Smart-phone Health Coaching Intervention to Promote Maintenance of Exercise in Breast Cancer Survivors:Protocol

NCT02620735 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2019-07-08

No results posted yet for this study

Summary

While physical activity (PA) appears to play an important role in disease control and the promotion of long-term health and well-being of cancer survivors, the large majority of breast cancer survivors are not physically active. Addressing this problem requires exercise promotion and an additional method of supporting long term exercise adherence. In response, an innovative health coaching intervention which uses mobile technology (iMOVE) to promote long-term PA in breast cancer survivors (BrCa) was developed. Project description: 107 inactive BrCa survivors will be randomized to receive a 12-week exercise program (CONTROL) OR a 12 week exercise program plus a concurrent health coaching program (iMOVE) consisting of telephone-based coaching sessions and interactive software delivered through a smart-phone and Fit-bit (wearable fitness technology) (INTERVENTION). Information on the feasibility and acceptability of the methods and intervention and examine the impact on fitness (primary), patient-reported, anthropometric, and physical (secondary) outcomes will be collected. Impact and relevance: PA has increasingly been identified as a modifiable factor that has the potential to impact cancer outcomes and improve quality of life. iMOVE is an innovative intervention with the potential to promote and maintain physical activity for breast cancer survivors. This study will be the first step in the evaluation of iMOVE and will help to determine whether a larger randomized controlled trial is needed.

Conditions

  • Breast Neoplasms

Interventions

DEVICE

Fit bit Device

Use of the fit bit flex for the duration of the study. Measures steps and sleep. Health Coaching

BEHAVIORAL

Exercise Only

12 week exercise program

BEHAVIORAL

Connected Wellness HealthCoach Software

Use of the app on Smart-phones and an online platform. Measures the following factors: Mood, Pain, energy,exercise not picked up by Fit bit.

BEHAVIORAL

Health Coaching

10 over the phone health coaching sessions.

Sponsors & Collaborators

  • Canadian Breast Cancer Foundation

    collaborator OTHER
  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Jennifer M Jones, PhD · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2019-07-31
Completion
2019-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02620735 on ClinicalTrials.gov