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

Last updated: June 25, 2024
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Lung Cancer

Lung Disease

Non-small Cell Lung Cancer

Treatment

AmDTx-PCSP

Questionnaires

AmDTx-2048

Clinical Study ID

NCT06008574
23-114
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically proven lung cancer

  • Patients with suspected primary lung cancer per recent chest CT scan (with orwithout contrast) may be enrolled in the trial. These patients may berandomized and begin study intervention without a biopsy. If a patientundergoes a biopsy after consent and the results are negative or if the patientdoes not proceed with surgery, the patient will be removed from the study. Thepatient 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 participantto 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 motivationto devote approximately 20 to 30 min daily, which is equal to 5 to 7 sessions a weekover the course of a minimum of 6 weeks to do the mindfulness meditations andpractices)

  • Willing to be randomized to mindfulness MBCR or CI group and complete allassessments

  • 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

Exclusion Criteria:

  • Currently engaging in app-based mindfulness or meditation for one or more times perweek

  • As per self-report or as documented in the medical record, current untreated (e.g.,no medication, no therapy) major psychotic disorder (schizotypal personalitydisorder, schizophreniform disorder, schizoaffective disorder). Patients diagnosedwith a major psychiatric disorder will be reviewed by the study PI to determineeligibility 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

Study Design

Total Participants: 6
Treatment Group(s): 3
Primary Treatment: AmDTx-PCSP
Phase:
Study Start date:
August 11, 2023
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

    Basking Ridge, New Jersey 07920
    United States

    Site Not Available

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    Middletown, New Jersey 07748
    United States

    Site Not Available

  • Memorial Sloan Kettering Bergen (All Protocol Activities)

    Montvale, New Jersey 07645
    United States

    Site Not Available

  • Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

    Commack, New York 11725
    United States

    Site Not Available

  • Memorial Sloan Kettering Westchester (All protocol activities)

    Harrison, New York 10604
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York 10065
    United States

    Site Not Available

  • Memorial Sloan Kettering Nassau (All Protocol Activities)

    Rockville Centre, New York 11553
    United States

    Site Not Available

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