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ICanSTEP : Increasing Physical Activity With Text Messaging

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02627079
First received: December 8, 2015
Last updated: July 7, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention
A Diagnosis of Any Hematologic or Solid Malignancy Other: Daily SMS text messaging

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: ICanSTEP: Increasing Physical Activity in Cancer Survivors Through a Text-messaging Exercise Motivation Program

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Mean difference in daily step count, as measured by Fitbit [ 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.

  • Mean difference in minutes of weekly exercise, as measured by Fitbit [ 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.

  • Mean difference in fatigue, as measured by questionnaire [ 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.

  • Mean difference in depression, as measured by questionnaire [ 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.

  • Mean difference in general activity, as measured by questionnaire [ 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.

  • Mean difference in quality of life, as measured by questionnaire [ 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.

  • Mean difference in body mass index (BMI) [ 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.


Estimated Enrollment: 30
Study Start Date: February 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cohort 1

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
Active Comparator: Cohort 2
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

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02627079

Contacts
Contact: Tykeytra Dale, BSN MS 919 6683726
Contact: Eileen Duffy, BNS OCN 919 6683726

Locations
United States, North Carolina
Duke Cancer Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Tykeytra Dale, BSN MS    919-668-3726      
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Bridget Koontz, MD Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02627079     History of Changes
Other Study ID Numbers: Pro00068978
Study First Received: December 8, 2015
Last Updated: July 7, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

ClinicalTrials.gov processed this record on September 19, 2017