International Randomized Controlled Trial to Evaluate the Effectiveness of a Nurse-delivered (FOCUS+) and a Web-based (iFOCUS) Psychoeducational Intervention for People With Advanced Cancer and Their Family Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 431
- 试验地点
- 17
- 主要终点
- Change in self-efficacy
研究概览
简要总结
The overall aim of this project is to evaluate the effectiveness, cost-effectiveness and mechanisms of action of two psychoeducational interventions (a face-to-face nurse-led intervention called FOCUS+ and an eHealth intervention called iFOCUS) aimed at improving the emotional function and self-efficacy of patients with advanced cancer and their family caregiver. Both interventions are compared to care as usual.
Both interventions focus on teaching dyads optimal ways to jointly manage the implications of advanced cancer and responding to their priority concerns and are designed to be tailored to the specific needs and wishes of the patient-caregiver dyads. Tailoring is based on information about the dyad obtained at enrollment (e.g. age, relationship, etc.) and the responses in the intervention sessions.
The overarching aim is addressed by five core intervention components:
- supporting family involvement and improving the dyads mutual communication,
- supporting outlook (i.e. increasing the dyad's capacity to identify positive or meaningful aspects related to their situation),
- increasing dyads' coping skills, i.e. their capacity to identify their coping strategies and take action
- help dyads reduce their uncertainty
- teaching symptom management and giving them confidence to handle specific tasks and problems
Project objectives:
- To compare 1) the face-to-face FOCUS+ intervention and 2) the iFOCUS web intervention to 3) care as usual in terms of their:
- Effect on the emotional function and self-efficacy (primary outcomes), appraisal of illness, uncertainty, hopelessness, coping, dyad communication, quality of life and healthcare resource use of patients with advanced cancer and their family caregivers
- Cost-effectiveness
- Effects on vulnerable subgroups (particularly women and those of lower socioeconomic status)
- Effectiveness in different healthcare systems
- To evaluate the implementation process of the interventions in terms of the acceptability, feasibility, usefulness as perceived by patients, family caregivers and healthcare staff in each country, and their mechanisms of action.
Data will be collected three times from patient-caregiver dyads: 1) baseline measure (t0) after which the dyad will immediately be randomized to one of the study arms, 2) first follow-up at 12 weeks after baseline (t1) and 3) second follow-up at 24 weeks after baseline (t2).
详细描述
STUDY SETTING
Both interventions (FOCUS+ and iFOCUS) will be administered in the homes of the patient-caregiver dyads (or in the location of the dyad's preference).
The intervention will be conducted in six countries (Belgium, Denmark, Ireland, Italy, the Netherlands and the United Kingdom). In each country, patients with advanced cancer and their primary family caregiver will be recruited and enrolled via participating hospitals. Inclusion criteria for hospitals participating in this study are having 1) to treat patients with advanced cancer and 2) an oncology care regimen.
SAMPLE SIZE
For the emotional functioning the EF10 subscale from the EORTC is used. For self-efficacy the CASE instrument is used. The investigators consider demonstration of an intervention effect (for each of both interventions) on at least one of these primary outcomes for either the patient or the caregiver at t1 as a success. A pre-determined strict fixed sequence (FS) procedure defines prospectively hierarchical ordering of the endpoints, for this study the hierarchical order is emotional functioning (1) and self-efficacy (2). Testing of null hypotheses proceeds according to their hierarchical order, that is, H(1)0 is tested first at a significance level of 5%, and if H(1)0 is rejected then H(2)0 is tested at the same significance level, otherwise H(2)0 is not tested at all. The strict FS approach has the highest power for testing the first hypothesis (outcome: emotional function) compared to the other methods, as it does not save any portion of alpha for testing later hypothesis. The reference mean value from EORTC for all cancer patients, stage III-IV is 71.5 (SD: 23.8). Alpha is set at 0.0125 instead of 0.05 to account for multiplicity (2 comparisons with control group * 2 participant groups [patients and caregivers]). 1-beta (i.e. statistical power) is set at 0.9. The expected difference between the control group and the intervention arms in the primary outcomes is 0.375 SD at t1 (12 weeks).
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
盲法说明
Due to the nature of the intervention neither the patient-caregiver dyads nor the intervention nurses (for the face-to-face FOCUS+ intervention) can be blinded to allocation. Data will be collected via a computer-assisted self-interview with a data collector that is present for assistance and additional explanations. Those conducting the data analyses will be unaware as to what trial arm dyads were randomized to until the end of the last data collection point.
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
- •Diagnosis of cancer: solid organ (lung, colorectal, breast, prostate and other)
- •No longer receives curative treatment (only life-prolonging or palliative treatments)
- •Written informed consent
- •Lives within feasible distance for intervention nurses to travel
排除标准
- •Brain cancer, non-solid cancers
- •Prognosis of less than 3 months
- •Has no informal caregivers
- •< 18 years old
- •Unable to participate in available languages
- •FAMILY CAREGIVER
- •Inclusion Criteria:
- •Written informed consent
- •Primary informal caregiver as determined by the patient
- •Lives within feasible distance for intervention nurses to travel
- •Exclusion Criteria:
- •Unable to physically or mentally participate
- •Cancer diagnosis in the last 12 months
- •<18 years old
- •Unable to participate in available languages
- •Inclusion Criterium:
- •Patient and/or family caregivers has access to and is familiar with use of internet
结局指标
主要结局
Change in self-efficacy
时间窗: T1 (baseline + 12 weeks)
For patients and for caregivers: the Lewis´ Cancer self-efficacy scale
Change in emotional functioning
时间窗: T1 (baseline + 12 weeks)
For patients and for caregivers: EORTC 10 emotional function items
次要结局
- Change in benefits of illness(T1 (baseline + 12 weeks), T2 (baseline + 24 weeks))
- Change in coping(T1 (baseline + 12 weeks), T2 (baseline + 24 weeks))
- Change in emotional functioning(T2 (baseline + 24 weeks))
- Change in patient social well-being(T1 (baseline + 12 weeks), T2 (baseline + 24 weeks))
- Change in ways of giving support(T1 (baseline + 12 weeks), T2 (baseline + 24 weeks))
- Change in self-efficacy(T2 (baseline + 24 weeks))
- Change in dyadic coping(T1 (baseline + 12 weeks), T2 (baseline + 24 weeks))
- Change in quality-adjusted life years(T1 (baseline + 12 weeks), T2 (baseline + 24 weeks))
- Change in patient quality of life(T1 (baseline + 12 weeks), T2 (baseline + 24 weeks))
- Change in caregiver quality of life(T1 (baseline + 12 weeks), T2 (baseline + 24 weeks))
- Change in patient social functioning(T1 (baseline + 12 weeks), T2 (baseline + 24 weeks))
- Change in patient overall health(T1 (baseline + 12 weeks), T2 (baseline + 24 weeks))
- Change in utilization of healthcare and associated services(T1 (baseline + 12 weeks), T2 (baseline + 24 weeks))
研究者
Joachim Cohen
Professor of Public Health and Palliative Care
Vrije Universiteit Brussel