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治験 NCT06008574 (CALM IT)（対象：肺癌）は実施中／登録終了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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メモリアル・スローン・ケタリングがんセンターA Study Comparing Mindfulness Apps to Decrease Anxiety in People With Lung Cancer (CALM IT)
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06008574 (CALM IT) は 介入研究 臨床試験 で、肺癌 に関するものです。現在は 実施中／登録終了 で、2023年8月11日 から開始しています。6 名の参加者 の募集が計画されています。この治験は メモリアル・スローン・ケタリングがんセンター によって主催され、2026年8月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年9月17日 です。
概要
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.
公式タイトル
Cancer Anxiety Pilot Mindfulness Interdisciplinary Trial (CALM IT)
疾患／病気
肺癌その他の研究識別子
- CALM IT
- 23-114
NCT番号
開始日
2023-08-11
最終更新日
2025-09-17
終了予定日
2026-08
目標参加者数
6
試験の種類
介入研究
治験の相・段階
該当なし
状況
実施中／登録終了
キーワード
Anxiety
Mindfulness Apps
23-114
Mindfulness Apps
23-114
主目的
支持療法
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的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. | Amdtx-pcsp Step-by-step program modules including meditation training and other activities relevant for people living with cancer アンケート 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) |
実薬対照薬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. | 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. アンケート 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) |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Adherence Retention rate | 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. | up to 3 months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Decrease in anxiety symptoms | These analyses apply to all continuous endpoints (PROMIS-Anxiety, IES, MAAS, PROMIS- Depression, PROMIS-Fatigue, PROMIS-Sleep Disturbance, LCSI) | up to 6 months |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
Histologically proven lung cancer
- Patients with suspected primary lung cancer per recent chest CT scan (with or without contrast) may be enrolled in the trial. These patients may be randomized and begin study intervention without a biopsy. If a patient undergoes a biopsy after consent and the results are negative or if the patient does not proceed with surgery, the patient will be removed from the study. The patient will continue to receive full access to the AmDTx app for 2-years.
- Scheduled for surgery with at least 14 days lead time (to allow the participant to start the mindfulness practice [intervention group] 14 days preoperatively)
Age ≥18 years of age at time of signing informed consent
Access to a smartphone/tablet with data connection
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 a minimum of 6 weeks to do the mindfulness meditations and practices)
Willing to be randomized to mindfulness MBCR or CI group and complete all assessments
High distress level (Distress Thermometer score ≥4 at initial visit)
Able to understand the study objectives and procedures, comply with the protocol, and sign an informed consent
Able to read, speak, and understand English
- Currently engaging in app-based mindfulness or meditation for one or more times per week
- 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
- Individuals with impaired decision-making capacity
- Patients that need to undergo neoadjuvant therapy (chemotherapy±radiation)
- Patients undergoing active treatment of other non-lung cancers
- Patients with recurrent lung cancer
メモリアル・スローン・ケタリングがんセンター737 件のアクティブな治験を探索連絡先情報がありません。
7 1カ国の場所
New Jersey
Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (All Protocol Activities), Montvale, New Jersey, 07645, United States
New York
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities), Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (All protocol activities), Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (All Protocol Activities), Rockville Centre, New York, 11553, United States