Assessment of a Tailored Home-Based Exercise Program on Symptoms, Well-Being, and Resilience Among Cancer Survivors With Multiple Chronic Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Change in Resilience as Assessed by Connor-Davidson Resilience Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
The iHBE program group
Tailored Technology-Enhance Home-based exercise program (iHBE)
Intervention: Tailored Technology-Enhance Home-based exercise program (iHBE) (Other)
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
Outcomes
Primary Outcomes
Change in Resilience as Assessed by Connor-Davidson Resilience Scale
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Change in Fatigue as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0-Fatigue 6a
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Physical Activity(12 weeks)
- Change in Brain-Derived Neurotrophic Factor Level (in Serum)(Pre-and post-intervention, up to 12 weeks)
- Change in Brain-Derived Neurotrophic Factor Level (in Sweat)(Pre- and post-intervention, up to 12 weeks)