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