The Effects of Chiropractic Care on Adults With Chronic Cancer-related Fatigue: a Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Eligible Randomized Participants
研究概览
简要总结
The goal of this randomized controlled study is to investigate the impact of chiropractic care on CCRF (Chronic Cancer Related Fatigue) and other health-related challenges that burden cancer survivors.
详细描述
To our knowledge, the impact of chiropractic care on CCRF and other health-related challenges that burden cancer survivors has yet to be investigated. Because this is a pilot trial, the primary outcomes center around feasibility and include 1) randomization, 2) compliance, 3) tolerability, 4) adherence, and 5) retention in each arm. Secondary outcomes include changes in patient-reported outcomes (PROs), electrocardiography (ECG) derived heart rate variability (HRV), impedance cardiography (ICG) derived pre-ejection period (PEP), and number of completed sit-to-stands.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years of age.
- •Self-report that they have been informed by their primary health care provider that they are cancer-free (this is sometimes referred to as 'complete remission' or 'cured').
- •Minimum of 3 months since the completion of their primary curative-intent cancer therapies including surgery, chemotherapy, radiotherapy, and/or immunotherapy (long-term hormone therapy permitted)
- •Scores in the moderate-to-severe range (i.e., at or above the 60th percentile) on the FACIT-Fatigue scale.
- •Fatigue onset was at some point during their illness/treatment & negatively impacts their quality of life & daily functioning.
排除标准
- •Chiropractic care within the past 2 weeks
- •Taking short-acting benzodiazepines which include midazolam/Versed & triazolam/Halcion.
- •Taking GLP-1 medications
- •Taking other types of prescription medications (including hormone therapy) and hasn't been on a stable dose for a minimum of 6 weeks with plans to change medications or doses during the study.
- •Disorders that cause fainting during rapid postural changes (e.g., POTS, orthostatic hypotension).
- •Not able to make a fist or grip objects with one or both hands
- •Deaf in one or both ears (hearing aids are ok)
- •Heart conditions, including pacemakers, which impact heart function
- •Diagnosed with rheumatoid arthritis, osteoporosis, or medically diagnosed cervical spine instability.
- •Current litigation related to a physical, health-related injury.
研究组 & 干预措施
Delayed Group
After the 6-week lab assessments, the participants in the delayed group will be offered 6 weeks of chiropractic care.
干预措施: Delayed Chiropractic Care (Other)
Immediate Group
After the baseline assessment, the participants in the intervention group will receive 12 weeks of chiropractic care.
干预措施: Immediate Chiropractic Care (Other)
结局指标
主要结局
Number of Eligible Randomized Participants
时间窗: 2 years
The proportion of eligible participants randomized into the study
Number of Participants Who Adhere to Study
时间窗: 2 years
Proportion of enrolled participants who adhere to the pre-baseline assessment lifestyle restrictions as instructed. This assesses compliance.
Number of Participants That Can Fulfill Study Activities
时间窗: 2 years
Proportion of participants that can fulfill the given baseline assessment as directed. This assesses tolerability
Number of Participants Who Chiropractic Sessions
时间窗: 2 years
Proportion of randomized adults attending ≥90% of chiro sessions within 7 days of the prescribed time frame. This assesses adherence to treatment.
Number of Enrolled Intervention Group Participants
时间窗: 2 years
Proportion of the immediate-start group attending the final assessment session. This assesses retention.
次要结局
- Changes in COMPASS-31(2 years)
- Changes in Perceived Stress Scale (PSS)(2 years)
- Heart Activity (ECG/HRV)(2 years)
- Impendence (ICG/PEP)(2 years)
- Sit to Stand Assessment(2 years)
- Change in Executive Function, Attention, and Inhibitory Control(2 years)
- Change in Visual Processing Speed(2 years)
- Change in Auditory Processing and Speech Recognition in Noise(2 years)
- Change in Fine Motor Skills and Dexterity(2 years)
- Change in Grip Strength(2 years)
- Changes in PROMIS-Fatigue 13a(2 years)
- Changes in PROMIS-29(2 years)
- Changes in PROMIS-Cog 8(2 years)
研究者
Tyson Perez, DC, PhD
Principal Investigator
Life University