clinically better and more economical. A major challenge in such trials is that a significant number of men refuse to be randomized because (a) the participant lives too far from a study centre and cannot come for supervised exercise; or (b) the participant has a strong preference as to which type of exercise program the participant wants to do. Experts have raised concerns that classic randomized trials are too restrictive, selective, and less practical; the study results are less applicable to the real world. Despite its obvious importance, it is not known whether men who refuse to be randomized to an exercise trial but are otherwise willing to participate would benefit similarly to men who are randomized. In this study, we will recruit men who are otherwise eligible for our randomized trial but refuse it for one of the reasons above. We will allow these men to choose either supervised group or home-based exercise, and then compare them to the men who are being randomized to the two treatments in 3 important ways. First, are participants similar in terms of personal characteristics, QOL, and fitness levels? Second, do participants respond similarly to exercise in terms of QOL and physical fitness benefits? Third, do participants actually exercise as much as the randomized men? This work will help the research team understand whether there is a need to change the way exercise trials are done in order to be more relevant and wide-reaching for Canadians with a variety of health conditions.
Status | Completed |
Enrollment | 56 |
Est. completion date | April 30, 2020 |
Est. primary completion date | April 30, 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 - fluent in English, - able to provide consent. Exclusion Criteria: - already meeting guidelines for moderate to vigorous physical activity (MVPA) - conditions that would interfere with ability to participate |
Country | Name | City | State |
---|---|---|---|
Canada | University of Calgary/Tom Baker Cancer Centre | Calgary | Alberta |
Canada | Scarborough and Rouge Hospital | Scarborough | Ontario |
Canada | University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) scale over time | The FACT-F is a questionnaire that includes 13 items measuring cancer-related fatigue. Total Score Range = 0-52 (higher score = lower fatigue) |
Baseline, 3, 6, 12 months | |
Primary | Change in 6 minute walk test (6MWT) scores over time | The 6MWT is a commonly used, validated measure that assesses functional endurance. | Baseline, 3, 6, 12 months | |
Secondary | Change in Functional Assessment of Cancer Therapy-General (FACT-G) scale over time | The FACT-G is a questionnaire that is well-validated and widely used to measure quality of life (QOL). Total Score Range = 0-108 (higher score = higher QOL) |
Baseline, 3, 6, 12 months | |
Secondary | Change in Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale over time | 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. Range = 0-48 (higher score = fewer prostate-specific symptoms) |
Baseline, 3, 6, 12 months | |
Secondary | Change in 5 Timed Chair Stand Test over time | A common, simple, and validated measure of functional lower body strength. | Baseline, 3, 6, 12 months | |
Secondary | Change in grip strength using a Jamar dynamometer over time | Grip strength is a measure of upper body strength and predicts long-term disability and mortality in middle-aged and older adults. | Baseline, 3, 6, 12 months | |
Secondary | Change in body composition (fat mass, fat free mass, and body fat percentage) measured via body impedance analysis (BIA) over time | Body composition will be measured using bioelectrical impedance analysis (BIA). | Baseline, 6, 12 months | |
Secondary | Change in fasting lipids over time | Fasting lipids will be measured. | Baseline, 6, 12 months | |
Secondary | Change in blood glucose over time | Blood glucose will be measured. | Baseline, 6, 12 months | |
Secondary | Change in glycated hemoglobin over time | Glycated hemoglobin will be measured. | Baseline, 6, 12 months | |
Secondary | Change in hemoglobin over time | Hemoglobin will be measured. | Baseline, 6, 12 months | |
Secondary | Change in prostate specific antigen (PSA) over time | Prostate-specific antigen (PSA) will be measured. | Baseline, 6, 12 months | |
Secondary | Change in weekly minutes of moderate-vigorous physical activity (MVPA) over time | Accelerometry will be used to measure weekly minutes of MVPA as an indicator of adherence at each time point. | Baseline, 3, 6, 12 months | |
Secondary | Change in Health Care Climate Questionnaire (HCCQ) over time | The Health Care Climate Questionnaire (HCCQ short form) assess participant perceptions of their health care team. Range = 0-7 (higher = better) |
Baseline only | |
Secondary | Change in Behavioral Regulations in Exercise Questionnaire-2 (BREQ-2) over time | Behavioral Regulations in Exercise Questionnaire-2 (BREQ-2) is a validated questionnaire that assess predictors of adherence. Comprised of 4 subscales: External regulation, range = 0-4 (higher = better) Introjected regulation, range = 0-4 (higher = better) Identified regulation, range = 0-4 (higher = better) Intrinsic regulation, range = 0-4 (higher = better) |
Baseline, 6, 12 months | |
Secondary | Change in Psychological Need Support and Frustration Scale - Relatedness Items (PNSF - Relatedness Items) over time | The Psychological Need Support and Frustration Scale - Relatedness Items will be used to measure relatedness. Total Score Range = 1-5 (higher = better) |
Baseline, 6, 12 months | |
Secondary | Change in Planning, Attitudes, & Barriers scale over time | The Planning, Attitudes, & Barriers (PAB) scale is a validated questionnaire that will be used to assess the likelihood of exercise behavior and adherence over time. Comprised of 11 subscales: Attitudes subscale, range = 1-7 (higher = better); Support subscale, range = 1-7 (higher = better); Motivation subscale, range = 1-7 (higher = better); Intentions subscale, range = 1-7 (higher = better); Planning subscale, range = 1-7 (higher = better); Disease/treatment influences subscale, range = 1-7 (higher = better); Disease/treatment frequency subscale, range = 1-7 (higher = better); Life-related influences subscale, range = 1-7 (higher = better); Life-related frequency subscale, range = 1-7 (higher = better); Motivated-related influences subscale, range = 1-7 (higher = better); Motivated-related frequency subscale, range = 1-7 (higher = better) Note: No total score is derived from this questionnaire |
Baseline, 6, 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
Recruiting |
NCT05156424 -
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03177759 -
Living With Prostate Cancer (LPC)
|
||
Completed |
NCT01331083 -
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
Active, not recruiting |
NCT04742361 -
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
|
Phase 3 | |
Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
Completed |
NCT02282644 -
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06305832 -
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05761093 -
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
|
||
Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
Completed |
NCT03290417 -
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
|
N/A | |
Active, not recruiting |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03679819 -
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
|
||
Completed |
NCT03554317 -
COMbination of Bipolar Androgen Therapy and Nivolumab
|
Phase 2 | |
Completed |
NCT03271502 -
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
|
N/A |