Multimodal Telerehabilitation of Rural Patients With Advanced Prostate Cancer

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 m

Первичные конечные точки

• Acceptability [Срок оценки: up to 12-week after initiation of study intervention]
• Functional Assessment of Cancer Therapy-Prostate (FACT-P) [Срок оценки: up to 12-week after initiation of study intervention]

Вторичные конечные точки (12)

• System Usability Score [Срок оценки: up to 12-week after initiation of study intervention]
• Exercise Adherence [Срок оценки: up to 12-week after initiation of study intervention]
• 30-second Sit-to-Stand Test [Срок оценки: up to 12-week after initiation of study intervention]
• 8-foot Timed Up and Go [Срок оценки: up to 12-week after initiation of study intervention]
• Activity Tracker [Срок оценки: up to 12-week after initiation of study intervention]
• Godin Leisure Score Index [Срок оценки: up to 12-week after initiation of study intervention]
• FACIT-Fatigue scale [Срок оценки: up to 12-week after initiation of study intervention]
• Brief Pain Inventory (BPI) [Срок оценки: up to 12-week after initiation of study intervention]
• Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: up to 12-week after initiation of study intervention]
• Hospital Anxiety and Depression Scale (HADS) [Срок оценки: up to 12-week after initiation of study intervention]
• Patient-Centered Communication (PCC) Scale [Срок оценки: up to 12-week after initiation of study intervention]
• Exercise Self-Efficacy Scale (EXSE) [Срок оценки: up to 12-week after initiation of study intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Huntsman Cancer Institute at University of Utah — Salt Lake City

Публикации

• Abetz L, Coombs JH, Keininger DL, Earle CC, Wade C, Bury-Maynard D, Copley-Merriman K, Hsu MA. Development of the cancer therapy satisfaction questionnaire: item generation and content validity testing. Value Health. 2005 Nov-Dec;8 Suppl 1:S41-53. doi: 10.1111/j.1524-4733.2005.00073.x. PMID 16336488
• AHRQ National Healthcare Quality and Disparities Report chartbook on rural health care. Rockville, MD: Agency for Healthcare Research and Quality (AHRQ); October 2017. AHRQ Pub. No. 17(18)-0001-2-EF.
• Akaike H.
• Alibhai SM, Breunis H, Timilshina N, Johnston C, Tomlinson G, Tannock I, Krahn M, Fleshner NE, Warde P, Canning SD, Klotz L, Naglie G. Impact of androgen-deprivation therapy on physical function and quality of life in men with nonmetastatic prostate cancer. J Clin Oncol. 2010 Dec 1;28(34):5038-45. doi: 10.1200/JCO.2010.29.8091. Epub 2010 Nov 1. PMID 21041715
• Amireault S, Godin G, Lacombe J, Sabiston CM. The use of the Godin-Shephard Leisure-Time Physical Activity Questionnaire in oncology research: a systematic review. BMC Med Res Methodol. 2015 Aug 12;15:60. doi: 10.1186/s12874-015-0045-7. PMID 26264621
• Annunziata MA, Muzzatti B, Bidoli E, Flaiban C, Bomben F, Piccinin M, Gipponi KM, Mariutti G, Busato S, Mella S. Hospital Anxiety and Depression Scale (HADS) accuracy in cancer patients. Support Care Cancer. 2020 Aug;28(8):3921-3926. doi: 10.1007/s00520-019-05244-8. Epub 2019 Dec 19. PMID 31858249
• Attkisson CC, Greenfield TK. The UCSF Client Satisfaction Scales: I. The Client Satisfaction Questionnaire-8. In The Use of Psychological Testing for Treatment Planning and Outcomes Assessment: Instruments for Adults;b Maruish, M.E., Ed.; Lawrence Erlbaum Associates Publishers: Mahwah, NJ, USA, 2004; pp. 799-811.
• Basaria S, Lieb J 2nd, Tang AM, DeWeese T, Carducci M, Eisenberger M, Dobs AS. Long-term effects of androgen deprivation therapy in prostate cancer patients. Clin Endocrinol (Oxf). 2002 Jun;56(6):779-86. doi: 10.1046/j.1365-2265.2002.01551.x. PMID 12072048

Идентификаторы

NCT: NCT07093177 · HCI173543

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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