An Exercise and COgnitive Rehabilitation Intervention for Older Cancer Survivors (The E-Co Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility of the intervention
研究概览
简要总结
The objective of the study is to evaluate the feasibility of a combined mobile health exercise and cognitive rehabilitation intervention and its effect on cognition in a single-arm pilot study that recruits cancer survivors.
详细描述
Cancer survivors (i.e., those who completed cancer-directed treatment) often experience long-term treatment-related effects, such as cancer-related cognitive decline (CRCD). Exercise and cognitive rehabilitation (rehab) interventions have been shown to improve CRCD symptoms in both cancer and non-cancer populations. Among older adults without cancer, studies have also demonstrated that multicomponent interventions combining exercise and cognitive rehab are more effective in improving cognitive dysfunction than either intervention alone. However, exercise adherence and self-efficacy are lower in older adults compared to younger adults, and combined interventions may be too demanding for older cancer survivors. Therefore, innovative ways are needed to integrate an exercise program within the context of a cognitive rehab program to increase exercise adherence and self-efficacy, and ultimately improve CRCD symptoms through a streamlined multicomponent intervention.
In this study, the investigators propose to refine a multicomponent Exercise and COgnitive rehab intervention (E-Co) and assess its feasibility in older cancer survivors.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥60 years at the time of consent
- •Have a diagnosis of any cancer
- •Have completed curative intent treatments
- •Patients on endocrine therapies are allowed to enroll
- •Patients with hematologic malignancies after autologous or allogeneic stem cell transplant are allowed to enroll as long as they have completed curative-intent treatment
- •Have concerns about memory or other thinking abilities following cancer treatment*
- •English speaking (because the interventions are available in English language only)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
- •No medical contraindications for exercise per oncologist#
- •Able to walk 4 meters#
- •Able to provide informed consent#
- •(*) Confirmed by asking the patient (#) Confirmed through eligibility confirmation with the patient's oncologist or their designee
排除标准
- •Physical, psychological, or social impairments that would interfere with patient's ability to participate in the study or participate in the intervention, as determined by the PIs and oncology team.
研究组 & 干预措施
E-Co
The E-Co intervention will integrate active components of a mobile health exercise intervention (GO-EXCAP) into a cognitive rehabilitation intervention (MAAT-G).
干预措施: E-Co (Behavioral)
结局指标
主要结局
Feasibility of the intervention
时间窗: Post-intervention at week 12
Feasibility is defined based on adherence to the intervention components: 1) At least 70% of patients provide exercise data on 50% on the intervention days; and 2) At least 70% of patients attend at least 8/10 of the MAAT-G workshops.
次要结局
- Controlled Oral Word Association (COWA)(Baseline and post-intervention at week 12)
- Self-reported cognition(Baseline and post-intervention at week 12)
- Cambridge Neuropsychological Test Automated Battery (CANTAB)(Baseline and post-intervention at week 12)
- Hopkins Verbal Learning Test-Revised (HVLT-R)(Baseline and post-intervention at week 12)
研究者
Kah Poh Loh
Associate Professor - Department of Medicine, Hematology/Oncology (SMD)
University of Rochester