Trial Information

Health Interventions in Men Undergoing Radical Prostatectomy- A Randomized Controlled Clinical Trial

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, namely recovery of erectile function 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.
We expect that our interventions will result in beneficial changes to the patient's overall
health status as represented in the short term by improvements in diet, objective clinical
measurements (such as reduction in weight, blood pressure, serum cholesterol and fasting
serum glucose levels), and overall health-related quality of life. These changes alone
justify having patients participate in a program such as this, but the investigators also
hypothesize that such an intervention will result in improved post-operative urological
outcomes, namely accelerated return of urinary continence and erectile functional recovery.
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 (body mass index [BMI], blood pressure [BP]), metabolic
parameters (fasting serum glucose, serum cholesterol), health-related quality of life,
recovery of erectile function 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 a
surgery, namely radical prostatectomy, there is no existing evidence thus far to support
this suspicion. The investigators hope to prove it with this pilot project. 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, erectile
function and 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.

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 weekly 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.