Ignite Creation Date:
2024-05-06 @ 1:10 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01748110
Status:
WITHDRAWN
Last Update Posted:
2017-01-26
First Post:
2012-12-10
Brief Title:
Health Interventions in Men Undergoing Radical Prostatectomy
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Health Interventions in Men Undergoing Radical Prostatectomy- A Randomized Controlled Clinical Trial
Status:
WITHDRAWN
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding could not be secured
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIM-UP
Brief Summary:
The goal of the study is to assess the impact of a health intervention involving both diet and exercise modification on outcomes following radical prostatectomy for the treatment of clinically localized prostate cancer The specific urological outcomes expected to be improved are accelerated andor improved recovery of erectile function EF as well as urinary continence both very commonly affected by this surgery Furthermore as demonstrated by changes in responses to various questionnaires an improvement in overall health-related quality of life is expected Finally an improvement in patients participating in the intervention groups in physical parameters including body mass index BMI blood pressure BP and metabolic parameters including serum glucose and cholesterol levels is expected
Detailed Description:
This project will assess whether a health-promotion intervention initiated prior to and continuing beyond radical prostatectomy for the treatment of clinically localized prostate cancer results in improvements in overall health health-related quality of life and specific urological outcomes specifically recovery of EF and urinary continence While there is an abundance of literature supporting the harmful impact that obesity has on prostate cancer risk delayed diagnosis surgical outcomes pathological outcomes and overall mortality there is a paucity of data on the impact of healthfitness interventions on immediate post-operative quality of life outcomes
Data supporting the benefit of lifestyle interventions in terms of overall health come from the Look AHEAD trial 1 which demonstrated clinically significant weight loss and improvements in diabetic control and cardiovascular risk factors in obese type 2 diabetics It is expected that this intervention will result in beneficial changes to the participants overall health status as represented in the short term by improvements in objective clinical measurements such as reduction in weight BP serum cholesterol and fasting serum glucose levels and overall health-related quality of life The investigators also hypothesize that such an intervention will result in improved post-operative urological outcomes namely accelerated return of urinary continence and EF Urologists are in a good position to promote healthy living and initiating interventions such as these prior to surgery can provide the foundation of a healthy lifestyle that will enable the patient to maintain the aforementioned benefits well beyond their surgery and extending beyond the urological domain
The goal is to prove that patients participating in one of two lifestyle interventions a more intense health promotion intervention or a less intense text-message program will report improved physical parameters BMI BP metabolic parameters fasting serum glucose serum cholesterol health-related quality of life recovery of EF and urinary continence the latter three as reported by questionnaires compared to patients who are given standard advice prior to radical prostatectomy
Specific Aim To evaluate by means of a randomized controlled clinical trial the relative benefits and costs of an intensive health-promotion intervention compared with a less intensive intervention consisting of regular daily text message health reminders compared with the standard advice given to patients undergoing radical prostatectomy While it is intuitive that healthier patients will feel better and have easier recoveries after radical prostatectomy there is no existing evidence thus far to support this The investigation will apply a single center randomized clinical 18 month study design and employ validated instruments to assess health related quality of life status EF and urinary continence
The study design will be a single center randomized clinical 3-arm study comparing the effects of an intensive lifestyle intervention based on the Look AHEAD regimen vs a less intensive text message intervention vs standard lifestyle advice typically provided prior to radical prostatectomy For the control arm participants will complete post-operative assessments at months 3 6 12 and 18 where they will repeat the baseline questionnaires and measures Please note that for all recruited patients who are not local the follow-up questionnaires will be obtained via mail and the physical parameters will be derived from direct contact with the patients local care provider In the event that this is not possible we will rely on patient self-report Standard practice associated with surgery and postoperative laboratory testing will be performed Patients may use a phosphodiesterase type 5 inhibitor sildenafil tadalafil or vardenafil following surgery as conventional on-demand therapy for erectile dysfunction ED
For the text message Tailored Rapid Interactive Mobile Messaging-TRIMM arm same as above for standard care plus Push and pull-type text messages will be delivered at a frequency of 3-4 timesday starting at least 4 weeks prior to surgery and continuing 8 weeks postoperatively Specific content has been developed and field-tested for acceptability Patients will be asked to select three of seven possible health-related goals targeting specific categories including dietary such as increasing fruit and vegetable consumption exercise such as more walking and behavioral such as less eating in response to stress goals All text message participants will also receive semi-weekly messages related to specific urological goals relating to their surgery such as performing Kegel exercises and maintaining intimate relationships At least one message daily will require a response and targeted feedback will be given based on the response For example participants will be issued a pedometer and asked to record their daily steps If steps reported for the day are above or below goal automatically generated instructionspraisealternatives will be proffered
For the intensive intervention same as standard care plus Weekly meetings starting at least 4 weeks prior to surgery and continuing 8 weeks postoperatively consisting of support group meetings 3 timesmonth using the Look AHEAD curriculum modified to a shorter term intervention plus a monthly individual follow-up visit This individual monthly visit would include a focused evaluation of the participant including review of his goals and feedback on his progress The intensive intervention will provide both relevant diet and exercise education and support for long-term lifestyle changes The intensive intervention will be facilitated by a physician or other trained provider At each monthly visit patients weight will be recorded and a review of their activity and diet logs conducted A topical lesson corresponding to the Look AHEAD curriculum 1 will be given and participants would be given a chance to discuss the lesson and any road-blocks to their progress that have occurred Participants will be issued a pedometer and asked to record their daily steps to be used as a surrogate for physical activity
The sample size will be 25 patients randomized to each study arm There will be a total of 5 arms a total of 125 patients with the study being divided based on patient proximity to the Johns Hopkins Hospital Local patients defined as those patients who are able to be physically present for all of the study sessions as well as follow-up appointments will be randomized to 3 arms control TRIMM and intensive intervention Distant patients defined as patients who are not able to be present for all study sessions as well as follow-up appointments will be randomized to 2 arms control and TRIMM Study procedures will involve screening and informed consent after initial consultation baseline evaluation including medical clearance and completion of validated questionnaires Randomization will be achieved by a computerized random number generator with patients stratified based on age Assessment tools will consist of the IIEF questionnaire the Quality of Erection Questionnaire QEQ and health related quality of life instruments RAND 12-item Health Survey SF-12 and the Expanded Prostate Cancer index Composite Short Form EPIC-26-sexual and urinary domains Standard practice associated with surgery blood transfusion and postoperative laboratory testing will be performed Patients will be prescribed a phosphodiesterase type 5 inhibitor sildenafil tadalafil or vardenafil at 1 month following surgery to be used as conventional on-demand therapy Adverse event monitoring will be performed
Data supporting the benefit of lifestyle interventions in terms of overall health come from the Look AHEAD trial 1 which demonstrated clinically significant weight loss and improvements in diabetic control and cardiovascular risk factors in obese type 2 diabetics It is expected that this intervention will result in beneficial changes to the participants overall health status as represented in the short term by improvements in objective clinical measurements such as reduction in weight BP serum cholesterol and fasting serum glucose levels and overall health-related quality of life The investigators also hypothesize that such an intervention will result in improved post-operative urological outcomes namely accelerated return of urinary continence and EF Urologists are in a good position to promote healthy living and initiating interventions such as these prior to surgery can provide the foundation of a healthy lifestyle that will enable the patient to maintain the aforementioned benefits well beyond their surgery and extending beyond the urological domain
The goal is to prove that patients participating in one of two lifestyle interventions a more intense health promotion intervention or a less intense text-message program will report improved physical parameters BMI BP metabolic parameters fasting serum glucose serum cholesterol health-related quality of life recovery of EF and urinary continence the latter three as reported by questionnaires compared to patients who are given standard advice prior to radical prostatectomy
Specific Aim To evaluate by means of a randomized controlled clinical trial the relative benefits and costs of an intensive health-promotion intervention compared with a less intensive intervention consisting of regular daily text message health reminders compared with the standard advice given to patients undergoing radical prostatectomy While it is intuitive that healthier patients will feel better and have easier recoveries after radical prostatectomy there is no existing evidence thus far to support this The investigation will apply a single center randomized clinical 18 month study design and employ validated instruments to assess health related quality of life status EF and urinary continence
The study design will be a single center randomized clinical 3-arm study comparing the effects of an intensive lifestyle intervention based on the Look AHEAD regimen vs a less intensive text message intervention vs standard lifestyle advice typically provided prior to radical prostatectomy For the control arm participants will complete post-operative assessments at months 3 6 12 and 18 where they will repeat the baseline questionnaires and measures Please note that for all recruited patients who are not local the follow-up questionnaires will be obtained via mail and the physical parameters will be derived from direct contact with the patients local care provider In the event that this is not possible we will rely on patient self-report Standard practice associated with surgery and postoperative laboratory testing will be performed Patients may use a phosphodiesterase type 5 inhibitor sildenafil tadalafil or vardenafil following surgery as conventional on-demand therapy for erectile dysfunction ED
For the text message Tailored Rapid Interactive Mobile Messaging-TRIMM arm same as above for standard care plus Push and pull-type text messages will be delivered at a frequency of 3-4 timesday starting at least 4 weeks prior to surgery and continuing 8 weeks postoperatively Specific content has been developed and field-tested for acceptability Patients will be asked to select three of seven possible health-related goals targeting specific categories including dietary such as increasing fruit and vegetable consumption exercise such as more walking and behavioral such as less eating in response to stress goals All text message participants will also receive semi-weekly messages related to specific urological goals relating to their surgery such as performing Kegel exercises and maintaining intimate relationships At least one message daily will require a response and targeted feedback will be given based on the response For example participants will be issued a pedometer and asked to record their daily steps If steps reported for the day are above or below goal automatically generated instructionspraisealternatives will be proffered
For the intensive intervention same as standard care plus Weekly meetings starting at least 4 weeks prior to surgery and continuing 8 weeks postoperatively consisting of support group meetings 3 timesmonth using the Look AHEAD curriculum modified to a shorter term intervention plus a monthly individual follow-up visit This individual monthly visit would include a focused evaluation of the participant including review of his goals and feedback on his progress The intensive intervention will provide both relevant diet and exercise education and support for long-term lifestyle changes The intensive intervention will be facilitated by a physician or other trained provider At each monthly visit patients weight will be recorded and a review of their activity and diet logs conducted A topical lesson corresponding to the Look AHEAD curriculum 1 will be given and participants would be given a chance to discuss the lesson and any road-blocks to their progress that have occurred Participants will be issued a pedometer and asked to record their daily steps to be used as a surrogate for physical activity
The sample size will be 25 patients randomized to each study arm There will be a total of 5 arms a total of 125 patients with the study being divided based on patient proximity to the Johns Hopkins Hospital Local patients defined as those patients who are able to be physically present for all of the study sessions as well as follow-up appointments will be randomized to 3 arms control TRIMM and intensive intervention Distant patients defined as patients who are not able to be present for all study sessions as well as follow-up appointments will be randomized to 2 arms control and TRIMM Study procedures will involve screening and informed consent after initial consultation baseline evaluation including medical clearance and completion of validated questionnaires Randomization will be achieved by a computerized random number generator with patients stratified based on age Assessment tools will consist of the IIEF questionnaire the Quality of Erection Questionnaire QEQ and health related quality of life instruments RAND 12-item Health Survey SF-12 and the Expanded Prostate Cancer index Composite Short Form EPIC-26-sexual and urinary domains Standard practice associated with surgery blood transfusion and postoperative laboratory testing will be performed Patients will be prescribed a phosphodiesterase type 5 inhibitor sildenafil tadalafil or vardenafil at 1 month following surgery to be used as conventional on-demand therapy Adverse event monitoring will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None