Clinical trial NCT03128333: Self-Monitoring Physical Activity With a Smartphone Application and Physiotherapy Coaching in Cancer Patients.
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2017-04-25
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: examine the effectiveness of the RunKeeper use with additional physiotherapy coaching
timeFrame: 6 months
Secondary outcomes:
measure: investigate the improvement in the percentage of patients meeting the prescribed total weekly minutes of leisure-time PA
timeFrame: 6 months
measure: investigate the improvement in patients' weekly total minutes of leisure-time PA and sedentary time
timeFrame: 6 months
measure: examine the improvement in patients' health-related quality of life (HR-QoL)
timeFrame: 6 months
measure: examine the improvement in patients' self-efficacy
timeFrame: 6 months
measure: explore patients' PA Stage of Change
timeFrame: 6 months
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: A. M.E. Walenkamp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: