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Tailored Home-Based Exercise Program for Multiple Chronic Conditions (iHBE)

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ClinicalTrials.gov Identifier: NCT03874754
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : December 7, 2020
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
A home-based, tailored, technology-enhanced home-based exercise program (iHBE) using a combination of the integrated mobile technologies (wearable device and phone application) and tailored home-based exercise will be pilot tested. Participants will choose one of the four home-based exercise options [National Institute of Aging (NIA) Go4Life (an exercise and physical activity campaign from the NIA), Iyengar-style yoga, walking, and modified Otago exercise] based on participants' preference and goals. The integrated mobile technologies system will allow the investigators to extract heart rate data directly from the wearable device to the research server. This data will be used to provide appropriate and personalized feedback on physical performance. The survey and notification to the participants on the smartphone.

Condition or disease Intervention/treatment Phase
Cancer Hypertension Diabetes Other: Tailored Technology-Enhance Home-based exercise program (iHBE) Not Applicable

Detailed Description:
The benefits of physical activity on managing chronic illnesses and multiple symptoms are well established. However, increasing the physical activity of persons living with Multiple Chronic Conditions (MCC), especially low -income cancer survivors with MCC, is challenging. Home-based exercise improves physical activity and symptoms among persons with the single chronic disease. One major challenge of the home-based exercise is the motivation and adherence. The mobile technologies (e.g., wearable device and smartphone application) have been used to improve motivation and monitor a person physical activity. Guided by the society to cells framework and previous preliminary findings, the investigators developed a technology-enhanced home-based exercise program using a combination of the integrated mobile technologies (wearable device and phone application) and tailored home-based exercise. Participants will choose one of the four home-based exercise options [National Institute of Aging (NIA) Go4Life, Iyengar-style yoga, walking, and modified Otago exercise] based on participants' preference and goals. The integrated mobile technologies system will allow the investigators to extract heart rate data directly from the wearable device to the research server. This data will be used to provide appropriate and personalized feedback on physical performance and trigger algorithms to send the survey and notification to the participants in real time. This pilot project will examine the feasibility of this technology-enhanced home exercise tailored to participants' goals and preferences. The intervention will leverage the cancer survivorship phase (post-treatment) to motivate self-care by combining tailored existing evidence-based physical activity programs and mobile technology for participants to engage in the resilience-enhancing physical activity. Identification of BDNF's role as one of the exercise outcomes provide a novel target for an intervention and increase the investigators' understanding of the underlying mechanism of symptoms and resilience. This study aims to examine the feasibility and acceptability of the iHBE program among low-income cancer survivors living with co-morbid conditions. Eight participants who have completed treatment for a solid tumor cancer with at least one comorbidity (e.g., diabetes and/or hypertension) will be assigned to an open-label trial of the idea. The investigators will gather feedback on goal setting, problem-solving strategies, exercise choices, and tracking mechanisms, program feasibility, and acceptability and modify the intervention as needed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The data collectors are blinded to the group allocation
Primary Purpose: Supportive Care
Official Title: Assessment of a Tailored Home-Based Exercise Program on Symptoms, Well-Being, and Resilience Among Cancer Survivors With Multiple Chronic Conditions
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: The iHBE program group
an intervention group
Other: Tailored Technology-Enhance Home-based exercise program (iHBE)
The tailored technology enhanced home-based exercise (iHBE) program is a 4-week program with 1 assessment home visit session, 4 home visits during exercise. The detail activities are presented in table 1. The technologies, a wearable device, and a smartphone application, will be used as a tool to monitor physical performance (heart rate [HR], step count), provide immediate feedback, send daily reminding message through Mobile Ecological Momentary Assessment (mEMA). The coded raw data without personal identification information from the wearable device will be sent to the servers where the investigators can store it in the database alongside the mEMA data and create custom reports showing Heart Rate (HR) 30 minute before each Ecological Momentary Assessment (EMA) survey, showing HR and previous self-report responses before/ after each automatically triggered EMA.
Other Name: iHBE

No Intervention: Usual Care (Control group)
A control group



Primary Outcome Measures :
  1. Change in Fatigue as assessed by self-reported fatigue questionnaire [ Time Frame: Pre- and post-intervention, up to 4 weeks ]
    6-items; self-reported fatigue (frequency, duration, intensity) and the impact on physical, mental, and social activities, has five response options (1 or never to 5 or always). The overall score range from 6 (no fatigue) to 30 (extreme fatigue)

  2. Change in Resilience as assessed by Connor-Davidson Resilience scale [ Time Frame: Pre- and post-intervention, up to 4 weeks ]
    Connor-Davidson Resilience scale: 10 item self-report rating scale 0 (not true at all) to 4 (true nearly all the time). The overall score range from 0 (no resilience) to 40 (High Resilience).

  3. Change in Physical well being [ Time Frame: Pre- and post-intervention, up to 4 weeks ]
    Physical well being as assessed by 36 item self-report instrument. The overall score derived from the physical functioning, role limitation-physical, and bodily pain domains. The overall score range from 0-400, with a score 400 reflecting the highest rating of physical health.

  4. Change in Mental well being [ Time Frame: Pre- and post-intervention, up to 4 weeks ]
    Mental well being is measured by the 36 item self-report instrument. The overall score derived from the mental health, role limitation-emotional domains. The total score range from 0 to 200, with the score of 200 indicated high mental well being


Secondary Outcome Measures :
  1. Physical activity [ Time Frame: 4 weeks ]
    The physical activity will be measured in a form of average step count/day and average active minutes/day measured by a wrist-worn wearable device.

  2. Change in Brain Derived Neurotrophic Factor level (in serum) [ Time Frame: Pre- and post-intervention, up to 4 weeks ]
    The level of Brain Derived Neurotrophic Factor in serum measured by ELISA. The level will be measured in nanograms/milliliter.

  3. Change in Brain Derived Neurotrophic Factor level (in sweat) [ Time Frame: Pre- and post-intervention, up to 4 weeks ]
    Brain Derived Neurotrophic Factor level in sweat collected through the sweat pad. The level will be measured in nanograms/milliliter.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • participants diagnosed with solid tumor cancer who have completed cancer treatment at least 6 months;
  • diagnosed with diabetes and/or hypertension for at least a year;
  • aged 21 years or older,
  • have an annual household incomes of below $30,000 for families of three,
  • the average fatigue level within the past 7 days at the level of 3 or more on the 0 (no fatigue) to 10 (worse fatigue) Likert scale
  • give informed consent.

Exclusion Criteria:

  • currently undergoing treatment for cancer;
  • have an active infection (e.g., fever, localized redness, swelling, sinus congestion);
  • diagnosed with a psychological disorder (e.g., suicidal or homicidal tendencies, extreme anxiety or depression)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03874754


Contacts
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Contact: Nada Lukkahatai, PhD 410-614-5297 nada.lukkahatai@jhu.edu

Locations
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United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21205
Contact: Nada Lukkahatai, PhD    240-750-9867    nada.lukkahatai@jhu.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Nada Lukkahatai, PhD Johns Hopkins School of Nursing
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03874754    
Other Study ID Numbers: J1886
P30NR018093-01 ( U.S. NIH Grant/Contract )
IRB00175781 ( Other Identifier: JHM IRB )
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The individual participant data (IPD) will not be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Multiple chronic conditions
Additional relevant MeSH terms:
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Multiple Chronic Conditions
Pathologic Processes
Chronic Disease
Disease Attributes