Physical Activity During Chemo- and/or Immunotherapy for Lung Cancer

NCT06993896 | Not Yet Recruiting

• 1 other identifier: APACHIE-01
• Study Type: observational
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Lung Cancer (NSCLC)

Keywords

lung cancer; chemotherapy; immunotherapy; physical activity

Outcome Measures

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.

  through study completion, 9 weeks

Secondary Outcomes (3)

• Degree of the impact of pain on the mean number of steps per week asessed using the Numeric Pain Rating Scale

  through study completion, 9 weeks

• Degree of the impact of distress on the mean number of steps per week asessed using the Distress Thermometer

  through study completion, 9 weeks

• Degree of the impact of fatigue on the mean number of steps per week asessed using the Fatigue Asessment Scale (FAS)

  through study completion, 9 weeks

Study Arms (1)

Patients with steps counted by their smart phone

The purpose is to obtain a patient's mean number of steps per week directly from the patient's smart phone which has a step counter.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving chemotherapy and/or immunotherapy for non-small cell lung cancer who possess a smart phone with a step counter.

You may qualify if:

• 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
• Age ≥18 years
• Written informed consent
• Capacity of the patient to consent

You may not qualify if:

• Small-cell lung cancer
• Karnofsky performance score \<60
• Thoracic surgery within 3 months prior to chemo- and/or immunotherapy
• Expected Non-Compliance

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Motor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Behavior

Study Officials

• Dirk Rades, Prof. Dr. med.

  University of Lubeck

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dirk Rades, Prof. Dr. med.

CONTACT

0049-451-500; dirk.rades@uksh.de

Sabine Bohnet, Dr. med.

CONTACT

0049-451-500; sabine.bohnet@uksh.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 29, 2025
• Study Start: June 16, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share