Ignite Creation Date:
2024-05-06 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03335631
Status:
COMPLETED
Last Update Posted:
2021-08-13
First Post:
2017-10-19
Brief Title:
Preference-Based Exercise RCT for Men With PC on ADT
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Preference-Based Trial of Two Exercise Delivery Methods in Men With PC on ADT
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PBExRCT
Brief Summary:
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
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
Detailed Description:
BACKGROUND The backbone of scientific evidence to address most scientific questions including behavioural interventions is randomized controlled trials RCTs Prostate cancer is the most common malignancy in men affecting 1 in 7 men Almost 50 of these men will receive androgen deprivation therapy ADT at some point after diagnosis to reduce disease progression and prolong survival ADT is associated with multiple adverse effects including diminished quality of life QOL fatigue reduced muscle mass and metabolic effects Numerous RCTs in the setting of men on ADT have demonstrated that exercise programs particularly supervised 11 in-centre programs are clinically effective However they are resource-intensive and have low scalability Alternative delivery models such as group-based supervised exercise or home-based exercise are promising alternatives but require rigorous efficacy data While conducting a two-centre exercise trial comparing different exercise delivery models fewer than 40 of eligible men agreed to participate Two common reasons why men declined participation were distance to exercise centres and unwillingness to be randomized Novel clinical trial designs such as preference-based trials may help answer effectiveness questions and enhance generalizability by recruiting a more representative pool of men Increased efficiencies in recruitment however may come at a cost of bias with non-randomized designs as well as differential effects of exercise and varying adherence In parallel with a multi-centre phase III RCT funded by CIHR we propose to conduct a pilot preference-based trial examining 3 key issues First can we successfully enroll men who are unwilling to be randomized due either to distance from centre or a strong preference for one exercise delivery model Second are these men different from men who are randomized in terms of baseline characteristics study retention and adherence to the intervention Third are the benefits of an exercise program similar to men who are randomized to the same arm
OBJECTIVES
To determine in men with PC on ADT who are otherwise eligible to participate in a RCT of different exercise delivery models but decline to be randomized due to distance from the study centre or strong preference for one exercise delivery model
1 What proportion of these men is willing to be enrolled in a preference-based trial
2 How comparable are baseline characteristics of men who agree to participate in the intervention arm of their choice and all those in the randomized study
3 How comparable are study retention and adherence to the intervention for men in the corresponding arms of the preference based trial and randomized trial
4 How comparable are the benefits in terms of quality of life QOL and physical fitness outcomes in those with a preference for a particular exercise and those without a preference
HYPOTHESES
1 Systematic differences exist in baseline characteristics specifically distance to the study centre age education prior experience with participating in exercise programs and fatigue severity among participants willing to be randomized versus not randomized to an exercise intervention
2 Adherence will be greater among those selecting treatment by preference vs being randomized
3 Benefits QOL and fitness will be greater among those selecting treatment versus being randomized
METHODS Patients aged 18 or older on ADT for high-risklocally advanced biochemically relapsed or asymptomatic metastatic prostate cancer will be eligible if they are otherwise eligible for an ongoing phase III RCT of exercise but decline to participate due to either distance from study centre or strong preference for one exercise delivery model The main phase III RCT is examining a 6-month individualized progressive mixed-modality exercise program including aerobic resistance and flexibility components delivered using one of two delivery models supervised in-centre group exercise 3 times weekly or home-based exercise supported by a Fitbit smart phone app and remote health coach
To meet the objectives of this pilot preference trial we will enroll 50 men per preference arm at three experienced study sites Princess Margaret Cancer Centre Toronto Scarborough and Rouge Hospital Scarborough and the University of Calgary Calgary and Aim 1 We will report the proportion of men who are eligible for the preference-based trial who agree to participate overall and by treatment arm and reason for refusal to be randomized
Aim 2Hypotheses 1 and 2 We will compare the participants in the preference-based trial to those in the RCT Comparisons of baseline characteristics will be between the total number of participants in the RCT compared separately to each arm of the preference trial ANOVA will be used for continuous variables and chi-square analysis for categorical variables Variables to be compared include distance from participants home to the study centre age education prior participation in an exercise program and symptom severity Differences will be presented with 95 CIs
Aim 3Hypothesis 3 Within-group change scores will be assessed for the preference-based groups and the mean changes along with the 95CIs will be reported Next we will compare these changes for the co-primary and secondary outcomes between the preference-based groups and the phase III RCT eg combined preference arms to combined RCT arm to obtain the so-called selection-effect Finally although it is subject to confounding by unknown preference effects in the RCT participants we will estimate the differences between outcomes in those randomized to and choosing each specific exercise delivery method using constrained linear mixed effects model adjusting for the baseline value and ADT duration Skewed data will be transformed as appropriate
SIGNIFICANCE Behavioural interventions require significant patient commitment and although most RCTs to date have shown evidence of benefit on various outcomes recruitment rates have been low and many otherwise eligible men are not willing to be randomized for different reasons Designing trials that allow inclusion of such men is obviously going to improve generalizability but whether the results of interventions are similarly effective and understanding the feasibility and potential biases of enrolling such men are fundamental unresolved issues This pilot study will take advantage of an existing trial to begin to answer these questions and determine whether a larger preference-based trial is worth undertaking Our findings have potential widespread implications for behavioural trials across many health care settings
OBJECTIVES
To determine in men with PC on ADT who are otherwise eligible to participate in a RCT of different exercise delivery models but decline to be randomized due to distance from the study centre or strong preference for one exercise delivery model
1 What proportion of these men is willing to be enrolled in a preference-based trial
2 How comparable are baseline characteristics of men who agree to participate in the intervention arm of their choice and all those in the randomized study
3 How comparable are study retention and adherence to the intervention for men in the corresponding arms of the preference based trial and randomized trial
4 How comparable are the benefits in terms of quality of life QOL and physical fitness outcomes in those with a preference for a particular exercise and those without a preference
HYPOTHESES
1 Systematic differences exist in baseline characteristics specifically distance to the study centre age education prior experience with participating in exercise programs and fatigue severity among participants willing to be randomized versus not randomized to an exercise intervention
2 Adherence will be greater among those selecting treatment by preference vs being randomized
3 Benefits QOL and fitness will be greater among those selecting treatment versus being randomized
METHODS Patients aged 18 or older on ADT for high-risklocally advanced biochemically relapsed or asymptomatic metastatic prostate cancer will be eligible if they are otherwise eligible for an ongoing phase III RCT of exercise but decline to participate due to either distance from study centre or strong preference for one exercise delivery model The main phase III RCT is examining a 6-month individualized progressive mixed-modality exercise program including aerobic resistance and flexibility components delivered using one of two delivery models supervised in-centre group exercise 3 times weekly or home-based exercise supported by a Fitbit smart phone app and remote health coach
To meet the objectives of this pilot preference trial we will enroll 50 men per preference arm at three experienced study sites Princess Margaret Cancer Centre Toronto Scarborough and Rouge Hospital Scarborough and the University of Calgary Calgary and Aim 1 We will report the proportion of men who are eligible for the preference-based trial who agree to participate overall and by treatment arm and reason for refusal to be randomized
Aim 2Hypotheses 1 and 2 We will compare the participants in the preference-based trial to those in the RCT Comparisons of baseline characteristics will be between the total number of participants in the RCT compared separately to each arm of the preference trial ANOVA will be used for continuous variables and chi-square analysis for categorical variables Variables to be compared include distance from participants home to the study centre age education prior participation in an exercise program and symptom severity Differences will be presented with 95 CIs
Aim 3Hypothesis 3 Within-group change scores will be assessed for the preference-based groups and the mean changes along with the 95CIs will be reported Next we will compare these changes for the co-primary and secondary outcomes between the preference-based groups and the phase III RCT eg combined preference arms to combined RCT arm to obtain the so-called selection-effect Finally although it is subject to confounding by unknown preference effects in the RCT participants we will estimate the differences between outcomes in those randomized to and choosing each specific exercise delivery method using constrained linear mixed effects model adjusting for the baseline value and ADT duration Skewed data will be transformed as appropriate
SIGNIFICANCE Behavioural interventions require significant patient commitment and although most RCTs to date have shown evidence of benefit on various outcomes recruitment rates have been low and many otherwise eligible men are not willing to be randomized for different reasons Designing trials that allow inclusion of such men is obviously going to improve generalizability but whether the results of interventions are similarly effective and understanding the feasibility and potential biases of enrolling such men are fundamental unresolved issues This pilot study will take advantage of an existing trial to begin to answer these questions and determine whether a larger preference-based trial is worth undertaking Our findings have potential widespread implications for behavioural trials across many health care settings
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None