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

NCT03128333 | Completed

• 1 other identifier: 201600902
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (5)

• investigate the improvement in the percentage of patients meeting the prescribed total weekly minutes of leisure-time PA

  6 months

• investigate the improvement in patients' weekly total minutes of leisure-time PA and sedentary time

  6 months

• examine the improvement in patients' health-related quality of life (HR-QoL)

  6 months

• examine the improvement in patients' self-efficacy

  6 months

• explore patients' PA Stage of Change

  6 months

Study Arms (2)

RunKeeper app + physiotherapy coaching

EXPERIMENTAL

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

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.

Other: Usual care

Interventions

RunKeeper app + physiotherapy coaching OTHER

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

RunKeeper app + physiotherapy coaching

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.

usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Related Publications (1)

• Ormel HL, van Zutphen EH, van der Schoot GGF, Gietema JA, Walenkamp AME. Effects of self-monitoring physical activity with a smartphone application combined with physiotherapy coaching in patients with cancer: a randomised controlled trial (SMART-COACH trial). J Cancer Surviv. 2025 Jul 15. doi: 10.1007/s11764-025-01862-w. Online ahead of print.

  PMID: 40665202 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• A. M.E. Walenkamp, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: April 25, 2017
• Study Start: April 21, 2017
• Primary Completion: October 27, 2020
• Study Completion: October 27, 2020
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)