A Diagnosis of Any Hematologic or Solid Malignancy Clinical Trial
Official title:
ICanSTEP: Increasing Physical Activity in Cancer Survivors Through a Text-messaging Exercise Motivation Program
NCT number | NCT02627079 |
Other study ID # | Pro00068978 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 4, 2016 |
Est. completion date | May 21, 2018 |
Verified date | June 2021 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | May 21, 2018 |
Est. primary completion date | February 6, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Eligible participants must be / have 1. age 18 or older, 2. a diagnosis of any hematologic or solid malignancy 3. a life expectancy of at least 12 months 4. ECOG < /=2 5. in active cancer treatment or have completed active cancer treatment within one year of obtaining consent (with the exception of adjuvant hormonal therapy), 6. not scheduled for any major surgery during the anticipated study period, 7. able to read and understand English 8. sedentary defined as participating in 2 or less days of dedicated physical activity per week, 9. consistent daily access to a smartphone 10. a text messaging plan that includes a minimum of 150 text messages a month at no additional cost 11. capable of providing informed consent. Exclusion Criteria: 1. Significant cardiac disease (i.e., left ventricular ejection fraction of <50%, unstable angina, placement of cardiac stents and myocardial infarction within previous 6 months) 2. Contraindications to a 6-minute walk test as recommended by the American Thoracic Society: (a) acute myocardial infarction (3-5 days), (b) unstable angina, (c) uncontrolled arrhythmias causing symptoms or hemodynamic compromise, (d) syncope, (e) acute endocarditis, (f) acute myocarditis or pericarditis, (g) uncontrolled heart failure, (h) acute pulmonary embolus or pulmonary infarction, (i) thrombosis of lower extremities, (j) suspected dissecting aneurysm, (k) uncontrolled asthma, (l) pulmonary edema, (m) room air desaturation at rest =85%, (n) respiratory failure, (o) acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise, (p) mental impairment leading to inability to cooperate, and (q) extensive bone metastases 3. ECOG >2 4. Participates in 3 or more days of dedicated physical activity per week 5. Known allergic reaction to nickel 6. No access to a smart phone or text messaging plan less than 150 messages per month 7. Physical or psychological contraindication to participation at the discretion of the treating physician. |
Country | Name | City | State |
---|---|---|---|
United States | Duke Cancer Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
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 Car — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility, as measured by the percentage of eligible patients who can be enrolled | 6 months | ||
Primary | Feasibility, as measured by accrual rate | 6 months | ||
Primary | Change in daily step count, as measured by Fitbit | Baseline, 12 weeks | ||
Primary | Change in minutes of weekly exercise, as measured by Fitbit | Baseline, 12 weeks | ||
Primary | Change in fatigue, as measured by questionnaire | Baseline, 12 weeks | ||
Primary | Change in depression, as measured by questionnaire | Baseline, 12 weeks | ||
Primary | Change in general activity, as measured by questionnaire | Baseline, 6 months | ||
Primary | Change in quality of life, as measured by questionnaire | Baseline, 12 weeks | ||
Primary | Change in body mass index (BMI) | Baseline, 12 weeks | ||
Secondary | 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 | |
Secondary | 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. | Baseline, 12 weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |