Combined Model of Online Remote Interventions for Cancer-Related Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in the Canadian Occupational Performance Measure (COPM) (Law et al., 1998)
研究概览
简要总结
Cancer survival rates have increased dramatically in recent years. However, many survivors report cognitive decline following treatment, which significantly impairs their quality of life. Online cognitive training programs have shown promise in improving cognitive functions in cancer survivors, but most studies report limited impact of training on everyday function. A complementary treatment approach is functional treatment delivered by occupational therapists, which directly targets daily function. Combining the two approaches has the potential to overcome the limitations of both approaches, enabling improved cognitive functions and transfer to daily function. Remotely-administrated interventions further make treatment accessible and cost-effective. The current study is aimed at testing the efficacy of a novel, combined, remotely-delivered treatment approach: Cognitive Retraining and Functional Treatment(CRAFT), using a Randomized Controlled Trial (RCT) design. 90 cancer survivors will be randomly assigned to receive 15 weeks of either the combined treatment, computerized training only, or treatment-as-usual. Outcomes will be assessed at completion, and following 3 months of no contact, to test immediate and enduring effects of treatment. Baseline predictors for treatment response will be further assessed.
Positive results in the proposed study could potentially change the therapeutic landscape for rehabilitation of cancer-related cognitive decline, which currently impair the lives of millions worldwide.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Randomization will take place only after the investigator will complete baseline assessment, so the assessment procedure wont be affected by group allocation. In addition, the investigator who will assess the outcomes post intervention and at 3 month follow up will be blind to the intervention allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjective concern about declines in cognitive functioning related to a diagnosis of cancer and/or cancer related treatment. This will be obtained by asking participants the question "do you have concerns about your memory or other thinking abilities following cancer treatment?". Participants are required to answer yes to this question.
- •interested in treatment and state they have 2 weekly hours available for the intervention.
- •Completion of active treatment for non-Central Nervous System (CNS) cancer (e.g., chemotherapy,radiation therapy and surgery) 6 months or more in the past.
- •Cognitive decline with no dementia: 21<Mini-Mental State Examination <27 (Folstein, Folstein, & McHugh, 1975) and/or 19< Montreal Cognitive Assessment <26 (Nasreddine et al., 2005);
- •Daily access to a computer and Internet facilities;
- •Able to sign an informed consent;
- •Stable psychiatric condition (according to participants self- report and medical file).
排除标准
- •no prior experience using computers;
- •History of a central nervous system tumor.
结局指标
主要结局
Change in the Canadian Occupational Performance Measure (COPM) (Law et al., 1998)
时间窗: Time 0: Baseline, before group allocation and intervention; Time 1: at completion of intervention, an average of 15 weeks after T0; Time 2: 3 months after Time 1 (an average of 6 months after enrollment)
A semi-structured interview used to assess the self-perception of clients' performance and satisfaction with their level of participation in daily functioning regarding the five most important problems they identified. The patient rates each problem on a 10-point scale indicating his level of performance (1= not able to do it at all, 10= able to do it extremely well) and level of satisfaction (1= not satisfied at all, 10 = extremely satisfied). Change is assessed by administering the interview at different time points.
Change in Functional Assessment of Cancer Therapy - Cognition (FACT COG) (Jacobs, Jacobsen, Booth-Jones, Wagner, & Anasetti, 2007)
时间窗: Time 0: Baseline, before group allocation and intervention; Time 1: at completion of intervention, an average of 15 weeks after T0; Time 2: 3 months after Time 1 (an average of 6 months after enrollment)
A self-report questionnaire for cancer patients with cognitive function issues. The tool includes 37-items assessing memory, concentration, language and thinking abilities. The items are grouped into 4 subscales: perceived cognitive impairment (PCI), perceived cognitive abilities (PCA), comments from others (OTH), and impact on quality of life (QOL). The items are rated on a 5-point Likert scale (0=never, 4 =several times a day) regarding the past 7 days, higher scores indicating greater QOL.
Change in Computerized Cognitive Assessments (Posit Science)
时间窗: Time 0: Baseline, before group allocation and intervention; Time 1: at completion of intervention, an average of 15 weeks after T0; Time 2: 3 months after Time 1 (an average of 6 months after enrollment)
Computerized Assessment will be used to assess neuro-cognitive function using five different tasks from posit science. Domains that will be assessed are sustained attention, visual working memory, speed of processing (visual and auditory) and flexibility
次要结局
- Change in the Generalized Anxiety Disorder (GAD -7) (Spitzer, Kroenke, Williams, & Löwe, 2006)(Time 0: Baseline, before group allocation and intervention; Time 1: at completion of intervention, an average of 15 weeks after T0; Time 2: 3 months after Time 1 (an average of 6 months after enrollment))
- Change in the Functional Assessment of Cancer Therapy-General practice (FACT-GP) (Cella et al., 1993)(Time 0: Baseline, before group allocation and intervention; Time 1: at completion of intervention, an average of 15 weeks after T0; Time 2: 3 months after Time 1 (an average of 6 months after enrollment))
- Change in the New General Self-Efficacy Scale (NGSE) (Chen, Gully, & Eden, 2001)(Time 0: Baseline, before group allocation and intervention; Time 1: at completion of intervention, an average of 15 weeks after T0; Time 2: 3 months after Time 1 (an average of 6 months after enrollment))
- Change in the Patient Health Questionnaire (PHQ-9)(Kroenke, Spitzer, & Williams, 2001)(Time 0: Baseline, before group allocation and intervention; Time 1: at completion of intervention, an average of 15 weeks after T0; Time 2: 3 months after Time 1 (an average of 6 months after enrollment))
- Change in the Functional Assessment of Cancer Therapy - Fatigue (FACT -F) (Yellen, Cella, Webster, Blendowski, & Kaplan, 1997)(Time 0: Baseline, before group allocation and intervention; Time 1: at completion of intervention, an average of 15 weeks after T0; Time 2: 3 months after Time 1 (an average of 6 months after enrollment))
- Change in the Ruminative Response Scale (RRS) (Treynor, Gonzalez, & Nolen-Hoeksema, 2003)(Time 0: Baseline, before group allocation and intervention; Time 1: at completion of intervention, an average of 15 weeks after T0; Time 2: 3 months after Time 1 (an average of 6 months after enrollment))
- Change in Performance Quality Rating Scale (PQRS) (Martini, Rios, Polatajko, Wolf, & McEwen, 2015)(Time 0: Baseline, before group allocation and intervention; Time 1: at completion of intervention, an average of 15 weeks after T0; Time 2: 3 months after Time 1 (an average of 6 months after enrollment))
- Social Presence (Hauber, Regenbrecht, Billinghurst, & Cockburn, 2006)(3 Time points during intervention (Week 1, Week 5, Week 10), CRAFT only)
- Satisfaction questionnaire and interview(Time 1: At completion of intervention (an average of 15 weeks after baseline) (CRAFT only))