Effectiveness of a Mindfulness Smartphone App to Reduce Emotional Distress in People With Cancer Waiting for Surgery
Effectiveness of a Mindfulness Smartphone App ("Staying Calm in the OR") to Reduce Distress in People With Cancer Waiting for Surgery: A Randomized Controlled Trial
Lung cancer and colorectal cancer accounted for the highest number of cancer deceases in 2016. Incidence is around 3.500 cases per year and patients are more commonly men (56%) aged around 69. This study focuses on people with a recent diagnosis of cancer who have been scheduled for surgery.
Evidence suggests that around 11% of people with cancer suffer from anxiety or adjustment disorders and 6,5% hold a diagnosis of major depressive disorder. Moreover, the perioperative period is the most distressing phase of the illness. However, a high number of patients do not have access to mental health services due to either limited resources and geographical limitations or the fear of being stigmatized. The aim is to explore the effectiveness of a mindfulness-based intervention for smartphones designed to reduce pre-surgical distress. It was conceived as a medical tool of prevention), with the purpose of diminishing emotional suffering and clinical complications after surgery. In 2020 Internet will be the most developed technology and almost everyone will have a smartphone; hence, an app for stress reduction will fit in this growing field.
Mindfulness is defined as the ability to pay attention to the present moment with a curious, non-judgmental attitude. Its training consists of both formal meditation practices and informal daily exercises. Mindfulness-based interventions are growing in our National Health System and rigorous researches are being conducted exhibiting good results regarding its effectiveness. However, the fact that Mindfulness instructors must be highly qualified makes these kinds of interventions exceedingly costly to implement. This team is experienced with mindfulness and has developed the app "En Calma en el Quirófano" ("Staying Calm in the OR") to reduce distress before surgery. It consists of a free, accessible, on-demand, short training through a series of guided meditation practices.
In this randomized controlled trial, participants are assigned either to the experimental ("Staying Calm in the OR") or the control arm (treatment as usual). The investigators expect anxiety and depression to be lower in the experimental arm; in addition, the researchers expect that "Staying Calm in the OR" participants will show higher levels of post-surgery recovery.
調査の概要
詳細な説明
Lung cancer and colorectal cancer accounted for the highest number of cancer deceases in 2016. Incidence is around 3.500 cases per year and patients are more commonly men (56%) aged around 69. This study focuses on people with a recent diagnosis of cancer who have been scheduled for surgery.
Evidence suggests that around 11% of people with cancer suffer from anxiety or adjustment disorders and 6,5% hold a diagnosis of major depressive disorder. Moreover, the perioperative period is the most distressing phase of the illness. However, a high number of patients do not have access to mental health services due to either limited resources and geographical limitations or the fear of being stigmatized. The aim is to explore the effectiveness of a mindfulness-based intervention for smartphones designed to reduce pre-surgical distress. It was conceived as a medical tool of prevention), with the purpose of diminishing emotional suffering and clinical complications after surgery. In 2020 Internet will be the most developed technology and almost everyone will have a smartphone; hence, an app for stress reduction will fit in this growing field.
Mindfulness is defined as the ability to pay attention to the present moment with a curious, non-judgmental attitude. Its training consists of both formal meditation practices and informal daily exercises. Mindfulness-based interventions are growing in our National Health System and rigorous researches are being conducted exhibiting good results regarding its effectiveness. However, the fact that Mindfulness instructors must be highly qualified makes these kinds of interventions exceedingly costly to implement. This team is experienced with mindfulness and has developed the app "En Calma en el Quirófano" ("Staying Calm in the OR") to reduce distress before surgery. It consists of a free, accessible, on-demand, short training through a series of guided meditation practices.
In this randomized controlled trial, participants are assigned either to the experimental ("Staying Calm in the OR") or the control arm (treatment as usual). The investigators expect anxiety and depression to be lower in the experimental arm; in addition, the researchers expect that EnCalma participants will show higher levels of post-surgery recovery.
Main hypothesis. Anxiety and depression symptoms will be significantly lower in the experimental arm after Staying Calm in the OR" training.
Secondary hypotheses. Recovery after surgery will be higher amongst participants in the experimental arm, who will exhibit fewer post-surgical complications, lower rates of hospitalizations, lower levels of analgesia, shorter hospitalizations and a better quality of life.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Madrid、スペイン、28045
- La Paz University Hospital
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Madrid、スペイン、28041
- 12 Octubre University Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 18 - 100 years old
- Diagnosis of cancer
- Being in waitlist for surgery for less than 14 days
- Signed informed consent
Exclusion Criteria:
- Acute severe mental disorder according to DSM-5 diagnostic criteria
- Not having a smartphone
- Not being able to download and use the smartphone app "Calm before Surgery"
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:App "Staying Calm in the OR"
"Staying Calm in the OR" is a mindfulness-based stress-reduction smartphone tailored for people who are waiting for surgery.
It consists of a free, accessible, on-demand, short training through a series of guided meditation practices.
They are based on widely studied mindfulness-based programs, such as Mindfulness-Based Stress Reduction (MBSR) or Mindfulness Self Compassion (MSC).
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"Staying Calm in the OR" is a mindfulness-based stress-reduction smartphone tailored for people who are waiting for surgery.
It consists of a free, accessible, on-demand, short training through a series of guided meditation practices.
They are based on widely studied mindfulness-based programs, such as Mindfulness-Based Stress Reduction (MBSR) ir Mindfulness Self Compassion (MSC).
他の名前:
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介入なし:Treatment as Usual (TAU)
Participants assigned to Treatment As Usual (TAU) arm will not download the app until the study is completed.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Change in anxiety and depression
時間枠:From baseline (15 days before surgery) to hospital discharge (around 7 days after surgery)
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Change in Hospital Anxiety and Depression Scale (HADS).
Anxiety and depressive symptoms are measured with this self-reported instrument.
The scores of the 15 items range from 0 to 4. The final score is the summatory of these items and range from 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
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From baseline (15 days before surgery) to hospital discharge (around 7 days after surgery)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Change in quality of life
時間枠:From baseline (15 days before surgery) to hospital discharge (around 7 days after surgery)
|
Change in World Health Organization Quality of Life Brief Scale (WHOQOL-BREF).
This is a self-reported instrument that how much the person is satisfied with many aspects of his or her live, and general domains of the quality of life construct.
There are 26 items and each one is scored from 0 to 5. Higher scores suggest better quality of life in direct items and poorer quality of life in reverse items.
The final score range from 0 to 130, and the higher the score the better the perceived quality of life.
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From baseline (15 days before surgery) to hospital discharge (around 7 days after surgery)
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Change in pain experience
時間枠:From baseline (15 days before surgery) to hospital discharge (around 7 days after surgery)
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Change in Visual Analog Scale (VAS) for pain.
In this visual scale, the evaluator needs to rate how much pain is he or she experiencing in the present moment.
Scores range from 0 (no pain at all) to 10 (extreme pain).
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From baseline (15 days before surgery) to hospital discharge (around 7 days after surgery)
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Presence of post-surgery complications
時間枠:Clavien-Dindo Scale score at hospital discharge (around 7 days after surgery)
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Clavien-Dindo Scale score. This scale measures complications in surgery. They evaluator has to choose among the following categories: Grade I. Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. This grade also includes wound infections opened at the bedside. Grade II. Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition also included. Grade III. Requiring surgical, endoscopic or radiological intervention
Grade IV. Life-threatening complication (including CNS complications) requiring IC/ICU-management
Grade V Death of a patient |
Clavien-Dindo Scale score at hospital discharge (around 7 days after surgery)
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Change in blood pressure
時間枠:From surgery to hospital discharge (around 7 days after surgery)
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Change in blood pressure, as registered by nursers during the hospitalization period
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From surgery to hospital discharge (around 7 days after surgery)
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Change in oxygen saturation
時間枠:From surgery to hospital discharge (around 7 days after surgery)
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Change in oxygen saturation, as registered by nursers during the hospitalization period
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From surgery to hospital discharge (around 7 days after surgery)
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Change in temperature
時間枠:From surgery to hospital discharge (around 7 days after surgery)
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Change in temperature, as registered by nursers during the hospitalization period
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From surgery to hospital discharge (around 7 days after surgery)
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Change in analgesia
時間枠:From surgery to hospital discharge (around 7 days after surgery)
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Change in analgesia, as registered by nursers during the hospitalization period
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From surgery to hospital discharge (around 7 days after surgery)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Level of satisfaction with "Calm Before Surgery"
時間枠:Hospital discharge (around 7 days after surgery)
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Level of satisfaction with smartphone app "Calm Before Surgery" measured by Client Satisfaction Questionnaire (CSQ-8).
This 8-item instrument explores how much a person is satisfied with different domains of healthcare services.
A final score between 8 and 32 is provided, with higher values indicating higher levels of satisfaction.
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Hospital discharge (around 7 days after surgery)
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協力者と研究者
捜査官
- 主任研究者:Beatriz Rodríguez-Vega, PhD、La Paz University Hospital; Madrid Autonomous University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- EC-CS
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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癌の臨床試験
-
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Staying Calm in the ORの臨床試験
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Brandon HathornBaylor Heart and Vascular Institute Cardiovascular Research Review Committee完了冠動脈疾患 | 心臓弁膜症
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Medisch Spectrum TwenteFoothills Medical Centre募集心血管疾患 | 生活の質 | 手術 | 運動不足 | 胸骨切開オランダ
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Aprea Therapeutics終了しましたマントル細胞リンパ腫 | 慢性リンパ性白血病 | 非ホジキンリンパ腫アメリカ