Digital Lifestyle Intervention for Lung Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lifestyle.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Lung Cancer (NSCLC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of a Digital Lifestyle Intervention on Health-Related Quality of Life in Non-Small Cell Lung Cancer Survivors (QUALUCA): a Multicenter Randomized Controlled Trial
Overview
The aim of this study is to assess the efficacy of a digital lifestyle intervention in non-small cell lung cancer (NSCLC) survivors 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 rehabilitation or treatment 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).
Interventions
- Behavioral Lifestyle
Participants assigned to the intervention group receive access to a lifestyle mobile application for three months after rehabilitation or treatment 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 with the study staff ensures that participants familiarize themselves with the mobile application and that they are ass
Primary outcome measures
- Health-related quality of life (Scale-Global health status) [Time frame: Change from baseline to 3 months]
Secondary outcome measures (11)
- Health-related quality of life (5 functional scales, 9 symptom scales/items) [Time frame: Change from baseline to 3 months]
- Lung cancer-specific health-related quality of life (10 symptom scales/items) [Time frame: Change from baseline to 3 months]
- Body mass index [kg/m²] [Time frame: Change from baseline to 3 months]
- Physical activity (self-reported) [Time frame: Change from baseline to 3 months]
- Functional exercise capacity [Time frame: Change from baseline to 3 months]
- Risk for low protein intake [Time frame: Change from baseline to 3 months]
- Appetite [Time frame: Change from baseline to 3 months]
- Psychological distress [Time frame: Change from baseline to 3 months]
- Cancer-related fatigue [Time frame: Change from baseline to 3 months]
- Enablement [Time frame: Change from baseline to 3 months]
- Self-rated health [Time frame: Weekly for 3 months]
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 or outpatient rehabilitation OR completion of planned surgery, chemotherapy, or radiation therapy for NSCLC within the past 24 weeks
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Switzerland · 4 centers
- Klinik Barmelweid AG — Barmelweid
- Zürcher RehaZentren | Klinik Davos — Davos
- Berner Reha Zentrum AG — Heiligenschwendi
- Zürcher RehaZentren | Klinik Wald — Wald
Publications
- Weber M, Raab AM, Schmitt KU, Busching G, Marcin T, Spielmanns M, Puhan MA, Frei A. Efficacy of a digital lifestyle intervention on health-related QUAlity of life in non-small cell LUng CAncer survivors following inpatient rehabilitation: protocol of the QUALUCA Swiss multicentre randomised controlled trial. BMJ Open. 2024 Mar 7;14(3):e081397. doi: 10.1136/bmjopen-2023-081397. PMID 38453202
Identifiers
NCT: NCT05819346 · 0