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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-99
SponsorUniversity of Surrey

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Exercise

    Behavioral

    8 week exercise intervention, 3x/wk

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: ExerciseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
t= 0, 4, 8, 16 & 30 weeks
2

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.

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

Secondary outcomes

1

Leisure time physical activity

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
2

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).

Time frame
t= 0, 4, 8, 16 & 30 weeks
3

Cardiovascular risk

Qrisk3. Estimation of cardiovascular risk based on demographical and physiological parameters

Time frame
t= 0, 4, 8 weeks
4

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

Time frame
weekly for 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Surrey

Lead sponsor

Royal Surrey County Hospital NHS Foundation Trust

Collaborator