Digital Lifestyle Intervention for Lung Cancer Survivors After Inpatient Rehabilitation

Non-Small Cell Lung Cancer (NSCLC) Clinical Trial

— QUALUCA  

Official title:

Effect of a Digital Lifestyle Intervention on Health-Related Quality of Life in Non-Small Cell Lung Cancer Survivors After Inpatient Rehabilitation (QUALUCA): a Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05819346
• Other study ID #: 0
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: August 2025

Study information

• Verified date: January 2024
• Source: Bern University of Applied Sciences
• Contact: Anja Frei, PhD
• Phone: +41 44 634 43 60
• Email: anja.frei[@]uzh.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer (NSCLC)

Intervention

Behavioral:
• Lifestyle
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.

Locations

Country	Name	City	State
Switzerland	Klinik Barmelweid AG	Barmelweid
Switzerland	Zürcher RehaZentren | Klinik Davos	Davos
Switzerland	Berner Reha Zentrum AG	Heiligenschwendi
Switzerland	Zürcher RehaZentren | Klinik Wald	Wald

Sponsors (1)

Lead Sponsor	Collaborator
Kai-Uwe Schmitt, PhD, MEng, ICID

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Usability (intervention group only)	mHealth App Usability Questionnaire (MAUQ)	At 3 months follow-up (end of the intervention)
Other	Acceptability, appropriateness, and feasibility (intervention group only)	Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) (4-item measures of implementation outcomes)	At 3 months follow-up (end of the intervention)
Other	Experiences and satisfaction with the digital lifestyle intervention (intervention group only)	Short semi-structured interview; outcomes will be qualitatively assessed (no scale is used)	At 3 months follow-up (end of the intervention)
Other	Treatments/support since baseline	Cancer treatments (e.g., chemotherapy) and therapies/support (e.g., physical therapy, self-help group) participants might have received during the last 3 months (2 items)	At 3 months follow-up (end of the intervention)
Primary	Health-related quality of life (Scale-Global health status)	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)	Change from baseline to 3 months
Secondary	Health-related quality of life (5 functional scales, 9 symptom scales/items)	European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) (28 items; 4-point Likert-type scale; 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning), 3 symptom scales (fatigue, nausea and vomiting, pain), 6 single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties); all scales and single-item measures range in score from 0 to 100)	Change from baseline to 3 months
Secondary	Lung cancer-specific health-related quality of life (10 symptom scales/items)	European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 29 (lung cancer-specific module) (EORTC QLQ-LC29) (29 items; 4-point Likert-type scale / 5 multi-item scales and 5 single items; all scales and single-item measures range in score from 0 to 100)	Change from baseline to 3 months
Secondary	Body mass index [kg/m²]	Computed using self-reported body weight [kg] and height [m]	Change from baseline to 3 months
Secondary	Physical activity (self-reported)	Modified Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ) (physical activity before inpatient rehabilitation and physical activity over the last week)	Change from baseline to 3 months
Secondary	Functional exercise capacity	1-Minute Sit-to-Stand Test (number of repetitions)	Change from baseline to 3 months
Secondary	Risk for low protein intake	Protein Screener 55+ (Pro55+) (10 items)	Change from baseline to 3 months
Secondary	Appetite	Simplified Nutritional Appetite Questionnaire (SNAQ) (4 items; 5-point Likert-type scale)	Change from baseline to 3 months
Secondary	Psychological distress	Short form of the Patient Health Questionnaire (PHQ-4) (4 items)	Change from baseline to 3 months
Secondary	Cancer-related fatigue	Brief Fatigue Inventory (BFI) (9 items)	Change from baseline to 3 months
Secondary	Enablement	Shortened version of the Patient Enablement Scale-13 (PEN-13) (5 out of 13 items; 5-point Likert-type scale)	Change from baseline to 3 months
Secondary	Self-rated health	EuroQol Group Visual Analogue Scale (EQ VAS) (vertical visual analog scale that takes values between 100 [best imaginable health] and 0 [worst imaginable health], on which respondents provide a global assessment of their health)	Weekly for 3 months