Clinical trial NCT05989854: The Remote Study: Investigating the Effects or Online Exercise on Quality of Life in Men With Prostate Cancer
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
Exercise
Online
Quality of Life
Lead sponsor: University of Surrey
Sponsor class: OTHER
Collaborators: name: Royal Surrey County Hospital NHS Foundation Trust
First posted: 2023-08-14
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Functional Assessment of Cancer Therapy-Prostate
timeFrame: t= 0, 4, 8, 16 & 30 weeks
measure: Functional Assessment of Cancer Therapy
timeFrame: t= 0, 4, 8, 16 & 30 weeks
Secondary outcomes:
measure: Leisure time physical activity
timeFrame: t= 0, 4, 8, 16 & 30 weeks
measure: Physical activity
timeFrame: t= 0, 4, 8, 16 & 30 weeks
measure: Cardiovascular risk
timeFrame: t= 0, 4, 8 weeks
measure: Exercise adherence
timeFrame: weekly for 8 weeks
measure: Health status
timeFrame: t= 0, 4, 8, 16 & 30 weeks
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: University of Surrey
state: Surrey
Study officials:
References: