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
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Sponsor
- Kai-Uwe Schmitt, PhD, MEng, ICID
- Enrollment
- 88
- Locations
- 4
- Primary Endpoint
- Health-related quality of life (Scale-Global health status)
- Status
- Recruiting
- Last Updated
- last year
Overview
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).
Investigators
Kai-Uwe Schmitt, PhD, MEng, ICID
Sponsor
Bern University of Applied Sciences
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)
Outcomes
Primary Outcomes
Health-related quality of life (Scale-Global health status)
Time Frame: Change from baseline to 3 months
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) (2 items; 7-point Likert-type scale; the score ranges from 0 to 100; a high score for the global health status represents a high HRQoL)
Secondary Outcomes
- Self-rated health(Weekly for 3 months)
- Lung cancer-specific health-related quality of life (10 symptom scales/items)(Change from baseline to 3 months)
- Health-related quality of life (5 functional scales, 9 symptom scales/items)(Change from baseline to 3 months)
- Body mass index [kg/m²](Change from baseline to 3 months)
- Physical activity (self-reported)(Change from baseline to 3 months)
- Functional exercise capacity(Change from baseline to 3 months)
- Risk for low protein intake(Change from baseline to 3 months)
- Appetite(Change from baseline to 3 months)
- Psychological distress(Change from baseline to 3 months)
- Cancer-related fatigue(Change from baseline to 3 months)
- Enablement(Change from baseline to 3 months)