A Digital Health Intervention to Improve Physical Function and Wellness of Lung Cancer Survivors

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.

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