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

Study Overview
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Brief Summary
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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.

Official Title
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Cancer Anxiety Pilot Mindfulness Interdisciplinary Trial (CALM IT)

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: AmDTx-PCSP
* Other: AmDTx-2048
* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven lung cancer 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 1 month 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective randomized pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBCR (mindfulness-based cancer survivorship group) (AmDTx-PCSP)<br>Patients randomized to the MBCR group will receive remote AmDTx-PCSP in the perioperative period (initiated at least 2 weeks before surgery). AmDTx-PCSP will be continued after surgery, for a minimum of 6 weeks total. AmDTx-PCSP is a step-by-step program including meditation training and other activities relevant for people living with cancer. The participants are asked to use AmDTx for about 20-30 minutes per day, at least 4 days per week, for 6 weeks. The participants are free to proceed at a faster pace and use AmDTx more than 20-30 per day if they choose. The first 3 modules of the program are required, and then the participant will be able to pick 3 additional modules based on topics that are most meaningful to them. | Other: AmDTx-PCSP<br>* Step-by-step program modules including meditation training and other activities relevant for people living with cancer<br>Other: Questionnaires<br>* 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)<br>|
| Active Comparator: CI (control) group (AmDTx-2048)<br>Patients randomized to the CI group will use a game called 2048, a cognitive training app, which is used as an control condition to control for expectancy and daily engagement. The participants will use AmDTx-2048 to engage in cognitive training with a puzzle game. The participants are asked to use AmDTx for about 20-30 minutes per day, at least 4 days per week, for 6 weeks. The participants are free to proceed at a faster pace and use AmDTx more than 20-30 per day if you choose. In this puzzle game, the participants will slide numbered tiles around a grid, matching tiles of the same value to combine them into one new tile displaying the sum of the previous two numbers. The goal is to match tiles until the sum of 2048 is reached on a single tile. There is no time limit. | Other: AmDTx-2048<br>* 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.<br>Other: Questionnaires<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence Retention rate | 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. | up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in anxiety symptoms | These analyses apply to all continuous endpoints (PROMIS-Anxiety, IES, MAAS, PROMIS- Depression, PROMIS-Fatigue, PROMIS-Sleep Disturbance, LCSI) | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Mindfulness Apps, 23-114