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

Primary Purpose

Cancer, Hypertension, Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored Technology-Enhance Home-based exercise program (iHBE)
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring Multiple chronic conditions

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 $50,000 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)

Sites / Locations

  • The Sidney Kimmel Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The iHBE program group

Usual Care (Control group)

Arm Description

Tailored Technology-Enhance Home-based exercise program (iHBE)

Participants were required to wear physical activity tracker (Fitbit) and respond to the daily symptoms survey (mEMA) while receiving usual care

Outcomes

Primary Outcome Measures

Change in Fatigue as Assessed by Self-reported Fatigue Questionnaire
Patient-Reported Outcomes Measures Information System (PROMIS) Short Form V1.0-Fatigue 6a. A 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). Higher score means a greater fatigue
Change in Resilience as Assessed by Connor-Davidson Resilience Scale
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). The higher score means a better resilience
Change in Physical Well Being
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.
Change in Mental Well Being
Mental component of the Short Form Survey (SF-36), the 36 item self-report instrument. The overall score was derived from the mental health, and role limitation-emotional domains. The total score range from 0 to 200, with a score of 200 indicating high mental well being

Secondary Outcome Measures

Physical Activity
The physical activity will be measured in a form of average step count/day measured by a wrist-worn wearable device.
Change in Brain-Derived Neurotrophic Factor Level (in Serum)
The level of Brain-Derived Neurotrophic Factor in serum was measured by ELISA. The level will be measured in nanograms/milliliter.
Change in Brain-Derived Neurotrophic Factor Level (in Sweat)
Brain-Derived Neurotrophic Factor level in sweat collected through the sweat pad. The level will be measured in nanograms/milliliter.

Full Information

First Posted
March 12, 2019
Last Updated
August 24, 2022
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT03874754
Brief Title
Tailored Home-Based Exercise Program for Multiple Chronic Conditions
Acronym
iHBE
Official Title
Assessment of a Tailored Home-Based Exercise Program on Symptoms, Well-Being, and Resilience Among Cancer Survivors With Multiple Chronic Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Hypertension, Diabetes
Keywords
Multiple chronic conditions

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a two-arm parallel assignment involving two groups of participants. One group receives exercise intervention, and the other group receives usual care (control group).
Masking
Outcomes Assessor
Masking Description
Single blinded marking: The data collectors are blinded to the group allocation
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The iHBE program group
Arm Type
Experimental
Arm Description
Tailored Technology-Enhance Home-based exercise program (iHBE)
Arm Title
Usual Care (Control group)
Arm Type
No Intervention
Arm Description
Participants were required to wear physical activity tracker (Fitbit) and respond to the daily symptoms survey (mEMA) while receiving usual care
Intervention Type
Other
Intervention Name(s)
Tailored Technology-Enhance Home-based exercise program (iHBE)
Other Intervention Name(s)
iHBE
Intervention Description
The tailored technology enhanced home-based exercise (iHBE) program is a 12-week program with 1 assessment home visit session, 5 home visits and 7 phone follow ups during exercise. 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.
Primary Outcome Measure Information:
Title
Change in Fatigue as Assessed by Self-reported Fatigue Questionnaire
Description
Patient-Reported Outcomes Measures Information System (PROMIS) Short Form V1.0-Fatigue 6a. A 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). Higher score means a greater fatigue
Time Frame
Pre- and post-intervention, up to 12 weeks
Title
Change in Resilience as Assessed by Connor-Davidson Resilience Scale
Description
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). The higher score means a better resilience
Time Frame
Pre- and post-intervention, up to 12 weeks
Title
Change in Physical Well Being
Description
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.
Time Frame
Pre- and post-intervention, up to 12 weeks
Title
Change in Mental Well Being
Description
Mental component of the Short Form Survey (SF-36), the 36 item self-report instrument. The overall score was derived from the mental health, and role limitation-emotional domains. The total score range from 0 to 200, with a score of 200 indicating high mental well being
Time Frame
Pre- and post-intervention, up to 12 weeks
Secondary Outcome Measure Information:
Title
Physical Activity
Description
The physical activity will be measured in a form of average step count/day measured by a wrist-worn wearable device.
Time Frame
12 weeks
Title
Change in Brain-Derived Neurotrophic Factor Level (in Serum)
Description
The level of Brain-Derived Neurotrophic Factor in serum was measured by ELISA. The level will be measured in nanograms/milliliter.
Time Frame
Pre-and post-intervention, up to 12 weeks
Title
Change in Brain-Derived Neurotrophic Factor Level (in Sweat)
Description
Brain-Derived Neurotrophic Factor level in sweat collected through the sweat pad. The level will be measured in nanograms/milliliter.
Time Frame
Pre- and post-intervention, up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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 $50,000 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nada Lukkahatai, PhD
Organizational Affiliation
Johns Hopkins School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The individual participant data (IPD) will not be shared with other researchers

Learn more about this trial

Tailored Home-Based Exercise Program for Multiple Chronic Conditions

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