Digital Lifestyle Intervention for Lung Cancer Survivors

NCT ID: NCT05819346

Last Updated: 2025-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2026-01-31

Brief Summary

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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

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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).

Conditions

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Non-Small Cell Lung Cancer (NSCLC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Digital lifestyle intervention

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

Group Type EXPERIMENTAL

Lifestyle

Intervention Type 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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kai-Uwe Schmitt, PhD, MEng, ICID

OTHER

Sponsor Role lead

Responsible Party

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Kai-Uwe Schmitt, PhD, MEng, ICID

Sponsor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Anja Frei, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

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Klinik Barmelweid AG

Barmelweid, , Switzerland

Site Status RECRUITING

Zürcher RehaZentren | Klinik Davos

Davos, , Switzerland

Site Status RECRUITING

Berner Reha Zentrum AG

Heiligenschwendi, , Switzerland

Site Status RECRUITING

Zürcher RehaZentren | Klinik Wald

Wald, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Anja Frei, PhD

Role: CONTACT

+41 44 634 43 60

References

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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.

Reference Type BACKGROUND
PMID: 38453202 (View on PubMed)

Other Identifiers

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0

Identifier Type: -

Identifier Source: org_study_id

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