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Impact of Multimodal Telerehabilitation in Rural Patients With Metastatic Prostate Cancer
NCT07032584 · University of Utah
In plain English
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Official title
Impact of Multimodal Telerehabilitation on Reducing Disparities in Rural Survivors of Metastatic Prostate Cancer
About this study
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.
Eligibility criteria
Inclusion Criteria:
1. Age 21 years or older
2. Confirmed diagnosis of prostate cancer
3. 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;
4. 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:
1. Have unstable angina, uncontrolled hypertension, recent myocardial infarction, pacemakers, painful or unstable bony metastases, or recent skeletal fractures.
2. Are engaged in a regular exercise rehabilitation program.
3. Have relocation plans within the next 6 months
4. 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.
Study design
Enrollment target: 74 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-05-27
Estimated completion: 2029-12
Last updated: 2025-08-01
Interventions
Other: Telerehabilitation Intervention
Primary outcomes
- • Functional Assessment of Cancer Therapy-Prostate (FACT-P) (up to 6 months from baseline)
Sponsor
University of Utah · other
With: United States Department of Defense, Huntsman Cancer Institute
Contacts & investigators
ContactManish Kohli, MD · contact · Manish.Kohli@hci.utah.edu · 801-646-4018
ContactAileen Gabriel · contact · aileen.gabriel@utah.edu · 9782109782
InvestigatorManish Kohli, MD · principal_investigator, University of Utah
All locations (1)
University of Utah Huntsman Cancer InstituteRecruiting
Salt Lake City, Utah, United States