Clinical trial NCT05819346: Digital Lifestyle Intervention for Lung Cancer Survivors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-Small Cell Lung Cancer (NSCLC)
Keywords: Physical activity
Exercise
Nutrition
Breathing
Relaxation
Mobile application
Rehabilitation aftercare
Lead sponsor: Bern University of Applied Sciences
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

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)

Primary outcomes:
measure: Health-related quality of life (Scale-Global health status)
timeFrame: Change from baseline to 3 months
Secondary outcomes:
measure: Health-related quality of life (5 functional scales, 9 symptom scales/items)
timeFrame: Change from baseline to 3 months
measure: Lung cancer-specific health-related quality of life (10 symptom scales/items)
timeFrame: Change from baseline to 3 months
measure: Body mass index [kg/m²]
timeFrame: Change from baseline to 3 months
measure: Physical activity (self-reported)
timeFrame: Change from baseline to 3 months
measure: Functional exercise capacity
timeFrame: Change from baseline to 3 months
measure: Risk for low protein intake
timeFrame: Change from baseline to 3 months
measure: Appetite
timeFrame: Change from baseline to 3 months
measure: Psychological distress
timeFrame: Change from baseline to 3 months
measure: Cancer-related fatigue
timeFrame: Change from baseline to 3 months
measure: Enablement
timeFrame: Change from baseline to 3 months
measure: Self-rated health
timeFrame: Weekly for 3 months
Other outcomes:
measure: Usability (intervention group only)
timeFrame: At 3 months follow-up (end of the intervention)
measure: Acceptability, appropriateness, and feasibility (intervention group only)
timeFrame: At 3 months follow-up (end of the intervention)
measure: Experiences and satisfaction with the digital lifestyle intervention (intervention group only)
timeFrame: At 3 months follow-up (end of the intervention)
measure: Treatments/support since baseline
timeFrame: At 3 months follow-up (end of the intervention)
Locations:
city: Barmelweid
country: Switzerland
facility: Klinik Barmelweid AG
city: Davos
country: Switzerland
facility: Zürcher RehaZentren | Klinik Davos
city: Heiligenschwendi
country: Switzerland
facility: Berner Reha Zentrum AG
city: Wald
country: Switzerland
facility: Zürcher RehaZentren | Klinik Wald
Study officials:
affiliation: University of Zurich
name: Anja Frei, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.