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

NCT05989854 | Recruiting

• 1 other identifier: 956732-956714-101614486
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Prostate cancer; Exercise; Online; Quality of Life

Outcome Measures

Primary Outcomes (2)

• 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.

  t= 0, 4, 8, 16 & 30 weeks

• 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.

  t= 0, 4, 8, 16 & 30 weeks

Secondary Outcomes (5)

• Leisure time physical activity

  t= 0, 4, 8, 16 & 30 weeks

• Physical activity

  t= 0, 4, 8, 16 & 30 weeks

• Cardiovascular risk

  t= 0, 4, 8 weeks

• Exercise adherence

  weekly for 8 weeks

• Health status

  t= 0, 4, 8, 16 & 30 weeks

Study Arms (1)

Exercise

EXPERIMENTAL

Exercise arm

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

8 week exercise intervention, 3x/wk

Exercise

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Surrey: lead
• Royal Surrey County Hospital NHS Foundation Trust: collaborator

Study Sites (1)

University of Surrey

Guildford, Surrey, GU2 7XH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Ralph Manders, PhD

CONTACT

+44(0)1483688668; r.manders@surrey.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 14, 2023
• Study Start: April 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)