Digital Lifestyle Intervention for Lung Cancer Survivors After Inpatient Rehabilitation

Trial Title: Digital Lifestyle Intervention for Lung Cancer Survivors After Inpatient Rehabilitation

NCT ID: NCT05819346

Condition: Non-Small Cell Lung Cancer (NSCLC)

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

Conditions: Keywords:
Physical activity
Exercise
Nutrition
Breathing
Relaxation
Mobile application
Rehabilitation aftercare

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Other

Masking: Single (Investigator)

Intervention:

Intervention type: Behavioral
Intervention name: Lifestyle
Description: Participants assigned to the intervention group receive access to a lifestyle mobile application for three months after inpatient rehabilitation has finished. The digital program is target group-specific and includes personalization and interactive elements without face-to-face appointments during the intervention. One virtual appointment at the beginning of the intervention (about one week post-rehabilitation) with the study staff ensures that participants familiarize themselves with the mobile application and that they are assigned to a suitable program level. The intervention is mainly based on the following behavior change technique (BCT) clusters: goals and planning, feedback and monitoring, shaping knowledge, and comparison of behavior.
Arm group label: Digital lifestyle intervention

Summary: The aim of this study is to assess the efficacy of a digital lifestyle intervention in non-small cell lung cancer (NSCLC) survivors following inpatient rehabilitation on health-related quality of life (HRQoL) over three months.

Detailed description: Lung cancer survivors suffer from reduced physical and psychological functioning as well as decreased overall health-related quality of life (HRQoL) due to cancer symptoms, cancer treatments, and comorbidities. Experienced symptoms by lung cancer survivors, such as cancer-related fatigue or dyspnea, persist after active treatment ends. Therefore, lung cancer survivors should receive continuous attention regarding their health and HRQoL beyond the expected cancer cure. Physical activity, healthy nutrition, and breathing/relaxation exercises before, during, and after cancer treatments can increase physical as well as psychological functioning and HRQoL. Thus, the adhesion to an appropriate healthy lifestyle is crucial and represents an effective adjunctive strategy in the management of lung cancer survivors. Most lung cancer survivors, however, are sedentary and fail to meet official lifestyle recommendations, for instance, of the American Cancer Society or the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR). The present project evaluates a mobile application for non-small cell lung cancer (NSCLC) survivors that will be used for three months after inpatient rehabilitation has finished. The main foci of the mobile application are physical activity, nutrition, and breathing/relaxation. The contents of the mobile application and the mobile application itself were developed in an iterative co-creation process involving software developers and potential users as well as researchers and clinicians from different disciplines (e.g., physical therapy and nutritional therapy).

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Age ≥ 18 years - Diagnosis of non-small cell lung cancer (NSCLC) - Estimated life expectancy of ≥ six months (judged by local investigators/responsible health professionals) - Undergoing inpatient rehabilitation - Knowledge of German to understand study material and assessments - Access to a cell phone or tablet - Written informed consent Exclusion Criteria: - Inability to provide informed consent - Inability to participate in the intervention because of physical, cognitive, or safety reasons (judged by local investigators/responsible health professionals)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Klinik Barmelweid AG

Address:
City: Barmelweid
Zip: 5017
Country: Switzerland

Status: Recruiting

Facility:
Name: Zürcher RehaZentren | Klinik Davos

Address:
City: Davos
Zip: 7272
Country: Switzerland

Status: Recruiting

Facility:
Name: Berner Reha Zentrum AG

Address:
City: Heiligenschwendi
Zip: 3625
Country: Switzerland

Status: Recruiting

Facility:
Name: Zürcher RehaZentren | Klinik Wald

Address:
City: Wald
Zip: 8636
Country: Switzerland

Status: Recruiting

Start date: August 1, 2023

Completion date: August 2025

Lead sponsor:
Agency: Kai-Uwe Schmitt, PhD, MEng, ICID
Agency class: Other

Source: Bern University of Applied Sciences

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05819346