Skip to main content
OpenTrials
Completed

NCT Number: NCT02391454

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RunKeeper App

Device

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.

Usual Care

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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)

Acronym: SMART

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 18, 2015
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.