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| ID | Type | Description | Link |
|---|---|---|---|
| P30NR018093-01 | U.S. NIH Grant/Contract | View source | |
| IRB00175781 | Other Identifier | JHM IRB |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The iHBE program group | Experimental | Tailored Technology-Enhance Home-based exercise program (iHBE) |
|
| Usual Care (Control group) | No Intervention | Participants were required to wear physical activity tracker (Fitbit) and respond to the daily symptoms survey (mEMA) while receiving usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailored Technology-Enhance Home-based exercise program (iHBE) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fatigue as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0-Fatigue 6a | Fatigue was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0-Fatigue 6a. This 6-item measure covers fatigue frequency, duration, intensity, and impact on daily activities. Responses were summed to generate a raw score (range 6-30), which was converted to a standardized T-score (mean = 50, SD = 10) based on the U.S. general population. Higher T-scores indicate greater fatigue (worse outcome). The reported outcome is the change in PROMIS Fatigue T-score from baseline to completion, where negative values indicate improvement. | Pre- and post-intervention, up to 12 weeks |
| Change in Resilience as Assessed by Connor-Davidson Resilience Scale | Resilience was assessed using the Connor-Davidson Resilience Scale (CD-RISC; 10 items). Each item is rated on a 5-point Likert scale (0 = not true at all to 4 = true nearly all the time). Raw scores are summed to produce a total score ranging from 0 to 40, with higher scores indicating greater resilience (better outcome). The reported outcome is the mean change in raw score, calculated as the score at the completion time point (12 weeks) minus the score at baseline. Positive values indicate improvement in resilience. | Pre- and post-intervention, up to 12 weeks |
| Change in Physical Well Being | Physical well-being was assessed using the 36-Item Short Form Health Survey (SF-36). The measure was derived from the physical functioning, role-physical, and bodily pain domains. Each domain is scored from 0 to 100, with higher scores indicating better physical health. The reported outcome is the mean change in the averaged domain scores from baseline to completion. Positive values indicate improvement in physical well-being. | Pre- and post-intervention, up to 12 weeks |
| Change in Mental Well Being | Mental well-being was assessed using the 36-Item Short Form Health Survey (SF-36). The Mental Component Score was calculated as the average of relevant domains (vitality, social functioning, role limitations due to emotional health, and mental health). Each domain is scored from 0 to 100, and the average domain score was used to represent overall mental well-being. Higher scores indicate better mental health. The reported outcome is the mean change in the averaged raw score from baseline to completion. Positive values indicate an improvement in mental well-being. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity | The physical activity will be measured in a form of average step count/day measured by a wrist-worn wearable device. | 12 weeks |
| Change in Brain-Derived Neurotrophic Factor Level (in Serum) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nada Lukkahatai, PhD | Johns Hopkins School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 21205 | United States |
The individual participant data (IPD) will not be shared with other researchers
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| ID | Title | Description |
|---|---|---|
| FG000 | The iHBE Program Group | Tailored Technology-Enhance Home-based exercise program (iHBE): The tailored technology-enhanced home-based exercise (iHBE) program is a 12-week program with 1 assessment home visit session, 2 home visits on the first and last week of the program and 10 weekly phone follow up. Participants were asked to choose their methods of exercise and set up weekly goals for exercise with the researcher. The technologies, a wearable device, and a smartphone application were used as a tool to monitor physical performance (heart rate [HR], step count), provide immediate feedback, and send daily reminding messages through Mobile Ecological Momentary Assessment (mEMA). The physical performance and goals were reviewed and adjusted by both participant and researcher weekly. |
| FG001 | Usual Care (Control Group) | Participants were required to wear physical activity tracker (Fitbit) and respond to the daily symptoms survey (mEMA) while receiving usual care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | The iHBE Program Group | Tailored Technology-Enhance Home-based exercise program (iHBE): The tailored technology-enhanced home-based exercise (iHBE) program is a 12-week program with 1 assessment home visit session, 2 home visits on the first and last week of the program and 10 weekly phone follow up. Participants were asked to choose their methods of exercise and set up weekly goals for exercise with the researcher. The technologies, a wearable device, and a smartphone application were used as a tool to monitor physical performance (heart rate [HR], step count), provide immediate feedback, and send daily reminding messages through Mobile Ecological Momentary Assessment (mEMA). The physical performance and goals were reviewed and adjusted by both participant and researcher weekly. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Fatigue as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0-Fatigue 6a | Fatigue was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0-Fatigue 6a. This 6-item measure covers fatigue frequency, duration, intensity, and impact on daily activities. Responses were summed to generate a raw score (range 6-30), which was converted to a standardized T-score (mean = 50, SD = 10) based on the U.S. general population. Higher T-scores indicate greater fatigue (worse outcome). The reported outcome is the change in PROMIS Fatigue T-score from baseline to completion, where negative values indicate improvement. | Posted | Mean | Standard Deviation | T-score | Pre- and post-intervention, up to 12 weeks |
|
Adverse event data were collected within 6 months from baseline study visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | The iHBE Program Group | Tailored Technology-Enhance Home-based exercise program (iHBE): The tailored technology-enhanced home-based exercise (iHBE) program is a 12-week program with 1 assessment home visit session, 2 home visits on the first and last week of the program and 10 weekly phone follow up. Participants were asked to choose their methods of exercise and set up weekly goals for exercise with the researcher. The technologies, a wearable device, and a smartphone application were used as a tool to monitor physical performance (heart rate [HR], step count), provide immediate feedback, and send daily reminding messages through Mobile Ecological Momentary Assessment (mEMA). The physical performance and goals were reviewed and adjusted by both participant and researcher weekly. |
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The study was interrupted by the COVID-19 pandemic, which led to unanticipated pauses in study activities and affected participant enrollment, intervention delivery, and follow-up assessments. As a result, the sample size was smaller than originally planned and some study procedures were modified. These factors may limit the generalizability of the findings and the ability to fully determine the intervention's effect.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nada Lukkahatai | Johns Hopkins School of Nursing | 2407509867 | nada.lukkahatai@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 14, 2018 | Jul 19, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| D000071069 | Multiple Chronic Conditions |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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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).
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Single blinded marking: The data collectors are blinded to the group allocation
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|
| Pre- and post-intervention, up to 12 weeks |
The level of Brain-Derived Neurotrophic Factor in serum was measured by ELISA. The level will be measured in nanograms/milliliter.
| Pre-and post-intervention, up to 12 weeks |
| 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. | Pre- and post-intervention, up to 12 weeks |
| BG001 | Usual Care (Control Group) | Participants were required to wear physical activity tracker (Fitbit) and respond to the daily symptoms survey (mEMA) while receiving usual care |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Fatigue | Fatigue will be assessed using the PROMIS Short Form v1.0 - Fatigue 6a, a 6-item self-report instrument that measures fatigue frequency, duration, and intensity, as well as its impact on physical, mental, and social activities. Each item is rated on a 5-point Likert scale (1 = never to 5 = always). Raw scores are converted to standardized T-scores (mean = 50, standard deviation = 10) based on the U.S. general population, with higher scores indicating greater fatigue. | Mean | Standard Deviation | T-score |
|
| Resilience | Resilience was measured by the 10-item Connor-Davidson Resilience Scale (CD-RISC-10), a self-report measure with items rated from 0 ('not true at all') to 4 ('true nearly all the time'). The total score ranges from 0 to 40, with higher scores indicating greater resilience. | Mean | Standard Deviation | units on a scale |
|
| Physical well-being | Physical well-being was assessed using the SF-36 Health Survey. The physical component summary was scored from the domains of physical functioning, role limitations due to physical health, and bodily pain (each ranging from 0 to 100). The average score were use for physical health score, with higher scores indicating better physical health. | Mean | Standard Deviation | units on a scale |
|
| Mental well-being | Mental well-being was assessed using the SF-36 Health Survey. Scores from the domains of vitality, social functioning, role limitations due to emotional problems, and mental health (each ranging from 0 to 100) were averaged to create a composite mental well-being score, with higher scores indicating better mental health. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Usual Care (Control Group) | Participants were required to wear physical activity tracker (Fitbit) and respond to the daily symptoms survey (mEMA) while receiving usual care |
|
|
| Primary | Change in Resilience as Assessed by Connor-Davidson Resilience Scale | Resilience was assessed using the Connor-Davidson Resilience Scale (CD-RISC; 10 items). Each item is rated on a 5-point Likert scale (0 = not true at all to 4 = true nearly all the time). Raw scores are summed to produce a total score ranging from 0 to 40, with higher scores indicating greater resilience (better outcome). The reported outcome is the mean change in raw score, calculated as the score at the completion time point (12 weeks) minus the score at baseline. Positive values indicate improvement in resilience. | Posted | Mean | Standard Deviation | score on a scale | Pre- and post-intervention, up to 12 weeks |
|
|
|
| Primary | Change in Physical Well Being | Physical well-being was assessed using the 36-Item Short Form Health Survey (SF-36). The measure was derived from the physical functioning, role-physical, and bodily pain domains. Each domain is scored from 0 to 100, with higher scores indicating better physical health. The reported outcome is the mean change in the averaged domain scores from baseline to completion. Positive values indicate improvement in physical well-being. | Posted | Mean | Standard Deviation | score on a scale | Pre- and post-intervention, up to 12 weeks |
|
|
|
| Primary | Change in Mental Well Being | Mental well-being was assessed using the 36-Item Short Form Health Survey (SF-36). The Mental Component Score was calculated as the average of relevant domains (vitality, social functioning, role limitations due to emotional health, and mental health). Each domain is scored from 0 to 100, and the average domain score was used to represent overall mental well-being. Higher scores indicate better mental health. The reported outcome is the mean change in the averaged raw score from baseline to completion. Positive values indicate an improvement in mental well-being. | Posted | Mean | Standard Deviation | score on a scale | Pre- and post-intervention, up to 12 weeks |
|
|
|
| Secondary | Physical Activity | The physical activity will be measured in a form of average step count/day measured by a wrist-worn wearable device. | Posted | Mean | Standard Deviation | steps/day | 12 weeks |
|
|
|
| Secondary | 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. | Due to the pandemic interruption with in-person research activity, we were unable to collect blood and sweat samples from the participants. Therefore, no data is available for this outcome. | Posted | Pre-and post-intervention, up to 12 weeks |
|
|
| Secondary | 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. | Due to the pandemic interruption with in-person research activity, we were unable to collect blood and sweat samples from the participants. Therefore, no data is available for this outcome. | Posted | Pre- and post-intervention, up to 12 weeks |
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Usual Care (Control Group) | Participants were required to wear physical activity tracker (Fitbit) and respond to the daily symptoms survey (mEMA) while receiving usual care | 0 | 12 | 0 | 12 | 0 | 12 |
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| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |