Clinical trial NCT06008574: A Study Comparing Mindfulness Apps to Decrease Anxiety in People With Lung Cancer
Official title: Cancer Anxiety Pilot Mindfulness Interdisciplinary Trial (CALM IT)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: Anxiety
Mindfulness Apps
23-114
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective randomized pilot study
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Adherence Retention rate
timeFrame: up to 3 months
Secondary outcomes:
measure: Decrease in anxiety symptoms
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (All Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All protocol activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Daniela Molena, MD
role: PRINCIPAL_INVESTIGATOR
References: