Advanced Lung CancerNCT07227623
A Digital Health Intervention to Improve Physical Function and Wellness of Lung Cancer Survivors
A study testing PROMOTE Digital Health App Intervention in people with Advanced Lung Cancer and Physical Function, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The rationale for the proposed project is to improve the experience and outcomes of individuals diagnosed with lung cancer treated for cure. Survival rates in patients with stages I-III lung cancer continue to increase given progress in early detection and more effective treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Lung Cancer, Physical Function
- What is being tested?
- PROMOTE Digital Health App Intervention
- 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
- 1 siteUnited States
- Study dates
- 6 Feb 2026to 28 Feb 2029
- 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
- Age ≥ 18 years
- Diagnosis of stage I-III non-small cell lung cancer
- Within six weeks of initiating treatment with curative intent that includes chemotherapy ± immunotherapy in the neo-adjuvant or adjuvant setting with surgery or as part of definitive chemoradiation
- Eastern Cooperative Oncology Group Performance Status = 0-2 (i.e., fully active to at least ambulatory and up and about more than 50% of waking hours)
- Ability to use a digital health intervention that includes verbal and written information in English
- Ability to complete questionnaires in English or Spanish
- Primary cancer care at one of the participating institutions
Who cannot join
- Significant uncontrolled psychiatric disorder or other co-morbid disease (e.g., dementia, cognitive impairment), which the treating oncology clinician reports would prohibit the patient's ability to participate in study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Joseph A. Greer, PhD, 617-643-2143, jgreer2@mgh.harvard.edu
Joseph A. Greer, PhD
About this study
Official title: Randomized Trial of a Digital Health Intervention to Improve Physical Function and Wellness of Lung Cancer Survivors
The rationale for the proposed project is to improve the experience and outcomes of individuals diagnosed with lung cancer treated for cure. Survival rates in patients with stages I-III lung cancer continue to increase given progress in early detection and more effective treatments. However, the survivorship needs of this population are considerable and too often overlooked, especially with respect to their health behaviors, such as physical activity and nutrition, as well as persistent symptoms and side effects, including breathing difficulties and sleep disturbance. To ensure that as many patients as possible can access the information, support, and skills they require to navigate the diagnosis and treatment of lung cancer, the investigators worked with a multidisciplinary team to create a digital health intervention, called "PROMOTE." The investigators designed the PROMOTE mobile app for lung cancer survivors undergoing treatment to help them improve physical function, manage breathlessness and insomnia, increase physical activity, maintain a healthy diet, and enhance their overall wellbeing. To achieve the long-term goal to have PROMOTE become widely available to all lung cancer survivors, the next step in this research program is to conduct a randomized trial to demonstrate the benefits of the digital health intervention. Specifically, the investigators hypothesize that, compared to patients receiving enhanced usual care, those assigned to PROMOTE will report improved physical function, less difficulty with breathlessness and sleep disturbance, increased physical activity, healthier eating behaviors, fewer symptoms of anxiety and depression, and better quality of life. The investigators also plan to examine whether PROMOTE leads to more effective coping and greater confidence in patients' ability to manage their health (i.e., self-efficacy). For this project, the investigators will enroll lung cancer survivors receiving care at an academic cancer center and two affiliated community sites that provide care for diverse patient populations to ensure the results apply to a wide range of individuals with lung cancer. Participants will be randomly assigned either to receive the PROMOTE app intervention for 12 weeks or to an enhanced usual care control group that includes health education materials. Participants will complete surveys at enrollment and again at 6, 12, and 24 weeks after enrollment. At the end of the study, those assigned to the control group will be permitted to receive the PROMOTE app as well.
Read the detailed description
Background: The population of lung cancer survivors continues to expand given advances in early cancer detection and cancer therapeutics significantly improving survival rates for these patients. However, interventions focused on survivorship are limited for those with lung cancer due to their historically poor prognosis. To address this unmet need, the investigators developed a digital health intervention, called "PROMOTE," for patients undergoing curative therapy for lung cancer to help them improve physical function, manage breathlessness and insomnia, increase physical activity, maintain a healthy diet, and enhance their overall wellbeing.
Objectives: The goal of the proposed study is to examine the impact of the PROMOTE mobile app intervention versus enhanced usual care (consisting of health education materials) on patient-reported outcomes in adults with non-small cell lung cancer (NSCLC) receiving treatment with curative intent that includes chemotherapy.
Study Aims: The specific aims are: 1) to evaluate the efficacy of PROMOTE versus enhanced usual care for improving patient-reported physical function (primary), dyspnea, sleep disturbance, physical activity, and eating behaviors; 2) to assess the efficacy of PROMOTE versus enhanced usual care for improving patient-reported self-efficacy, mood symptoms, and quality of life; and 3) to explore mediators and moderators of the effect of PROMOTE on patient-reported outcomes.
Study Design: The investigators will conduct a randomized controlled trial of PROMOTE versus enhanced usual care in 250 adult patients with stages I-III NSCLC receiving treatment with curative intent that includes chemotherapy. The investigators will examine the effect of the intervention on patient-reported physical function and other meaningful survivorship outcomes. Patients will be recruited from the Massachusetts General Hospital Cancer Center and two affiliated community sites. Participants will be randomized in a 1:1 fashion, stratified by study site and lung cancer treatment to ensure balanced representation between the two study groups on these factors. Patients assigned to PROMOTE will receive a tablet computer with instructions on how to use the digital app. Participants will complete self-report outcome measures at enrollment and again at 6, 12, and 24 weeks post-enrollment to evaluate the short and long-term impact of PROMOTE.
- Conditions
- Advanced Lung Cancer, Physical Function
- Being tested
- PROMOTE Digital Health App Intervention, Enhanced Usual Care
- Keywords
- Lung Cancer, Behavioral Intervention, Digital Health App, Physical Function
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROMOTE Digital Health App InterventionBehavioural
Patients will receive the PROMOTE digital health app, which includes educational modules focused on helping lung cancer survivors improve their physical function, management of breathlessness, sleep, physical activity, nutrition, and overall wellbeing.
Enhanced Usual CareBehavioural
Patients will receive standard oncology care plus health educational materials about treatments for lung cancer, side effect management, and survivorship from the American Cancer Society (either in electronic or hardcopy formats).
| Study group | Role | What they receive |
|---|---|---|
| PROMOTE Digital Health App Intervention | Experimental | Patients will receive a study-issued tablet computer with the PROMOTE app that includes the following modules: 1) introductory education regarding the diagnosis and treatment trajectory of lung cancer; 2) behavioral interventions for improving physical function by managing fluctuations in energy and fostering engagement in valued life activities; 3) evidence-based breathing techniques for coping with dyspnea and improving lung function; 4) cognitive-behavioral strategies for enhancing sleep quality and efficiency; 5) approaches for increasing physical activity through adaptation and graded exercises; 6) tips for healthy eating and managing digestive side effects of cancer treatment, and 7) skills for managing mood symptoms through effective problem-, emotion-, and acceptance-based coping strategies. Patients will complete the intervention modules at their desired pace over approximately 10 weeks, in addition to their standard oncology care. Receives: Behavioral: PROMOTE Digital Health App Intervention |
| Enhanced Usual Care | Active comparator | Patients will receive standard oncology care plus health educational materials about treatments for lung cancer, side effect management, and survivorship from the American Cancer Society (either in electronic or hardcopy formats). Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported Physical Function
To compare patient-reported physical function at 12 weeks using the PROMIS Physical Function 8b Short Form, which is an 8-item measure that evaluates self-perceived capability of one's upper extremities, lower extremities, and activities of daily living (total scale score range: 8-40), with higher scores indicating better functioning.
Measured: 12 weeks
Secondary outcomes (3)
Patient-reported Dyspnea
To compare patient-reported dyspnea using the PROMIS Dyspnea Severity 10a Short Form, which is a 10-item measure that assesses the severity of shortness of breath or difficulty breathing in response to various specific activities (total scale score range: 0-30), with higher scores indicating worse dyspnea.
Measured: 12 weeks
Patient-reported Sleep Disturbance
To compare patient-reported sleep disturbance at 12 weeks using the PROMIS Sleep Disturbance 8a Short Form, which is an 8-item measure that evaluates difficulties with sleep onset, maintenance, and quality (total scale score: 8-40), with higher scores indicating greater sleep disturbance.
Measured: 12 weeks
Patient-reported Exercise and Eating Behaviors
To compare patient-reported exercise and eating behaviors at 12 weeks using the Simple Lifestyle Indicator Questionnaire, which is a 12-item measure that assesses multiple health behavior and wellness domains including physical activity, diet, alcohol use, smoking, and stress level (total score range: 0-10), with higher scores indicating a healthier lifestyle.
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 posted13 Nov 2025
- Study start6 Feb 2026
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Joseph A. Greer, Ph.D., Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227623
- Sponsor's protocol ID
- 24-529
- Other IDs
- RSG-24-1310262-01-CPHP
- Status last verified
- Mar 2026
- First submitted
- 10 Nov 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of a Digital Health Intervention to Improve Physical Function and Wellness of Lung Cancer Survivors
- ClinicalTrials.gov ID
- NCT07227623
- Acronym / sponsor ID
- 24-529
- Conditions
- Advanced Lung Cancer, Physical Function
- Keywords
- Lung Cancer, Behavioral Intervention, Digital Health App, Physical Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 13 Nov 2025 (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.
The rationale for the proposed project is to improve the experience and outcomes of individuals diagnosed with lung cancer treated for cure. Survival rates in patients with stages I-III lung cancer continue to increase given progress in early detection and more effective treatments. However, the survivorship needs of this population are considerable and too often overlooked, especially with respect to their health behaviors, such as physical activity and nutrition, as well as persistent symptoms and side effects, including breathing difficulties and sleep disturbance. To ensure that as many patients as possible can access the information, support, and skills they require to navigate the diagnosis and treatment of lung cancer, the investigators worked with a multidisciplinary team to create a digital health intervention, called "PROMOTE." The investigators designed the PROMOTE mobile app for lung cancer survivors undergoing treatment to help them improve physical function, manage breathlessness and insomnia, increase physical activity, maintain a healthy diet, and enhance their overall wellbeing. To achieve the long-term goal to have PROMOTE become widely available to all lung cancer survivors, the next step in this research program is to conduct a randomized trial to demonstrate the benefits of the digital health intervention. Specifically, the investigators hypothesize that, compared to patients receiving enhanced usual care, those assigned to PROMOTE will report improved physical function, less difficulty with breathlessness and sleep disturbance, increased physical activity, healthier eating behaviors, fewer symptoms of anxiety and depression, and better quality of life. The investigators also plan to examine whether PROMOTE leads to more effective coping and greater confidence in patients' ability to manage their health (i.e., self-efficacy). For this project, the investigators will enroll lung cancer survivors receiving care at an academic cancer center and two affiliated community sites that provide care for diverse patient populations to ensure the results apply to a wide range of individuals with lung cancer. Participants will be randomly assigned either to receive the PROMOTE app intervention for 12 weeks or to an enhanced usual care control group that includes health education materials. Participants will complete surveys at enrollment and again at 6, 12, and 24 weeks after enrollment. At the end of the study, those assigned to the control group will be permitted to receive the PROMOTE app as well.
Detailed description
Background: The population of lung cancer survivors continues to expand given advances in early cancer detection and cancer therapeutics significantly improving survival rates for these patients. However, interventions focused on survivorship are limited for those with lung cancer due to their historically poor prognosis. To address this unmet need, the investigators developed a digital health intervention, called "PROMOTE," for patients undergoing curative therapy for lung cancer to help them improve physical function, manage breathlessness and insomnia, increase physical activity, maintain a healthy diet, and enhance their overall wellbeing.
Objectives: The goal of the proposed study is to examine the impact of the PROMOTE mobile app intervention versus enhanced usual care (consisting of health education materials) on patient-reported outcomes in adults with non-small cell lung cancer (NSCLC) receiving treatment with curative intent that includes chemotherapy.
Study Aims: The specific aims are: 1) to evaluate the efficacy of PROMOTE versus enhanced usual care for improving patient-reported physical function (primary), dyspnea, sleep disturbance, physical activity, and eating behaviors; 2) to assess the efficacy of PROMOTE versus enhanced usual care for improving patient-reported self-efficacy, mood symptoms, and quality of life; and 3) to explore mediators and moderators of the effect of PROMOTE on patient-reported outcomes.
Study Design: The investigators will conduct a randomized controlled trial of PROMOTE versus enhanced usual care in 250 adult patients with stages I-III NSCLC receiving treatment with curative intent that includes chemotherapy. The investigators will examine the effect of the intervention on patient-reported physical function and other meaningful survivorship outcomes. Patients will be recruited from the Massachusetts General Hospital Cancer Center and two affiliated community sites. Participants will be randomized in a 1:1 fashion, stratified by study site and lung cancer treatment to ensure balanced representation between the two study groups on these factors. Patients assigned to PROMOTE will receive a tablet computer with instructions on how to use the digital app. Participants will complete self-report outcome measures at enrollment and again at 6, 12, and 24 weeks post-enrollment to evaluate the short and long-term impact of PROMOTE.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROMOTE Digital Health App Intervention | Experimental | Behavioral: PROMOTE Digital Health App InterventionPatients will receive a study-issued tablet computer with the PROMOTE app that includes the following modules: 1) introductory education regarding the diagnosis and treatment trajectory of lung cancer; 2) behavioral interventions for improving physical function by managing fluctuations in energy and fostering engagement in valued life activities; 3) evidence-based breathing techniques for coping with dyspnea and improving lung function; 4) cognitive-behavioral strategies for enhancing sleep quality and efficiency; 5) approaches for increasing physical activity through adaptation and graded exercises; 6) tips for healthy eating and managing digestive side effects of cancer treatment, and 7) skills for managing mood symptoms through effective problem-, emotion-, and acceptance-based coping strategies. Patients will complete the intervention modules at their desired pace over approximately 10 weeks, in addition to their standard oncology care. |
| Enhanced Usual Care | Active comparator | Behavioral: Enhanced Usual CarePatients will receive standard oncology care plus health educational materials about treatments for lung cancer, side effect management, and survivorship from the American Cancer Society (either in electronic or hardcopy formats). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Diagnosis of stage I-III non-small cell lung cancer
- Within six weeks of initiating treatment with curative intent that includes chemotherapy ± immunotherapy in the neo-adjuvant or adjuvant setting with surgery or as part of definitive chemoradiation
- Eastern Cooperative Oncology Group Performance Status = 0-2 (i.e., fully active to at least ambulatory and up and about more than 50% of waking hours)
- Ability to use a digital health intervention that includes verbal and written information in English
Key exclusion criteria (1 listed)
- Significant uncontrolled psychiatric disorder or other co-morbid disease (e.g., dementia, cognitive impairment), which the treating oncology clinician reports would prohibit the patient's 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 |
|---|---|---|
| PROMOTE Digital Health App InterventionPatients will receive the PROMOTE digital health app, which includes educational modules focused on helping lung cancer survivors improve their physical function, management of breathlessness, sleep, physical activity, nutrition, and overall wellbeing. | Behavioural | PROMOTE Digital Health App Intervention |
| Enhanced Usual CarePatients will receive standard oncology care plus health educational materials about treatments for lung cancer, side effect management, and survivorship from the American Cancer Society (either in electronic or hardcopy formats). | Behavioural | Enhanced Usual Care |
Primary outcome
Patient-reported Physical Function
Time frame: 12 weeks
To compare patient-reported physical function at 12 weeks using the PROMIS Physical Function 8b Short Form, which is an 8-item measure that evaluates self-perceived capability of one's upper extremities, lower extremities, and activities of daily living (total scale score range: 8-40), with higher scores indicating better functioning.
3 secondary outcomes
Patient-reported Dyspnea
Time frame: 12 weeks
Patient-reported Sleep Disturbance
Time frame: 12 weeks
Patient-reported Exercise and Eating Behaviors
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 19 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROMOTE Digital Health App Intervention in people with Advanced Lung Cancer and Physical Function, run by Massachusetts General Hospital at 1 site 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 7 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 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Joseph A. Greer, PhD (617-643-2143, jgreer2@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported Physical Function (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 19 Mar 2026; AzTrials last refreshed its copy on 30 Oct 2026.