Lung CancerTHRIVENCT06427954
Mobile Application to Improve Health-Related Outcomes in Patients With Advanced Lung Cancer
A study testing Digital Health App in people with Lung Cancer, run by Massachusetts General Hospital at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Digital Health App
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Aug 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Jennifer Temel, MD, 617-724-4000, JTEMEL@mgh.harvard.edu
Jennifer Temel, MD
- Recruiting
University of California Los Angeles
Los Angeles, California, 90024
Anne Walling, AWalling@mednet.ucla.edu
- Not yet recruiting
Veteran Affairs Greater Los Angeles Health Care
Los Angeles, California, 90073
Anne Walling, anne.walling@va.gov
About this study
Official title: Randomized Trial of Mobile Application to Improve Health-Related Outcomes in Patients With Advanced Lung Cancer
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.
Read the detailed 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.
- Conditions
- Lung Cancer
- Being tested
- Digital Health App
- Keywords
- Quality of life
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Health AppBehavioural
access to a digital health app
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Cancer Therapy - Lung (FACT-L)
Quality of Life (higher scores indicate better quality of life)
Measured: 12 weeks
Secondary outcomes (2)
MD Anderson Symptom Inventory (MDASI)
Physical Symptoms (higher scores indicate worse symptoms)
Measured: 12 weeks
Hospital Anxiety and Depression Scale (HADS)
Anxiety and Depression Symptoms (higher scores indicate worse symptoms)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start6 Aug 2024
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Jennifer Temel, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427954
- Sponsor's protocol ID
- 24-091
- Acronym
- THRIVE
- Status last verified
- Jul 2026
- First submitted
- 17 May 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Mobile Application to Improve Health-Related Outcomes in Patients With Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT06427954
- Acronym / sponsor ID
- THRIVE / 24-091
- Conditions
- Lung Cancer
- Keywords
- Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THRIVE Digital Health App | Active comparator | Behavioral: Digital Health AppPatients 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. |
| Usual Care | No intervention | –Patients assigned to the usual care group will not receive the digital app but rather standard oncology care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Health Appaccess to a digital health app | Behavioural | THRIVE Digital Health App |
Primary outcome
Functional Assessment of Cancer Therapy - Lung (FACT-L)
Time frame: 12 weeks
Quality of Life (higher scores indicate better quality of life)
2 secondary outcomes
MD Anderson Symptom Inventory (MDASI)
Time frame: 12 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Health App in people with Lung Cancer, run by Massachusetts General Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Temel (6177244000, jtemel@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Cancer Therapy - Lung (FACT-L) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.