Monitoring and Telecoaching of Physical Activity in Patients With Stage III and IV Non-small Cell Lung Cancer

NCT03883243 | Unknown

• 1 other identifier: S62244
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective non-randomised control study to evaluate the efficacy of a physical activity promotion program on the experience of physical activity in patients with stage III and IV non-small cell lung cancer (NSCLC) with documented disease control (stable disease, partial or complete response defined by RECIST V1.1) at least 6 months after start of first line treatment. The trial will consist of 4 visits. An outpatient clinic visit in which the eligible patients are invited (V1), a screenings visit (V2), a third visit (V3) at which the patients will be divided into the intervention or the control group, according to owning a smartphone and their affinity with it, followed by the start of the intervention consisting of 8 weeks telecoaching by means of an application and step counter and a final visit (V4) 8 weeks after starting up the intervention.

Conditions

Exercise; Neoplasms

Keywords

Telecoaching; Physical activity; Lung cancer

Outcome Measures

Primary Outcomes (1)

• Change in average daily number of steps

  To assess the impact of a telecoaching program on physical activity in patients with stage III and IV NSCLC in addition to usual care. This will be measured by the Dynaport movemonitor (Dynaport®), as the change in average daily number of steps at baseline (1 week preceding V3) and at the end (1 week preceding V4) in the intervention and the control group.

  8 weeks

Secondary Outcomes (2)

• Change in health status

  8 weeks

• Change in exercise capacity

  8 weeks

Other Outcomes (2)

• Pro Active questionnaire

  8 weeks

• health related quality of life: SGRQ

  8 weeks

Study Arms (2)

Control

NO INTERVENTION

Patients will only receive a brochure explaining the importance of physical activity with recommendations to improve it.

Telecoaching

EXPERIMENTAL

Patients will receive a brochure explaining the importance of physical activity with recommendations to improve it. Next to this patients will receive the telecoaching intervention in which a coaching application linked to a step counter is installed on the patients smartphone, which will weekly give a new physical activity goal to improve the amount of steps per day for 8 weeks.

Device: Telecoaching

Interventions

Telecoaching DEVICE

A telecoaching application linked to a step counter will be installed on a patients smartphone for 8 weeks. The application shows a daily goal (expressed as amount of steps per day) to the patient. This goal is weekly revised and patients themselves are able to increase the goal every week with 500 or 1000 steps/day. Every evening, they are able to check the daily feedback platform, which gives them insights in their physical activity pattern of the day and previous weeks. At a regular basis, 'tip of the day' messages appear as a pop-up, to keep patients motivated.

Telecoaching

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients actively participating in a pulmonary rehabilitation program
• Patients with sequential chemoradiotherapy for stadium III non-small cell lung cancer
• The presence of orthopedic problems not allowing an increase in PA levels

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (26)

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Related Links

• Treatment stage IV NSCLC (Dutch)

MeSH Terms

Conditions

Motor Activity; Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Behavior; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Wim Janssens, Prof. Dr.

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Patients are evenly divided into the telecoaching group or usual care group according to owning a smartphone and their affinity with it.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Wim Janssens

Model Details: Prospective non-randomised controlled pilot study. 16 patients will be included in the intervention group and 16 patients will be included in a matched control group receiving only usual care.

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: March 20, 2019
• Study Start: March 15, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 24, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)