Ignite Creation Date:
2024-05-06 @ 3:52 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02391454
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2015-03-03
Brief Title:
Self-monitoring Physical Activity With a SMARTphone Application in Cancer Patients a Feasibility Study SMART
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
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
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMART
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 N15 or Group B usual care the RunKeeper app N15 Directly after randomization Group B will be sent a brief users 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 parametersendpoints 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
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 N15 or Group B usual care the RunKeeper app N15 Directly after randomization Group B will be sent a brief users 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 parametersendpoints 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None