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The Remote Study: Investigating the Effects or Online Exercise on Quality of Life in Men With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of Surrey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring Prostate cancer, Exercise, Online, Quality of Life

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Have had an orchiectomy OR; Are receiving a GnRH agonist/antagonist OR; Are currently receiving Abiraterone, Enzalutamide, Apalutamide or Darolutamide Long-term retention is planned (intending to remain on the above stated treatments for at least the next 6 months). Exclusion Criteria: Patients who are currently classed as in active treatment i.e. are currently receiving chemotherapy/radiation therapy (Note: Patients that are included in the study but after inclusion are moved onto chemo/radiation therapy, will still be able to participate in the project). Patients who are stratified as high risk for having a cardiovascular event. Acute illness; or any musculoskeletal, cardiovascular or neurological disorder that could inhibit or put them at risk from exercising, as determined by screening and their clinician. Men with painful or unstable bony metastases.

Sites / Locations

  • University of Surrey

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise

Arm Description

Exercise arm

Outcomes

Primary Outcome Measures

Functional Assessment of Cancer Therapy-Prostate
Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. Twenty-seven questions about physical, social/family, emotional and functional well-being are graded from 0-4 (0 = not at all; 4 = very much), yielding a total between 0 and 108.
Functional Assessment of Cancer Therapy
Functional Assessment of Cancer Therapy fatigue (FACIT-f) questionnaire. The FACIT-Fatigue is a validated questionnaire that was originally developed for the precise evaluation of fatigue levels in cancer patients with anemia. It consists of 13 questions using a 5 point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). It has been used frequently in the clinical trial setting (please see appendix 1). Responses to each question are added with equal weight to obtain a total score. The range of possible scores is 0-52, with 0 corresponding to the highest level of fatigue and 52 corresponding to the lowest level of fatigue.

Secondary Outcome Measures

Leisure time physical activity
Godin Leisure Time Exercise Questionnaire. This is a 3 question self-report questionnaire - indirect measure of physical activity
Physical activity
The Dukes Activity Status Index. The Duke Activity Status Index (DASI) is a 12-item questionnaire that utilized self-reported physical work capacity to estimate peak metabolic equivalents (METs).
Cardiovascular risk
Qrisk3. Estimation of cardiovascular risk based on demographical and physiological parameters
Exercise adherence
Session adherence. The number of sessions attended, and % of scheduled sessions performed. Every exercise session either completed or not completed over the 8 week intervention period
Health status
eq-5d-5l. It comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels: no problems, slight problems, some problems, severe problems and unable to do. Each level of answer consists of each level of score ranges from 1 to 5. Each participant will have a health status consisting of 5 digits. Using the set of weights from Vietnamese population provided from the EuroGroup, we can convert each EQ-5D health state into a single summary index value. The index value ranges from 0 to 1, higher scores meaning better health quality.

Full Information

First Posted
July 24, 2023
Last Updated
August 9, 2023
Sponsor
University of Surrey
Collaborators
Royal Surrey County Hospital NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05989854
Brief Title
The Remote Study: Investigating the Effects or Online Exercise on Quality of Life in Men With Prostate Cancer
Official Title
An Individualised 8-week Remote Exercise Intervention to Improve QoL, Cardiometabolic Risk and Physical Activity Level in Men With Prostate Cancer Undergoing ADT Treatment.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Surrey
Collaborators
Royal Surrey County Hospital NHS Foundation Trust

4. Oversight

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

5. Study Description

Brief Summary
Currently, there are few opportunities for patients with cancer to have individual exercise guidance, and this has further been impacted by the Covid-19 pandemic. However, during the pandemic the use of virtual/remote platforms has been crucial in delivering care to cancer patients. The investigators think that remote exercise training may also offer a solution to support positive change in prostate cancer patients. As a result, the investigators have developed a remote/online exercise programme to explore this further. This study will explore the effectiveness of an 8-week remote exercise and behavioural support intervention, and whether prostate cancer patients feel they benefit from this. The study also aims to see if this sort of exercise programme can be delivered to more prostate cancer patients in the future. This project is open to men with prostate cancer on long term hormone therapy. The intervention will be comprised of one remote supervised session per week, completed 1-1 using an online platform and up to two additional sessions, depending on its suitability for the patient, will be prescribed as unsupervised home-based exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, Exercise, Online, Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
Exercise arm
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
8 week exercise intervention, 3x/wk
Primary Outcome Measure Information:
Title
Functional Assessment of Cancer Therapy-Prostate
Description
Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. Twenty-seven questions about physical, social/family, emotional and functional well-being are graded from 0-4 (0 = not at all; 4 = very much), yielding a total between 0 and 108.
Time Frame
t= 0, 4, 8, 16 & 30 weeks
Title
Functional Assessment of Cancer Therapy
Description
Functional Assessment of Cancer Therapy fatigue (FACIT-f) questionnaire. The FACIT-Fatigue is a validated questionnaire that was originally developed for the precise evaluation of fatigue levels in cancer patients with anemia. It consists of 13 questions using a 5 point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). It has been used frequently in the clinical trial setting (please see appendix 1). Responses to each question are added with equal weight to obtain a total score. The range of possible scores is 0-52, with 0 corresponding to the highest level of fatigue and 52 corresponding to the lowest level of fatigue.
Time Frame
t= 0, 4, 8, 16 & 30 weeks
Secondary Outcome Measure Information:
Title
Leisure time physical activity
Description
Godin Leisure Time Exercise Questionnaire. This is a 3 question self-report questionnaire - indirect measure of physical activity
Time Frame
t= 0, 4, 8, 16 & 30 weeks
Title
Physical activity
Description
The Dukes Activity Status Index. The Duke Activity Status Index (DASI) is a 12-item questionnaire that utilized self-reported physical work capacity to estimate peak metabolic equivalents (METs).
Time Frame
t= 0, 4, 8, 16 & 30 weeks
Title
Cardiovascular risk
Description
Qrisk3. Estimation of cardiovascular risk based on demographical and physiological parameters
Time Frame
t= 0, 4, 8 weeks
Title
Exercise adherence
Description
Session adherence. The number of sessions attended, and % of scheduled sessions performed. Every exercise session either completed or not completed over the 8 week intervention period
Time Frame
weekly for 8 weeks
Title
Health status
Description
eq-5d-5l. It comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels: no problems, slight problems, some problems, severe problems and unable to do. Each level of answer consists of each level of score ranges from 1 to 5. Each participant will have a health status consisting of 5 digits. Using the set of weights from Vietnamese population provided from the EuroGroup, we can convert each EQ-5D health state into a single summary index value. The index value ranges from 0 to 1, higher scores meaning better health quality.
Time Frame
t= 0, 4, 8, 16 & 30 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have had an orchiectomy OR; Are receiving a GnRH agonist/antagonist OR; Are currently receiving Abiraterone, Enzalutamide, Apalutamide or Darolutamide Long-term retention is planned (intending to remain on the above stated treatments for at least the next 6 months). Exclusion Criteria: Patients who are currently classed as in active treatment i.e. are currently receiving chemotherapy/radiation therapy (Note: Patients that are included in the study but after inclusion are moved onto chemo/radiation therapy, will still be able to participate in the project). Patients who are stratified as high risk for having a cardiovascular event. Acute illness; or any musculoskeletal, cardiovascular or neurological disorder that could inhibit or put them at risk from exercising, as determined by screening and their clinician. Men with painful or unstable bony metastases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ralph Manders, PhD
Phone
+44(0)1483688668
Email
r.manders@surrey.ac.uk
Facility Information:
Facility Name
University of Surrey
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7XH
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralph J Manders, PhD
Phone
01483688668
Email
r.manders@surrey.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No de-identified data will be shared with other researchers to protect patient confidentiality

Learn more about this trial

The Remote Study: Investigating the Effects or Online Exercise on Quality of Life in Men With Prostate Cancer

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