Addressing Fatigue, Anxiety, and Cognitive Impairment Through Rhythmic Effects: A Pilot Feasibility Study Using a Group Drumming Intervention With Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- The mean rate-of-change patterns (trend) of group drumming on fatigue over time as compared to an attention control group will be measured using FACIT-F
研究概览
简要总结
Evaluate the feasibility of a six-week group drumming intervention on fatigue, anxiety, and cognitive impairment when compared to an attentional control for cancer patients who have undergone at least one treatment session of chemotherapy or radiation therapy.
详细描述
The AIMS related to specific outcomes are:
AIM 1. Evaluate the feasibility of a group drumming intervention.
RQ 1.1 What are the rates of recruitment?
RQ 1.2 What are the potential barriers to recruitment?
RQ 1.3 Was the group drumming intervention protocol delivered as designed?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18 and over who have received at least one session of chemotherapy or radiation treatment and self-report symptoms of fatigue or anxiety at a level 4 or above on a scale of 0-
- •Active treatment through one-year post completion of active treatment.
- •At least one week after surgery.
- •Ability to read and write in English.
排除标准
- •Total deafness or severely impaired hearing.
- •Absence of arms and/or hands.
- •Current engagement in group drumming.
- •Scheduled for surgery in the next 12 weeks.
- •Currently taking medications for diagnosis of dementia or Alzheimer's disease.
- •Substantial, uncorrected vision loss.
结局指标
主要结局
The mean rate-of-change patterns (trend) of group drumming on fatigue over time as compared to an attention control group will be measured using FACIT-F
时间窗: Baseline, 3 weeks, 6 weeks, and 8 weeks after group has ended between intervention and attention control groups.
The mean rate-of-change for the group post-baseline (trend) will be analyzed. Fatigue will also be analyzed by looking at trend of individual FACIT-F scores that can range between 0 and 52. The FACIT-F is a 13-item symptom subscale measuring fatigue with chronic illness that has been validated among various cancer diagnosis and has been used in interventional, repeat measure studies with a test-retest reliability of r=0.90 and internal consistency of a=0.95 (Minton \& Stone, 2008).
Anxiety severity levels of change over time will be compared to an attentional control group using the STAI-Y form.
时间窗: Baseline, 3 weeks, 6 weeks, and 8 weeks after group has ended between intervention and attention control groups.
Anxiety will be analyzed by looking at gain of individual State section of State Trait Anxiety Inventory-State Scale (STAI) scores at 3 weeks, 6 weeks, and 8 weeks after group has ended between intervention and attention control groups. The STAI-form Y-1 will be used to measure state anxiety. It has been used with cancer patients to measure state anxiety with a Cronbach's alpha score of .94 for state anxiety. STAI-form Y-1-inventory consists of 20 anxiety questions like "I feel calm" with participants rating their answers on a four-point Likert scale (1=not at all, 4=very much so). STAI-Y has a minimum score of 20 to a maximum score of 80. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
Fatigue will be analyzed by looking at the degree of overall treatment impact (gain) changes over time in group and individual Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) scores.
时间窗: Baseline, 3 weeks, 6 weeks, and 8 weeks after group has ended between intervention and attention control groups.
FACIT-F scores can range between 0 and 52 (0 is the worst possible score). The FACIT-F is a 13-item symptom subscale measuring fatigue with chronic illness that has been validated among various cancer diagnosis and has been used in interventional, repeat measure studies with a test-retest reliability of r=0.90 and internal consistency of a=0.95 (Minton \& Stone, 2008).
Anxiety change patterns over time will be compared to an attentional control group using the STAI-Y form.
时间窗: Baseline, 3 weeks, 6 weeks, and 8 weeks after group has ended between intervention and attention control groups.
Anxiety will be analyzed by looking at the trend of individual using State section of State Trait Anxiety Inventory-State Scale (STAI) scores at 3 weeks, 6 weeks, and 8 weeks after group has ended between intervention and attention control groups. The STAI-form Y-1 will be used to measure state anxiety. It has been used with cancer patients to measure state anxiety with a Cronbach's alpha score of .94 for state anxiety. STAI-form Y-1-inventory consists of 20 anxiety questions like "I feel calm" with participants rating their answers on a four-point Likert scale (1=not at all, 4=very much so). STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
次要结局
- Cognitive function of cancer patients who participate in a 6-week group drumming intervention will show improvement in cognitive function, as measured by the Functional Assessment of Cancer Therapy-Cognition (FACT-COG).(Baseline, 3 weeks, 6 weeks, and 8 weeks after group has ended between intervention and attention control groups.)
研究者
Shelley White
Principal Investigator
University of Utah