Memory Training Intervention for Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Memory Performance
研究概览
简要总结
This is a randomized controlled trial to evaluate the ACTIVE memory training intervention and ACTIVE speed of processing training to waitlist, no-contact control conditions. Specific aims and hypotheses are:
Aim 1: Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors (BCS).
Hypothesis 1: BCS assigned to the memory intervention arm will perceive the intervention as more acceptable and useful than BCS assigned to the attention control condition.
Aim 2: Establish preliminary efficacy of the ACTIVE memory training intervention relative to the attention control and no-contact control conditions.
Hypothesis 2: Memory training will result in greater memory enhancement immediately post and 2-months post-intervention relative to attention control or no-contact control conditions.
详细描述
Memory deficits are a prevalent, bothersome, and potentially debilitating symptom for millions of breast cancer survivors (BCS). Evidence-based treatment is difficult because there has been little intervention research in this area. Memory training may be a viable treatment option for BCS in need. Therefore, the purpose of this study is to examine the acceptability, usefulness, and preliminary efficacy of the memory training intervention from the Advanced Cognitive Training in Vital Elderly (ACTIVE) trial, the largest controlled trial of cognitive interventions in the behavioral sciences. The memory training intervention will be compared to attention control and no-contact control groups. Specific aims are to (1) evaluate the acceptability and usefulness of the memory intervention in BCS and (2) establish preliminary efficacy of the ACTIVE memory training intervention relative to attention control and no-contact control conditions. Acceptability and usefulness will be assessed through self-report. Memory will be assessed through objective neuropsychological tests. A total of 108 eligible BCS will be randomized to memory training, attention control, or no-contact control. A blinded and trained tester will perform data collection and neuropsychological testing at three time points: baseline prior to the intervention, immediately post-intervention, and 2 months post-intervention. Findings will provide information about the acceptability, usefulness, and preliminary efficacy of the ACTIVE memory training intervention on memory performance in BCS. Positive results will lead to a larger, full-scale study to determine efficacy of memory training interventions for BCS. Nursing interventional research in this area is vital to the development of evidence-based interventions to address memory deficits in BCS.
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
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female gender (breast cancer is rare in men);
- •self-reported memory impairment and desire for treatment (to focus on BCS in greatest need);
- •first diagnosis of non-metastatic breast cancer (to control for multiple treatments or brain metastases in women with recurrent or metastatic disease);
- •≥ 1 year post-treatment including surgery, radiation, and/or chemotherapy (reduce confounding factors related to acute effects of treatment);32
- •age ≥ 40 years (our prior studies indicate approximately 75% of BCS meet this criterion and reduce sample variability);
- •post-menopausal (majority are post-menopausal at diagnosis and reduce sample variability); and
- •able to read, write, understand, and speak English (to ensure informed consent).
排除标准
- •Women will be excluded if they have other co-morbidities or deficits that would sufficiently impair performance or inhibit cognitive training including:
- •substantial cognitive decline (score < 24 on the Mini Mental State Exam (MMSE);33
- •history of stroke, encephalitis, traumatic brain injury, brain surgery, dementia, Alzheimer disease, or Parkinson disease;
- •cranial radiation therapy or intrathecal therapy;
- •current active major depression or substance abuse or history of bipolar disorder, psychosis, schizophrenia, or learning disability;
- •history of or current other cancer except for basal cell skin cancer; or
- •receiving other cognitive training (to avoid exposure to other training).
结局指标
主要结局
Memory Performance
时间窗: 2-month post intervention
Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors.
次要结局
- Symptom distress(2-month follow-up)
- Subjective Cognitive Function(2-month follow-up)
研究者
Diane Von Ah
Associate Professor, Department Chair, School of Nursing
Indiana University