NCT07093177 · University of Utah
Multimodal Telerehabilitation of Rural Patients With Advanced Prostate Cancer
What this study is about
Prostate cancer has a significant impact on patient quality of life (QoL) directly, as well as through the management of localized disease (such as surgery and radiation-related incontinence, erectile dysfunction, and bowel dysfunction), and via direct side effects of androgen deprivation therapy (ADT) resulting in a considerable physical and psychological burden.
View original scientific description
Prostate cancer has a significant impact on patient quality of life (QoL) directly, as well as through the management of localized disease (such as surgery and radiation-related incontinence, erectile dysfunction, and bowel dysfunction), and via direct side effects of androgen deprivation therapy (ADT) resulting in a considerable physical and psychological burden. Recent studies demonstrated the efficacy of multimodal rehabilitation for functional recovery, improvements in QoL, reduction in cancer symptoms, and secondary and tertiary prevention. Despite the mounting evidence regarding the benefits of multimodal rehabilitation for this population, multiple barriers limit the access of prostate cancer survivors to cancer rehabilitation, especially in rural areas. This study is a pilot study to assess usability, acceptability, and exercise adherence in 12-week multimodal telerehabilitation in patients receiving ADT with either high-risk or metastatic prostate cancer residing in rural areas.
Interventions
BEHAVIORAL
Telerehabilitation Unit
Telerehabilitation is the use of information and communication technology (ICT) to deliver rehabilitation services remotely in participants' homes or other settings. A telerehab unit consists of a touchscreen tablet, a portable bike, elastic bands, and a pulse oximeter. A mobile Wi-Fi hotspot device will be provided for participants who have limited or no internet connection for the duration of the study. The telerehab unit is designed to work in areas with limited internet connectivity as all multimedia materials are stored locally on the tablet.
Primary outcome measures
Acceptability
Time frame: up to 12-week after initiation of study intervention
To evaluate system usability, acceptability, and exercise adherence of 12-week multimodal telerehabilitation. The acceptability of telerehabilitation will be assessed using the Client Satisfaction Questionnaire (CSQ). The CSQ is an 8-item questionnaire measuring the acceptability and patient satisfaction of the multimodal telerehabilitation. CSQ scores range from 8 to 32, with lower scores indicating lower satisfaction and higher scores indicating better satisfaction. An average CSQ score \> 20 will indicate satisfactory acceptability.
Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Time frame: up to 12-week after initiation of study intervention
To assess the range of responses to the telerehabilitation program by measuring disease-specific quality of life (QOL). 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 the 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 18 and 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, as indicated by zip code in RUCA areas
Exclusion criteria
- Unstable angina, uncontrolled hypertension, recent myocardial infarction, pacemakers, painful or unstable bony metastases, or recent skeletal fractures
- Engaged in a regular exercise rehabilitation program
- Relocation plans within next 3 months
- Participating in another clinical trial
- Have a working telephone line in their home or a cell phone.
Where
- Salt Lake City, Utah
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 Apr 13, 2026 · Source of record for eligibility and locations