An interventional study of Daily SMS text messaging in A Diagnosis of Any Hematologic or Solid Malignancy, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-10.
Sponsored by Duke University · Not applicable, Interventional, and Other
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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Eligible participants must be / have
Exclusion Criteria:
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..
Other: Daily SMS text messaging
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.
Other: Daily SMS text messaging
Feasibility, as measured by the percentage of eligible patients who can be enrolled
Time frame: 6 months
Feasibility, as measured by accrual rate
Time frame: 6 months
Change in daily step count, as measured by Fitbit
Time frame: Baseline, 12 weeks
Change in minutes of weekly exercise, as measured by Fitbit
Time frame: Baseline, 12 weeks
Change in fatigue, as measured by questionnaire
Time frame: Baseline, 12 weeks
Change in depression, as measured by questionnaire
Time frame: Baseline, 12 weeks
Change in general activity, as measured by questionnaire
Time frame: Baseline, 6 months
Change in quality of life, as measured by questionnaire
Time frame: Baseline, 12 weeks
Change in body mass index (BMI)
Time frame: Baseline, 12 weeks
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.
Time frame: Baseline, 12 weeks
Mean difference in minutes of weekly exercise, 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 12 weeks
Plan to share: No
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Duke University