Prostate CancerNCT07032584
Impact of Multimodal Telerehabilitation in Rural Patients With Metastatic Prostate Cancer
A study testing Telerehabilitation Intervention in people with Prostate Cancer and Metastatic Prostate Cancer, run by University of Utah at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostate Cancer, Metastatic Prostate Cancer, Androgen Deprivation Therapy
- What is being tested?
- Telerehabilitation Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2025to Dec 2029
- Phase
- Interventional
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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 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
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Manish Kohli, MD, 801-646-4018, Manish.Kohli@hci.utah.edu
About this study
Official title: Impact of Multimodal Telerehabilitation on Reducing Disparities in Rural Survivors of Metastatic Prostate Cancer
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.
Read the detailed description
Background. Prostate cancer patients receiving androgen deprivation therapy frequently experience debilitating side effects significantly affecting their quality of life. Recent studies demonstrated the efficacy of multimodal rehabilitation for secondary and tertiary prevention in prostate cancer patients, reduction of cancer symptoms, and improvements in functional recovery and QOL. Despite the mounting evidence regarding the benefits of multimodal rehabilitation for this population, multiple barriers limit the access of these patients to cancer rehabilitation, especially in rural areas. Telemedicine approaches have the potential to improve access to cancer rehabilitation. This team's previous studies showed a high acceptance of home-based telerehabilitation in older adults with chronic health conditions and cancer and a positive impact on clinical outcomes. In a recent pilot usability study, the investigators demonstrated that multimodal telerehabilitation is well accepted by patients with metastatic bladder cancer who expressed strong interest in home-based cancer telerehabilitation. However, the impact of multimodal telerehabilitation in patients with metastatic prostate cancer residing in rural areas has not been studied systematically. New models to deliver cancer rehabilitation in rural areas are urgently needed.
Objective. The primary objective of the proposed research is to assess the feasibility of an innovative home-based cancer telerehabilitation model in prostate cancer patients undergoing androgen-deprivation therapy by (1) assessing the potential impact of individualized multimodal telerehabilitation on quality of life, fitness, physical activity, and socio-behavioral outcomes; (2) identifying acceptance, needs, and preferences for home telerehabilitation in prostate cancer patients depending on the cancer stage. The proposed multimodal telerehabilitation model allows a rehabilitation therapy team to set up individualized rehabilitation plans using a web-based care management portal and monitor patient progress online. Patients at home follow a safe and effective personalized exercise plan guided by interactive touch-screen technology combined with behavioral counseling, social support, and interactive education. The design of the telerehabilitation system is based on the cloud-based Internet-of-Things architecture allowing real-time monitoring of cardiovascular parameters and exercise performance. The patient's level of exertion during exercise is automatically identified by a validated AI-driven algorithm supporting exercise safety and efficacy.
Primary Aim: (1) Determine the effect of multimodal cancer telerehabilitation on disease-specific quality of life (QoL) in prostate cancer patients receiving androgen deprivation therapy in a pilot randomized controlled trial. The QoL will be the primary endpoint measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale.
Secondary Aims: (2) Determine the effect of cancer telerehabilitation on the following functional, socio-behavioral, and cognitive outcomes at 6 months: fitness, mobility, exercise self-efficacy, adherence, motivation, cancer symptoms, patient-provider communication, social support, depression, satisfaction with care, and financial toxicity; (3) Identify acceptance, needs, preferences, barriers, and facilitators for home-based cancer telerehabilitation in prostate cancer patients using qualitative analysis; (4) Evaluate primary and secondary aims in specific subgroups stratified by cancer stage and explore possible interactions; (5) Compare the longitudinal trajectories of primary and secondary outcomes in the intervention and control groups. Evaluate relations between primary and secondary outcomes, including quality of life, exercise self-efficacy, adherence, motivation, patient-provider communication, and social support.
Study Design. To evaluate the efficacy of multimodal cancer telerehabilitation, the research team will conduct a randomized clinical trial beginning in month 7 of the project. Seventy-four eligible patients will be enrolled and randomly assigned to one of two study groups: the telerehabilitation (TR) intervention or best available care (BAC) control group. The individual prostate cancer patient receiving ADT and residing in a rural area will be the unit of analysis. For each participant, the study will assess the effect of TR on quality of life, functional outcomes, cancer symptoms, socio-behavioral parameters, financial toxicity, and satisfaction with medical care.
- Being tested
- Telerehabilitation Intervention
- Keywords
- Telerehabilitation, Rural Health
- 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 InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation Intervention | Experimental | Participants in the Telerehabilitation Intervention group (TR) will receive a comprehensive baseline examination conducted by the blinded assessment team. They will also be evaluated by the clinical PT who will prescribe an individualized exercise plan and train them how to perform the exercises. Patients will be mailed exercise equipment (portable bike, elastic bands, pulse oximeter, and activity tracker) with the necessary instructions. Additionally, the TR group will also receive a touchscreen tablet for computer-mediated support in following their individualized exercise plans at their homes daily. The tablet will contain multimedia instructional materials on how to set up and use the telerehab unit. Receives: Other: Telerehabilitation Intervention |
| Best Available Care | Other | Participants in the Best Available Care (BAC) group will receive a comprehensive baseline examination conducted by the blinded assessment team. They will also be evaluated by the clinical PT who will prescribe an individualized exercise plan and train them how to perform the exercises. Patients will be mailed exercise equipment (portable bike, elastic bands, pulse oximeter, and activity tracker) with the necessary instructions. Receives: Other: Telerehabilitation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months from baseline
Secondary outcomes (6)
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.
Measured: up to 6 months from baseline
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.
Measured: up to 6 months from baseline
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.
Measured: up to 6 months from baseline
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.
Measured: up to 6 months from baseline
Exercise Self-Efficacy Scale (EXSE)
To assess exercise self-efficacy.
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 6 months from baseline
Behavioral Regulation in Exercise Questionnaire 3 (BREQ-3)
To assess participant exercise motivation.
BREQ-3 is an assessment measuring a patient's exercise motivation. BREQ-3 reports 6 sub-scores: Amotivation and External, Introjected, Identified, Integrated, and Intrinsic regulation.
BREQ-3 score ranges from 0 to 96. Lower score means low motivation, higher scores indicate higher motivation
This outcome measure will report mean BREQ-3.
Measured: up to 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start27 May 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (162)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Huntsman Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Manish Kohli, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032584
- Sponsor's protocol ID
- HCI177474
- Other IDs
- HT94252410264
- Status last verified
- Jul 2025
- First submitted
- 15 Jun 2025
- Last updated
- 1 Aug 2025
- 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 16336488National Healthcare Quality and Disparities Report: Chartbook on Rural Healthcare [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2021 Nov. Report No.: 22-0010. Available from http://www.ncbi.nlm.nih.gov/books/NBK576369/
PubMed 35263059Akaike 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 31858249Basaria 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 11984095Bourke L, Sohanpal R, Nanton V, Crank H, Rosario DJ, Saxton JM. A qualitative study evaluating experiences of a lifestyle intervention in men with prostate cancer undergoing androgen suppression therapy. Trials. 2012 Nov 14;13:208. doi: 10.1186/1745-6215-13-208.
PubMed 23151126