Impact of Multimodal Telerehabilitation in Rural Patients With Metastatic Prostate Cancer

Utah System of Higher Education (USHE)

Status: Not yet enrolling

Conditions: Metastatic Prostate Cancer; Androgen Deprivation Therapy; Prostate Cancer

Treatments: Other: Telerehabilitation Intervention

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07032584

IRB_00177474

Details and patient eligibility

About

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. We 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, we will compare the quality of life and cancer symptoms in these two groups.

We hope that our 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 we demonstrate this in our 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.

Full 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. Our 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, we 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, we 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, we will assess the effect of TR on quality of life, functional outcomes, cancer symptoms, socio-behavioral parameters, financial toxicity, and satisfaction with medical care.

Enrollment: 74 estimated patients

Sex: Male

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

Telerehabilitation Intervention

Experimental group

Description:

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.

Treatment:

Other: Telerehabilitation Intervention

Best Available Care

Other group

Description:

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.

Treatment:

Other: Telerehabilitation Intervention