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临床试验/NCT06662435
NCT06662435已完成不适用

A Pilot and Mixed-Methods Study of GYNecologic Cancer-Related COGnitive Impairment

Northwestern University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Assessment Compliance

研究概览

简要总结

The goal of this study is to test a home-based and patient-tailored cognitive training intervention among gynecologic cancer patients who have completed chemotherapy and who have experienced cancer-related cognitive impairment.

详细描述

Gynecologic cancers are prevalent and long-term survivorship is increasing. In the United States, survivors of gynecologic cancer number over one million individuals and constitute more than 10% of all cancer survivors. Curative treatment usually involves systemic chemotherapy.

A distressing long-term side effect of cytotoxic chemotherapy is cancer-related cognitive impairment (CRCI), or "chemo brain," which has been reported to be present in up to 75% of patients and can linger for months or even decades after chemotherapy treatment. Despite increasing prevalence, patients report that CRCI has not been a focus of assessment or treatment, and the lack of understanding from providers has led to patient disempowerment. Within gynecologic oncology, CRCI is under-reported and understudied with no established effective treatment.

There is no currently established standard of care for managing CRCI in cancer survivors. However, existing literature highlights cognitive training as a promising nonpharmacological intervention. Cognitive training programs consist of structured cognitive exercises designed to target specific cognitive domains. It is postulated to engage neuroplasticity mechanisms, promote the formation of new neural connections, enhance cognitive reserve, and subsequently improve cognitive function and mitigate impairment. Clinically, cognitive training interventions have been shown to not only ameliorate subjective concerns but also improve objective cognitive function, such as memory and attention. It has also been associated with improved daily functioning and physical function.

The BrainHQ (Posit Science®) is an adaptive cognitive training program that addresses CRCI through scientifically validated exercises and an adaptive algorithm targeting memory, attention, and processing speed. The program's efficacy has been documented in diverse settings, including breast cancer survivors. Despite its use in other populations, cognitive training's potential in gynecologic oncology patients is unexplored.

This study will enroll patients with advanced gynecologic cancers who have completed adjuvant chemotherapy and are currently in surveillance with at least stable disease. Patients will be included if they screen positive for subjective report of cognitive impairment. This project will provide important, currently unknown information on the feasibility and acceptability of a cognitive training intervention in patients with advanced gynecologic cancers who report cognitive impairment following primary systemic therapy.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female; ≥18 years of age
  • Presents to clinic with a confirmed diagnosis of a gynecologic cancer (e.g., ovarian, endometrial, cervical, or vulvar cancer) who have completed adjuvant chemotherapy with at least stable disease at time of screening.
  • Screen positive for subjective cognitive impairment by answering affirmatively to at least one of three screener questions
  • Fluent in spoken and written English
  • Have access to the internet to complete assessments

排除标准

  • Patients who have not received chemotherapy
  • Patients with pre-existing neuropsychiatric disorders that would impact cognitive function, such as dementia, Alzheimer's disease, and schizophrenia.
  • Patients with non-gynecologic causes of incurable metastatic cancers.
  • Patients undergoing active interventions in other cognitive trials or patients currently using cognitive training programs such as Brain HQ, Luminosity, Elevate, Peak, Fit Brains, or CogniFit.
  • Patients with self-report of learning disability or an unwillingness to participate in technology-based cognitive training programs.
  • Pregnant women or prisoners
  • Patients with impaired-decision making capacity

结局指标

主要结局

Assessment Compliance

时间窗: 20 weeks

Assessment compliance will be defined as completing the cognitive assessments at baseline and at 10 weeks. The study will be considered feasible in terms of assessment compliance if at least 65% of all patients are compliant.

Adherence

时间窗: 10 weeks

Adherence will be defined as completing ≥80% of intended BrainHQ exercises over 10 weeks. The intervention would be considered not feasible if ≤ 28/40 of patients are considered adherent.

次要结局

  • Acceptability(10 weeks)
  • Change in Patient Reported Cognitive Function(20 weeks)
  • Change in Objective Cognitive Function(20 weeks)
  • Change in Physical Function(20 weeks)
  • Change in Fatigue(20 weeks)
  • Change in Illness Impact on Social Roles and Daily Tasks(20 weeks)
  • Change in Sleep Disturbance(20 weeks)
  • Change in Depression(20 weeks)
  • Change in Anxiety(20 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emma Barber

Principal Investigator

Northwestern University

研究点 (1)

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