Health Interventions in Men Undergoing Radical Prostatectomy

NCT01748110 | Withdrawn

• 1 other identifier: NA_00070555
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Prostate Cancer; Erectile Dysfunction Following Radical Prostatectomy; Urinary Incontinence

Keywords

quality of life; erectile function

Outcome Measures

Primary Outcomes (12)

• Change in erectile function (EF)

  The International Index of Erectile Function (IIEF) will be administered. This is a 15 item questionnaire . The questionnaire measures Erectile Function (scored from 0-30), Intercourse satisfaction (0-15), orgasmic function (0-10), Sexual Desire (2-10) and Overall satisfaction (2-10).

  From baseline (4 weeks before surgery) to 3 months after surgery

• Change in EF

  The International Index of Erectile Function (IIEF) will be administered. This is a 15 item questionnaire . The questionnaire measures Erectile Function (scored from 0-30), Intercourse satisfaction (0-15), orgasmic function (0-10), Sexual Desire (2-10) and Overall satisfaction (2-10).

  From baseline (4 weeks before surgery) to 6 months after surgery

• Change in EF

  The International Index of Erectile Function (IIEF) will be administered. This is a 15 item questionnaire . The questionnaire measures Erectile Function (scored from 0-30), Intercourse satisfaction (0-15), orgasmic function (0-10), Sexual Desire (2-10) and Overall satisfaction (2-10).

  From baseline (4 weeks before surgery) to 12 months after surgery

• Change in EF

  The International Index of Erectile Function (IIEF) will be administered. This is a 15 item questionnaire . The questionnaire measures Erectile Function (scored from 0-30), Intercourse satisfaction (0-15), orgasmic function (0-10), Sexual Desire (2-10) and Overall satisfaction (2-10).

  From baseline (4 weeks before surgery) to 18 months after surgery

• Change in EF

  The Quality of Erection (QEL) questionnaire will be administered. This is a 6 item questionnaire addressing the patient's perception of erectile rigidity during sexual activity. It is scored from 0-100 with 100 indicating the highest quality erection

  From baseline (4 weeks before surgery) to 3 months after surgery

• Change in EF

  The Quality of Erection (QEL) questionnaire will be administered. This is a 6 item questionnaire addressing the patient's perception of erectile rigidity during sexual activity. It is scored from 0-100 with 100 indicating the highest quality erection

  From baseline (4 weeks before surgery) to 6 months after surgery

• Change in EF

  The Quality of Erection (QEL) questionnaire will be administered. This is a 6 item questionnaire addressing the patient's perception of erectile rigidity during sexual activity. It is scored from 0-100 with 100 indicating the highest quality erection

  From baseline (4 weeks before surgery) to 12 months after surgery

• Change in EF

  The Quality of Erection (QEL) questionnaire will be administered. This is a 6 item questionnaire addressing the patient's perception of erectile rigidity during sexual activity. It is scored from 0-100 with 100 indicating the highest quality erection

  From baseline (4 weeks before surgery) to 18 months after surgery

• Change in Urinary function

  The expanded prostate cancer index (EPIC-26) urinary domain will be administered. This is a 7 item questionnaire addressing the patient's perception of their urinary function over the previous 4 weeks. Higher scores indicate a greater degree of urinary dysfunction

  From baseline (4 weeks before surgery) to 3 months after surgery

• Change in Urinary function

  The expanded prostate cancer index (EPIC-26) urinary domain will be administered. This is a 7 item questionnaire addressing the patient's perception of their urinary function over the previous 4 weeks. Higher scores indicate a greater degree of urinary dysfunction

  From baseline (4 weeks before surgery) to 6 months after surgery

• Change in Urinary function

  The expanded prostate cancer index (EPIC-26) urinary domain will be administered. This is a 7 item questionnaire addressing the patient's perception of their urinary function over the previous 4 weeks. Higher scores indicate a greater degree of urinary dysfunction

  From baseline (4 weeks before surgery) to 12 months after surgery

• change in urinary function

  The expanded prostate cancer index (EPIC-26) urinary domain will be administered. This is a 7 item questionnaire addressing the patient's perception of their urinary function over the previous 4 weeks. Higher scores indicate a greater degree of urinary dysfunction

  From baseline (4 weeks before surgery) to 18 months after surgery

Secondary Outcomes (24)

• change in health related quality of life

  From baseline (4 weeks before surgery) to 3 months after surgery

• change in health related quality of life

  From baseline (4 weeks before surgery) to 6 months after surgery

• change in health related quality of life

  From baseline (4 weeks before surgery) to 12 months after surgery

• change in health related quality of life

  From baseline (4 weeks before surgery) to 18 months after surgery

• change in sexual satisfaction

  From baseline (4 weeks before surgery) to 3 months after surgery

Study Arms (5)

Local Control Group

NO INTERVENTION

This arm is for patients in the District of Columbia (DC), (Maryland) MD, (Virginia) VA area that are able to attend all follow up visits at 3 month, 6 month, 12 month and 18 months post operative periods that have been randomized to standard recommendations for fitness/health interventions prior to surgery.

Local TRIMM Group

EXPERIMENTAL

This arm is for patients in the DC, MD, VA area that are able to attend all follow up visits at 3 month, 6 month, 12 month and 18 months post operative periods that have been randomized to receive daily text message reminder and prompts targeted to the patient's dietary, fitness and urologic goals and needs using the Tailored Rapid Interactive Mobile Messaging (TRIMM) method. Patients will receive these text messages from 4 weeks prior to surgery until 8 week after surgery

Behavioral: TRIMM

Local Intensive Group

EXPERIMENTAL

This arm is for patients in the DC, MD, VA area that are able to attend all follow up visits at 3 month, 6 month, 12 month and 18 months post operative periods that have been randomized to undergo intensive in-person fitness interventions according to the Look AHEAD model. This will involve attendance at weekly support group meetings and personal monthly meetings with a health care provider/

Behavioral: Intensive Fitness Intervention

Distant Control Group

NO INTERVENTION

This arm is for geographically distant patients that are unable to attend all follow up visits at 3 month, 6 month, 12 month and 18 months post operative periods that have been randomized to standard recommendations for fitness/health interventions prior to surgery.

Distant TRIMM Group

EXPERIMENTAL

This arm is for geographically distant patients that are unable to attend all follow up visits at 3 month, 6 month, 12 month and 18 months post operative periods that have been randomized to receive daily text message reminder and prompts targeted to the patient's dietary, fitness and urologic goals and needs using the Tailored Rapid Interactive Mobile Messaging (TRIMM) method. Patients will receive these text messages from 4 weeks prior to surgery until 8 week after surgery

Behavioral: TRIMM

Interventions

Intensive Fitness Intervention BEHAVIORAL

This intervention will involve adhering to health interventions such as behavior and diet modification, and exercise. Patients will follow-up monthly with a health counselor to verify progress.

Also known as: Look AHEAD model

Local Intensive Group

TRIMM BEHAVIORAL

text message intervention.

Also known as: Tailored Rapid Interactive Mobile Messaging

Distant TRIMM Group; Local TRIMM Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Incontinence

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arthur L Burnett, MD, MBA

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: December 12, 2012
• Study Start: December 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 26, 2017

Record last verified: 2017-01

Locations

US (1)