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Behavioural Intervention

Mindfulness Apps for Lung Cancer (CALM IT Trial)

N/A

Recruiting

Led By Daniela Molena, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

CALM IT Trial Summary

This trial aims to test if an app (AmDTx) can improve care for lung cancer patients before and after surgery.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Since this trial involves non-medical interventions like mindfulness apps and questionnaires rather than drugs or invasive procedures, significant side effects are not expected.

CALM IT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence Retention rate

Secondary outcome measures

Decrease in anxiety symptoms

CALM IT Trial Design

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,818 Total Patients Enrolled

Daniela Molena, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

2 Previous Clinical Trials

4,060 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment currently available for this test?

"According to the clinicaltrials.gov database, this study is currently open for recruitment. It was initially posted on August 11th 2023 and it's most recent update was recorded on August 22nd 23rd."

Answered by AI

How many subjects are currently participating in this experiment?

"Affirmative, according to the information stored on clinicaltrials.gov this research project is actively recruiting patients. It was launched on August 11th 2023 and has undergone its most recent update on August 22nd of the same year. Eighty individuals are sought from 7 distinct sites for inclusion in the trial."

Answered by AI

How many health care facilities are facilitating this research endeavor?

"The following medical sites are currently recruiting patients for this trial: Memorial Sloan Kettering Monmouth (All Protocol Activities) in Middletown, Memorial Sloan Kettering Bergen (All Protocol Activities) in Montvale, and Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) in Commack. There are 7 other locations that have been identified as potential recruitment centers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study Comparing Mindfulness Apps to Decrease Anxiety in People With Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06008574.