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Completed

NCT Number: NCT03128333

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen

Groningen, 9713 GZ, 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 (iPhone ≥4 or Android phones)
  • Active user of the RunKeeper app
  • Severe cardiac (recent cardiovascular event) or psychiatric disease
  • Patients following supervised oncologic rehabilitation

Treatment and study plan

RunKeeper app + physiotherapy coaching

Other

RunKeeper app for half a year to self-monitor leisure-time PA.

Usual Care

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Acronym: SMART-COACH

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 25, 2017
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.

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