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Набор скоро начнётся NCT06813001

ACT-Based Nursing Intervention for Ovarian Cancer Patients: A Pilot Study

Без фазы С лечением Ovarian Neoplasm ; Psychological Distress

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: ACT-based nursing intervention.
Кому может быть актуально
Состояния в реестре: Ovarian Neoplasm ; Psychological Distress. Базовые параметры: 19 лет — 75 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
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

Development of ACT (Acceptance and Commitment Therapy)-Based Nurse-led Intervention for Ovarian Cancer Patients

Обзор

The purpose of this study is to evaluate the feasiblity and effectiveness of an Acceptance and Commitment Therapy (ACT)-based nursing intervention aimed at managing psychological flexibility, distress, anxiety, depression, fear of cancer recurrence/progression, quality of life, and symptoms. Patients will participate in a single online session with a nurse, followed by a daily self-monitoring survey online for one week. Data will be collected at baseline (prior to the ACT session), on day 8 (after one week of self-monitoring), and at 5 weeks. Primary outcome is psychological flexibility.

Подробное описание

This study is a preliminary single-group pre-post design aimed at developing and evaluating the feasibility of an ACT-based nursing intervention for distress management in patients with ovarian cancer. A total of 25 ovarian cancer patients who consent to participate will be enrolled in the study. Paticipants will receive a one-time ACT-based nursing intervention lasting approximately 60 minutes.

The researcher will coordinate schedules with participants to deliver the ACT-based nursing intervention using Zoom, a video conferencing platform which minimizes time and location constraints. Before the intervention, the research will ensure that the participants' video conferencing is working properly to minimize potential difficulties during the session.

Following the single-session intervention, the researcher will send a daily Google Form link to participants for seven consecutive days. Participants will be encouraged to access the link and complete self-monitoring surveys to reinforce the key components addressed in the program.

Вмешательства

  • Другое ACT-based nursing intervention
    ACT-based nursing intervention is a 1:1 single online session with a nurse, which takes about 60 minutes followed by a daily self-monitoring survey for one week, which encourages patients to practice ACT.

Первичные конечные точки

  • Change from baseline psychological distress on the last day of self-monitoring (Day 8) [Срок оценки: Psychological distress will be assessed at baseline and on the last day of self-monitoring (Day 8).]
Вторичные конечные точки (6)
  • Change from baseline depression [Срок оценки: within 3 weeks after the last day of self-monitoring (window: 7 days)]
  • Change from anxiety [Срок оценки: within 3 weeks after the last day of self-monitoring (window: 7 days)]
  • Change from fear of cancer recurrence [Срок оценки: within 3 weeks after the last day of self-monitoring (window: 7 days)]
  • Change from psychological flexibility [Срок оценки: within 3 weeks after the last day of self-monitoring (window: 7 days)]
  • Change from quality of life [Срок оценки: within 3 weeks after the last day of self-monitoring (window: 7 days)]
  • Change from symptoms [Срок оценки: within 3 weeks after the last day of self-monitoring (window: 7 days)]

Критерии участия

Критерии включения

  • adult (19 ≤ age ≤ 75).
  • ovarian cancer patients with FIGO stage 2-3.
  • Those who have completed first-line chemotherapy for ovarian cancer (excluding maintenance therapy) within the past 2 years.

Критерии исключения

  • Patients with cognitive problems such as dementia or psychiatric problems such as major depression or generalized anxiety, or who are actively receiving treatment for any of these conditions.
  • Patients with history of cancer recurrence.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06813001 · 4-2024-1286

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗