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

NCT ID: NCT03128333

Last Updated: 2024-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-21

Study Completion Date

2020-10-27

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

RunKeeper app + physiotherapy coaching

Intervention Type OTHER

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.

Group Type OTHER

Usual care

Intervention Type 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.

Interventions

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RunKeeper app + physiotherapy coaching

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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A. M.E. Walenkamp, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

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University Medical Center Groningen

Groningen, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 40665202 (View on PubMed)

Other Identifiers

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201600902

Identifier Type: -

Identifier Source: org_study_id

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