NCT02824861

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 2, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

3.1 years

First QC Date

July 2, 2016

Last Update Submit

April 15, 2019

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Change in Weekly average of mean daily step counts

    8 weeks

  • Change from Baseline in Self-efficacy to perform exercise

    8 weeks

  • Change from Baseline in Self-regulation

    8 weeks

  • Change from Baseline in Fatigue

    8 weeks

Study Arms (2)

Text Intervention

EXPERIMENTAL

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 Control

ACTIVE COMPARATOR

Participants receive and wear a fitbit only for 8 weeks

Behavioral: Bemobile

Interventions

BemobileBEHAVIORAL
Active ControlText Intervention

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cancer diagnosis
  • Impending graduation from oncology rehabilitation

You may not qualify if:

  • Metastatic cancer
  • Concurrent radiation or chemotherapy
  • No cell phone
  • Inability to read or speak English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vermont

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 2, 2016

First Posted

July 7, 2016

Study Start

July 1, 2015

Primary Completion

July 30, 2018

Study Completion

November 1, 2018

Last Updated

April 17, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

No plan to make individual participant data available

Locations

US(1)