Impact of Multimodal Telerehabilitation in Rural Patients With Metastatic Prostate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age21+
SponsorUniversity of Utah
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Telerehabilitation Intervention
Other interventionTheTelerehabilitation Intervention (TR) group utilizes a touchscreen tablet equipped with a computer-guided rehabilitation program that provides ongoing support and feedback for home-based rehabilitation.
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: Telerehabilitation InterventionExperimental treatment 1 intervention
Group B: Best Available CareOther 1 intervention
Trial outcomes
Primary outcomes
1
Functional Assessment of Cancer Therapy-Prostate (FACT-P)
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.
Time frame
up to 6 months from baselineSecondary outcomes
1
30-second Sit-to-Stand Test
To assess functional mobility. The 30-second Sit-to-Stand Test records the number of times a participant can come to a full standing position in 30 seconds. This outcome measure will report mean Sit-to-Stand score.
Time frame
up to 6 months from baseline2
Godin Leisure Score Index
To assess physical activity. Godin Leisure Score Index is a questionnaire to assess time spent in leisure exercise. Godin Leisure Score Index is a continuous index, with a minimum of 0. Lower scores indicate lower activity, and higher scores indicate higher activity. This outcome measure will report the mean Godin Leisure Score Index.
Time frame
up to 6 months from baseline3
8-foot Timed Up and Go
To assess functional fitness in study participants. The 8-foot Timed Up and Go measures the amount of time participants can stand (from a sitting position), walk 8-feet away, walk 8-feet back, and sit down. This outcome measure will report the mean results in seconds.
Time frame
up to 6 months from baseline4
FACIT-Fatigue
To assess self-reported fatigue and its impact on daily activities in study participants. FACIT-Fatigue is a 5-point Likert scale from "0 Not at all" to "4 Very much". FACIT-Fatigue is a 13-item questionnaire with a minimum score of 0 and a maximum score of 52. Lower scores indicate worse QOL, and higher scores indicate better QOL. This outcome measure will report the mean FACIT-Fatigue total score.
Time frame
up to 6 months from baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Utah
Lead sponsor
United States Department of Defense
Collaborator
Huntsman Cancer Institute
Collaborator
Source ClinicalTrials.gov