NCT06427954

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
18mo left

Started Aug 2024

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Aug 2024Dec 2027

First Submitted

Initial submission to the registry

May 17, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 24, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

August 6, 2024

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

3.1 years

First QC Date

May 17, 2024

Last Update Submit

November 21, 2024

Conditions

Lung Cancer

Keywords

Quality of life

Outcome Measures

Primary Outcomes (1)

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

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

    12 weeks

Secondary Outcomes (2)

  • MD Anderson Symptom Inventory (MDASI)

    12 weeks

  • Hospital Anxiety and Depression Scale (HADS)

    12 weeks

Other Outcomes (5)

  • Brief Cope (Modified)

    12 weeks

  • Cancer Self-Efficacy Scale

    12 weeks

  • FACT-L

    Over 24 weeks

  • +2 more other outcomes

Study Arms (2)

THRIVE Digital Health App

ACTIVE COMPARATOR

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.

Behavioral: Digital Health App

Usual Care

NO INTERVENTION

Patients assigned to the usual care group will not receive the digital app but rather standard oncology care.

Interventions

Digital Health AppBEHAVIORAL

access to a digital health app

THRIVE Digital Health App

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California Los Angeles

Los Angeles, California, 90024, United States

RECRUITING

Veteran Affairs Greater Los Angeles Health Care

Los Angeles, California, 90073, United States

NOT YET RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Jennifer Temel

CONTACT

6177244000jtemel@partners.org

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
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 17, 2024

First Posted

May 24, 2024

Study Start

August 6, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

November 25, 2024

Record last verified: 2024-11

Locations

US(3)