Multimodal Telerehabilitation of Rural Patients With Advanced Prostate Cancer

NCT ID: NCT07093177

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2028-09-30

Brief 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 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Multimodal Telerehabilitation

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.

Group Type: EXPERIMENTAL

Telerehabilitation Unit

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manish Kohli, MD

Role: PRINCIPAL_INVESTIGATOR

Huntsman Cancer Institute/ University of Utah

Locations

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, United States

Countries

United States

Central Contacts

Manish Kohli, MD

Role: CONTACT

Manish.Kohli@hci.utah.edu

801-646-4018

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Other Identifiers

HCI173543

Identifier Type: -

Identifier Source: org_study_id