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Trial record 2 of 7 for:    Walenkamp | Recruiting, Not yet recruiting Studies

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

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ClinicalTrials.gov Identifier: NCT03128333
Recruitment Status : Recruiting
First Posted : April 25, 2017
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
A.M.E. Walenkamp, University Medical Center Groningen

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cancer Other: RunKeeper app + physiotherapy coaching Other: Usual care Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Self-monitoring Physical Activity With a Smartphone Application and Physiotherapy Coaching in Cancer Patients: a Randomized Controlled Trial (SMART-COACH Trial)
Actual Study Start Date : April 21, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

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.

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03128333


Contacts
Contact: A. M.E. Walenkamp, MD, PhD +31 50 3612821 a.walenkamp@umcg.nl
Contact: H. L. Ormel +31 50 361 2821 h.l.ormel@umcg.nl

Locations
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9713 GZ
Contact: A. M.E. Walenkamp, MD, PhD    +31 50 3612821    a.walenkamp@umcg.nl   
Contact: H. L. Ormel    +31 50 3612821    h.l.ormel@umcg.nl   
Principal Investigator: A. M.E. Walenkamp, MD, PhD         
Sponsors and Collaborators
University Medical Center Groningen
Investigators
Principal Investigator: A. M.E. Walenkamp, MD, PhD University Medical Center Groningen

Responsible Party: A.M.E. Walenkamp, Principal investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03128333     History of Changes
Other Study ID Numbers: 201600902
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No