Duke Cancer Center
Durham, North Carolina, 27710, United States
NCT Number: NCT02627079
The proposed pilot study will develop and test feasibility and preliminary efficacy of an exercise motivation intervention using a 12-week smartphone-text messaging program tailored to physical activity data retrieved from a Fitbit. Target population is 15 cancer survivors and 15 patients actively undergoing cancer treatment.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Durham, North Carolina, 27710, United States
Cancer survivors have substantial residual cardiometabolic risk due to the fact that they are living longer and are exposed to the same lifestyle and environmental factors that have led to the drastic increase in obesity and diabetes in Western societies over the last four decades. In addition, survivors' cardiovascular health is significantly impaired due to cancer treatment. Research has shown that physical activity improves quality of life in cancer survivors, ameliorates treatment-related side effects reduces the risk of cancer recurrence, and extends overall survival. Despite these advantages, most cancer patients are sedentary. The early survivor period is a teachable moment to improve healthy behaviors. Social Cognitive Theory argues that to change exercise behavior, we must increase behavior change self-efficacy of participants (i.e., confidence), increase their outcome expectations that changing their behavior will lead to better health, enhance motivation to exercise, enhance their ability to regulate their behavior (self-regulation), teach them tangible behavior change skills, and help them overcome barriers to behavior change. In this study validated patient-reported outcomes will be performed at baseline and at 12 weeks - FACIT-F to document general cancer symptoms with additional questions on fatigue, the Beck Depression Inventory (BDI-II), and the modified Godin-Leisure Questionnaire as a measure of activity level. The investigators will also perform baseline and 3 month weight / BMI and 6-minute walk testing as a second well-validated objective measure of fitness. At enrollment and at 3 months, patients will be queried as to barriers to behavior change. At 3 months, patients will be asked by 5-point Likert scale how helpful the program was in increasing their physical activity. Six months after enrollment (+/- 4 weeks), level of physical activity and use of Fitbit will be determined.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Eligible participants must be / have
Exclusion criteria
Time frame: 6 months
Time frame: 6 months
Time frame: Baseline, 12 weeks
Time frame: Baseline, 12 weeks
Time frame: Baseline, 12 weeks
Time frame: Baseline, 12 weeks
Time frame: Baseline, 6 months
Time frame: Baseline, 12 weeks
Time frame: Baseline, 12 weeks
Time frame: Baseline, 12 weeks
This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time.
Time frame: Baseline, 12 weeks
This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time.
Time frame: Baseline, 12 weeks
This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time.
Time frame: Baseline, 12 weeks
This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time.
Time frame: Baseline, 12 weeks
This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time.
Time frame: Baseline, 12 weeks
This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time.
Time frame: Baseline, 12 weeks
This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time.
Duke University
Other
ICanSTEP: Increasing Physical Activity in Cancer Survivors Through a Text-messaging Exercise Motivation Program
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