Prostate CancerNCT07093177
Multimodal Telerehabilitation of Rural Patients With Advanced Prostate Cancer
A study testing Telerehabilitation Unit in people with Prostate Cancer, run by University of Utah at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Telerehabilitation Unit
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112
Manish Kohli, MD, 801-646-4018, Manish.Kohli@hci.utah.edu
Manish Kohli, MD
About this study
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.
Read the detailed 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.
Telemedicine approaches have the potential to improve access to cancer rehabilitation. This research team's previous studies showed a high acceptance of home-based telerehabilitation in older adults with chronic health conditions and a positive impact on QoL. In recent pilot usability studies, we demonstrated that multimodal telerehabilitation is well-accepted by patients with advanced bladder cancer who expressed strong interest in home-based cancer telerehabilitation. However, the feasibility of multimodal telerehabilitation in patients with advanced prostate cancer residing in rural areas has not been studied systematically. Additionally, barriers and facilitators of implementing prostate cancer telerehabilitation in rural areas are not well understood and require further exploration.
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.
The enrolled patients will have access to a tailored cancer rehabilitation program via a home-based telerehabilitation system, remote supervision, and interactive education and counseling sessions to enhance support and adherence. A comprehensive assessment by a physical therapist will be conducted remotely using the previously validated app. After the initial assessment, the patients will be individually prescribed resistance and aerobic exercises based on metastasis location, pain, fatigue, and current fitness levels. Physical exercises specific to prostate cancer, such as pelvic floor exercises, will be tailored to individual impairments. Interactive education on exercise benefits and safety, behavioral change strategies, principles of lifestyle changes, and vocational, cognitive, and sexual rehabilitation will be provided via the telerehabilitation system. Social support will be delivered via group tele-counseling sessions. Automated analysis of daily exercise logs will alert the telerehabilitation team about low exercise adherence and prompt tailored feedback to the patients. As in this research team's previous interventions, support will be available throughout the study to assist patients in using the telerehabilitation system successfully.
- Conditions
- Prostate Cancer
- Being tested
- Telerehabilitation Unit
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation UnitBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Telerehabilitation | Experimental | Participation in a remote telerehabilitation program for 12 weeks.
Based on the remote physical therapy assessment, a physical therapist will prescribe an individualized rehabilitation plan to each participant. Exercise regimens, lengths of sessions, repetition counts, and frequency of workouts may be tailored depending on individual needs and capabilities. Receives: Behavioral: Telerehabilitation Unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
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.
Measured: up to 12-week after initiation of study intervention
Functional Assessment of Cancer Therapy-Prostate (FACT-P)
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.
Measured: up to 12-week after initiation of study intervention
Secondary outcomes (18)
System Usability Score
To evaluate system usability, acceptability, and exercise adherence of 12-week multimodal telerehabilitation.
The System Usability Score is a 10-item questionnaire to evaluate the perceived usability of the multimodal telerehabilitation. The System Usability Score ranges from 0 to 100, with lower scores indicating worse usability and higher scores indicating better usability. An average SUS score > 68 will indicate satisfactory usability.
This outcome measure will report the mean System Usability Score.
Measured: up to 12-week after initiation of study intervention
Exercise Adherence
To evaluate system usability, acceptability, and exercise adherence of 12-week multimodal telerehabilitation.
Participants will complete daily exercise logs to assess their adherence to their telerehabilitation protocol. Individual exercise adherence will be calculated by dividing the number of days the patient exercised using the HAT system by the total number of days the patients were expected to exercise (12 weeks x 3 days per week to exercise = 36 days total). The overall exercise adherence will be considered satisfactory if at least 75% of patients had individual exercise adherence > 70%.
This outcome measure will report mean exercise adherence.
Measured: up to 12-week after initiation of study intervention
30-second Sit-to-Stand Test
To assess the range of responses to the telerehabilitation program by measuring functional fitness before and after the intervention.
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 the mean Sit-to-Stand score.
Measured: up to 12-week after initiation of study intervention
8-foot Timed Up and Go
To assess the range of responses to the telerehabilitation program by measuring functional fitness before and after the intervention.
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.
Measured: up to 12-week after initiation of study intervention
Activity Tracker
To assess the range of responses to the telerehabilitation program by measuring functional fitness before and after the intervention.
Participants will be provided with an activity tracker (i.e., Fitbit), and the activity logs will be extracted to assess physical activity. The Fitbit has been validated as a measure of physical activity in men with prostate cancer.
This outcome measure will report the mean moderate-to-vigorous physical activity (MVPA; minutes/day) measured from participants' Fitbit.
Measured: up to 12-week after initiation of study intervention
Godin Leisure Score Index
To assess the range of responses to the telerehabilitation program by measuring functional fitness before and after the intervention.
Physical activity will be measured using the Godin Leisure Score Index, which is a validated short questionnaire used to measure leisure-time physical activity in cancer research. 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.
Measured: up to 12-week after initiation of study intervention
FACIT-Fatigue scale
To assess the range of responses to the telerehabilitation program by measuring cancer symptoms before and after the intervention.
This measure will 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.
Measured: up to 12-week after initiation of study intervention
Brief Pain Inventory (BPI)
To assess the range of responses to the telerehabilitation program by measuring cancer symptoms before and after the intervention.
The BPI questionnaire is used to assess pain and its effect on activities of daily living. Scores range from 0-10, with lower scores indicating less pain and higher scores indicating more severe pain.
This outcome measure will report the mean BPI score.
Measured: up to 12-week after initiation of study intervention
Pittsburgh Sleep Quality Index (PSQI)
To assess the range of responses to the telerehabilitation program by measuring cancer symptoms before and after the intervention.
PSQI is a 19-item, self-report questionnaire used to measure sleep quality. PSQI scores range from 0 to 21, with lower scores indicating better sleep quality and higher scores indicating worse sleep quality.
Measured: up to 12-week after initiation of study intervention
Hospital Anxiety and Depression Scale (HADS)
To assess the range of responses to the telerehabilitation program by measuring cancer symptoms before and after the intervention.
HADS is 14-item, self-report questionnaire used to measure anxiety and depression. HADS scores range from 0 to 21, with lower scores indicating normal or less anxiety/depression and higher scores indicating more severe anxiety/depression.
Measured: up to 12-week after initiation of study intervention
Patient-Centered Communication (PCC) Scale
To assess the range of responses to the telerehabilitation program by measuring socio-behavioral indicators before and after the intervention.
The PCC scale is a 7-item questionnaire assessing health care communication
The PCC scale scores range from 0 to 100, with lower scores indicating a worse communication and higher scores indicating better patient-centered communication.
Measured: up to 12-week after initiation of study intervention
Exercise Self-Efficacy Scale (EXSE)
To assess the range of responses to the telerehabilitation program by measuring socio-behavioral indicators before and after the intervention.
EXSE assesses exercise self-efficacy, or a patient's belief in their ability to continue regular exercise. This is an 8-item questionnaire. Each item is a 10-point scale, ranging from 0% (Not at All Confident) to 100% (Highly Confident).
Total score ranges from 0 to 100, with lower scores indicating worse exercise self-efficacy and higher scores indicating better exercise self-efficacy.
Measured: up to 12-week after initiation of study intervention
Outcome Expectations for Exercise scale
To assess the range of responses to the telerehabilitation program by measuring socio-behavioral indicators before and after the intervention.
Outcome Expectations for Exercise Scale is a 15-item questionnaire. Each item is a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree).
Total score ranges from 15 to 75, with lower scores indicating worse exercise attitudes and higher scores indicating better exercise attitudes.
Measured: up to 12-week after initiation of study intervention
Exercise Adherence Questionnaire
To assess the range of responses to the telerehabilitation program by measuring socio-behavioral indicators before and after the intervention.
The Medical Outcome Study (MOS) Exercise Adherence Questionnaire assesses patient adherence to exercise.
MOS Exercise Adherence Questionnaire is a 40-item questionnaire. Scores range from 0 to 100, with lower scores indicating worse exercise adherence and higher scores indicating better exercise adherence.
Measured: up to 12-week after initiation of study intervention
Financial Toxicity Questionnaire
To assess the range of responses to the telerehabilitation program by measuring socio-behavioral indicators before and after the intervention.
Financial Toxicity Questionnaire scores range from 0 to 48, with lower scores indicating worse financial toxicity and higher scores indicating better financial toxicity.
Measured: up to 12-week after initiation of study intervention
Cancer Therapy Satisfaction Questionnaire (CTSQ)
To assess the range of responses to the telerehabilitation program by measuring socio-behavioral indicators before and after the intervention.
The CTSQ is a 16-item questionnaire measuring patient satisfaction with cancer treatment. CTSQ scores range from 0-100, with lower scores indicating less satisfaction and higher scores indicating greater satisfaction.
Measured: up to 12-week after initiation of study intervention
Frequency Web portal system Usage
To identify barriers and facilitators of implementing a cancer telerehabilitation program in rural areas using Technology Acceptance Model and Consolidated Framework for Implementation Research 2.0.
The acceptance and usage pattern of the cancer telerehabilitation will be measured by analyzing web portal system logs to identify the frequency and timing of its usage. This outcome measure will report frequency of web portal system logs.
Measured: up to 12-week after initiation of study intervention
Attitudinal Survey
To identify barriers and facilitators of implementing a cancer telerehabilitation program in rural areas using Technology Acceptance Model and Consolidated Framework for Implementation Research 2.0.
The acceptance and usage pattern of the cancer telerehabilitation will be measured by an attitudinal survey. Attitudinal survey scores range from 0 to 55, with lower scores indicating more negative attitudes and higher scores indicating more positive attitudes.
Measured: up to 12-week after initiation of study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start24 Feb 2026
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (172)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manish Kohli, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093177
- Sponsor's protocol ID
- HCI173543
- Status last verified
- Apr 2026
- First submitted
- 8 Jul 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abetz L, Coombs JH, Keininger DL, Earle CC, Wade C, Bury-Maynard D, Copley-Merriman K, Hsu MA. Development of the cancer therapy satisfaction questionnaire: item generation and content validity testing. Value Health. 2005 Nov-Dec;8 Suppl 1:S41-53. doi: 10.1111/j.1524-4733.2005.00073.x.
PubMed 16336488AHRQ National Healthcare Quality and Disparities Report chartbook on rural health care. Rockville, MD: Agency for Healthcare Research and Quality (AHRQ); October 2017. AHRQ Pub. No. 17(18)-0001-2-EF.
Akaike H.
Alibhai SM, Breunis H, Timilshina N, Johnston C, Tomlinson G, Tannock I, Krahn M, Fleshner NE, Warde P, Canning SD, Klotz L, Naglie G. Impact of androgen-deprivation therapy on physical function and quality of life in men with nonmetastatic prostate cancer. J Clin Oncol. 2010 Dec 1;28(34):5038-45. doi: 10.1200/JCO.2010.29.8091. Epub 2010 Nov 1.
PubMed 21041715Amireault S, Godin G, Lacombe J, Sabiston CM. The use of the Godin-Shephard Leisure-Time Physical Activity Questionnaire in oncology research: a systematic review. BMC Med Res Methodol. 2015 Aug 12;15:60. doi: 10.1186/s12874-015-0045-7.
PubMed 26264621Annunziata MA, Muzzatti B, Bidoli E, Flaiban C, Bomben F, Piccinin M, Gipponi KM, Mariutti G, Busato S, Mella S. Hospital Anxiety and Depression Scale (HADS) accuracy in cancer patients. Support Care Cancer. 2020 Aug;28(8):3921-3926. doi: 10.1007/s00520-019-05244-8. Epub 2019 Dec 19.
PubMed 31858249Attkisson CC, Greenfield TK. The UCSF Client Satisfaction Scales: I. The Client Satisfaction Questionnaire-8. In The Use of Psychological Testing for Treatment Planning and Outcomes Assessment: Instruments for Adults;b Maruish, M.E., Ed.; Lawrence Erlbaum Associates Publishers: Mahwah, NJ, USA, 2004; pp. 799-811.
Basaria S, Lieb J 2nd, Tang AM, DeWeese T, Carducci M, Eisenberger M, Dobs AS. Long-term effects of androgen deprivation therapy in prostate cancer patients. Clin Endocrinol (Oxf). 2002 Jun;56(6):779-86. doi: 10.1046/j.1365-2265.2002.01551.x.
PubMed 12072048Beck SL, Schwartz AL, Towsley G, Dudley W, Barsevick A. Psychometric evaluation of the Pittsburgh Sleep Quality Index in cancer patients. J Pain Symptom Manage. 2004 Feb;27(2):140-8. doi: 10.1016/j.jpainsymman.2003.12.002.
PubMed 15157038Bedra M, McNabney M, Stiassny D, Nicholas J, Finkelstein J. Defining patient-centered characteristics of a telerehabilitation system for patients with COPD. Stud Health Technol Inform. 2013;190:24-6.
PubMed 23823363Bedra M, Finkelstein J. Feasibility of post-acute hip fracture telerehabilitation in older adults. Stud Health Technol Inform. 2015;210:469-73.
PubMed 25991191Bennett KJ, Pumkam C, Bellinger JD, Probst JC. Cancer screening delivery in persistent poverty rural counties. J Prim Care Community Health. 2011 Oct 1;2(4):240-9. doi: 10.1177/2150131911406123. Epub 2011 May 17.
PubMed 23804842Benzo R. Satori: Awakening to Outcomes That Matter: The Impact of Social Support in Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2017 Sep;14(9):1385-1386. doi: 10.1513/AnnalsATS.201707-526ED. No abstract available.
PubMed 28862500Berger AM, Mooney K. Dissemination and Implementation of Guidelines for Cancer-Related Fatigue. J Natl Compr Canc Netw. 2016 Nov;14(11):1336-1338. doi: 10.6004/jnccn.2016.0144. No abstract available.
PubMed 27799505Blanchard CM, Courneya KS, Rodgers WM, Murnaghan DM. Determinants of exercise intention and behavior in survivors of breast and prostate cancer: an application of the theory of planned behavior. Cancer Nurs. 2002 Apr;25(2):88-95. doi: 10.1097/00002820-200204000-00002.
PubMed 11984095
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Telerehabilitation of Rural Patients With Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT07093177
- Acronym / sponsor ID
- HCI173543
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Telemedicine approaches have the potential to improve access to cancer rehabilitation. This research team's previous studies showed a high acceptance of home-based telerehabilitation in older adults with chronic health conditions and a positive impact on QoL. In recent pilot usability studies, we demonstrated that multimodal telerehabilitation is well-accepted by patients with advanced bladder cancer who expressed strong interest in home-based cancer telerehabilitation. However, the feasibility of multimodal telerehabilitation in patients with advanced prostate cancer residing in rural areas has not been studied systematically. Additionally, barriers and facilitators of implementing prostate cancer telerehabilitation in rural areas are not well understood and require further exploration.
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.
The enrolled patients will have access to a tailored cancer rehabilitation program via a home-based telerehabilitation system, remote supervision, and interactive education and counseling sessions to enhance support and adherence. A comprehensive assessment by a physical therapist will be conducted remotely using the previously validated app. After the initial assessment, the patients will be individually prescribed resistance and aerobic exercises based on metastasis location, pain, fatigue, and current fitness levels. Physical exercises specific to prostate cancer, such as pelvic floor exercises, will be tailored to individual impairments. Interactive education on exercise benefits and safety, behavioral change strategies, principles of lifestyle changes, and vocational, cognitive, and sexual rehabilitation will be provided via the telerehabilitation system. Social support will be delivered via group tele-counseling sessions. Automated analysis of daily exercise logs will alert the telerehabilitation team about low exercise adherence and prompt tailored feedback to the patients. As in this research team's previous interventions, support will be available throughout the study to assist patients in using the telerehabilitation system successfully.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimodal Telerehabilitation | Experimental | Behavioral: Telerehabilitation UnitParticipation in a remote telerehabilitation program for 12 weeks. Based on the remote physical therapy assessment, a physical therapist will prescribe an individualized rehabilitation plan to each participant. Exercise regimens, lengths of sessions, repetition counts, and frequency of workouts may be tailored depending on individual needs and capabilities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telerehabilitation UnitTelerehabilitation 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. | Behavioural | Multimodal Telerehabilitation |
Primary outcome
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.
18 secondary outcomes
System Usability Score
Time frame: up to 12-week after initiation of study intervention
Exercise Adherence
Time frame: up to 12-week after initiation of study intervention
30-second Sit-to-Stand Test
Time frame: up to 12-week after initiation of study intervention
8-foot Timed Up and Go
Time frame: up to 12-week after initiation of study intervention
Activity Tracker
Time frame: up to 12-week after initiation of study intervention
Godin Leisure Score Index
Time frame: up to 12-week after initiation of study intervention
FACIT-Fatigue scale
Time frame: up to 12-week after initiation of study intervention
Brief Pain Inventory (BPI)
Time frame: up to 12-week after initiation of study intervention
Pittsburgh Sleep Quality Index (PSQI)
Time frame: up to 12-week after initiation of study intervention
Hospital Anxiety and Depression Scale (HADS)
Time frame: up to 12-week after initiation of study intervention
Patient-Centered Communication (PCC) Scale
Time frame: up to 12-week after initiation of study intervention
Exercise Self-Efficacy Scale (EXSE)
Time frame: up to 12-week after initiation of study intervention
Outcome Expectations for Exercise scale
Time frame: up to 12-week after initiation of study intervention
Exercise Adherence Questionnaire
Time frame: up to 12-week after initiation of study intervention
Financial Toxicity Questionnaire
Time frame: up to 12-week after initiation of study intervention
Cancer Therapy Satisfaction Questionnaire (CTSQ)
Time frame: up to 12-week after initiation of study intervention
Frequency Web portal system Usage
Time frame: up to 12-week after initiation of study intervention
Attitudinal Survey
Time frame: up to 12-week after initiation of study intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 16336488Abetz L, Coombs JH, Keininger DL, Earle CC, Wade C, Bury-Maynard D, Copley-Merriman K, Hsu MA. Development of the cancer therapy satisfaction questionnaire: item generation and content validity testing. Value Health. 2005 Nov-Dec;8 Suppl 1:S41-53. doi: 10.1111/j.1524-4733.2005.00073.x.
- BackgroundAHRQ National Healthcare Quality and Disparities Report chartbook on rural health care. Rockville, MD: Agency for Healthcare Research and Quality (AHRQ); October 2017. AHRQ Pub. No. 17(18)-0001-2-EF.
- BackgroundAkaike H.
- Background: PubMed 21041715Alibhai SM, Breunis H, Timilshina N, Johnston C, Tomlinson G, Tannock I, Krahn M, Fleshner NE, Warde P, Canning SD, Klotz L, Naglie G. Impact of androgen-deprivation therapy on physical function and quality of life in men with nonmetastatic prostate cancer. J Clin Oncol. 2010 Dec 1;28(34):5038-45. doi: 10.1200/JCO.2010.29.8091. Epub 2010 Nov 1.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manish Kohli, MD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation Unit in people with Prostate Cancer, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manish Kohli, MD (801-646-4018, Manish.Kohli@hci.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: up to 12-week after initiation of study intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07093177, which also lists 172 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.