The updated Consolidated Framework for Implementation Research based on user feedback.
Laura J Damschroder, Caitlin M Reardon, Marilla A Opra Widerquist...
https://pubmed.ncbi.nlm.nih.gov/36309746/Actively Recruiting
Led by University of Utah · Updated on 2025-08-01
74
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are investigating how multimodal telerehabilitation impacts quality of life and symptoms in men with metastatic prostate cancer receiving androgen deprivation therapy. This trial focuses on patients living in rural areas who often face barriers to cancer rehabilitation due to travel and cost. The study aims to assess if home-based exercise supported by technology can improve fitness, reduce symptoms, and enhance overall well-being compared to standard care without this technology. Participants are randomly assigned to one of two groups. The telerehabilitation TR group receives a personalized exercise plan prescribed by a physical therapist, exercise equipment including a portable bike, elastic bands, pulse oximeter, and activity tracker, plus a touchscreen tablet with interactive rehabilitation software for daily use at home. The control group, best available care BAC, also receives exercise equipment and an individualized exercise plan but without the telerehabilitation tablet support. Both groups are monitored over six months. Throughout the study, participants undergo comprehensive baseline and follow-up assessments by a blinded team. Measurements include quality of life using the FACT-P scale, fitness tests like the 30-second sit-to-stand, mobility assessments, exercise self-efficacy, motivation, cancer symptoms, patient-provider communication, social support, depression, satisfaction with care, and financial impact. The study tracks adherence and motivation to exercise, and collects data on acceptance and preferences for telerehabilitation. The total participation lasts six months, with ongoing monitoring and data collection to evaluate outcomes and safety.
CONDITIONS
Impact of Multimodal Telerehabilitation in Rural Patients With Metastatic Prostate Cancer
M
Manish Kohli, MD
A
Aileen Gabriel
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University of Utah
Lead Sponsor
United States Department of Defense
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Computer-Guided Telerehabilitation | Best Available Care | Guideline-Based Exercise Rehabilitation |
|---|---|---|---|
| What it is | A tablet-based telerehabilitation system delivers guided, home-based physical rehabilitation with ongoing support for rural patients undergoing ADT for metastatic prostate cancer. | Participants receive local standard supportive management without telerehabilitation or additional rehabilitation guidance in the trial. | International guidelines recommend supervised, individualized exercise and rehabilitation for men with metastatic prostate cancer on ADT, adapted for rural access barriers. |
| Role in study | Investigational intervention arm; participants are assigned to receive telerehabilitation and monitored for functional outcomes and quality of life. | Comparator arm; participants continue with usual supportive management, serving as the control for the intervention. | Represents guideline-recommended clinical practice for exercise and rehabilitation in metastatic prostate cancer with ADT, not included in the randomized trial arms. |
| Primary use | To improve physical functioning, mobility, and quality of life through accessible home-based rehabilitation, targeting rural patients with barriers to clinic-based exercise. | To maintain supportive management for metastatic prostate cancer patients on ADT in rural settings, without dedicated rehabilitation intervention. | To reduce treatment-related side effects, preserve muscle function, increase mobility, and improve quality of life using supervised exercise tailored for cancer patients on ADT. |
| How it is delivered | Tablet-guided physical rehabilitation is performed at home with ongoing support and computerized feedback. | Usual supportive management delivered through routine care; no additional rehabilitation intervention or guidance provided. | Supervised, individualized exercise therapy delivered by qualified rehabilitation professionals; in-person or adapted via remote platforms for rural patients. |
| Evidence status | Effectiveness and patient outcomes for tablet-based telerehabilitation in this population are under active investigation; no published results yet. | Effectiveness of supportive management alone for maintaining function is not systematically reported, and serves as a comparator to the intervention in this study. | Supervised exercise therapy significantly improves physical function, muscle strength, fatigue, and quality of life in ADT-treated prostate cancer patients, including those with metastatic disease. |
| Important limitations | Effectiveness and patient adherence to computer-guided home rehabilitation in rural metastatic prostate cancer has not been established; technology, connectivity, or engagement may present barriers. | Supportive management alone may leave functional deficits and muscle weakness unaddressed, especially in rural patients with limited access to rehabilitation services. | Access to supervised exercise therapy may be limited by workforce shortages, travel barriers, and rural healthcare infrastructure; adaptation to remote delivery is supported but uneven. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants undergo a comprehensive baseline examination and receive an individualized exercise plan with training on how to perform the exercises.
1 visit (in-person)
Duration - Up to 6 months
Participants in the telerehabilitation group use a touchscreen tablet with a computer-guided rehabilitation program to support daily home-based rehabilitation, while participants in the best available care group follow an individualized exercise plan with provided equipment.
Daily use of equipment at home with ongoing remote support; follow-up visits as scheduled by study team
Duration - Up to 6 months
Participants complete follow-up assessments to evaluate quality of life, functional outcomes, and socio-behavioral measures up to 6 months from baseline.
Multiple follow-up visits (in-person or remote) during the 6-month period
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/35062177/University of Utah
Lead Sponsor
United States Department of Defense
Collaborating Sponsor