Self-monitoring Physical Activity With a SMARTphone Application in Cancer Patients: a Feasibility Study (SMART) (SMART)

May 3, 2024 updated by: University Medical Center Groningen

Self-monitoring and Empowering Physical Activity With a SMARTphone Application During or After Cancer Treatment in a 12 Week Follow-up: a Randomized Feasibility Study (SMART-trial)

Rationale: Cancer treatment is increasingly successful, resulting in a rising number of cancer survivors. A substantial number of survivors may experience long-term and late side effects from their cancer treatment. In addition, evidence is accumulating that an active lifestyle positively influences cancer treatment outcome and changes the recurrence rates of the disease. Therefore, physical activity (PA) programs are urgently needed and should be incorporated in current treatment regimens. It is noted though that cancer patients and survivors experience difficulties in remaining physically active. A 'smartphone application' (app) may be an accessible way to counteract these problems. The app 'RunKeeper', founded by Mr. Jason Jacobs, 2008, FitnessKeeper Inc. (RunKeeper) is a free, widely spread and well-known app for self-monitoring PA. Convenient features of RunKeeper are self-monitoring PA with GPS or stopwatch, recording progress, goal setting, and personal records. In this study the investigators aim to determine if the RunKeeper app use improves PA by self-monitoring and empowering PA during or after cancer treatment in comparison with usual care in a 12-week follow-up.

Objective: The primary objective is to identify an improvement in PA as measured by the PASE questionnaire when using the RunKeeper app in comparison with usual care for 12 weeks during or after cancer treatment. The investigators hypothesize that the RunKeeper app might assist in stimulating and improving PA behavior. Secondary objectives are to explore the usability of the RunKeeper app.

Study design: The present study is a single-centre prospective two-armed randomized controlled feasibility study.

Study population: Adult patients diagnosed with cancer currently being treated or under surveillance at the department of Medical Oncology at the UMCG.

Intervention: Patients who give informed consent will be randomized in one of the two study arms; 'Group A', usual care (N=15) or 'Group B', usual care + the RunKeeper app (N=15). Directly after randomization, Group B will be sent a brief user's manual for RunKeeper and requested to install the RunKeeper app. Group B will use the RunKeeper app for 12 weeks to self-monitor PA.

Main study parameters/endpoints: The primary endpoint is to calculate the effect-size of the RunKeeper app use for 12 weeks on PA as compared to usual care as measured by the Physical Activity Scale for the Elderly (PASE) questionnaire. The investigators hypothesize that the RunKeeper app might assist in stimulating and improving PA behavior.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

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, 9700 RB
        • 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

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
  • Active user of the RunKeeper app
  • Severe cardiac (recent cardiovascular event) or psychiatric disease
  • Severe kidney or liver impairment
  • Pancytopenia
  • 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
Other: Group A
usual care
Other: Usual care
Experimental: Group B
usual care + RunKeeper app
Other: Usual care
Device: RunKeeper App
Group B will use the RunKeeper app for 12 weeks to self-monitor PA. In the scope of this study, patients merely have to self-monitor PA (e.g. swimming, biking, hiking, running) by GPS or stopwatch function with RunKeeper. Furthermore, patients are requested to activate the 'training reminder' option in the RunKeeper app, which is explained in the user's manual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calculate the effect-size of the RunKeeper app use for 12 weeks on PA as compared to usual care
Time Frame: 12 weeks
The primary endpoint is to calculate the effect-size of the RunKeeper app use for 12 weeks on PA as compared to usual care as measured by the PASE.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To explore the usability of the RunKeeper app use for 12 weeks.
Time Frame: 12 weeks
The secondary endpoint is the usability of the RunKeeper app as measured by the System Usability Scale (SUS).
12 weeks
To explore patients' experiences of the usability of the RunKeeper app use for 12 weeks.
Time Frame: 12 weeks
The secondary endpoint is to identify patients' experiences of the usability of RunKeeper as measured by a semi-structured interview.
12 weeks

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

March 3, 2015

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimated)

March 18, 2015

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMART-2014

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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