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Идёт набор NCT05053230

A Study Evaluating the Integrative Medicine at Home (IM@HOME) Program in People With Cancer

Без фазы С лечением Head and Neck Cancer Head and Neck Tumor Thoracic Tumor Thoracic Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: IM@Home, Enhanced usual care.
Кому может быть актуально
Состояния в реестре: Head and Neck Cancer, Head and Neck Tumor, Thoracic Tumor, Thoracic Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Integrative Medicine for Patient-reported Outcomes, Values, and Experience (IMPROVE)

Обзор

The overarching long-term goal of the Integrative Medicine for Patient-reported Outcomes Values and Experience (IMPROVE) research program is to evaluate whether integrating a virtual mind-body programming, Integrative Medicine at Home (IM@Home), will improve patient perceived values, outcomes, and experiences as they undergo systemic cancer treatment such as chemotherapy, immunotherapy, radiotherapy, targeted agents, cytoreductive surgery.

Вмешательства

  • Поведенческое IM@Home
    Participants in the IM@Home group will receive a 12-week virtual, synchronous, mind-body and fitness program. The Classes will be conducted via Zoom video conferencing platform. Patients will choose from a variety of weekly classes, occurring one to four times per week. An Integrative Medicine Service (IMS) clinical therapist (e.g., licensed dance therapist, certified yoga instructor, nurse specialist/physical trainer) with specific expertise in the oncology setting will lead each session. Activ
  • Поведенческое Enhanced usual care
    Patients in the enhanced usual care will receive usual care. In addition, once enrolling into the trial, they will be given a handout to encourage them to visit the MSK's multimedia page on the Integrative Medicine website to access pre-recorded, on-demand meditation audio or video recordings for meditation, guided imagery, and relaxation.

Первичные конечные точки

  • Average Fatigue Severity from the Brief Fatigue Inventory (BFI) [Срок оценки: 12 weeks]
Вторичные конечные точки (10)
  • Symptom intensity as measured by Edmonton Symptom Assessment Scale (ESAS) [Срок оценки: 12 weeks]
  • Insomnia severity as measured by Insomnia Severity Index (ISI) [Срок оценки: 12 weeks]
  • Effect of treatments on psychological distress as measured by Hospital Anxiety and Depression Scale (HADS) [Срок оценки: 12 weeks]
  • Pain as measured by Patient Reported Outcomes Measurement Information System (PROMIS®) Scale v1.2 - Global Health [Срок оценки: 12 weeks]
  • Participants treatment outcome expectancy as measured by Mao Expectancy of Treatment Effects (METE) [Срок оценки: 12 weeks]
  • Satisfaction of intervention [Срок оценки: 12 weeks]
  • Recommendation of Intervention to Others [Срок оценки: 12 weeks]
  • Number of Treatment Disruptions [Срок оценки: 12 weeks]
  • Number of Unplanned medical visits [Срок оценки: 12 weeks]
  • Participant Attendance to IM@Home Sessions [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • Age ≥ 18 years or older
  • Karnofsky score 60 or greater
  • Life expectancy greater than six months
  • English speaking

Additional Inclusion Criteria for Head and Neck, Thoracic, Gynecologic, Melanoma and Breast Baskets

  • Patients with a diagnosis of head and neck tumors, thoracic tumors, gynecological tumors, melanoma, breast cancer, or gynecologic cancer
  • Actively receiving systemic oncological treatment or radiotherapy, or within 4 weeks of radiotherapy completion or primary cytoreductive surgery
  • Worst fatigue over the last 7 days rated 4 or greater on (0-10 scale)

Additional Inclusion Criteria for First Remission Gynecologic Cancer Basket

  • Patients with a diagnosis or clinical suspicion of gynecologic malignancy who have completed definitive first line treatment (maintenance hormonal or targeted therapies are allowed)

Additional Inclusion Criteria for the Advanced Cancer Basket:

  • Patients with a diagnosis of Stage III or IV lung cancer; any stage pancreatic cancer, unresectable cholangiocarcinoma, unresectable liver cancer, unresectable ampullary or peri-ampullary cancer, or other stage IV gastrointestinal cancer; stage III or IV ovarian or fallopian tube cancers or other stage IV gynecologic cancer; stage IV breast cancer; stage III testicular cancer or any stage IV genitourinary cancer; stage IV sarcoma; stage IV melanoma; stage IV endocrine cancer; lymphoma, myeloma, or Leukemia
  • Actively receiving oncological treatment, radiotherapy or active surveillance

Additional Inclusion Criteria for the Cancer Survivor Basket:

  • Completed active cancer treatment (e.g., surgery, radiation, chemotherapy) (maintenance hormonal or targeted therapies are allowed).
  • Worst fatigue over the last 7 days rated 4 or greater on (0-10 scale)

Критерии исключения

  • Cognitive impairment that would preclude response to study assessments or require the use of Legally Authorized Representatives
  • Unwilling to accept random assignment
  • Concurrently enroll onto ongoing competing trials of integrative medicine interventions with symptom/toxicity as primary outcome. Note, however, patient will be allowed to enroll on other therapeutic protocols

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 7 центров
  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
  • Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities) — Commack
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center — New York
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale

Публикации

  • Bryl KL, Silverwood S, Desai K, Schobert K, Li X, Chimonas S, Mao JJ, Gillespie EF. Benefits and Challenges of a Digital Exercise and Mind-Body Program During Active Cancer Treatment: Qualitative Study of Patients' Perceptions. JMIR Cancer. 2026 Jan 16;12:e80075. doi: 10.2196/80075. PMID 41543884
  • Mao JJ, Bryl K, Gillespie EF, Green A, Hung TKW, Baser R, Panageas K, Postow MA, Daly B. Randomized clinical trial of a digital integrative medicine intervention among patients undergoing active cancer treatment. NPJ Digit Med. 2025 Jan 14;8(1):29. doi: 10.1038/s41746-024-01387-z. PMID 39809874

Идентификаторы

NCT: NCT05053230 · 21-369

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗