Status:
ACTIVE_NOT_RECRUITING
A Study Comparing Mindfulness Apps to Decrease Anxiety in People With Lung Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to find out if it is practical to provide the program contained within the smartphone app AmDTx before and after lung cancer surgery. AmDTx is a platform that re-configure...
Eligibility Criteria
Inclusion
- Histologically proven lung cancer
- Patients with suspected primary lung cancer per recent chest CT scan (with or without contrast) may be enrolled in the trial. These patients may be randomized and begin study intervention without a biopsy. If a patient undergoes a biopsy after consent and the results are negative or if the patient does not proceed with surgery, the patient will be removed from the study. The patient will continue to receive full access to the AmDTx app for 2-years.
- Scheduled for surgery with at least 14 days lead time (to allow the participant to start the mindfulness practice \[intervention group\] 14 days preoperatively)
- Age ≥18 years of age at time of signing informed consent
- Access to a smartphone/tablet with data connection
- Willing to give time for mindfulness practice (Patients need to have the motivation to devote approximately 20 to 30 min daily, which is equal to 5 to 7 sessions a week over the course of a minimum of 6 weeks to do the mindfulness meditations and practices)
- Willing to be randomized to mindfulness MBCR or CI group and complete all assessments
- High distress level (Distress Thermometer score ≥4 at initial visit)
- Able to understand the study objectives and procedures, comply with the protocol, and sign an informed consent
- Able to read, speak, and understand English
Exclusion
- Currently engaging in app-based mindfulness or meditation for one or more times per week
- As per self-report or as documented in the medical record, current untreated (e.g., no medication, no therapy) major psychotic disorder (schizotypal personality disorder, schizophreniform disorder, schizoaffective disorder). Patients diagnosed with a major psychiatric disorder will be reviewed by the study PI to determine eligibility before consent
- Individuals with impaired decision-making capacity
- Patients that need to undergo neoadjuvant therapy (chemotherapy±radiation)
- Patients undergoing active treatment of other non-lung cancers
- Patients with recurrent lung cancer
Key Trial Info
Start Date :
August 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2026
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06008574
Start Date
August 11 2023
End Date
August 1 2026
Last Update
September 17 2025
Active Locations (7)
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1
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, New York, United States, 11725