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

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.

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.

What data supports the effectiveness of the treatment AmDTx-2048 for lung cancer?

Research shows that mindfulness-based treatments, like the one in the study, can help cancer patients by reducing distress and improving quality of life. Similar mobile app-based mindfulness interventions have been effective for other cancer patients, suggesting potential benefits for lung cancer patients as well. ^{1 2 3 4 5}

Is the mindfulness app AmDTx-2048 safe for use in humans?

The research does not provide specific safety data for the mindfulness app AmDTx-2048, but mindfulness-based interventions, including app-based ones, have been studied in cancer patients and generally focus on improving quality of life without reported safety concerns. ^{2 3 5 6 7}

How is the treatment AmDTx-2048 different from other treatments for lung cancer?

AmDTx-2048 is unique because it is a mindfulness app designed to help lung cancer patients manage stress and improve their quality of life, unlike traditional treatments that focus on directly targeting the cancer itself. This app-based approach offers a convenient and accessible way for patients to engage in mindfulness practices, which can help reduce anxiety, depression, and fatigue. ^{8 9 10 11 12}

Research Team

Daniela Molena, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Intra-individual study of mindfulness: ecological momentary perspective in post-surgical lung cancer patients. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of mHealth Mindfulness Intervention for Cancer Patients and Informal Cancer Caregivers: A Feasibility Study Within an Integrated Health Care Delivery System. [2020]

3. England 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. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction training for oncology patients: patients' appraisal and changes in well-being. [2008]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. England 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. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a novel application of a mindfulness phone application for patients with brain tumours: a feasibility study. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of a 4-Week Mindfulness Intervention among Cancer Survivors Compared to a Breathing Control. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Reach versus effectiveness: The design and protocol of randomized clinical trial testing a smartphone application versus in-person mindfulness-based smoking cessation intervention among young cancer survivors. [2023]

10. Iran pubmed.ncbi.nlm.nih.gov

Effectiveness of Mindfulness-Based Stress Reduction Therapy on the Quality of Life of Patients with Lung Cancer. [2023]

11. United States 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). [2021]

12. England pubmed.ncbi.nlm.nih.gov

Effectiveness of mindfulness-based interventions on anxiety, depression, and fatigue in people with lung cancer: A systematic review and meta-analysis. [2023]