This clinical trial studies how well a mindfulness mobile application (app) called AmDTx, works to decrease anxiety in patients with lung cancer. AmDTx provides a combination of cognitive exercises, guided meditation sessions, audio lectures, reminders, journaling features, and tools to measure mental well being. People with lung cancer often experience high levels of emotional distress, anxiety, and depression. Using cognitive (thinking, reasoning, and remembering) training through a smartphone app, may help to decrease anxiety and symptoms of anxiety for patients who have lung cancer and are planning to have surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06008574.
PRIMARY OBJECTIVE:
I. To determine the feasibility (reach, retention, adherence) and acceptability of AmDTx-Personalized Cancer Stewardship Program (PCSP) (mindfulness-based cancer recovery [MBCR] group) and the control AmDTx-2048 (control intervention [CI] group) in patients with lung cancer who are scheduled to undergo surgery.
SECONDARY OBJECTIVE:
I. Estimate the preliminary comparative effects between the two groups (MBCR versus [vs.] CI) to decrease anxiety and comorbid symptoms of distress and anxiety (e.g., depression, fatigue, and sleep disturbance) at 3 months and 6 months after baseline.
EXPLORATORY OBJECTIVE:
I. To assess associations between psycho-biometric data and self-reported stress data collected by the smartphone applications (apps) with self-reported outcome data from validated psychometric scales (e.g., Impact of Events Scale [IES], Patient-Reported Outcomes Measurement Information System [PROMIS] short form version [v] 1.0 – Anxiety-8a).
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive remote MBCR therapy using the AmDTx-PCSP app, composed of a step-by-step program with 9 modules that include guided meditations, audio lectures and discourses, reminders, a timer to facilitate self-guided meditation, journaling features, and psycho-biometric recordings and feedback, over 20-30 minutes per day at least 4 days per week, beginning at least 2 weeks before standard of care (SOC) surgery and then continuing after SOC surgery for a minimum of 6 total weeks on study.
GROUP II: Patients receive cognitive training within the AmDTx-2048 app using a cognitive training puzzle exercise called 2048 over 20-30 minutes per day at least 4 days per week for 6 weeks on study.
After completion of study intervention, patients are followed up at 3 and 6 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorDaniela Molena
