Bemobile Intervention to Support Physical Activity in Cancer Survivors

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02824861
• Other study ID #: CHRMS15-405
• Secondary ID: VCC1504
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: November 1, 2018

Study information

• Verified date: April 2019
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 1, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Bemobile

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Step counts	Mean daily step counts as assessed by Actigraph Accelerometer	8 weeks
Primary	Change from Baseline in Moderate to Vigorous Physical Activity (MVPA)	Weekly accumulated minutes spent in MVPA as assessed by Actigraph Accelerometer	8 weeks
Secondary	Change in Weekly average of mean daily step counts	Step counts assessed during the intervention with the Fitbit One	8 weeks
Secondary	Change from Baseline in Self-efficacy to perform exercise	Scale developed by Garcia and King	8 weeks
Secondary	Change from Baseline in Self-regulation	Scale Developed R. Umstattd	8 weeks
Secondary	Change from Baseline in Fatigue	Fatigue Symptom Inventory (FSI)	8 weeks