Mindfulness Apps for Lung Cancer
(CALM IT Trial)

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen byDaniela Molena, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

This trial is for adults over 18 with lung cancer, scheduled for surgery, who own a smartphone/tablet and can use it. They should understand the study, consent to participate, be willing to practice mindfulness, and have a high distress level. People already using meditation apps or needing pre-surgery chemo/radiation cannot join.

Inclusion Criteria

I might have lung cancer based on a recent CT scan and can start the trial without a biopsy.

I understand the study's goals, can follow the rules, and am willing to sign a consent form.

I am willing to join a study group and complete all required assessments.

See 7 more

Exclusion Criteria

My lung cancer has come back after treatment.

I am unable to make my own medical decisions.

I use a mindfulness or meditation app at least once a week.

See 3 more

Treatment Details

Interventions

AmDTx-2048 (Behavioural Intervention)

Trial OverviewThe study tests if the AmDTx app helps reduce anxiety in lung cancer patients before and after surgery. The app adapts to patient needs via doctor's prescriptions. Participants will either use this mindfulness program or a control intervention (CI) alongside answering questionnaires.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: MBCR (mindfulness-based cancer survivorship group) (AmDTx-PCSP)Experimental Treatment2 Interventions

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.

Group II: CI (control) group (AmDTx-2048)Active Control2 Interventions

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.