A Study Comparing Mindfulness Apps to Decrease Anxiety in People With Lung Cancer

Trial Title: A Study Comparing Mindfulness Apps to Decrease Anxiety in People With Lung Cancer

NCT ID: NCT06008574

Condition: Lung Cancer

Conditions: Official terms:
Lung Neoplasms

Conditions: Keywords:
Anxiety
Mindfulness Apps
23-114

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: A prospective randomized pilot study

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: AmDTx-PCSP
Description: Step-by-step program modules including meditation training and other activities relevant for people living with cancer
Arm group label: MBCR (mindfulness-based cancer survivorship group) (AmDTx-PCSP)

Intervention type: Other
Intervention name: AmDTx-2048
Description: Cognitive training exercise called "2048".AmDTx-2048 is a modified version of a popular game called "2048. It is a fun and relaxing puzzle game". Within "2048", participants slide numbered tiles around a grid, matching tiles of the same value.
Arm group label: CI (control) group (AmDTx-2048)

Intervention type: Other
Intervention name: Questionnaires
Description: Distress Thermometer (DT)2, Demographic Information and medical history, Assessment for Contamination, Impact of Event Score (IES-R), Mindfulness Attention Awareness Scale (MAAS), PROMIS Short Form v1.0 - Anxiety - 8a, Depression - 4a, Fatigue 4a, Sleep Disturbance 4a, The Lung Cancer Stigma Inventory (LCSI)
Arm group label: CI (control) group (AmDTx-2048)
Arm group label: MBCR (mindfulness-based cancer survivorship group) (AmDTx-PCSP)

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-configures according to the specific needs of patients through physician prescriptions.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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 Criteria: - 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Address:
City: Basking Ridge
Zip: 07920
Country: United States

Facility:
Name: Memorial Sloan Kettering Monmouth (All Protocol Activities)

Address:
City: Middletown
Zip: 07748
Country: United States

Facility:
Name: Memorial Sloan Kettering Bergen (All Protocol Activities)

Address:
City: Montvale
Zip: 07645
Country: United States

Facility:
Name: Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

Address:
City: Commack
Zip: 11725
Country: United States

Facility:
Name: Memorial Sloan Kettering Westchester (All protocol activities)

Address:
City: Harrison
Zip: 10604
Country: United States

Facility:
Name: Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Address:
City: New York
Zip: 10065
Country: United States

Facility:
Name: Memorial Sloan Kettering Nassau (All Protocol Activities)

Address:
City: Rockville Centre
Zip: 11553
Country: United States

Start date: August 11, 2023

Completion date: August 2025

Lead sponsor:
Agency: Memorial Sloan Kettering Cancer Center
Agency class: Other

Source: Memorial Sloan Kettering Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06008574
http://www.mskcc.org/mskcc/html/44.cfm