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Trial Title:
The Remote Study: Investigating the Effects or Online Exercise on Quality of Life in Men With Prostate Cancer
NCT ID:
NCT05989854
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Prostate cancer
Exercise
Online
Quality of Life
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Exercise
Description:
8 week exercise intervention, 3x/wk
Arm group label:
Exercise
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.
Criteria for 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Surrey
Address:
City:
Guildford
Zip:
GU2 7XH
Country:
United Kingdom
Contact:
Last name:
Ralph J Manders, PhD
Phone:
01483688668
Email:
r.manders@surrey.ac.uk
Start date:
October 2023
Completion date:
September 2024
Lead sponsor:
Agency:
University of Surrey
Agency class:
Other
Collaborator:
Agency:
Royal Surrey County Hospital NHS Foundation Trust
Agency class:
Other
Source:
University of Surrey
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05989854