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 and nutrition plan guided by interactive touch-screen technology combined with behavioral counseling, social support, and interactive education and empowerment. 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. The ultimate goal of this pilot feasibility project is to establish the extent of the impact of the proposed patient-centered cancer telerehabilitation model on disease-specific quality of life, and functional and symptom outcomes and to obtain sufficient evidence for a definitive randomized clinical trial evaluating this approach in a multi-center study.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Each enrolled patient will undergo a four-week multimodal prehabilitation before the commencement of the CAR-T therapy. During CAR-T therapy, the patients will use an interactive app supporting cancer self-care education and early mobilization while undergoing chemotherapy, infusion, in-hospital toxicity monitoring, and recovery (the duration depends on the specific CAR-T treatment regimen). After completion of the CAR-T procedures and hospital discharge, the patients will undergo a 12-week home-based multimodal telerehabilitation.
Individualized rehabilitation plans using a web-based care management portal. Patients at home follow a safe and effective personalized exercise and nutrition plan guided by interactive touch-screen technology combined with behavioral counseling, social support, and interactive education and empowerment.
interventionNames
Device: Home Automated Telemanagement (HAT) Patient Unit
Primary outcomes (2)
measure
System Usability Score - Feasibility
timeFrame
up to 12 weeks after completion of the CAR-T procedures.
description
To assess the feasibility of a multimodal cancer telerehabilitation model in patients with hematologic malignancies undergoing CAR-T therapy by evaluating system usability, acceptability, and exercise adherence. This outcome measure will report the System Usability Score for home telerehabilitation in patients undergoing CAR-T therapy.
The System Usability Scale (SUS) is a 10-item, 5-point Likert questionnaire that yields a single usability score on a 0-100 scale; the minimum possible score is 0 (worst perceived usability) and the maximum is 100 (best perceived usability). This outcome measure will report the mean System Usability Score at 12 weeks after completion of the CAR-T procedure.
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
21 Years
Show eligibility criteria text
Inclusion Criteria:
* age \>21
* confirmed diagnosis of lymphoma or myeloma
* commercial FDA-approved CAR-T delivery planned for ≥4 weeks following enrollment
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Access to a working telephone line in their home or a cell phone.
Exclusion Criteria:
* have unstable angina, uncontrolled hypertension, recent myocardial infarction, pacemakers, painful or unstable bony metastases, or recent skeletal fractures;
* are engaged in a regular exercise rehabilitation program;
* have relocation plans within next 6 months;
* participate in another clinical trial.
References
Publications (183)
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measure
Adherence Indicators - Feasibility
timeFrame
up to 12 weeks after completion of the CAR-T procedures.
description
To assess the feasibility of a multimodal cancer telerehabilitation model in patients with hematologic malignancies undergoing CAR-T therapy by evaluating daily exercise logs. This outcome measure will report adherence based on daily exercise logs in patients utilizing the home telerehabilitation after undergoing CAR-T therapy.
Adherence will be defined as the percentage of exercise sessions of the total number of prescribed exercise sessions.
Secondary outcomes (13)
measure
6-minute walk distance (6MWD)
timeFrame
up to 12 weeks after completion of the CAR-T procedures.
description
6MWD is an assessment of functional and aerobic capacity by measuring how far a patient can walk over 6 minutes.
This outcome measure will report mean 6MWD.
measure
Short Physical Performance Battery (SPPB)
timeFrame
up to 12 weeks after completion of the CAR-T procedures.
description
The Short Physical Performance Battery (SPPB) is a series of assessments to measure balance, strength, and physical functioning. SPPB scores range from 0-12, with lower scores indicating severe limitations and higher scores indicating better physical functioning.
This outcome measure will report mean SPPB.
measure
Godin Leisure Score Index
timeFrame
up to 12 weeks after completion of the CAR-T procedures.
description
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 cores indicate higher activity.
This outcome measure will report mean Godin Leisure Score Index.
measure
Extended Activities of Daily Living (ADL)
timeFrame
up to 12 weeks after completion of the CAR-T procedures.
description
The Extended ADL scale is an assessment of functional independence. Extended ADL is a 22-item questionnaire, with each item scaled from 0 to 3.
The Extended ADL total score ranges from 0 to 66, with lower scores indicating better functional independence and higher scores indicating worse functional independence.
measure
36-Item Short Form Survey (SF-36)
timeFrame
up to 12 weeks after completion of the CAR-T procedures.
description
SF-36 is a questionnaire that assesses patient health. This outcome measure will report 8 sub-scores: physical function, pain, limitations due to physical health issues, limitations due to personal/emotional issues, emotional well-being, social functioning, energy/fatigue, and general health perceptions.
Each sub-score ranges from 0-100, with higher score indicating more favorable health and lower score indicating less favorable health.
measure
European Organization For Research And Treatment Of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
timeFrame
up to 12 weeks after completion of the CAR-T procedures.
description
EORTC QLQ-C30 is a questionnaire to assess health-related quality of life in cancer patients. Patients indicate which symptoms/problems they have experienced during the past week, from "1 Not at All" to "4 Very Much".
The assessment will report data as 15 subscales with scores from 0-100. A high score indicates a higher response level.
A high functional scale score (FS) represents a high/healthy level of function and includes Physical, Role, Emotional, Cognitive, and Social functioning. A high symptom scale score (SS) represent a high level of symptomatology/problems and includes Fatigue, Nausea and vomiting, Pain, Dyspnoea, Insomnia, Appetite loss, Constipation, Diarrhoea, Financial difficulties, and Global health status/QoL.
This outcome will report the mean score of each subscale.
measure
Functional Assessment of Cancer Therapy-Fatigue (FACT-F)
timeFrame
up to 12 weeks after completion of the CAR-T procedures.
description
The FACT-F is a self-reported evaluation of fatigue in cancer patients. This questionnaire has patients rank statements regarding Physical, Social/Family, Emotional, and Functional well-being and Fatigue from 0 "Not at All" to 4 "Very Much".
The FACT-F has a minimum of 0 and a maximum of 52, with higher scores indicating less fatigue and lower scores indicating more fatigue.
measure
Numeric Rating Scale (NRS)
timeFrame
up to 12 weeks after completion of the CAR-T procedures.
description
NRS is a single-item question assessing pain. NRS scores range from 0-10, with lower scores indicating less pain and higher scores indicating more pain.
This outcome measure will report mean NRS.
measure
Exercise Self-Efficacy Scale (EXSE)
timeFrame
up to 12 weeks after completion of the CAR-T procedures.
description
The EXSE assesses exercise self-efficacy, or a patient's belief in their ability to continue regular exercise.
Outcome Expectations for Exercise Scale 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
Behavioral Regulation in Exercise Questionnaire 3 (BREQ-3)
timeFrame
up to 12 weeks after completion of the CAR-T procedures.
description
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 scores indicate lower motivation, and higher scores indicate higher motivation.
This outcome measure will report the mean BREQ-3.
measure
Outcome Expectations for Exercise Scale
timeFrame
up to 12 weeks after completion of the CAR-T procedures.
description
The Outcome Expectations for Exercise Scale assesses beliefs and attitudes about the benefits of exercise.
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
Medical Outcome Study (MOS) Exercise Adherence Questionnaire
timeFrame
up to 12 weeks after completion of the CAR-T procedures.
description
The 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
Telerehab user attitudes
timeFrame
up to 12 weeks after completion of the CAR-T procedures.
description
Telerehab user attitudes measure patients' overall feelings about remote rehabilitation technology and service. The minimum possible score is 11 (worst perceived attitude) and the maximum is 55 (best perceived attitude).
This outcome measure will report the mean Telerehab user attitudes at 12 weeks after completion of the CAR-T procedure.
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