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Bemobile Intervention to Support Physical Activity in Cancer Survivors

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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

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.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: Bemobile Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Bemobile: A Text Intervention to Support Physical Activity in Cancer Survivors
Actual Study Start Date : July 2015
Actual Primary Completion Date : July 30, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Behavioral: Bemobile
Active Comparator: Active Control
Participants receive and wear a fitbit only for 8 weeks
Behavioral: Bemobile



Primary Outcome Measures :
  1. Change from Baseline in Step counts [ Time Frame: 8 weeks ]
    Mean daily step counts as assessed by Actigraph Accelerometer

  2. 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


Secondary Outcome Measures :
  1. Change in Weekly average of mean daily step counts [ Time Frame: 8 weeks ]
    Step counts assessed during the intervention with the Fitbit One

  2. Change from Baseline in Self-efficacy to perform exercise [ Time Frame: 8 weeks ]
    Scale developed by Garcia and King

  3. Change from Baseline in Self-regulation [ Time Frame: 8 weeks ]
    Scale Developed R. Umstattd

  4. Change from Baseline in Fatigue [ Time Frame: 8 weeks ]
    Fatigue Symptom Inventory (FSI)



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824861


Locations
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United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
University of Vermont
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Responsible Party: Nancy Gell, Assistant Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT02824861    
Other Study ID Numbers: CHRMS15-405
VCC1504 ( Other Identifier: Vermont Cancer Center )
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to make individual participant data available