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Active, Not Recruiting

NCT Number: NCT06008574

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AmDTx-PCSP

Other

Step-by-step program modules including meditation training and other activities relevant for people living with cancer

AmDTx-2048

Other

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.

questionnaires

Other

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)

Primary outcomes

  1. Adherence Retention rate

    Time frame: up to 3 months

    Retention rates will be calculated separately as the proportion of enrolled participants who complete the 4-week and 3-month follow-up surveys. Adherence: The AmDTx app automatically collects adherence data, including date, time, length, and name of session to which participants listened, and transfers the data to the researchers on a weekly basis.

Secondary outcomes

  1. Decrease in anxiety symptoms

    Time frame: up to 6 months

    These analyses apply to all continuous endpoints (PROMIS-Anxiety, IES, MAAS, PROMIS- Depression, PROMIS-Fatigue, PROMIS-Sleep Disturbance, LCSI)

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Cancer Anxiety Pilot Mindfulness Interdisciplinary Trial (CALM IT)

Acronym: CALM IT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 23, 2023
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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