Prehabilitation in Prostate Cancer Patients, TelePrehabTrial
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Physical Exercise
Pelvic Floor exercise
Sexual counseling
Nutritional supplement
Stress management
Standard pre-surgical preparation and pt. information.
Sponsored by
About this trial
This is an interventional other trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria: Male > 18 years Diagnosed with prostate cancer and referred to robot assisted nerve sparring RP Adequacy in written and spoken Danish Cognitively well-functioning Able to understand the study procedures and willing to provide signed informed consent Exclusion Criteria: Severe comorbidities that would prevent the patient from exercising, e.g. recent fractures, severe heart disease or neurological disorders. No possibility to use a smartphone or tablet.
Sites / Locations
- Regional Hospital GoedstrupRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention Group
Control Group
Arm Description
Outcomes
Primary Outcome Measures
Recruitment rate
Percentage of eligible patients who accepted to participate in the study. Recruitment rate is measured by dividing the number of patients consented by the number of patients screened.
Protocol adherence, assessed by study-specific questionnaire
The pt. will every week register his adherence to the intervention protocol. The number of intervention components which were not fulfilled during the prehabilitation period will be counted, and the percentage of deviation will be calculated compared to the total number of intervention components.
Number of participants who received the nutritional and mental health intervention.
Total number of participants who after the initial screening, needed the Nutritional and Mental Health intervention.
Retention rate
Percentage of participants completing the full prehabilitation period, and full follow-up after the surgery. Retention rate is measured by dividing the number of patients completing the study with the number of patients consented.
Secondary Outcome Measures
6-minute-walk-test (6MWT)
The 6MWT is a performance-based sub-maximal exercise test, used to assess aerobic capacity and endurance. The test covers the distance a person can walk on a 30-meters walkway, in the time of 6 minutes.
30 seconds sit-to-stand test (30STS)
30STS test is used to assess the leg strength and endurance. The test discovers how many times a person is able to rise up and sit down from a chair within 30 seconds.
Grip strength test
Grip strength is a measure of muscular strength or the maximum force/tension generated by the forearm muscles.
Self-reported physical activity
A questionnaire measuring physical activity consisting of three questions designed by The Swedish National Board of Health and Welfare (BHW).
Hospital Anxiety and Depression Scale (HADS)
Hospital Anxiety and Depression Scale is a questionnaire used to identify anxiety disorders and depression among patients in nonpsychiatric hospital clinics. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains.
12-Item short form Health Survey (SF-12)
The SF-12 is a short form of the 36-Item Short-form Health Survey (SF-36). It contains 12 items, and is a patient-reported survey of the patient's perception of health related quality of life, during the last 4 weeks.
5-Item International Index of Erectile Function (IIEF-5)
IIEF-5 is an abridged five-item version of the International Index of Erectile Function. It is a self-administered, multi-dimensional measure of erectile function.
24-hour Pad Weigh Test
The 24-hour Pad Weigh Test is used to investigate urinary incontinence.
Nutritional Risk Screening
NRS-2002 is a validated tool for nutritional screening of patients between 18 and 90 years of age.
Full Information
NCT ID
NCT05608746
First Posted
October 25, 2022
Last Updated
November 18, 2022
Sponsor
University of Aarhus
Collaborators
Gødstrup Hospital, Aarhus University, Institute of Clinical Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05608746
Brief Title
Prehabilitation in Prostate Cancer Patients, TelePrehabTrial
Official Title
Prehabilitation in Prostate Cancer Patients Undergoing Nerve Sparring Robot Assisted Radical Prostatectomy.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Gødstrup Hospital, Aarhus University, Institute of Clinical Medicine
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
Localized prostate cancer is commonly treated with radical prostatectomy (RP). Following surgery adverse effects such as urinary incontinence, erectile dysfunction associated with decreased quality of life and decreased physical function are common.
Traditionally, interventions to reduce these adverse effects are introduced postoperatively. However, a growing body of literature shows the benefit of interventions prior to surgery to enhance treatment success, known as prehabilitation.
Hence, the main purpose of this study is to develop and investigate the feasibility of prehabilitation using telehealth, to implement several interventions prior to elective RP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Physical Exercise
Intervention Description
Home-based individualized training, consisting of unsupervised aerobic exercise and resistance exercise, with moderate intensity. The pt. receives an exercise manual and exercise videos online, through an APP.
Intervention Type
Other
Intervention Name(s)
Pelvic Floor exercise
Intervention Description
Patients will be assessed by a physiotherapist and instructed in a pelvic floor exercise program, accessed through the APP. Furthermore, the pt. is provided with general information about pelvic floor anatomy and muscle function.
Intervention Type
Other
Intervention Name(s)
Sexual counseling
Intervention Description
Patients will be provided with 1 video-consultation with a clinical sexologist, during the prehabilitation period. The patients will be instructed in strategies to improve postoperative communication regarding, sex, realistic expectations, erectile dysfunction and the use of aids.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional supplement
Intervention Description
Patients are systematically screened for malnutrition to assess the nutritional status. Patients are given recommendations with dietary advice online, through the APP. If the patient is at nutritional risk, the patient is provided with a nutritional supplement.
Intervention Type
Other
Intervention Name(s)
Stress management
Intervention Description
Patients are systematically screened for anxiety and depression. If patients are at risk of anxiety or depression, they are referred to a consultation with a nurse, who will provide information and strategies to handle the uncertainties they may experience.
Intervention Type
Other
Intervention Name(s)
Standard pre-surgical preparation and pt. information.
Intervention Description
One week preoperatively the usual regime for the presurgical preparation and information will be followed.
Primary Outcome Measure Information:
Title
Recruitment rate
Description
Percentage of eligible patients who accepted to participate in the study. Recruitment rate is measured by dividing the number of patients consented by the number of patients screened.
Time Frame
24 months
Title
Protocol adherence, assessed by study-specific questionnaire
Description
The pt. will every week register his adherence to the intervention protocol. The number of intervention components which were not fulfilled during the prehabilitation period will be counted, and the percentage of deviation will be calculated compared to the total number of intervention components.
Time Frame
24 months
Title
Number of participants who received the nutritional and mental health intervention.
Description
Total number of participants who after the initial screening, needed the Nutritional and Mental Health intervention.
Time Frame
24 months
Title
Retention rate
Description
Percentage of participants completing the full prehabilitation period, and full follow-up after the surgery. Retention rate is measured by dividing the number of patients completing the study with the number of patients consented.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
6-minute-walk-test (6MWT)
Description
The 6MWT is a performance-based sub-maximal exercise test, used to assess aerobic capacity and endurance. The test covers the distance a person can walk on a 30-meters walkway, in the time of 6 minutes.
Time Frame
12 months
Title
30 seconds sit-to-stand test (30STS)
Description
30STS test is used to assess the leg strength and endurance. The test discovers how many times a person is able to rise up and sit down from a chair within 30 seconds.
Time Frame
12 months
Title
Grip strength test
Description
Grip strength is a measure of muscular strength or the maximum force/tension generated by the forearm muscles.
Time Frame
12 months
Title
Self-reported physical activity
Description
A questionnaire measuring physical activity consisting of three questions designed by The Swedish National Board of Health and Welfare (BHW).
Time Frame
12 months
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Hospital Anxiety and Depression Scale is a questionnaire used to identify anxiety disorders and depression among patients in nonpsychiatric hospital clinics. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains.
Time Frame
12 months
Title
12-Item short form Health Survey (SF-12)
Description
The SF-12 is a short form of the 36-Item Short-form Health Survey (SF-36). It contains 12 items, and is a patient-reported survey of the patient's perception of health related quality of life, during the last 4 weeks.
Time Frame
12 months
Title
5-Item International Index of Erectile Function (IIEF-5)
Description
IIEF-5 is an abridged five-item version of the International Index of Erectile Function. It is a self-administered, multi-dimensional measure of erectile function.
Time Frame
12 months
Title
24-hour Pad Weigh Test
Description
The 24-hour Pad Weigh Test is used to investigate urinary incontinence.
Time Frame
6, 24 and 50 weeks post surgery.
Title
Nutritional Risk Screening
Description
NRS-2002 is a validated tool for nutritional screening of patients between 18 and 90 years of age.
Time Frame
At baseline (4 weeks before the surgery).
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male > 18 years
Diagnosed with prostate cancer and referred to robot assisted nerve sparring RP
Adequacy in written and spoken Danish
Cognitively well-functioning
Able to understand the study procedures and willing to provide signed informed consent
Exclusion Criteria:
Severe comorbidities that would prevent the patient from exercising, e.g. recent fractures, severe heart disease or neurological disorders.
No possibility to use a smartphone or tablet.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Malene Blumenau Pedersen, Phd student
Phone
+45 78430568
Email
malblu@rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Jørgen Bjerggaard Jensen, Professor
Phone
+45 30915682
Email
bjerggaard@skejby.rm.dk
Facility Information:
Facility Name
Regional Hospital Goedstrup
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malene B. Pedersen
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prehabilitation in Prostate Cancer Patients, TelePrehabTrial
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