Multimodal Telerehabilitation of Rural Patients With Advanced Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Acceptability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Telerehabilitation Unit (Behavioral)
结局指标
主要结局
Acceptability
时间窗: up to 12-week after initiation of study intervention
To evaluate system usability, acceptability, and exercise adherence of 12-week multimodal telerehabilitation. The acceptability of telerehabilitation will be assessed using the Client Satisfaction Questionnaire (CSQ). The CSQ is an 8-item questionnaire measuring the acceptability and patient satisfaction of the multimodal telerehabilitation. CSQ scores range from 8 to 32, with lower scores indicating lower satisfaction and higher scores indicating better satisfaction. An average CSQ score \> 20 will indicate satisfactory acceptability.
Functional Assessment of Cancer Therapy-Prostate (FACT-P)
时间窗: up to 12-week after initiation of study intervention
To assess the range of responses to the telerehabilitation program by measuring disease-specific quality of life (QOL). 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 the mean FACT-P total score.
次要结局
- System Usability Score(up to 12-week after initiation of study intervention)
- 30-second Sit-to-Stand Test(up to 12-week after initiation of study intervention)
- 8-foot Timed Up and Go(up to 12-week after initiation of study intervention)
- Godin Leisure Score Index(up to 12-week after initiation of study intervention)
- Patient-Centered Communication (PCC) Scale(up to 12-week after initiation of study intervention)
- Financial Toxicity Questionnaire(up to 12-week after initiation of study intervention)
- Brief Pain Inventory (BPI)(up to 12-week after initiation of study intervention)
- Cancer Therapy Satisfaction Questionnaire (CTSQ)(up to 12-week after initiation of study intervention)
- Activity Tracker(up to 12-week after initiation of study intervention)
- Pittsburgh Sleep Quality Index (PSQI)(up to 12-week after initiation of study intervention)
- Hospital Anxiety and Depression Scale (HADS)(up to 12-week after initiation of study intervention)
- Exercise Adherence Questionnaire(up to 12-week after initiation of study intervention)
- Exercise Adherence(up to 12-week after initiation of study intervention)
- FACIT-Fatigue scale(up to 12-week after initiation of study intervention)
- Exercise Self-Efficacy Scale (EXSE)(up to 12-week after initiation of study intervention)
- Outcome Expectations for Exercise scale(up to 12-week after initiation of study intervention)
- Frequency Web portal system Usage(up to 12-week after initiation of study intervention)
- Attitudinal Survey(up to 12-week after initiation of study intervention)