NCT07032584 · University of Utah
Impact of Multimodal Telerehabilitation in Rural Patients With Metastatic Prostate Cancer
What this study is about
People with prostate cancer may have a decreased quality of life due to the cancer itself and due to a lifesaving cancer treatment. Physical therapy, including regular exercise, helps patients with cancer to reduce disease symptoms and improve their quality of life.
View original scientific description
People with prostate cancer may have a decreased quality of life due to the cancer itself and due to a lifesaving cancer treatment. Physical therapy, including regular exercise, helps patients with cancer to reduce disease symptoms and improve their quality of life. However, cancer rehabilitation programs in rural areas are not readily available and may require constant travel and significant financial resources, which may limit access to these services on a continuous basis. Technology can allow patients residing in rural areas to exercise at home under the supervision of their rehabilitation team. However, it is unclear how effective this approach is. This research team will conduct a clinical trial in which half of the randomly chosen participants receiving hormonal prostate cancer therapy will use this new technology to exercise at home. Another half - will exercise at home without this new technology. After six months, the study will compare the quality of life and cancer symptoms in these two groups. The investigators hope that this study will demonstrate that the patients who were helped by the new technology to exercise at home will have better fitness, fewer symptoms, and better quality of life. If the study demonstrates this in this project, other patients with cancer residing in rural areas will be able to take advantage of this technology. This approach can be extended to people with different diseases who have difficulties accessing medical care in rural areas to undergo required physical, cognitive, and occupational rehabilitation, and improve their quality of life.
Interventions
OTHER
Telerehabilitation Intervention
TheTelerehabilitation Intervention (TR) group utilizes a touchscreen tablet equipped with a computer-guided rehabilitation program that provides ongoing support and feedback for home-based rehabilitation.
Primary outcome measures
Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Time frame: up to 6 months from baseline
To assess disease-specific quality of life (QOL) in prostate cancer patients. FACT-P is a 5-point Likert scale from "0 Not at all" to "4 Very much". The FACT-P is a 39-item questionnaire with a minimum score of 0 and a maximum score of 156. Lower scores indicate worse QOL, and higher scores indicate better QOL. This outcome measure will report mean FACT-P total score.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 21 years or older
- Confirmed diagnosis of prostate cancer
- Men receiving standard-of-care ADT either for high-risk, locally advanced prostate cancer or as a part of multicomponent management of metastatic prostate cancer;
- Residing in a rural community defined by the Rural-Urban Commuting Area (RUCA) codes from the Federal Office of Rural Health Policy (4 and higher).
Exclusion criteria
- Have unstable angina, uncontrolled hypertension, recent myocardial infarction, pacemakers, painful or unstable bony metastases, or recent skeletal fractures.
- Are engaged in a regular exercise rehabilitation program.
- Have relocation plans within the next 6 months
- Participate in another clinical trial related to prostate cancer or rehabilitation. The patients will also be required to have a working telephone line in their home or a cell phone.
Where
- Salt Lake City, Utah
Collaborators
United States Department of Defense, Huntsman Cancer Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 1, 2025 · Source of record for eligibility and locations