CALM IT: A Study Comparing Mindfulness Apps to Decrease Anxiety in People With Lung Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MBCR (mindfulness-based cancer survivorship group) (AmDTx-PCSP) 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
Step-by-step program modules including meditation training and other activities relevant for people living with cancer
Other: Questionnaires
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)
|
| Active Comparator: CI (control) group (AmDTx-2048) 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
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.
Other: Questionnaires
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)
|
Outcome Measures
Primary Outcome Measures
- Adherence Retention rate [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 Outcome Measures
- Decrease in anxiety symptoms [up to 6 months]
These analyses apply to all continuous endpoints (PROMIS-Anxiety, IES, MAAS, PROMIS- Depression, PROMIS-Fatigue, PROMIS-Sleep Disturbance, LCSI)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically proven lung cancer
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Scheduled for surgery with at least 14 days lead time (to allow the participant to start the mindfulness practice [intervention group] 14 days preoperatively)
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Age ≥18 years of age at time of signing informed consent
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Access to a smartphone/tablet with data connection
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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)
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Willing to be randomized to mindfulness MBCR or CI group and complete all assessments
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High distress level (Distress Thermometer score ≥4 at initial visit)
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Able to understand the study objectives and procedures, comply with the protocol, and sign an informed consent
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Able to read, speak, and understand English
Exclusion Criteria:
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Currently engaging in app-based mindfulness or meditation for one or more times per week
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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
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Individuals with impaired decision-making capacity
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Patients that need to undergo neoadjuvant therapy (chemotherapy±radiation)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memorial Sloan Kettering Basking Ridge (All Protocol Activities) | Basking Ridge | New Jersey | United States | 07920 |
| 2 | Memorial Sloan Kettering Monmouth (All Protocol Activities) | Middletown | New Jersey | United States | 07748 |
| 3 | Memorial Sloan Kettering Bergen (All Protocol Activities) | Montvale | New Jersey | United States | 07645 |
| 4 | Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) | Commack | New York | United States | 11725 |
| 5 | Memorial Sloan Kettering Westchester (All protocol activities) | Harrison | New York | United States | 10604 |
| 6 | Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York | United States | 10065 |
| 7 | Memorial Sloan Kettering Nassau (All Protocol Activities) | Rockville Centre | New York | United States | 11553 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
Investigators
- Principal Investigator: Daniela Molena, MD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 23-114