Assessing the Feasibility of Different Types of Massage to Reduce Anxiety During Chemotherapy Infusion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Participation rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Platelet count less than 20,
- •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
研究组 & 干预措施
Supportive Care (FL, HNS, HA, combination, no massage)
Patients receive massage therapy according to a randomized schedule to the FL, HNS, hands/arms (HA), combination of all three groups (FL, HNS, HA) or no massage therapy over 30 minutes over 5 chemotherapy sessions total on study. Patients also undergo saliva sample collection on study.
干预措施: Best Practice (Other)
Supportive Care (FL, HNS, HA, combination, no massage)
Patients receive massage therapy according to a randomized schedule to the FL, HNS, hands/arms (HA), combination of all three groups (FL, HNS, HA) or no massage therapy over 30 minutes over 5 chemotherapy sessions total on study. Patients also undergo saliva sample collection on study.
干预措施: Biospecimen Collection (Procedure)
Supportive Care (FL, HNS, HA, combination, no massage)
Patients receive massage therapy according to a randomized schedule to the FL, HNS, hands/arms (HA), combination of all three groups (FL, HNS, HA) or no massage therapy over 30 minutes over 5 chemotherapy sessions total on study. Patients also undergo saliva sample collection on study.
干预措施: Massage Therapy (Procedure)
Supportive Care (FL, HNS, HA, combination, no massage)
Patients receive massage therapy according to a randomized schedule to the FL, HNS, hands/arms (HA), combination of all three groups (FL, HNS, HA) or no massage therapy over 30 minutes over 5 chemotherapy sessions total on study. Patients also undergo saliva sample collection on study.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Participation rate
时间窗: Up to 1 year
Will consider the study feasible if \>=70% of patients are able to complete the massage intervention at each session. Descriptive summary will be provided (including 95% confidence intervals \[CI\]).
Completion rate
时间窗: Up to 1 year
Descriptive summary will be provided (including 95% CI).
次要结局
- Change in anxiety levels (State-Trait Anxiety Inventory)(Up to 1 year)
- Change in anxiety levels (Edmonton Symptom Assessment System)(Up to 1 year)
- Change in anxiety levels salivary amylase)(Up to 1 year)