Cancer, Diabetes, Hypertension
Conditions
Keywords
Multiple chronic conditions
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.
Interventions
OTHERTailored 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, 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.
Sponsors
National Institute of Nursing Research (NINR)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Single blinded marking: The data collectors are blinded to the group allocation
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fatigue as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0-Fatigue 6a | Pre- and post-intervention, up to 12 weeks | 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. |
| Change in Resilience as Assessed by Connor-Davidson Resilience Scale | Pre- and post-intervention, up to 12 weeks | 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. |
| Change in Physical Well Being | Pre- and post-intervention, up to 12 weeks | 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. |
| Change in Mental Well Being | Pre- and post-intervention, up to 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brain-Derived Neurotrophic Factor Level (in Serum) | 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. |
| Change in Brain-Derived Neurotrophic Factor Level (in Sweat) | Pre- and post-intervention, up to 12 weeks | Brain-Derived Neurotrophic Factor level in sweat collected through the sweat pad. The level will be measured in nanograms/milliliter. |
| Physical Activity | 12 weeks | The physical activity will be measured in a form of average step count/day measured by a wrist-worn wearable device. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| 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 | 12 |
| Total | 34 |
Baseline characteristics
| Characteristic | Total | Usual Care (Control Group) | The iHBE Program Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 31 Participants | 11 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 1 Participants | 2 Participants |
| Age, Continuous | 73.18 years STANDARD_DEVIATION 6.75 | 74 years STANDARD_DEVIATION 4.79 | 72.73 years STANDARD_DEVIATION 7.69 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 12 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Fatigue | 50.15 T-score STANDARD_DEVIATION 9.81 | 45.17 T-score STANDARD_DEVIATION 7.93 | 52.64 T-score STANDARD_DEVIATION 9.89 |
| Mental well-being | 63.91 units on a scale STANDARD_DEVIATION 30.37 | 54.15 units on a scale STANDARD_DEVIATION 38.5 | 73.66 units on a scale STANDARD_DEVIATION 16.25 |
| Physical well-being | 48.44 units on a scale STANDARD_DEVIATION 30.09 | 54.37 units on a scale STANDARD_DEVIATION 32.4 | 42.52 units on a scale STANDARD_DEVIATION 28.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 7 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 5 Participants | 9 Participants |
| Region of Enrollment United States | 34 Participants | 12 Participants | 22 Participants |
| Resilience | 36.41 units on a scale STANDARD_DEVIATION 7.64 | 38.11 units on a scale STANDARD_DEVIATION 8.43 | 35.56 units on a scale STANDARD_DEVIATION 7.32 |
| Sex: Female, Male Female | 20 Participants | 6 Participants | 14 Participants |
| Sex: Female, Male Male | 14 Participants | 6 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 12 |
| other Total, other adverse events | 0 / 22 | 0 / 12 |
| serious Total, serious adverse events | 0 / 22 | 0 / 12 |
Outcome results
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.
Time frame: Pre- and post-intervention, up to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The iHBE Program Group | Change in Fatigue as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0-Fatigue 6a | -1.61 T-score | Standard Deviation 6.75 |
| Usual Care (Control Group) | Change in Fatigue as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0-Fatigue 6a | 4.26 T-score | Standard Deviation 7.95 |
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.
Time frame: Pre- and post-intervention, up to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The iHBE Program Group | Change in Mental Well Being | 2.51 score on a scale | Standard Deviation 6.29 |
| Usual Care (Control Group) | Change in Mental Well Being | 0.16 score on a scale | Standard Deviation 16.21 |
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.
Time frame: Pre- and post-intervention, up to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The iHBE Program Group | Change in Physical Well Being | 14.48 score on a scale | Standard Deviation 26.48 |
| Usual Care (Control Group) | Change in Physical Well Being | -2.83 score on a scale | Standard Deviation 17.67 |
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.
Time frame: Pre- and post-intervention, up to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The iHBE Program Group | Change in Resilience as Assessed by Connor-Davidson Resilience Scale | 0.00 score on a scale | Standard Deviation 4.97 |
| Usual Care (Control Group) | Change in Resilience as Assessed by Connor-Davidson Resilience Scale | 0.89 score on a scale | Standard Deviation 6.41 |
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.
Time frame: Pre-and post-intervention, up to 12 weeks
Population: 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.
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.
Time frame: Pre- and post-intervention, up to 12 weeks
Population: 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.
Secondary
Physical Activity
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The iHBE Program Group | Physical Activity | 1279.11 steps/day | Standard Deviation 2986.71 |
| Usual Care (Control Group) | Physical Activity | 805.46 steps/day | Standard Deviation 1682.42 |