PROMOTE mobile app to improve physical function and wellbeing in lung cancer survivors

Randomized Trial of a Digital Health Intervention to Improve Physical Function and Wellness of Lung Cancer Survivors

This project tests whether the PROMOTE mobile app can help adults with stage I–III non-small cell lung cancer undergoing curative chemotherapy improve their physical function and overall wellbeing.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Massachusetts General Hospital (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT07227623 on ClinicalTrials.gov

What this trial studies

Researchers will randomize adults with stage I–III non-small cell lung cancer who are within six weeks of starting curative-intent chemotherapy (with or without immunotherapy) to use the PROMOTE digital health app or receive enhanced usual care consisting of health education materials. The PROMOTE app delivers behavioral support for physical activity, breathlessness and sleep management, and healthy eating, and collects patient-reported outcomes over the treatment period. The primary outcome is patient-reported physical function, with secondary outcomes including dyspnea, sleep disturbance, physical activity, eating behaviors, self-efficacy, mood symptoms, and quality of life. Investigators will also explore mediators and moderators to understand who benefits most from the intervention.

Who should consider this trial

Good fit: Adults (≥18) with stage I–III non-small cell lung cancer who are within six weeks of starting curative-intent treatment that includes chemotherapy, have ECOG performance status 0–2, can use an English-language digital app, and receive primary cancer care at a participating site are ideal candidates.

Not a fit: Patients with significant uncontrolled psychiatric or cognitive disorders that preclude participation, those unable to use an English-language digital intervention, or patients not receiving curative-intent chemotherapy are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If effective, PROMOTE could help lung cancer survivors increase activity, reduce breathlessness and sleep problems, and improve quality of life during and after curative treatment.

How similar studies have performed: Behavioral and digital health interventions have shown benefits for physical activity and symptom management in cancer and pulmonary populations, but applying a dedicated app to early-stage lung cancer survivorship care is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where this trial is running

Boston, Massachusetts

• Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Study coordinator: Joseph A. Greer, PhD

Conditions: Advanced Lung Cancer, Physical Function, Lung Cancer, Behavioral Intervention, Digital Health App