NCT07186556招募中不适用
Cancer-related Fatigue and Its Biological Contributors in Adolescent and Young Adult Brain Tumor Survivors: Effects of a Tele-exercise Intervention
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Cancer Related Fatigue
研究概览
简要总结
The goal of this research study is to learn about the effects of the RISE-YA intervention on cancer-related fatigue in young adults who are brain cancer survivors.
详细描述
Primary Objective:
Test the efficacy of RISE-YA to improve CRF
Secondary Objectives:
- Test the efficacy of RISE-YA to improve PA and physical function in fatigued YA brain tumor survivors.
- Determine A) cross-sectional associations of CRF with oxidative phosphorylation (OxPhos) and with inflammation, and B) the effect of RISE-YA on OxPhos and on inflammation.
Exploratory Objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is currently between the ages of 18-39 years
- •Their primary brain tumor was diagnosed at age 15-39 years
- •Is 6 months to <5 years post curative treatment
- •Has been treated with chemotherapy and radiation, given most patients receive both therapies.
- •Functional Assessment of Chronic Illness therapy (FACIT)-Fatigue ≤
- •FACIT-Fatigue will be used as a screener because this 13-item scale can be completed relatively quickly in clinic
- •Currently engage in <150 minutes of PA and < 2 sessions of muscle strengthening exercise per week (assessed by Godin Leisure-Time PA Questionnaire)
- •Must be able to speak, write, and read English
- •No exercise contraindication as assessed by screening with the Physical Activity Readiness Questionnaire PAR-Q+. In addition, participants' care teams will be notified of their participation in the study.
- •Must be able to provide informed consent/assent.
排除标准
- •Non-English speaking
- •Screen failure for exercise safety
- •Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease
- •Recent fracture or acute musculoskeletal injury that precludes ability to participate in supervised exercise training sessions
- •History of underlying chronic disease, secondary malignances, germline genetic syndrome, or recurrent disease requiring re-irradiation of the brain
- •Cognitive and/or major sensory deficits that would impede the completion of research activities and assessments as deemed by the clinical team.
- •Self-report of pregnancy
- •Documented developmental disorders (e.g., Autism) or major psychotic illness (e.g., schizophrenia)
研究组 & 干预措施
Participant Group/Arm
Experimental
Participants will randomized at baseline stratifying by gender and CRF level
干预措施: Survivorship Education (Behavioral)
Intervention Group
Experimental
Participants will randomized at baseline stratifying by gender and CRF level
干预措施: RISE-YA Intervention (Behavioral)
结局指标
主要结局
Cancer Related Fatigue
时间窗: Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks)
To compare changes in cancer related fatigue at T2 and T3 relative to T1 between participants in the RISE-YA intervention and participants in the attention control. Measure: Multi-dimensional Fatigue Inventory. Scores range from 20 to 100, with higher values indicating greater fatigue severity
次要结局
- Physical Activity (PS)(Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks))
- Physical Function: Timed up and Go(Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks))
- Physical Function: Single Leg Stand(Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks))
- Physical Function: 1-minute chair stand(Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks))
- Physical Function: 6-minute walk test(Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks))
- Soluble tumor necrosis factor receptor-2 (sTNFR2)(Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks))
- Physical Function: handgrip strength(Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks))
- Systemic immune inflammation index(Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks))
- High-sensitivity C-reactive protein (hs-CRP)(Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks))
- Interleukin-6 (IL-6)(Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks))
- Tumor necrosis factor (TNF)(Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks))
- Interleukin-1 receptor alpha (IL-1ra)(Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks))
- Interleukin-10 (IL-10)(Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks))
- Oxidative phosphorylation (OxPhos)(Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks))
研究者
研究点 (1)
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