Physical Activity During Chemo- and/or Immunotherapy for Lung Cancer
ConditionLung Cancer (NSCLC)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Schleswig-Holstein
About this trial
The main goal of this trial is to describe the pattern of physical activity in patients with non-small cell lung cancer during chemo- and/or immunotherapy, to evaluate potential predictors of those patterns and to assess potential correlations with patient reported outcomes (pain-, distress-, and fatigue scores). To reach this goal, this trial will be first trial in which the mean number of steps per week performed at baseline and during each week of chemo- and or immunotherapy will be collected in a standardized prospective way. The trial is exploratory in nature with the aim to generate scientific hypotheses to be investigated in future clinical trials.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically proven non-small cell lung cancer
Indication for chemo- and/or immunotherapy
Possession of and ability to use a smart phone that includes a step counter
Willingness to wear the smart phone close to the body at any time
Disqualifiers
Small-cell lung cancer
Karnofsky performance score <60
Thoracic surgery within 3 months prior to chemo- and/or immunotherapy
Expected Non-Compliance
Trial population
Patients receiving chemotherapy and/or immunotherapy for non-small cell lung cancer who possess a smart phone with a step counter.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
38 Participants
are grouped into 1 trial groupGroup A: Patients with steps counted by their smart phone
Trial outcomes
Primary outcomes
1
Mean number of steps per week performed at baseline and during the first three cycles of chemo- and/or immunotherapy for lung cancer
The primary endpoint is to assess the mean number of steps per week during the first three cycles of chemo- and/or immunotherapy for lung cancer. The baseline value is represented by the mean number of steps during the last week prior to chemotherapy and/or immunotherapy. Any type of smart phone is allowed, as long as it has a step counter.
Time frame
through study completion, 9 weeksSecondary outcomes
1
Degree of the impact of pain on the mean number of steps per week asessed using the Numeric Pain Rating Scale
Pain will be assessed prior to chemo- and/or immunotherapy, weekly during the three cycles of chemo- and/or immunotherapy, and at end of treatment with the Numeric Pain Rating Scale (self-assessment, ranging from 0 points = no pain to 10 points = maximum pain). Pain scores of 0-5 points will be compared to pain scores of 6-10 points.
Time frame
through study completion, 9 weeks2
Degree of the impact of distress on the mean number of steps per week asessed using the Distress Thermometer
Distress will be assessed prior to chemo- and/or immunotherapy, weekly during the three cycles of chemo- and/or immunotherapy, and at end of treatment with the Distress Thermometer (self-assessment, ranging from 0 points = no distress to 10 points = maximum distress). Distress scores of 0-5 points will be compared to distress scores of 6-10 points.
Time frame
through study completion, 9 weeks3
Degree of the impact of fatigue on the mean number of steps per week asessed using the Fatigue Asessment Scale (FAS)
Fatigue will be assessed prior to chemo- and/or immunotherapy, weekly during the three cycles of chemo- and/or immunotherapy, and at end of treatment with the Fatigue Assessment Scale (FAS) (self-assessment, ranging from 0 points = no fatigue to 50 points = maximum fatigue) \[© FAS (Fatigue Assessment Scale)\]. Fatigue scores of 0-21 points (no fatigue) will be compared to fatigue scores of 22-50 points (substantial fatigue).
Time frame
through study completion, 9 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: