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

Prostate Cancer Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05989854
• Other study ID #: 956732-956714-101614486
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: September 2024

Study information

• Verified date: August 2023
• Source: University of Surrey
• Contact: Ralph Manders, PhD
• Phone: +44(0)1483688668
• Email: r.manders[@]surrey.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Exercise
8 week exercise intervention, 3x/wk

Locations

Country	Name	City	State
United Kingdom	University of Surrey	Guildford	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
University of Surrey	Royal Surrey County Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Leisure time physical activity	Godin Leisure Time Exercise Questionnaire. This is a 3 question self-report questionnaire - indirect measure of physical activity	t= 0, 4, 8, 16 & 30 weeks
Secondary	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).	t= 0, 4, 8, 16 & 30 weeks
Secondary	Cardiovascular risk	Qrisk3. Estimation of cardiovascular risk based on demographical and physiological parameters	t= 0, 4, 8 weeks
Secondary	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	weekly for 8 weeks
Secondary	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.	t= 0, 4, 8, 16 & 30 weeks