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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
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.
interventionNames
Behavioral: Telerehabilitation Unit
Primary outcomes (2)
measure
Acceptability
timeFrame
up to 12-week after initiation of study intervention
description
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.
Eligibility
Eligibility (as posted)
Sex
Male
Minimum age
18 Years
Show eligibility criteria text
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
References
Publications (172)
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measure
Functional Assessment of Cancer Therapy-Prostate (FACT-P)
timeFrame
up to 12-week after initiation of study intervention
description
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 outcomes (18)
measure
System Usability Score
timeFrame
up to 12-week after initiation of study intervention
description
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.
measure
Exercise Adherence
timeFrame
up to 12-week after initiation of study intervention
description
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.
measure
30-second Sit-to-Stand Test
timeFrame
up to 12-week after initiation of study intervention
description
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.
measure
8-foot Timed Up and Go
timeFrame
up to 12-week after initiation of study intervention
description
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.
measure
Activity Tracker
timeFrame
up to 12-week after initiation of study intervention
description
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.
measure
Godin Leisure Score Index
timeFrame
up to 12-week after initiation of study intervention
description
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.
measure
FACIT-Fatigue scale
timeFrame
up to 12-week after initiation of study intervention
description
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.
measure
Brief Pain Inventory (BPI)
timeFrame
up to 12-week after initiation of study intervention
description
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.
measure
Pittsburgh Sleep Quality Index (PSQI)
timeFrame
up to 12-week after initiation of study intervention
description
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.
measure
Hospital Anxiety and Depression Scale (HADS)
timeFrame
up to 12-week after initiation of study intervention
description
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.
measure
Patient-Centered Communication (PCC) Scale
timeFrame
up to 12-week after initiation of study intervention
description
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.
measure
Exercise Self-Efficacy Scale (EXSE)
timeFrame
up to 12-week after initiation of study intervention
description
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.
measure
Outcome Expectations for Exercise scale
timeFrame
up to 12-week after initiation of study intervention
description
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.
measure
Exercise Adherence Questionnaire
timeFrame
up to 12-week after initiation of study intervention
description
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.
measure
Financial Toxicity Questionnaire
timeFrame
up to 12-week after initiation of study intervention
description
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.
measure
Cancer Therapy Satisfaction Questionnaire (CTSQ)
timeFrame
up to 12-week after initiation of study intervention
description
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.
measure
Frequency Web portal system Usage
timeFrame
up to 12-week after initiation of study intervention
description
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.
measure
Attitudinal Survey
timeFrame
up to 12-week after initiation of study intervention
description
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.
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