Multimodal Telerehabilitation of Rural Patients With Advanced Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT07093177
- Lead Sponsor
- University of Utah
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 30
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Acceptability 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) 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.
- Secondary Outcome Measures
Name Time Method System Usability Score up to 12-week after initiation of study intervention To evaluate system usability, acceptability, and exercise adherence of 12-week multimodal telerehabilitation.
The System Usability Score is a 10-item questionnaire to evaluate the perceived usability of the multimodal telerehabilitation. The System Usability Score ranges from 0 to 100, with lower scores indicating worse usability and higher scores indicating better usability. An average SUS score \> 68 will indicate satisfactory usability.
This outcome measure will report the mean System Usability Score.30-second Sit-to-Stand Test up to 12-week after initiation of study intervention To assess the range of responses to the telerehabilitation program by measuring functional fitness before and after the intervention.
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 the mean Sit-to-Stand score.8-foot Timed Up and Go up to 12-week after initiation of study intervention To assess the range of responses to the telerehabilitation program by measuring functional fitness before and after the intervention.
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 12-week after initiation of study intervention To assess the range of responses to the telerehabilitation program by measuring functional fitness before and after the intervention.
Physical activity will be measured using the Godin Leisure Score Index, which is a validated short questionnaire used to measure leisure-time physical activity in cancer research. 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.Patient-Centered Communication (PCC) Scale up to 12-week after initiation of study intervention To assess the range of responses to the telerehabilitation program by measuring socio-behavioral indicators before and after the intervention.
The PCC scale is a 7-item questionnaire assessing health care communication
The PCC scale scores range from 0 to 100, with lower scores indicating a worse communication and higher scores indicating better patient-centered communication.Financial Toxicity Questionnaire up to 12-week after initiation of study intervention To assess the range of responses to the telerehabilitation program by measuring socio-behavioral indicators before and after the intervention.
Financial Toxicity Questionnaire scores range from 0 to 48, with lower scores indicating worse financial toxicity and higher scores indicating better financial toxicity.Brief Pain Inventory (BPI) up to 12-week after initiation of study intervention To assess the range of responses to the telerehabilitation program by measuring cancer symptoms before and after the intervention.
The BPI questionnaire is used to assess pain and its effect on activities of daily living. Scores range from 0-10, with lower scores indicating less pain and higher scores indicating more severe pain.
This outcome measure will report the mean BPI score.Cancer Therapy Satisfaction Questionnaire (CTSQ) up to 12-week after initiation of study intervention To assess the range of responses to the telerehabilitation program by measuring socio-behavioral indicators before and after the intervention.
The CTSQ is a 16-item questionnaire measuring patient satisfaction with cancer treatment. CTSQ scores range from 0-100, with lower scores indicating less satisfaction and higher scores indicating greater satisfaction.Activity Tracker up to 12-week after initiation of study intervention To assess the range of responses to the telerehabilitation program by measuring functional fitness before and after the intervention.
Participants will be provided with an activity tracker (i.e., Fitbit), and the activity logs will be extracted to assess physical activity. The Fitbit has been validated as a measure of physical activity in men with prostate cancer.
This outcome measure will report the mean moderate-to-vigorous physical activity (MVPA; minutes/day) measured from participants' Fitbit.Pittsburgh Sleep Quality Index (PSQI) up to 12-week after initiation of study intervention To assess the range of responses to the telerehabilitation program by measuring cancer symptoms before and after the intervention.
PSQI is a 19-item, self-report questionnaire used to measure sleep quality. PSQI scores range from 0 to 21, with lower scores indicating better sleep quality and higher scores indicating worse sleep quality.Hospital Anxiety and Depression Scale (HADS) up to 12-week after initiation of study intervention To assess the range of responses to the telerehabilitation program by measuring cancer symptoms before and after the intervention.
HADS is 14-item, self-report questionnaire used to measure anxiety and depression. HADS scores range from 0 to 21, with lower scores indicating normal or less anxiety/depression and higher scores indicating more severe anxiety/depression.Exercise Adherence Questionnaire up to 12-week after initiation of study intervention To assess the range of responses to the telerehabilitation program by measuring socio-behavioral indicators before and after the intervention.
The Medical Outcome Study (MOS) Exercise Adherence Questionnaire assesses patient adherence to exercise.
MOS Exercise Adherence Questionnaire is a 40-item questionnaire. Scores range from 0 to 100, with lower scores indicating worse exercise adherence and higher scores indicating better exercise adherence.Exercise Adherence up to 12-week after initiation of study intervention To evaluate system usability, acceptability, and exercise adherence of 12-week multimodal telerehabilitation.
Participants will complete daily exercise logs to assess their adherence to their telerehabilitation protocol. Individual exercise adherence will be calculated by dividing the number of days the patient exercised using the HAT system by the total number of days the patients were expected to exercise (12 weeks x 3 days per week to exercise = 36 days total). The overall exercise adherence will be considered satisfactory if at least 75% of patients had individual exercise adherence \> 70%.
This outcome measure will report mean exercise adherence.FACIT-Fatigue scale up to 12-week after initiation of study intervention To assess the range of responses to the telerehabilitation program by measuring cancer symptoms before and after the intervention.
This measure will 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.Exercise Self-Efficacy Scale (EXSE) up to 12-week after initiation of study intervention To assess the range of responses to the telerehabilitation program by measuring socio-behavioral indicators before and after the intervention.
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.Outcome Expectations for Exercise scale up to 12-week after initiation of study intervention To assess the range of responses to the telerehabilitation program by measuring socio-behavioral indicators before and after the intervention.
Outcome Expectations for Exercise Scale is a 15-item questionnaire. Each item is a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree).
Total score ranges from 15 to 75, with lower scores indicating worse exercise attitudes and higher scores indicating better exercise attitudes.Frequency Web portal system Usage up to 12-week after initiation of study intervention To identify barriers and facilitators of implementing a cancer telerehabilitation program in rural areas using Technology Acceptance Model and Consolidated Framework for Implementation Research 2.0.
The acceptance and usage pattern of the cancer telerehabilitation will be measured by analyzing web portal system logs to identify the frequency and timing of its usage. This outcome measure will report frequency of web portal system logs.Attitudinal Survey up to 12-week after initiation of study intervention To identify barriers and facilitators of implementing a cancer telerehabilitation program in rural areas using Technology Acceptance Model and Consolidated Framework for Implementation Research 2.0.
The acceptance and usage pattern of the cancer telerehabilitation will be measured by an attitudinal survey. Attitudinal survey scores range from 0 to 55, with lower scores indicating more negative attitudes and higher scores indicating more positive attitudes.
Trial Locations
- Locations (1)
Huntsman Cancer Institute at University of Utah
🇺🇸Salt Lake City, Utah, United States
Huntsman Cancer Institute at University of Utah🇺🇸Salt Lake City, Utah, United States