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Self-monitoring Physical Activity With a SMARTphone Application in Cancer Patients: a Feasibility Study (SMART)

Self-monitoring and Empowering Physical Activity With a SMARTphone Application During or After Cancer Treatment in a 12 Week Follow-up: a Randomized Feasibility Study (SMART-trial)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02391454
Acronym
SMART
Enrollment
32
Registered
2015-03-18
Start date
2015-02-28
Completion date
2015-10-31
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

Neoplasms, Cell Phones, Motor Activity, Feasibility

Brief summary

Rationale: Cancer treatment is increasingly successful, resulting in a rising number of cancer survivors. A substantial number of survivors may experience long-term and late side effects from their cancer treatment. In addition, evidence is accumulating that an active lifestyle positively influences cancer treatment outcome and changes the recurrence rates of the disease. Therefore, physical activity (PA) programs are urgently needed and should be incorporated in current treatment regimens. It is noted though that cancer patients and survivors experience difficulties in remaining physically active. A 'smartphone application' (app) may be an accessible way to counteract these problems. The app 'RunKeeper', founded by Mr. Jason Jacobs, 2008, FitnessKeeper Inc. (RunKeeper) is a free, widely spread and well-known app for self-monitoring PA. Convenient features of RunKeeper are self-monitoring PA with GPS or stopwatch, recording progress, goal setting, and personal records. In this study the investigators aim to determine if the RunKeeper app use improves PA by self-monitoring and empowering PA during or after cancer treatment in comparison with usual care in a 12-week follow-up. Objective: The primary objective is to identify an improvement in PA as measured by the PASE questionnaire when using the RunKeeper app in comparison with usual care for 12 weeks during or after cancer treatment. The investigators hypothesize that the RunKeeper app might assist in stimulating and improving PA behavior. Secondary objectives are to explore the usability of the RunKeeper app. Study design: The present study is a single-centre prospective two-armed randomized controlled feasibility study. Study population: Adult patients diagnosed with cancer currently being treated or under surveillance at the department of Medical Oncology at the UMCG. Intervention: Patients who give informed consent will be randomized in one of the two study arms; 'Group A', usual care (N=15) or 'Group B', usual care + the RunKeeper app (N=15). Directly after randomization, Group B will be sent a brief user's manual for RunKeeper and requested to install the RunKeeper app. Group B will use the RunKeeper app for 12 weeks to self-monitor PA. Main study parameters/endpoints: The primary endpoint is to calculate the effect-size of the RunKeeper app use for 12 weeks on PA as compared to usual care as measured by the Physical Activity Scale for the Elderly (PASE) questionnaire. The investigators hypothesize that the RunKeeper app might assist in stimulating and improving PA behavior.

Interventions

DEVICERunKeeper App

Group B will use the RunKeeper app for 12 weeks to self-monitor PA. In the scope of this study, patients merely have to self-monitor PA (e.g. swimming, biking, hiking, running) by GPS or stopwatch function with RunKeeper. Furthermore, patients are requested to activate the 'training reminder' option in the RunKeeper app, which is explained in the user's manual.

OTHERUsual care

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 * Active user of the RunKeeper app * Severe cardiac (recent cardiovascular event) or psychiatric disease * Severe kidney or liver impairment * Pancytopenia * Patients following supervised oncologic rehabilitation

Design outcomes

Primary

MeasureTime frameDescription
Calculate the effect-size of the RunKeeper app use for 12 weeks on PA as compared to usual care12 weeksThe primary endpoint is to calculate the effect-size of the RunKeeper app use for 12 weeks on PA as compared to usual care as measured by the PASE.

Secondary

MeasureTime frameDescription
To explore patients' experiences of the usability of the RunKeeper app use for 12 weeks.12 weeksThe secondary endpoint is to identify patients' experiences of the usability of RunKeeper as measured by a semi-structured interview.
To explore the usability of the RunKeeper app use for 12 weeks.12 weeksThe secondary endpoint is the usability of the RunKeeper app as measured by the System Usability Scale (SUS).

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026