Bemobile Intervention to Support Physical Activity in Cancer Survivors

Bemobile: A Text Intervention to Support Physical Activity in Cancer Survivors

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Bemobile

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: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05405
      • University of Vermont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Step counts	Mean daily step counts as assessed by Actigraph Accelerometer	8 weeks
Change from Baseline in Moderate to Vigorous Physical Activity (MVPA)	Weekly accumulated minutes spent in MVPA as assessed by Actigraph Accelerometer	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weekly average of mean daily step counts	Step counts assessed during the intervention with the Fitbit One	8 weeks
Change from Baseline in Self-efficacy to perform exercise	Scale developed by Garcia and King	8 weeks
Change from Baseline in Self-regulation	Scale Developed R. Umstattd	8 weeks
Change from Baseline in Fatigue	Fatigue Symptom Inventory (FSI)	8 weeks

Collaborators and Investigators

• Sponsor: University of Vermont

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): July 30, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: July 2, 2016
• First Submitted That Met QC Criteria: July 6, 2016
• First Posted (Estimate): July 7, 2016

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CHRMS15-405; VCC1504 (Other Identifier: Vermont Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to make individual participant data available