Different Types of Massage Therapy to Reduce Anxiety During Chemotherapy Infusion in Patients With Cancer

Официальное название

Assessing the Feasibility of Different Types of Massage to Reduce Anxiety During Chemotherapy Infusion

Обзор

This clinical trial tests how well different types of massage therapy works to reduce anxiety during chemotherapy infusions in patients with cancer. Many cancer patients experience moderate to severe anxiety and anxiety can worsen by the anticipation of medical procedures that patients have to receive, particularly chemotherapy. Massage therapy, as a complementary treatment, has shown promise in lessening both physical and psychological symptoms associated with cancer and its treatments. Research has also shown the benefits of massage therapy in reducing pain, stress, anxiety, nausea (upset stomach), fatigue (tiredness), and depression in cancer patients. Different types of massage therapy may potentially reduce some cancer patients' symptoms, enhance their treatment, and reduce treatment related side effects.

Подробное описание

PRIMARY OBJECTIVES:

I. To assess the feasibility of 30-minute massages targeting various body regions among patients with cancer receiving anticancer therapy infusion.

II. Assess which type of massage is preferred by patients with cancer receiving anticancer therapy infusion.

SECONDARY OBJECTIVE:

I. To assess the change in anxiety levels after each type of massage therapy during infusion.

EXPLORATORY OBJECTIVE:

I. To evaluate changes in other symptoms, such as: pain, fatigue, nausea, depression, and overall well-being, using data obtained from the Edmonton Symptoms Assessment scale (ESAS) after each type of massage therapy.

OUTLINE:

Patients receive massage therapy according to a randomized schedule to the feet/legs (FL), head/neck/shoulder (HNS), hands/arms (HA), combination of all three groups (FL, HNS, HA) or no massage therapy over 30 minutes for 5 chemotherapy sessions total on study. Patients also undergo saliva sample collection on study.

Вмешательства

• Другое Best Practice
  Receive no massage therapy
• Процедура Biospecimen Collection
  Undergo saliva sample collection
• Процедура Massage Therapy
  Receive FL therapy
• Процедура Massage Therapy
  Receive HNS therapy
• Процедура Massage Therapy
  Receive HA therapy
• Процедура Massage Therapy
  Receive combination FL, HNS, and HA therapy
• Другое Questionnaire Administration
  Ancillary studies

Первичные конечные точки

• Participation rate [Срок оценки: Up to 1 year]
• Completion rate [Срок оценки: Up to 1 year]

Вторичные конечные точки (3)

• Change in anxiety levels (State-Trait Anxiety Inventory) [Срок оценки: Up to 1 year]
• Change in anxiety levels (Edmonton Symptom Assessment System) [Срок оценки: Up to 1 year]
• Change in anxiety levels salivary amylase) [Срок оценки: Up to 1 year]

Критерии участия

Критерии включения

• Participant must be 18 years of age or older at time of consent
• The study is open to all participants regardless of gender, race, or ethnicity
• Participants should have had at least 1 cycle of the chemotherapy regimen at the time of recruitment
• Participant must have a baseline anxiety score > 3 on the Visual Analog scale (VAS)
• Scheduled for at least six more infusion sessions
• Participant has had complete blood count (CBC) lab work completed in the past 24 hours

Критерии исключения

• Platelet count less than 20,000. Patients taking anticoagulants are not excluded, as the protocol for massage in infusion ensures that deep pressure massage is never performed, and patient's massage will not exceed a 3 on the Walton scale
• Absolute neutrophil count (ANC) less than 500
• Patient has received radiation therapy to any of the targeted areas within the past 90 days
• Any patient that is currently using a cold therapy device that would interfere with their ability to have a massage without removing the device (cold gloves, cold socks)
• Had surgery on their foot, leg, head, neck, shoulder, hands, or arms within the past three months
• Participant has rashes, open wounds, or any skin conditions that could be exacerbated by massage
• Known allergies to creams, lotions, or any other substances that may be used during the massage therapy sessions
• Ongoing uncontrolled active psychiatric condition that would interfere in the conduct of the study (e.g., mood disorders, anxiety, psychosis disorders, or substance use), as determined by the patient's primary cancer team
• Participants with a known allergy to Bioton dual-purpose massage cream or any of its ingredients will be excluded from the study
• In order to minimize undue influence and coercion, the study team will not personally solicit an employee for participation: An employee who is under the direct/indirect supervision of the principal investigator (PI)/a co-investigator/the study manager and a direct study team member
• Pregnancy
• Any participants with bone metastasis

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• City of Hope at Irvine Lennar — Irvine

Идентификаторы

NCT: NCT07184294 · 24302 · NCI-2025-06187 · 24302 · P30CA033572

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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