Remote Mindfulness Breathing Training for Patients Undergoing Chemotherapy
Effects of Remote Mindfulness Breathing Training on Symptom Distress, Fatigue and Psychological Well-Being in Patients Undergoing Chemotherapy
This randomized controlled trial will evaluate the effects of a mobile-delivered remote mindfulness breathing training program on symptom distress, fatigue, anxiety, and depression in adults with cancer who are receiving chemotherapy.
A total of 80 participants will be randomly assigned in a 1:1 ratio to either an intervention group or a control group. The intervention group will complete 5 to 10 minutes of guided mindfulness breathing practice each day for 3 weeks using a mobile-accessible video. The control group will receive usual care and one approximately 5-minute mindfulness breathing instruction session. Outcomes will be assessed at baseline and at the end of the 3-week intervention.
Przegląd badań
Status
Warunki
Szczegółowy opis
This study is a prospective, two-arm, assessor-blinded randomized controlled trial involving adults with any type of cancer who are receiving chemotherapy in inpatient units or at the Tri-Service General Hospital breast surgery outpatient clinic.
After providing written informed consent and completing the baseline assessment, eligible participants will be randomly allocated by computer in a 1:1 ratio to the intervention group or the control group. The intervention group will receive a mobile-delivered remote mindfulness breathing training program and will be instructed to practice with a guided video for approximately 5 to 10 minutes daily for 3 weeks. The control group will receive usual care and one approximately 5-minute mindfulness breathing stress-reduction instruction session.
Study assessments will be conducted before the intervention and at the end of week 3. Symptom distress will be assessed using the National Comprehensive Cancer Network Distress Thermometer, fatigue using the Brief Fatigue Inventory, anxiety using the Generalized Anxiety Disorder-7, and depression using the Patient Health Questionnaire-9. To reduce measurement bias, the post-intervention assessment will be conducted by a research assistant who is unaware of the participants' group assignments.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Lei-Yu Chen
- Numer telefonu: 671419 +886-2-2764-2151
- E-mail: leiyu841125@gmail.com
Lokalizacje studiów
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Taipei City
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Taipei, Taipei City, Tajwan, 105
- Tri-Service General Hospital Songshan Branch
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Kontakt:
- Lei-Yu Chen
- Numer telefonu: 671419 +886-2-2764-2151
- E-mail: leiyu841125@gmail.com
-
Taipei, Taipei City, Tajwan, 114
- Tri-Service General Hospital
-
Kontakt:
- Lei-Yu Chen
- Numer telefonu: 671419 +886-2-2764-2151
- E-mail: leiyu841125@gmail.com
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
Adults aged 20 years or older with full legal capacity. Diagnosed with any type of cancer and currently receiving chemotherapy as an inpatient or at the Tri-Service General Hospital breast surgery outpatient clinic.
Able to understand Chinese or Taiwanese and able to read and operate a smartphone or tablet.
Willing to participate in the study and accept random assignment. Have access to a personal mobile device capable of accessing the study materials.
Exclusion Criteria:
Severe psychiatric disorders, such as schizophrenia or bipolar disorder, or neurodegenerative diseases, such as moderate or severe dementia.
Clinical deterioration or poor prognosis requiring a change in treatment or transition to palliative or hospice care.
Concurrent participation in another psychological intervention study that may affect emotional outcomes.
Deemed unsuitable for breathing training or receiving prolonged sedation.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Mobile Remote Mindfulness Breathing Training
Participants will complete 5 to 10 minutes of guided mobile-delivered remote mindfulness breathing practice daily for 3 weeks, in addition to usual care.
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Participants will use a mobile-accessible guided video to practice mindfulness awareness combined with slow diaphragmatic breathing for approximately 5 to 10 minutes daily for 3 weeks during chemotherapy, in addition to usual care.
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Aktywny komparator: Brief Mindfulness Breathing Instruction
Participants will receive usual care and one approximately 5-minute mindfulness breathing stress-reduction instruction session.
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Participants will receive one approximately 5-minute mindfulness breathing stress-reduction instruction session in addition to usual care.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Distress Level Assessed by the NCCN Distress Thermometer
Ramy czasowe: Baseline and Week 3
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The NCCN Distress Thermometer is a single-item self-report scale ranging from 0 (no distress) to 10 (extreme distress).
Higher scores indicate greater distress.
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Baseline and Week 3
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Change in Fatigue Assessed by the Brief Fatigue Inventory
Ramy czasowe: Baseline and Week 3
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The Brief Fatigue Inventory contains 9 items rated from 0 to 10.
The global fatigue score is calculated as the mean of the completed items, with higher scores indicating greater fatigue severity and interference.
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Baseline and Week 3
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Change in Anxiety Assessed by the Generalized Anxiety Disorder-7
Ramy czasowe: Baseline and Week 3
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The Generalized Anxiety Disorder-7 contains 7 items rated from 0 to 3, producing a total score ranging from 0 to 21.
Higher scores indicate greater anxiety severity.
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Baseline and Week 3
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Change in Depression Assessed by the Patient Health Questionnaire-9
Ramy czasowe: Baseline and Week 3
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The Patient Health Questionnaire-9 contains 9 items rated from 0 to 3, producing a total score ranging from 0 to 27.
Higher scores indicate greater depressive symptom severity.
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Baseline and Week 3
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Współpracownicy i badacze
Śledczy
- Główny śledczy: Lei-Yu Chen, Tri-Service General Hospital (TSGH)
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- MB-2026-01
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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