Panoramica

Idoneità

Dettagli del Disegno

Bracci e Interventi

Misure di Esito

Siti dello Studio

Fonte: NCT06427954

In fase di reclutamento

THRIVE: Mobile Application to Improve Health-Related Outcomes in Patients With Advanced Lung Cancer

Interventistico

Fase non elencata

Mass General Hospital

Multi-site randomized trial of the THRIVE digital health application versus usual care to evaluate the effect of THRIVE on quality of life (QOL), physical and psychological symptoms, coping, and self-efficacy in 250 patients with newly diagnosed advanced lung cancer.

Mostra Descrizione Dettagliata

Categoria di Trattamento

Comportamentale

Mutazioni richieste

Nessuno

Studio Iniziato

2024-08-06

Ultimo Aggiornamento dello Sponsor

2024-11-25

Completamento Stimato

2027-09-01

Idoneità

Criteri di Inclusione

* Adults (greater than or equal to 18 years)

* Diagnosed with advanced non-small cell lung cancer (NSCLC) that is not being treated with curative intent or extensive stage small cell lung cancer (SCLC) within the past 12 weeks.

* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 0-2 (i.e., fully active to at least ambulatory and up and about more than 50% of waking hours).

* Sufficient English proficiency to utilize THRIVE in English (Note: patients can complete outcome measures in Spanish if preferred).

* Significant uncontrolled psychiatric disorder (e.g., psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (e.g., dementia, cognitive impairment), which the treating oncology clinician reports would prohibit the ability to participate in study procedures.

Criteri di Esclusione

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Dettagli del Disegno

AllocazioneRandomized

Modello di InterventoParallel Assignment

MascheramentoSingle

Numero da Arruolare250

Bracci e Interventi

Bracci

Interventi

Tipo: Active Comparator

Descrizione: Patients assigned to the intervention will be provided a study-issued tablet computer from which they will access the THRIVE digital health app. Study staff will give intervention patients a comprehensive tutorial and detailed instructions regarding how to use the app. Tutorial sessions may be conducted in person during a clinic appointment, via telephone, and/or via Zoom videoconferencing. Participants will complete the intervention modules at their desired pace over approximately 10 weeks.

Interventi:

Digital Health App

Misure di Esito

Misure di Esito Primarie

Functional Assessment of Cancer Therapy - Lung (FACT-L)12 weeks

Quality of Life (higher scores indicate better quality of life)

Misure di Esito Secondarie

MD Anderson Symptom Inventory (MDASI)12 weeks

Physical Symptoms (higher scores indicate worse symptoms)

Hospital Anxiety and Depression Scale (HADS)12 weeks

Anxiety and Depression Symptoms (higher scores indicate worse symptoms)

Brief Cope (Modified)12 weeks

Coping (higher scores indicate greater use of coping strategy)

Cancer Self-Efficacy Scale12 weeks

Self-efficacy (higher scores indicate greater self-efficacy)

FACT-LOver 24 weeks

Quality of Life (higher scores indicate better quality of life)

MDASIOver 24 weeks

Physical Symptoms (higher scores indicate worse symptoms)

HADSOver 24 weeks

Anxiety and Depression Symptoms (higher scores indicate worse symptoms)

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Siti dello Studio

Questo studio ha 3 siti

Mass General Hospital
Boston, Massachusetts, US

In fase di reclutamento

Boston, Massachusetts, 02114 US

Mass General Hospital

In fase di reclutamento

Los Angeles, California, 90024 US

University of California Los Angeles

Non ancora in reclutamento

Los Angeles, California, 90073 US

Veteran Affairs Greater Los Angeles Health Care

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