Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bemobile Intervention to Support Physical Activity in Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02824861
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Nancy Gell, University of Vermont

Tracking Information
First Submitted Date  ICMJE July 2, 2016
First Posted Date  ICMJE July 7, 2016
Last Update Posted Date April 17, 2019
Actual Study Start Date  ICMJE July 2015
Actual Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2016)
  • Change from Baseline in Step counts [ Time Frame: 8 weeks ]
    Mean daily step counts as assessed by Actigraph Accelerometer
  • Change from Baseline in Moderate to Vigorous Physical Activity (MVPA) [ Time Frame: 8 weeks ]
    Weekly accumulated minutes spent in MVPA as assessed by Actigraph Accelerometer
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2016)
  • Change in Weekly average of mean daily step counts [ Time Frame: 8 weeks ]
    Step counts assessed during the intervention with the Fitbit One
  • Change from Baseline in Self-efficacy to perform exercise [ Time Frame: 8 weeks ]
    Scale developed by Garcia and King
  • Change from Baseline in Self-regulation [ Time Frame: 8 weeks ]
    Scale Developed R. Umstattd
  • Change from Baseline in Fatigue [ Time Frame: 8 weeks ]
    Fatigue Symptom Inventory (FSI)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bemobile Intervention to Support Physical Activity in Cancer Survivors
Official Title  ICMJE Bemobile: A Text Intervention to Support Physical Activity in Cancer Survivors
Brief Summary This study evaluates a technology based intervention (physical activity tracker, text messages, health coach, global positioning system enabled location based feedback on physical activity) to support physical activity in cancer survivors after completing oncology rehabilitation. In Phase 1 all participants received the full intervention. In phase II participants are randomly assigned to receive the full intervention or a fitbit only.
Detailed Description This intervention, offered to participants after completing oncology rehabilitation, integrates known preferences and determinants of physical activity participation in women and breast cancers survivors including social support, professional guidance, self-efficacy, goal setting, self-regulation, and environmental awareness delivered through accessible technology. For the iteration phase, the investigators will conduct an initial, abbreviated intervention wave lasting 4 weeks; the investigators will then incorporate participant input and feedback on the specific components to refine the intervention prior to a pilot trial. Means of delivering the components include communication and support through tailored text messaging, health coaching phone calls, self-monitoring of physical activity through a wearable sensor, and environmental assessment of community physical activity options (e.g., parks, fitness centers, trails) based on global positioning system information.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Cancer
Intervention  ICMJE Behavioral: Bemobile
Study Arms  ICMJE
  • Experimental: Text Intervention
    Participants receive text messages to a personal cell phone over 8 weeks, wear a fitbit to monitor physical activity, and communicate with a health coach intermittently over 2 weeks
    Intervention: Behavioral: Bemobile
  • Active Comparator: Active Control
    Participants receive and wear a fitbit only for 8 weeks
    Intervention: Behavioral: Bemobile
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2019)
70
Original Estimated Enrollment  ICMJE
 (submitted: July 6, 2016)
50
Actual Study Completion Date  ICMJE November 1, 2018
Actual Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Cancer diagnosis
  • Impending graduation from oncology rehabilitation

Exclusion Criteria:

  • Metastatic cancer
  • Concurrent radiation or chemotherapy
  • No cell phone
  • Inability to read or speak English.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02824861
Other Study ID Numbers  ICMJE CHRMS15-405
VCC1504 ( Other Identifier: Vermont Cancer Center )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plan to make individual participant data available
Responsible Party Nancy Gell, University of Vermont
Study Sponsor  ICMJE University of Vermont
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Vermont
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP