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

NCT ID: NCT05989854

Last Updated: 2024-12-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-06-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Exercise

Exercise arm

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

8 week exercise intervention, 3x/wk

Interventions

Exercise

8 week exercise intervention, 3x/wk

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Royal Surrey County Hospital NHS Foundation Trust

OTHER

Sponsor Role: collaborator

University of Surrey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Surrey

Guildford, Surrey, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Ralph Manders, PhD

Role: CONTACT

r.manders@surrey.ac.uk

+44(0)1483688668

Facility Contacts

Ralph J Manders, PhD

Role: primary

r.manders@surrey.ac.uk

01483688668

Other Identifiers

956732-956714-101614486

Identifier Type: -

Identifier Source: org_study_id