Downsides of Being Well-Informed: Tracking and Preventing Chemotherapy-Related Cognitive Problems in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 主要终点
- Between-group differences in mean change in the perceived frequency of cognitive symptoms from baseline to T1, and from baseline to T2.
研究概览
简要总结
Previous cross-sectional studies have shown that informing cancer patients about potential chemotherapy-related cognitive symptoms may negatively affect perceived cognitive symptoms and verbal memory performance. A multicenter, randomized study in newly diagnosed breast cancer patients receiving (neo) adjuvant chemotherapy was performed to evaluate this Adverse Information Effect (AIE) over time and investigated whether inviting patients to self-affirm can reduce such AIEs on perceived cognitive symptoms and cognitive test performance.
详细描述
Rationale:
Although information about their treatment and its side-effects is requested by cancer patients, is vital for informed decision making and can positively impact patients' health outcomes and illness perceptions, this kind of information can also adversely impact perceived cognitive symptoms and cognitive test performance. Previous studies have shown that informing cancer patients about potential chemotherapy-related cognitive symptoms may negatively affect perceived cognitive symptoms and verbal memory performance. A multicenter, randomized study in newly diagnosed breast cancer patients receiving (neo) adjuvant chemotherapy was performed to evaluate this Adverse Information Effect (AIE) over time and investigated whether inviting patients to self-affirm can reduce such AIEs on perceived cognitive symptoms and cognitive test performance.
Main objectives and hypotheses:
The overall aim of the study was to investigate the occurrence and duration of AIEs on the perceived frequency of cognitive symptoms, the perceived severity of cognitive symptoms and cognitive performance in breast cancer patients, and to examine ways to reduce such AIEs. First, evaluated the effect of providing breast cancer patients with additional factual written information about potential chemotherapy-related cognitive symptoms before chemotherapy-initiation on perceived cognitive symptoms and cognitive performance was evaluated, and the duration of such effects was assessed. Building on previous findings that breast cancer patients showed an increase in perceived cognitive symptoms and a decrease in verbal memory performance after receiving cognitive side-effect information, it was hypothesized that communicating about potential chemotherapy-related cognitive symptoms will result in AIEs, and it was explored to what extent these AIEs persist over time. Second, this study aimed to translate the beneficial effects of self-affirmation to the oncology domain, and examined the efficacy of a text-integrated self-affirmation intervention in reducing the impact of AIEs on perceived cognitive symptoms and cognitive performance in breast cancer patients when communicating about chemotherapy-related cognitive symptoms. It was hypothesized that a textual self-affirmation intervention would reduce AIEs in breast cancer patients, building on evidence from health promotion and stereotype threat research outside the oncology domain that individuals' self-concepts can be affirmed via text-integrated health messages and that allowing individuals the opportunity for self-affirmation can reduce stereotype threat effects.
The main research questions were:
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
- Single (Care Provider)
盲法说明
Health care professionals were blinded to group assignment, but due to the nature of the study, patients were not. However, patients were not informed about the main outcomes and specific hypotheses of the study, or about the study's experimental conditions and the content of the texts that they did not receive until after T2.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary breast cancer diagnosis stage I-III
- •Scheduled to receive (neo) adjuvant chemotherapy
- •18 years or older
- •Sufficient command of the Dutch language
- •Internet access
排除标准
- •A history of neurological and psychiatric symptoms that influence cognitive functioning
- •Previous cancer diagnosis
- •Using drugs
- •Drinking more than three alcoholic drinks a day
结局指标
主要结局
Between-group differences in mean change in the perceived frequency of cognitive symptoms from baseline to T1, and from baseline to T2.
时间窗: Prior to chemotherapy-initiation (baseline; T0), six months (T1), and twelve months (T2) later
Six items of the revised Medical Outcomes Study - cognitive functioning subscale (MOS-cog; Stewart \& Ware, 1992) to measure the perceived frequency of cognitive symptoms. Participants indicated the frequency of experiencing a range of day-to-day problems in six aspects of cognitive functioning during the past week (including today). Higher mean scores indicate better perceived cognitive functioning (range 0-100).
Between-group differences in mean change in the perceived severity of cognitive symptoms from baseline to T1, and from baseline to T2.
时间窗: Prior to chemotherapy-initiation (baseline; T0), six months (T1), and twelve months (T2) later
Two items of the M.D. Anderson Symptom Inventory Multiple Myeloma module (MDASI-MM part 1; Cleeland et al., 2000; Jones et al., 2013) to measure the perceived severity of cognitive symptoms. Patients reported the severity of two cognitive symptoms at their worst in the last 24 hours on a 0-10 scale, with 0 being 'not present' and 10 being 'as bad as you can imagine': difficulty remembering and difficulty paying attention (concentrating). Higher mean scores indicate more severe symptoms.
Between-group differences in mean change in verbal memory performance from baseline to T1, and from baseline to T2.
时间窗: Prior to chemotherapy-initiation (baseline; T0), six months (T1), and twelve months (T2) later
Online, adapted version of the Groningen Fifteen Words Test (Rey, 1964) measuring immediate recall (range 0-45), delayed recall (range 0-15) and recognition (range 0-30). Higher scores indicate better performance.
Between-group differences in mean change in information processing speed and executive functioning from baseline to T1, and from baseline to T2.
时间窗: Prior to chemotherapy-initiation (baseline; T0), six months (T1), and twelve months (T2) later
Online version of the Trail Making Test (TMT; Reitan \& Wolfson, 1985) part A and B (and TMT-B to TMT-A ratio B/A) to measure the speed of information processing and executive functioning. The score on each part represents the amount of time in seconds required to complete the task. Higher scores indicate worse information processing and executive functioning.
次要结局
- Between-group differences in mean change in the levels of anxiety from baseline to T1, and from baseline to T2.(Prior to chemotherapy-initiation (baseline; T0), six months (T1), and twelve months (T2) later)
- Between-group differences in pre-existing knowledge (prior to the experiment) about the potential cognitive symptoms of cancer treatment measured at twelve months follow-up (T2).(Measured at twelve months follow-up (T2))
- Between-group differences in mean change in the levels of depression from baseline to T1, and from baseline to T2.(Prior to chemotherapy-initiation (baseline; T0), six months (T1), and twelve months (T2) later)
- Between-group differences in mean change in the perceived severity of other cancer-related symptoms from baseline to T1, and from baseline to T2.(Prior to chemotherapy-initiation (baseline; T0), six months (T1), and twelve months (T2) later)
研究者
Wendy Jacobs
MSc, study coordinator/PhD candidate
Radboud University Medical Center