Mindfulness Apps for Lung Cancer

(CALM IT Trial)

Recruiting at 6 trial locations

Overseen By Christian Nelson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Psychotic disorders, Neoadjuvant therapy, Recurrent lung cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a mindfulness app, AmDTx (referred to as AmDTx-2048 in the trial title), can assist individuals before and after lung cancer surgery. Participants will either use AmDTx for mindfulness activities or play a puzzle game for comparison. The researchers aim to determine if the app can reduce stress and support recovery. Individuals diagnosed with lung cancer, scheduled for surgery, and possessing a smartphone might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative methods for enhancing recovery and managing stress.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that mindfulness programs like AmDTx-PCSP are usually well-received by people with lung cancer. Studies have found that these programs can help lower distress and depression and improve the quality of life for cancer patients. They focus on meditation and activities that help people manage their cancer experience.

No reports of serious side effects have emerged from these mindfulness programs. Most participants find them easy to handle and beneficial. The programs are designed to be safe and supportive, offering a gentle option for those undergoing cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how mindfulness and cognitive training apps might help lung cancer patients. Traditional treatments for lung cancer usually focus on surgery, chemotherapy, and radiation therapy, which primarily target the cancer cells themselves. This trial is different because it investigates whether digital tools like the AmDTx-PCSP mindfulness program and the AmDTx-2048 cognitive training game can improve patients' mental well-being and resilience around surgery. The mindfulness app offers meditation and personalized modules to help with stress, while the 2048 game provides cognitive training through a fun, engaging puzzle. These approaches aim to support patients' mental health alongside their physical treatment.

What evidence suggests that this trial's treatments could be effective for lung cancer?

Research has shown that mindfulness-based programs, such as AmDTx-PCSP, which participants in this trial may receive, can significantly benefit people with lung cancer. Studies have found that these programs reduce cancer-related stress and depression. They also enhance quality of life, self-kindness, and mindfulness skills. Mindfulness programs are associated with improved mental health and physical symptoms. Participants often report feeling less anxious and more at peace. ^{1 2 4 5 6}

Who Is on the Research Team?

Daniela Molena, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Perioperative Treatment

Participants use the AmDTx app for mindfulness or cognitive training starting at least 2 weeks before surgery

2 weeks

Remote app usage

Postoperative Treatment

Continued use of the AmDTx app for mindfulness or cognitive training for a minimum of 6 weeks after surgery

6 weeks

Remote app usage

Follow-up

Participants are monitored for safety and effectiveness after treatment, including completion of follow-up surveys

3 months

What Are the Treatments Tested in This Trial?

Interventions

• AmDTx-2048

Trial Overview 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.

How Is the Trial Designed?

Group I: MBCR (mindfulness-based cancer survivorship group) (AmDTx-PCSP) Experimental Treatment 2 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 Control 2 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

A 4-week mindfulness program for 36 cancer survivors led to significant reductions in perceived stress and sedentary time, along with improvements in sleep quality and daily physical activity after the intervention.

The study suggests that abbreviated mindfulness interventions are feasible and effective for cancer survivors, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of a 4-Week Mindfulness Intervention among Cancer Survivors Compared to a Breathing Control. Wirth, MD., Franco, R., Wagner Robb, S., et al.[2019]

Women with breast cancer who used a mobile app for mindfulness training reported significantly higher quality of life compared to those in the waitlist control group over an 8-week period.

The mindfulness training also led to increased dispositional mindfulness in participants, indicating that the app may help improve mental well-being alongside physical health after a breast cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life among women diagnosed with breast Cancer: A randomized waitlist controlled trial of commercially available mobile app-delivered mindfulness training. Rosen, KD., Paniagua, SM., Kazanis, W., et al.[2022]

Mindfulness-based stress reduction (MBSR) shows promising psychological benefits for cancer patients, as indicated by various instruments measuring its impact, although the effectiveness of these instruments varies.

The review highlights the need for more rigorous intervention studies on MBSR in cancer care to better understand its benefits and to refine the tools used to measure its effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring the psychological impact of mindfulness meditation on health among patients with cancer: a literature review. Matchim, Y., Armer, JM.[2007]

A study involving 30 lung cancer patients showed that mindfulness-based stress reduction therapy significantly improved their quality of life after eight sessions, compared to a control group that received no intervention (P<0.001).

The results suggest that incorporating psychological support, like mindfulness therapy, can be beneficial for lung cancer patients, highlighting the importance of addressing mental health during medical treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Mindfulness-Based Stress Reduction Therapy on the Quality of Life of Patients with Lung Cancer. Aminnasab, A., Hatami, M., Ahadi, H.[2023]

Mindfulness-based stress reduction training significantly improved quality of life and reduced physical symptoms in 47 cancer patients, with benefits observed immediately after training and even stronger effects reported one year later.

Participants experienced decreased mood disturbances, such as depression and anger, indicating that mindfulness training can help cancer patients manage stress and enhance their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction training for oncology patients: patients' appraisal and changes in well-being. Kieviet-Stijnen, A., Visser, A., Garssen, B., et al.[2008]

This study investigates the effectiveness of an online Mindfulness-Based Cancer Recovery (MBCR) program delivered during chemotherapy, focusing on reducing fatigue in breast and colorectal cancer patients, with a target sample size of 178 participants.

If successful, the MBCR program could serve as an important adjunctive treatment during chemotherapy, potentially improving not only fatigue but also other symptoms like sleep disturbance, pain, and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ONE-MIND Study: Rationale and protocol for assessing the effects of ONlinE MINDfulness-based cancer recovery for the prevention of fatigue and other common side effects during chemotherapy. Carlson, LE., Subnis, UB., Piedalue, KL., et al.[2020]

The pilot study of the 'Breathe Easier' mindfulness-based intervention showed strong feasibility among 62 participants, with 79% completing the 8-week program, indicating that such interventions can be effectively implemented for lung cancer survivors and their families.

Participants who engaged in level 1 yoga reported significant improvements in dyspnea, fatigue, sleep quality, and stress, while level 2 participants showed mixed results, highlighting the need for tailored approaches in mindfulness interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective Pilot Study Evaluating Feasibility and Preliminary Effects of Breathe Easier: A Mindfulness-based Intervention for Survivors of Lung Cancer and Their Family Members (Dyads). McDonnell, KK., Gallerani, DG., Newsome, BR., et al.[2021]

An 8-week mindfulness treatment delivered through an app was feasible for some patients with brain tumors, with 20 participants starting the study, but only 10 completed it, highlighting challenges in recruitment and retention.

Participants who completed the program reported significant improvements in mindfulness and illness-related quality of life, although there was a decline in social/family quality of life, indicating the need for further research to optimize engagement and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a novel application of a mindfulness phone application for patients with brain tumours: a feasibility study. De Tommasi, C., Richardson, E., Reale, M., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06008574

A Study Comparing Mindfulness Apps to Decrease Anxiety ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10522728/

Mindfulness-Based Interventions for Survivors of Lung Cancer ... RCTs reported significant outcomes for reduced cancer-related distress and depression, and improved QOL, self-compassion, mindfulness skills, and rumination.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0272735824001260

Positive health outcomes of mindfulness-based ... Mindfulness-based interventions (MBIs) improve positive health outcomes for cancer patients and survivors. Significant effects are observed for all positive ...

4. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2022.901247/full

The Impact of Mindfulness-Based Stress Reduction (MBSR ... This meta-analysis aimed to evaluate the effectiveness of the MBSR program on psychological states and QoL in lung cancer patients.

5. cancer.jmir.org cancer.jmir.org/2025/1/e54154

Benefits of Remote-Based Mindfulness on Physical Symptom ... Benefits of Remote-Based Mindfulness on Physical Symptom Outcomes in Cancer Survivors: Systematic Review and Meta-Analysis.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4457793/

Mindfulness-Based Stress Reduction for lung cancer ... We examined whether Mindfulness-Based Stress Reduction might be a feasible and effective intervention for patients with lung cancer and partners.