Health Interventions in Men Undergoing Radical Prostatectomy
| Status: | Withdrawn |
|---|---|
| Conditions: | Prostate Cancer, Cancer, Erectile Dysfunction, Overactive Bladder, Urology |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology, Oncology |
| Healthy: | No |
| Age Range: | 40 - 65 |
| Updated: | 1/27/2017 |
| Start Date: | December 2012 |
| End Date: | July 2014 |
Health Interventions in Men Undergoing Radical Prostatectomy- A Randomized Controlled Clinical Trial
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 and/or 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.
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 and/or 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.
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 health/fitness 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 patient's 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 times/day, 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
instructions/praise/alternatives 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 times/month 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, patient's
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.
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 health/fitness 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 patient's 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 times/day, 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
instructions/praise/alternatives 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 times/month 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, patient's
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.
Inclusion Criteria:
- men 40-65 years of age
- localized prostate cancer (clinical stage < T2b, Gleason grade < 7, pre-operative
prostate specific antigen (PSA) < 10)
- scheduled to undergo curative nerve-sparing prostatectomy at the Johns Hopkins
Hospital
Exclusion Criteria:
- in a stable relationship for at least 6 months
- moderately to severely impaired preoperative erectile function (IIEF-erectile
function domain score < 16)
- answering less than 2-3 times or > to question #6 on the IIEF
- severe lower urinary tract symptoms International Prostate Symptom Score (IPSS) >20
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