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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Active Comparator | Cohort 1 will include 15 sedentary participants who have completed all cancer therapy except adjuvant hormonal therapy. All participants will be provided a Fitbit. Participants will then be provided daily SMS text messaging tailored to their activity level for 12 weeks.. |
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| Cohort 2 | Active Comparator | Cohort 2 will include 15 sedentary participants in active treatment. All participants will be provided a Fitbit. Participants will then be provided daily SMS text messaging tailored to their activity levels for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily SMS text messaging | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility, as measured by the percentage of eligible patients who can be enrolled | 6 months | |
| Feasibility, as measured by accrual rate | 6 months | |
| Change in daily step count, as measured by Fitbit | Baseline, 12 weeks | |
| Change in minutes of weekly exercise, as measured by Fitbit | Baseline, 12 weeks | |
| Change in fatigue, as measured by questionnaire | Baseline, 12 weeks | |
| Change in depression, as measured by questionnaire | Baseline, 12 weeks | |
| Change in general activity, as measured by questionnaire | Baseline, 6 months | |
| Change in quality of life, as measured by questionnaire | Baseline, 12 weeks | |
| Change in body mass index (BMI) | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean difference in daily step count, as measured by Fitbit | This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time. | Baseline, 12 weeks |
| Mean difference in minutes of weekly exercise, as measured by Fitbit |
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Inclusion Criteria:
Eligible participants must be / have
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bridget Koontz, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Cancer Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34050402 | Result | Koontz BF, Levine E, McSherry F, Niedzwiecki D, Sutton L, Dale T, Streicher M, Rushing C, Owen L, Kraus WE, Bennett G, Pollak KI. Increasing physical activity in Cancer Survivors through a Text-messaging Exercise motivation Program (ICanSTEP). Support Care Cancer. 2021 Dec;29(12):7339-7349. doi: 10.1007/s00520-021-06281-y. Epub 2021 May 28. |
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This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time. |
| Baseline, 12 weeks |
| Mean difference in fatigue, as measured by questionnaire | This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time. | Baseline, 12 weeks |
| Mean difference in depression, as measured by questionnaire | This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time. | Baseline, 12 weeks |
| Mean difference in general activity, as measured by questionnaire | This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time. | Baseline, 12 weeks |
| Mean difference in quality of life, as measured by questionnaire | This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time. | Baseline, 12 weeks |
| Mean difference in body mass index (BMI) | This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time. | Baseline, 12 weeks |