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

Lung Cancer Clinical Trial

— THRIVE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06427954
• Other study ID #: 24-091
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: December 2027

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Multi-site randomized controlled trial of the THRIVE digital health application versus usual care in 250 patients diagnosed with advanced lung cancer within the previous 12 weeks to examine the effect of the intervention on patient-reported QOL, physical symptoms, anxiety and depression symptoms, coping, and self-efficacy. Participants will be randomized in a 1:1 fashion and stratified by study site and lung cancer type to ensure a balanced representation of these factors between the two study groups. The study team will provide iPads to patients assigned to THRIVE and provide instructions on how to use the iPad and digital app. The study team will administer patient-reported outcome measures at enrollment and again at six, 12, and 24 weeks post-enrollment to evaluate the short and long-term impact of THRIVE.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: December 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• Digital Health App
access to a digital health app

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	United States Department of Defense

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Brief Cope (Modified)	Coping (higher scores indicate greater use of coping strategy)	12 weeks
Other	Cancer Self-Efficacy Scale	Self-efficacy (higher scores indicate greater self-efficacy)	12 weeks
Other	FACT-L	Quality of Life (higher scores indicate better quality of life)	Over 24 weeks
Other	MDASI	Physical Symptoms (higher scores indicate worse symptoms)	Over 24 weeks
Other	HADS	Anxiety and Depression Symptoms (higher scores indicate worse symptoms)	Over 24 weeks
Primary	Functional Assessment of Cancer Therapy - Lung (FACT-L)	Quality of Life (higher scores indicate better quality of life)	12 weeks
Secondary	MD Anderson Symptom Inventory (MDASI)	Physical Symptoms (higher scores indicate worse symptoms)	12 weeks
Secondary	Hospital Anxiety and Depression Scale (HADS)	Anxiety and Depression Symptoms (higher scores indicate worse symptoms)	12 weeks