Internet-based WOrk-related Cognitive Rehabilitation for Cancer Survivors: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 261
- 试验地点
- 1
- 主要终点
- Change from baseline Goal Attainment Scaling (GAS) at 3 and 6 months follow-up.
研究概览
简要总结
Many of the occupationally active cancer survivors experience cognitive problems.Both from an individual and a societal perspective, it is important to sustain cancer survivors' employability.The aim of the current study is to develop an internet-based cognitive intervention programme for occupationally active cancer survivors confronted with cognitive problems, and to evaluate the (cost-)effectiveness of this program. A three-armed randomized controlled trial will be conducted with six months of follow-up, including two intervention groups (i.e., basic and extensive cognitive rehabilitation program) and one waitlist control group. Primary and secondary outcomes will be measured at baseline (T0), at three months, upon completion of the intervention (T1), and at three months post-intervention (T2).In total, 261 cancer survivors (18 - 65 years) who have returned to work and who experience cognitive problems will be recruited.
详细描述
The proposed study will evaluate the (cost-)effectiveness of an internet-based cognitive intervention program in achieving personal work-related rehabilitation goals in occupationally active cancer survivors confronted with cognitive problems. Secondary outcomes will be among others subjective cognitive function, work function and quality of life.
It is hypothesized that:
- both cancer survivors who undergo the basic or extensive cognitive rehabilitation program will achieve better their pre-set rehabilitation goals, both at baseline till treatment endpoint (T1) and follow-up (T2), compared to cancer survivors in the waitlist control group.
- cancer survivors with baseline cognitive deficits (measured with neuropsychological tests) will achieve better their pre-set rehabilitation goals after the extended cognitive rehabilitation program than after the basic cognitive rehabilitation program.
A three-armed randomized controlled trial with two intervention groups (i.e., an extensive and a basic cognitive rehabilitation program) and one waitlist control group will be conducted.
The cognitive rehabilitation program will be delivered online; either as a self-help intervention or as an online therapist-guided intervention. The therapists will be cognitive trainers who have undergone additional training in issues related to cancer-related cognitive decline.
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
- None
盲法说明
Blinding of participants and professionals is not possible for this type of intervention. Blinding for assessment is not applicable since measurements are computer-based.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Working age (18 - 65 years) at the time of study entry
- •Histologically confirmed cancer (all tumour types except for brain tumours).
- •Completed primary therapy including chemotherapy, targeted agents and/or immunotherapy 6 months ago. Patients who are still receiving hormonal therapy can be included in the trial.
- •Experience cancer/cancer treatment-related cognitive problems. Both patients with and without cognitive impairment assessed with neuropsychological tests, formally assessed with neuropsychological tests, will be included in the study.
- •Fixed or temporary employment contract (with at least six months left of their contract).
- •Being at work for a minimum of 12 working hours/week.
排除标准
- •Psychiatric or neurological disorder that can interfere with current study aims.
- •Lack basic proficiency in Dutch.
- •Participating in comparable studies or programmes.
结局指标
主要结局
Change from baseline Goal Attainment Scaling (GAS) at 3 and 6 months follow-up.
时间窗: T0 (baseline), T1 (12 weeks), T2 (26 weeks)
Individually defined work-related treatment goals will be measured using the 6-point Goal Attainment Scale (GAS) on personal outcome (-3, achievement of the goal after training is worse; -2, achievement of the goal is the same; 1, partial achievement of the goal; 0, achievement of the goal; 1, exceeding the goal, and 2, greatly exceeding the goal). Patients will formulate three treatment goals at baseline, in collaboration with their cognitive therapist. Attainment of the goals is measured in a standardized way, i.e., an overall GAS T-score will be computed for each participant on basis of aggregated GAS scores involving attainment of multiple personal treatment goals, according a summary scoring algorithm that calculates the extent to which patients' goals are met.
次要结局
- Change from baseline Work involvement (WIS) at 3 and 6 months follow-up.(T0 (baseline), T1 (12 weeks), T2 (26 weeks))
- Change from baseline Coping (CERQ) at 3 and 6 months follow-up.(T0 (baseline), T1 (12 weeks), T2 (26 weeks))
- Change in Health-Related Quality of Life (SF-36) at 3 and 6 months follow-up.(T0 (baseline), T1 (12 weeks), T2 (26 weeks))
- Change from baseline Fatigue (SF-36) at 3 and 6 months follow-up.(T0 (baseline), T1 (12 weeks), T2 (26 weeks))
- Change from baseline Neuropsychological functioning (ACS) at 3 and 6 months follow-up.(T0 (baseline), T1 (12 weeks), T2 (26 weeks))
- Change from baseline Job characteristics (JCQ) at 3 and 6 months follow-up.(T0 (baseline), T1 (12 weeks), T2 (26 weeks))
- Change from baseline Depression and anxiety (HADS) at 3 and 6 months follow-up.(T0 (baseline), T1 (12 weeks), T2 (26 weeks))
- Change from baseline Work ability (WAI) at 3 and 6 months follow-up.(T0 (baseline), T1 (12 weeks), T2 (26 weeks))
- Change from baseline Work functioning (WRFQ) at 3 and 6 months follow-up.(T0 (baseline), T1 (12 weeks), T2 (26 weeks))
- Change from baseline Cognitive problems (CSC-W DV) at 3 and 6 months follow-up.(T0 (baseline), T1 (12 weeks), T2 (26 weeks))
- Change from baseline Need for recovery after a work day (VBBA) at 3 and 6 months follow-up.(T0 (baseline), T1 (12 weeks), T2 (26 weeks))