Self-Monitoring Physical Activity With a Smartphone Application and Physiotherapy Coaching in Cancer Patients. (SMART-COACH)

November 9, 2020 updated by: A.M.E. Walenkamp, University Medical Center Groningen

Effectiveness of Self-monitoring Physical Activity With a Smartphone Application and Physiotherapy Coaching in Cancer Patients: a Randomized Controlled Trial (SMART-COACH Trial)

The aim of this study is to examine whether self-monitoring PA with the RunKeeper app with additional physiotherapy coaching is superior in improving patients' self-reported leisure-time PA compared with usual care in cancer patients after 12 weeks.

This is a single-center, prospective, two-armed, randomized controlled trial. Adult cancer patients and cancer survivors are randomized in one of the two study arms, (Group A) RunKeeper app + physiotherapy coaching or (Group B) usual care.

Patients assigned to the intervention group will be instructed to use the RunKeeper app for 12 weeks to self-monitor leisure-time PA. In addition, patients will be educated about the health risks of a sedentary lifestyle, inactivity and (when applicable) other unhealthy lifestyle behaviors (e.g. unhealthy diet, overweight or obesity, sun exposure, alcohol intake). Benefits of a behavior change, becoming physically active and pursuing a healthy lifestyle will be explained by a trained physiotherapist who will also coach the patient during the PA program. The biweekly physiotherapy coaching starts at baseline and will follow a structured sequence of strategies to change patients PA behavior which will contribute to the adoption of leisure-time PA in patients daily living, so the program will be optimally tailored to the patients capabilities and preferences.

The primary endpoint is to examine the effectiveness of the RunKeeper use with additional physiotherapy coaching in improving patients' leisure-time PA compared with usual care in cancer patients as measured by the PASE subscale leisure-time Sum Score at baseline, 6, 12 and 26 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients >18 years of age diagnosed with cancer (regardless of type/taxonomy) at the medical oncology department, UMCG
  • Patients undergoing cancer treatment or surveillance
  • WHO-performance score ≤1
  • Signed informed consent

Exclusion Criteria:

  • Inability to read or understand the Dutch language
  • Inability to handle or not in possession of a smartphone (iPhone ≥4 or Android phones)
  • Active user of the RunKeeper app
  • Severe cardiac (recent cardiovascular event) or psychiatric disease
  • Patients following supervised oncologic rehabilitation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RunKeeper app + physiotherapy coaching
Group A will use the RunKeeper app for half a year to self-monitor leisure-time PA. Besides, patients are requested to activate the 'training reminder' option in the RunKeeper app, which is all explained in a brief user's manual. In addition, patients will be educated about the health risks of a sedentary lifestyle, inactivity and (when applicable) other unhealthy lifestyle behaviors (e.g. unhealthy diet, overweight or obesity, sun exposure, alcohol intake). Benefits of a behavior change, becoming physically active and pursuing a healthy lifestyle will be explained by a trained physiotherapist who will also coach the patient during the PA program.
Other: RunKeeper app + physiotherapy coaching
RunKeeper app for half a year to self-monitor leisure-time PA.
Other: usual care
In the UMCG, patients who receive cancer treatment or in surveillance after treatment are normally advised to live healthy, stay active, and to maintain their weight.
Other: Usual care
In the UMCG, patients who receive cancer treatment or in surveillance after treatment are normally advised to live healthy, stay active, and to maintain their weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
examine the effectiveness of the RunKeeper use with additional physiotherapy coaching
Time Frame: 6 months
To examine the effectiveness of the RunKeeper use with additional physiotherapy coaching in improving patients' leisure-time PA compared with usual care in cancer patients as measured by the PASE subscale leisure-time Sum Score at baseline, 6, 12 and 26 weeks.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
investigate the improvement in the percentage of patients meeting the prescribed total weekly minutes of leisure-time PA
Time Frame: 6 months
To investigate the improvement in the percentage of patients meeting the prescribed total weekly minutes of leisure-time PA with moderate to vigorous intensity corresponding to the NNGB as measured by accelerometry (ActiGraph GT3X-BT) at baseline, 12 and 26 weeks.
6 months
investigate the improvement in patients' weekly total minutes of leisure-time PA and sedentary time
Time Frame: 6 months
To investigate the improvement in patients' weekly total minutes of leisure-time PA and sedentary time as measured by the PASE subscales leisure-time Total Minutes of PA and Sedentary Time at baseline, 6, 12 and 26 weeks.
6 months
examine the improvement in patients' health-related quality of life (HR-QoL)
Time Frame: 6 months
To examine the improvement in patients' health-related quality of life (HR-QoL) as measured by the European Organization for Treatment of Cancer QoL (EORTC QLQ-C30) questionnaire at baseline, 12 and 26 weeks.
6 months
examine the improvement in patients' self-efficacy
Time Frame: 6 months
To examine the improvement in patients' self-efficacy as measured by the Algemene Competentie Schaal (ALCOS) questionnaire at baseline, 12 and 26 weeks.
6 months
explore patients' PA Stage of Change
Time Frame: 6 months
To explore patients' PA Stage of Change as measured by the Physician-based Assessment and Counseling for Exercise (PACE) questionnaire at baseline, 12 and 26 weeks.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: A. M.E. Walenkamp, MD, PhD, University Medical Center Groningen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2017

Primary Completion (Actual)

October 27, 2020

Study Completion (Actual)

October 27, 2020

Study Registration Dates

First Submitted

April 20, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (Actual)

April 25, 2017

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 9, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 201600902

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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