An interventional study of Tailored Technology-Enhance Home-based exercise program (iHBE) in Cancer, Hypertension and Diabetes, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-10-14.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Not applicable, Interventional, and Supportive care
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's enrollment of 34 is below the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 582 studies on the registry; 71 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 68 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tailored Technology-Enhance Home-based exercise program (iHBE)
Other: 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
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.
Also known as: iHBE
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
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
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
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
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
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
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
| Milestone | The iHBE Program Group | Usual Care (Control Group) |
|---|---|---|
| Started | 22 | 12 |
| Completed | 14 | 6 |
| Not completed | 8 | 6 |
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.
| T-score | The iHBE Program Group | Usual Care (Control Group) |
|---|---|---|
| Change in Fatigue as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0-Fatigue 6a | -1.61 ± 6.75 | 4.26 ± 7.95 |
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.
| score on a scale | The iHBE Program Group | Usual Care (Control Group) |
|---|---|---|
| Change in Resilience as Assessed by Connor-Davidson Resilience Scale | 0.00 ± 4.97 | 0.89 ± 6.41 |
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.
| score on a scale | The iHBE Program Group | Usual Care (Control Group) |
|---|---|---|
| Change in Physical Well Being | 14.48 ± 26.48 | -2.83 ± 17.67 |
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.
| score on a scale | The iHBE Program Group | Usual Care (Control Group) |
|---|---|---|
| Change in Mental Well Being | 2.51 ± 6.29 | 0.16 ± 16.21 |
The physical activity will be measured in a form of average step count/day measured by a wrist-worn wearable device.
| steps/day | The iHBE Program Group | Usual Care (Control Group) |
|---|---|---|
| Physical Activity | 1279.11 ± 2986.71 | 805.46 ± 1682.42 |
The level of Brain-Derived Neurotrophic Factor in serum was measured by ELISA. The level will be measured in nanograms/milliliter.
No measurements were reported for this outcome.
Brain-Derived Neurotrophic Factor level in sweat collected through the sweat pad. The level will be measured in nanograms/milliliter.
No measurements were reported for this outcome.
Collected over Adverse event data were collected within 6 months from baseline study visit. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| The iHBE Program Group | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Usual Care (Control Group) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | The iHBE Program Group | Usual Care (Control Group) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 1 | 3 |
| >=65 years | 20 | 11 | 31 |
| Age, Continuous(years) | The iHBE Program Group | Usual Care (Control Group) | Total |
|---|---|---|---|
| Mean | 72.73 ± 7.69 | 74 ± 4.79 | 73.18 ± 6.75 |
| Sex: Female, Male(Participants) | The iHBE Program Group | Usual Care (Control Group) | Total |
|---|---|---|---|
| Female | 14 | 6 | 20 |
| Male | 8 | 6 | 14 |
| Ethnicity (NIH/OMB)(Participants) | The iHBE Program Group | Usual Care (Control Group) | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 20 | 12 | 32 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | The iHBE Program Group | Usual Care (Control Group) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 12 | 7 | 19 |
| White | 9 | 5 | 14 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | The iHBE Program Group | Usual Care (Control Group) | Total |
|---|---|---|---|
| United States | 22 | 12 | 34 |
| Fatigue(T-score) | The iHBE Program Group | Usual Care (Control Group) | Total |
|---|---|---|---|
| Mean | 52.64 ± 9.89 | 45.17 ± 7.93 | 50.15 ± 9.81 |
| Resilience(units on a scale) | The iHBE Program Group | Usual Care (Control Group) | Total |
|---|---|---|---|
| Mean | 35.56 ± 7.32 | 38.11 ± 8.43 | 36.41 ± 7.64 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — The individual participant data (IPD) will not be shared with other researchers
Ran from Aug 2019 to primary completion in Jan 2021, 17 months.
Results were first posted in Sep 2022, 1 year 7 months after primary completion.
Of 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's 17 months is below that.
Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins →