Health TrialsbyHealthPanel

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

ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Digital Health App

    Behavioral

    access to a digital health app

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: THRIVE Digital Health AppActive comparator 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

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

Time frame
12 weeks

Secondary outcomes

1

MD Anderson Symptom Inventory (MDASI)

Physical Symptoms (higher scores indicate worse symptoms)

Time frame
12 weeks
2

Hospital Anxiety and Depression Scale (HADS)

Anxiety and Depression Symptoms (higher scores indicate worse symptoms)

Time frame
12 weeks

Other outcomes

1

Brief Cope (Modified)

Coping (higher scores indicate greater use of coping strategy)

Time frame
12 weeks
2

Cancer Self-Efficacy Scale

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

Time frame
12 weeks
3

FACT-L

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

Time frame
Over 24 weeks
4

MDASI

Physical Symptoms (higher scores indicate worse symptoms)

Time frame
Over 24 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov
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