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临床试验/NCT04783402
NCT04783402Enrolling By Invitation不适用

A Telehealth-based Cognitive-adaptive Training for Women With Breast Cancer in Risk to Suffer Cancer and Chemotherapy-related Cognitive Impairment: a Randomized Controlled Trial.

Universidad de Granada2 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2020年10月31日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
98
试验地点
2
主要终点
Subjective cognitive Function:

研究概览

简要总结

The present randomized controlled trial has the main objective to study the effects of a videoconferenced occupational therapy program in preventing cancer and chemotherapy-related cognitive impairment and other health outcomes, as well as in improving quality of live and occupational performance of women undergoing chemotherapy for breast cancer.

详细描述

The chemotherapy-related cognitive impairment (also called chemobrain) has a great incidence among breast cancer population. However, the knowledge about effective interventions of supportive care is still inconsistent. Furthermore, the majority of programs targeted to this problem has been applied in survivorship, while the onset of cognitive impairment and the decline in quality of life occur during medical treatments. In this line, actual evidence suggests testing the effectiveness of interventions in a preventive setting in patients with breast cancer scheduled to receive neurotoxic chemotherapy. In addition, telehealth approaches have become a promising practice and increasingly more frequent among healthcare disciplines.

Our objective is to study the effects of a videoconferenced cognitive training in combination with cognitive-behavioral strategies to prevent or mitigate the cancer- and chemotherapy-related cognitive impairment in women with breast cancer who undergo this treatment, as well as to improve quality of life and allow an optimal adaptation to the occupational needs derived from medical treatment.

This study will use a two-arm, single blinded randomized clinical trial design. Eligible women will be randomized to one of the following groups: the experimental group that will receive the e-OTCAT program (12 weeks), or the control group that will receive and educational handbook and standard care. The study outcomes will be assessed after intervention and at 6-month follow-up post-randomization.

This study may contribute the need to include disciplines such as occupational therapy in the supportive care of cancer patients during the active phase of the disease, as well as the potential advantages provided by a telehealth approach related to economic, temporal and geographical barriers.

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 (Outcomes Assessor)

盲法说明

Single

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female with breast cancer who are going to start chemotherapy
  • Stage I-III breast cancer
  • No evidence of disease at time of screening
  • Must be able to speak, read and write Spanish well to complete written and verbal assessment, neurocognitive tests and study tasks
  • Must have basic phone skills

排除标准

  • History of neurological disorder with cognitive symptoms (i.e., Parkinson's disease, Alzheimer disease, seizure disorder, multiple sclerosis, etc.)
  • History of psychiatric disorder such as mental retardation, bipolar disorder, schizophrenia, etc.
  • History of traumatic brain injury with ≥ 30' of consciousness or cognitive sequelae as per self-report or as documented in the medical record
  • Prior history of cancer or secondary diagnosis of cancer
  • Prior history of chemotherapy
  • A hearing or visual deficit

结局指标

主要结局

Subjective cognitive Function:

时间窗: Participants will be followed over 6 months

The primary outcome will be assessed with the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) will be used to assess the subjective cognitive functioning.

次要结局

  • Overall Quality of Life(Participants will be followed over 6 months)
  • Objective Cognitive Function: Attention(Participants will be followed over 6 months)
  • Objective Cognitive Function: Working Memory and Processing Speed(Participants will be followed over 6 months)
  • Psychological status(Participants will be followed over 6 months)
  • Cancer-Related Fatigue(Participants will be followed over 6 months.)
  • Objective Cognitive Function: Verbal Memory(Participants will be followed over 6 months)
  • Quality of Sleep(Participants will be followed over 6 months.)
  • Occupational Performance(Participants will be followed over 6 months)

研究者

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

Lydia Mª Martín-Martín

Lecturer, PhD researcher and investigator

Universidad de Granada

研究点 (2)

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