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Continence, Sexual Function, Fitness and the Health of Men After Surgery for Prostate Cancer (CONTROL4LIFE)

Primary Purpose

Prostate Cancer, Incontinence, Metabolic Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pelvic floor exercise program
General exercise
Physical Activity Counseling
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: have a diagnosis of prostate cancer (stage I to IV); be scheduled for a prostatectomy surgery (any surgical approach); have no restriction to participate in at least mild levels of physical activity, as confirmed by the Physical Activity Readiness Questionnaire (PAR-Q+); speak and understand English. adult: 18 years of age or older optional exercise component: willing and able to commit to the 12-week intervention Exclusion Criteria: have any medical conditions that may interfere with continence (i.e. neurological diseases); have any contraindications to exercise testing or training; have recent (>6 months) modifications to any medication aiming to reduce urinary incontinence (i.e. Myrbetric); do not have regular access to the internet and a smart device or a computer at home/ at their community center; are already receiving a pelvic floor exercise program through a pelvic floor physical therapist from their community.

Sites / Locations

  • University of Alberta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Pelvic floor exercise program and general exercise programming

Pelvic floor exercises and standard care (physical activity counseling)

Outcomes

Primary Outcome Measures

Completion Rate
The number of participants completing the study including all planned outcomes

Secondary Outcome Measures

Recruitment rate
Percentage of participants who are eligible and agree to participate
Adherence rate
Adherence to the intervention components
24-hour pad test
Mean: Individual's urine loss by measuring weight (grams) of an absorbent pad
Expanded Prostate Cancer Index Composite for Clinical Practice
16-questions: urinary function, sexual and erectile function, bowel and hormonal function; Scores: 0 (no symptoms) to 60 (most severe symptoms); Higher scores indicate worse functioning
International Consultation on Incontinence Questionnaire
13 questions: occurrence and bother of lower urinary tract symptoms, quality of life; Range of scores: 0-20 voiding subscale; 0-20 incontinence symptoms; Higher scores indicate worse functioning
36-Item Short Form Survey
Quality of life measure: Items are scored 0-100 (percentage of total possible score): Higher scores equal better quality of life
Edmonton Symptom Assessment Scale
11-item ordinal scale; Range 0-60; with higher scores indicating higher symptom burden
Self-efficacy Questionnaire: Incontinence
6 item ordinal scale: Range 0-60; Higher scores indicating higher self-efficacy
Grip Strength
Dyanometer: mean in kgs
Lower body strength
Sit-to-stand: mean number completed in 30 seconds
Upper limb mobility
Shoulder Range of Motion: mean value in degrees
Flexibility
Sit and reach: mean value in cm
Balance
One-leg stance test: mean time in seconds
Walking endurance
Six-minute walk test: mean distance in metres
Body Mass Index
Height and weight will be combined to calculate BMI: mean: weight in kilograms divided by height in metres squared
Glucose
mmol/L (mean value)
Insulin level
mmol/L (mean value)
Lipid profile
Cholesterol level: mg/dL (mean value)
Hemoglobin A1c
Value in percentage (mean value)

Full Information

First Posted
September 12, 2023
Last Updated
October 11, 2023
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT06072911
Brief Title
Continence, Sexual Function, Fitness and the Health of Men After Surgery for Prostate Cancer
Acronym
CONTROL4LIFE
Official Title
Continence, Sexual and Metabolic Health Programming to Promote Prostate Cancer Wellness for Life (CONTROL4LIFE)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 15, 2024 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The Continence, Sexual and Metabolic Health (CONTROL 4 LIFE) study will evaluate the recovery of continence, sexual function, and health outcomes in individuals who have undergone surgery for prostate cancer. The purpose of this study is to better understand the timelines of recovery for these outcomes after surgery for prostate cancer. As part of this study, all participants will receive resources offered by Alberta Health Services regarding pre- and post-prostatectomy care, including information on pelvic floor exercises. Through the CONTROL 4 LIFE study, the investigators will also be evaluating outcomes related to physical activity, fitness and quality of life. These assessments will enable the investigators to better understand how well and how long it takes for individuals to recover after surgery for prostate cancer.
Detailed Description
The investigators aim to conduct a trial examining the feasibility and the effects of a combined pelvic health rehabilitation and exercise program that can be delivered both in-person and virtually in individuals who have been treated with prostatectomy for prostate cancer. This hybrid format will support equitable program delivery regardless of location of residence. To address issues faced by men with prostate cancer, the investigators propose an intervention (offered virtually and in-person) that includes: 1) online education to support continence, sexual and overall health; 2) a group exercise fitness program that considers the needs and restrictions specific to the early post-prostatectomy surgical period, and 3) functional and intensive pelvic floor muscle exercise retraining to promote continence and sexual recovery. Main objectives of this study Determine the feasibility, defined as the acceptability and appropriateness, of a combined pelvic health rehabilitation and exercise fitness program that can be delivered both in-person and virtually. Determine the effects of the program on the primary outcome measure of urinary continence in comparison with usual care. Secondary objectives of this study To determine the effects of the program on cardiometabolic indicators in comparison with usual care. To determine the effects of the program on general fitness, secondary outcomes of urinary continence, sexual function, self-efficacy, and cancer symptom burden, in comparison with usual care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Incontinence, Metabolic Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Zelen design with randomization
Masking
ParticipantOutcomes Assessor
Masking Description
The participants will be randomized after the baseline assessment and will have the option to take part in an additional exercise intervention component.
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Pelvic floor exercise program and general exercise programming
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Pelvic floor exercises and standard care (physical activity counseling)
Intervention Type
Behavioral
Intervention Name(s)
Pelvic floor exercise program
Intervention Description
General exercises will be prescribed along with a specialized pelvic floor program
Intervention Type
Behavioral
Intervention Name(s)
General exercise
Intervention Description
A general progressive resistance exercise program
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity Counseling
Intervention Description
Advice on increasing physical activity
Primary Outcome Measure Information:
Title
Completion Rate
Description
The number of participants completing the study including all planned outcomes
Time Frame
Final assessment at one year
Secondary Outcome Measure Information:
Title
Recruitment rate
Description
Percentage of participants who are eligible and agree to participate
Time Frame
One year
Title
Adherence rate
Description
Adherence to the intervention components
Time Frame
Post-intervention: 12 weeks
Title
24-hour pad test
Description
Mean: Individual's urine loss by measuring weight (grams) of an absorbent pad
Time Frame
24 hours at two time points: immediate post surgery and 12 weeks
Title
Expanded Prostate Cancer Index Composite for Clinical Practice
Description
16-questions: urinary function, sexual and erectile function, bowel and hormonal function; Scores: 0 (no symptoms) to 60 (most severe symptoms); Higher scores indicate worse functioning
Time Frame
One-year
Title
International Consultation on Incontinence Questionnaire
Description
13 questions: occurrence and bother of lower urinary tract symptoms, quality of life; Range of scores: 0-20 voiding subscale; 0-20 incontinence symptoms; Higher scores indicate worse functioning
Time Frame
One-year
Title
36-Item Short Form Survey
Description
Quality of life measure: Items are scored 0-100 (percentage of total possible score): Higher scores equal better quality of life
Time Frame
One-year
Title
Edmonton Symptom Assessment Scale
Description
11-item ordinal scale; Range 0-60; with higher scores indicating higher symptom burden
Time Frame
One year
Title
Self-efficacy Questionnaire: Incontinence
Description
6 item ordinal scale: Range 0-60; Higher scores indicating higher self-efficacy
Time Frame
One year
Title
Grip Strength
Description
Dyanometer: mean in kgs
Time Frame
12 weeks
Title
Lower body strength
Description
Sit-to-stand: mean number completed in 30 seconds
Time Frame
12-weeks
Title
Upper limb mobility
Description
Shoulder Range of Motion: mean value in degrees
Time Frame
12 weeks
Title
Flexibility
Description
Sit and reach: mean value in cm
Time Frame
12-weeks
Title
Balance
Description
One-leg stance test: mean time in seconds
Time Frame
12-weeks
Title
Walking endurance
Description
Six-minute walk test: mean distance in metres
Time Frame
12-weeks
Title
Body Mass Index
Description
Height and weight will be combined to calculate BMI: mean: weight in kilograms divided by height in metres squared
Time Frame
12-weeks
Title
Glucose
Description
mmol/L (mean value)
Time Frame
12-weeks
Title
Insulin level
Description
mmol/L (mean value)
Time Frame
12-weeks
Title
Lipid profile
Description
Cholesterol level: mg/dL (mean value)
Time Frame
12-weeks
Title
Hemoglobin A1c
Description
Value in percentage (mean value)
Time Frame
12-weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: have a diagnosis of prostate cancer (stage I to IV); be scheduled for a prostatectomy surgery (any surgical approach); have no restriction to participate in at least mild levels of physical activity, as confirmed by the Physical Activity Readiness Questionnaire (PAR-Q+); speak and understand English. adult: 18 years of age or older optional exercise component: willing and able to commit to the 12-week intervention Exclusion Criteria: have any medical conditions that may interfere with continence (i.e. neurological diseases); have any contraindications to exercise testing or training; have recent (>6 months) modifications to any medication aiming to reduce urinary incontinence (i.e. Myrbetric); do not have regular access to the internet and a smart device or a computer at home/ at their community center; are already receiving a pelvic floor exercise program through a pelvic floor physical therapist from their community.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret L McNeely
Phone
780-492-6007
Email
mmcneely@ualberta.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Chris Sellar
Phone
780-492-6007
Email
frmace@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Hoy, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Howard Evans, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Margaret McNeely
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be housed on the University of Alberta's Dataverse
IPD Sharing Time Frame
Following completion of the study and primary publication.

Learn more about this trial

Continence, Sexual Function, Fitness and the Health of Men After Surgery for Prostate Cancer

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