Идёт набор NCT07502157

Massage, Oncology, Pain, Anxiety, Feasibility

Без фазы С лечением Gynecologic 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: Massage Therapy, Attention Control.
Кому может быть актуально: Состояния в реестре: Gynecologic Cancer. Базовые параметры: 18 лет — 85 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: 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

The Impact of Massage Therapy on Pain and Anxiety of Patients With Gynecologic Cancer While Receiving Infusion Treatment (IMPACT)

Обзор

The goal of this clinical trial is to determine the feasibility of studying massage therapy in patients with gynecologic cancers while receiving infusion treatments. The central hypothesis is that it is feasible to implement a massage intervention study in an infusion center at an academic hospital, and measure pain and anxiety in patients with gynecological cancer. The main questions it aims to answer are: Can investigators evaluate feasibility to conduct a study from a design standpoint? Can investigators assess the use of randomization, blinding of assessors, potential to control the study with an attention group, and recruitment/retention processes? Can investigators successfully collect outcome measures of pain and anxiety, pre/post intervention? Researchers will investigate degree of resources needed, such as massage therapists, assessors, and timing of delivery intervention. Assess positive/negative effects on target population determining massage modality and anatomical location. Researchers will compare massage therapy to an attention control group, to see if massage therapy works to treat pain and anxiety in patients with cancer. Establish variability in outcome measures. Participants will: Be randomized and receive either massage therapy or attention control over the course of three consecutive infusion therapy treatments. Each infusion therapy treatment occurs every 2-4 weeks.

Вмешательства

Процедура Massage Therapy
Gynecologic patient receiving an infusion will receive massage therapy for 15-20 minutes. The patient will have a choice of a hand, foot, or posterior neck and shoulder Swedish massage.
Процедура Attention Control
Massage therapist sits with gynecologic patient receiving an infusion asking questions for no more than 15 minutes.

Первичные конечные точки

Recruitment feasibility [Срок оценки: 6 months]
Retention [Срок оценки: 6 months]
Randomization [Срок оценки: 6 months]
Percentage of accessors successful blinded [Срок оценки: 6 months]
Number of participants that completed 3 or more sessions [Срок оценки: 6 months]

Вторичные конечные точки (3)

Change in Defense and Veterans Pain Rating Scale (DVPRS) [Срок оценки: Pre and post infusion therapy treatment (Up to 9 weeks)]
Change in State-Trait Anxiety Inventory (STAI) [Срок оценки: Pre and post infusion therapy treatment (Up to 9 weeks)]
Temporal Summation, Pain Threshold using von Frey Monofilaments [Срок оценки: Pre and Post infusion therapy treatment (Up to 9 weeks)]

Критерии участия

Критерии включения

Patients with gynecologic cancer receiving active treatment of infusion, including but not limited to chemotherapy, immunotherapy, antibiotics, and blood.
Patients with gynecological cancer undergoing an infusion for the first time.