An interventional study of RunKeeper app + physiotherapy coaching and Usual care in Cancer, sponsored by University Medical Center Groningen. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-06.
Sponsored by University Medical Center Groningen · Not applicable, Interventional, and Supportive care
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.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's enrollment of 63 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →University Medical Center Groningen is the lead sponsor of 625 studies on the registry; 174 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
RunKeeper app for half a year to self-monitor leisure-time PA.
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.
examine the effectiveness of the RunKeeper use with additional physiotherapy coaching
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.
Time frame: 6 months
investigate the improvement in the percentage of patients meeting the prescribed total weekly minutes of leisure-time PA
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.
Time frame: 6 months
investigate the improvement in patients' weekly total minutes of leisure-time PA and sedentary time
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.
Time frame: 6 months
examine the improvement in patients' health-related quality of life (HR-QoL)
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.
Time frame: 6 months
examine the improvement in patients' self-efficacy
To examine the improvement in patients' self-efficacy as measured by the Algemene Competentie Schaal (ALCOS) questionnaire at baseline, 12 and 26 weeks.
Time frame: 6 months
explore patients' PA Stage of Change
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.
Time frame: 6 months
Plan to share: No
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Medical Center Groningen →