Androgen Deprivation Therapy, Metastatic Prostate Cancer, Prostate Cancer
Conditions
Keywords
Telerehabilitation, Rural Health
Brief 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. 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.
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.
Interventions
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.
Sponsors
United States Department of Defense
Huntsman Cancer Institute
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Cancer Therapy-Prostate (FACT-P) | up to 6 months from baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-second Sit-to-Stand Test | up to 6 months from baseline | 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. |
| 8-foot Timed Up and Go | up to 6 months from baseline | 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. |
| Godin Leisure Score Index | up to 6 months from baseline | 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. |
| Exercise Self-Efficacy Scale (EXSE) | up to 6 months from baseline | 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. |
| Behavioral Regulation in Exercise Questionnaire 3 (BREQ-3) | up to 6 months from baseline | 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. |
| FACIT-Fatigue | up to 6 months from baseline | 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. |
Countries
United States
Contacts
Primary ContactManish Kohli, MD
Backup ContactAileen Gabriel
Outcome results
None listed