Cancer Anxiety Pilot Mindfulness Interdisciplinary Trial (CALM IT)

Memorial Sloan Kettering Cancer Center7 sites in 1 country6 target enrollmentAugust 11, 2023

ConditionsLung Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Lung Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 6
Locations: 7
Primary Endpoint: Adherence Retention rate
Status: Active, not recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

August 11, 2023

End Date

August 1, 2026

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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.