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

April 23, 2019 updated by: Wim Janssens, KU Leuven

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The objective of this pilot study is to investigate if physical activity can be improved by telecoaching in patients with advanced stages of lung cancer in remission. We hypothesize that a smartphone application, designed for a population with respiratory symptoms, will increase daily physical activity, which translates into significant improvements on quality of life. This uncontrolled pilot study will therefore address if a 8-week PA promotion telecoaching program in addition to usual care has the potential to improve physical activity and quality of life in patients with lung cancer for a limited burden and at low cost.

This trial consists of 4 visits:

Visit 1 (V1, outpatient clinic):

Patients will be screened for inclusion in the study during follow up visits in the outpatient lung cancer clinic. If oncological check-up 6 months after starting initial lung cancer treatment demonstrates objective response (partial response or complete response defined by RECIST V1.1) the patient is asked to join the study. If the patient wants to join the study a screening visit (V2) will be planned.

Visit 2 (V2, screening visit (run-in)):

During V2 all eligible patients who have signed the informed consent will enter the run in epoch of 1 to 2 weeks.

Patients are asked about their medical history (baseline demographic data) and their previous respiratory treatment including their oncological stage and type. Co-morbidities will also be assessed and a basic lung function will be performed.

On V2 patient will receive a Dynaport movemonitor to wear one week before V3. For patients where the run in period is more than one week, they will receive a telephone reminder to wear a PROactive monitor. Patients are instructed to wear the device during waking hours. A measurement of more than 8 hours of wearing time will be defined as a 'valid day). The tri-axial accelerometer will captured steps waked per day, movement intensity and time spent in sitting, lying walking and high-intense activities.

Visit 3 (V3, baseline, allocation):

Patients will complete the web-based version of the clinical visit of the PROactive questionnaire. Two six-minutes walk tests will be performed and the patient will complete 2 quality of life questionnaires (SGRQ and QLQ-C30). During V3, the patients are divided into either control (usual care) or telecoaching group based on personal preferences and the abilities of using and having a smartphone.

Patients in both groups will receive a brochure during this visit explaining the importance of physical activity with recommendations to improve it. This brochure will be discussed together with the patients.

In the intervention group patients will recieve the telecoaching intervention consisting of the following components: 1: motivational interview with the investigator discussing motivation, barriers, favourite activities and strategies to become more active; 2: a pedometer giving direct feedback on the amount of steps; 3: the coaching application linked to the pedometer, which will be installed on the patient's smartphone and which will be coaching the patient for 8 weeks by means of improving the amount of steps per day. 4: telephone contact when a patient is non-compliant with either the use of the coaching intervention or with achieving the physical activity goals for 2 consecutive weeks.

All patients will be equipped with the Dynaport movemonitor one week before V4 and will be instructed to wear the monitor for 7 consecutive days.

Visit 4 (V4, end of the study, 8 weeks post allocation):

V4 is the end of the study. All assessments performed on V3 will be repeated during this study visit.

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  1. Patients diagnosed with stage III or stage IV NSCLC who have a documented disease control (stable disease, partial or complete response defined by RECIST V1.1) at least 6 months after start of first line treatment. Stage III patients can only be included, if first line treatment consisted of concurrent chemoradiotherapy and a consolidation immunotherapy if indicated (if PDL1 > 1% and no potential contraindications for immunotherapy). Stage IV patients, should have received only immunotherapy (PDL1 > 50%) or a treatment of at least 4 cycles of a platinum based chemotherapy with or without immunotherapy. Maintenance therapy with chemotherapy and/or immunotherapy and administration of local radiotherpy is allowed. Patients with objective response can be included in the study until 2 years after starting up initial treatment.
  2. > 18 years
  3. Patients who are able to engage in a remote coaching program through the use of a smartphone

Exclusion criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
Patients will only receive a brochure explaining the importance of physical activity with recommendations to improve it.
EXPERIMENTAL: Telecoaching
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in average daily number of steps
Time Frame: 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in health status
Time Frame: 8 weeks

Change in health status assessed by QLQ-C30 (Cancer quality of life questionnaire) at baseline (1 week preceding) and at the end (1 week preceding) in the intervention and the control group.

All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level
8 weeks
Change in exercise capacity
Time Frame: 8 weeks
Change in exercise capacity by 6 minutes walking distance at baseline and at the end in the intervention and the control group.
8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pro Active questionnaire
Time Frame: 8 weeks
symptoms and difficulties perceived during exercise: Absolute difference in points from baseline values
8 weeks
health related quality of life: SGRQ
Time Frame: 8 weeks
measured by SGRQ: proportion of patients with a minimal change of -4 points on SGRQ
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Investigators

  • Principal Investigator: Wim Janssens, Prof. Dr., KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 15, 2019

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

February 4, 2019

First Submitted That Met QC Criteria

March 18, 2019

First Posted (ACTUAL)

March 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 24, 2019

Last Update Submitted That Met QC Criteria

April 23, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S62244

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No, because this is a pilot trail we are not going to share the data with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neoplasms

Clinical Trials on Telecoaching

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe