Digital Lifestyle Intervention for Lung Cancer Survivors

NCT05819346 | Recruiting

• 1 other identifier: 0
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 4

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.

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Keywords

Physical activity; Exercise; Nutrition; Breathing; Relaxation; Mobile application; Rehabilitation aftercare

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Health-related quality of life (5 functional scales, 9 symptom scales/items)

  Change from baseline to 3 months

• Lung cancer-specific health-related quality of life (10 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

Other Outcomes (4)

• Usability (intervention group only)

  At 3 months follow-up (end of the intervention)

• Acceptability, appropriateness, and feasibility (intervention group only)

  At 3 months follow-up (end of the intervention)

• Experiences and satisfaction with the digital lifestyle intervention (intervention group only)

  At 3 months follow-up (end of the intervention)

Study Arms (2)

Digital lifestyle intervention

EXPERIMENTAL

Self-management mobile application covering physical activity, nutrition, and breathing/relaxation

Behavioral: Lifestyle

Control

NO INTERVENTION

Usual care (study participation does not interfere with or change any other planned treatments)

Interventions

Lifestyle BEHAVIORAL

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 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.

Digital lifestyle intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kai-Uwe Schmitt, PhD, MEng, ICID: lead

Study Sites (4)

Klinik Barmelweid AG

Barmelweid, 5017, Switzerland

RECRUITING

Zürcher RehaZentren | Klinik Davos

Davos, 7272, Switzerland

RECRUITING

Berner Reha Zentrum AG

Heiligenschwendi, 3625, Switzerland

RECRUITING

Zürcher RehaZentren | Klinik Wald

Wald, 8636, Switzerland

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Motor Activity; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anja Frei, PhD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anja Frei, PhD

CONTACT

+41 44 634 43 60; anja.frei@uzh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: August 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

CH (4)