Protocol of a Randomized Controlled Trial on the Effectiveness and Cost-effectiveness of a Supported Employment Intervention Aimed at Enhancing Work Participation of Unemployed or Work-disabled Cancer Survivors: the PLACES Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Paid employment (yes/no)
研究概览
简要总结
The primary objective of this study is to evaluate the effectiveness of the PLACES intervention on paid employment re-entry in unemployed and work-disabled cancer survivors, compared to CAU.
Secondary Objectives are:
- To evaluate the cost-effectiveness of the PLACES intervention aimed at unemployed or work-disabled cancer survivors.
- To evaluate the effectiveness of the PLACES intervention on time until paid employment, type of employment, change in working hours, quality of life, quality of working life, work ability, and self-efficacy regarding RTW, in unemployed or work-disabled cancer survivors.
- To evaluate the process of conducting the PLACES intervention in terms of recruitment, reach, dose delivered, dose received, fidelity and context.
Participants in the intervention group will receive the PLACES intervention with a maximum duration of 1 year, and participants in the control group will receive CAU.
详细描述
Participants in the intervention group (n=82) will receive a tailored supported employment intervention, based on the principles of individual placement and support (IPS). This includes support in seeking, returning to and maintaining paid employment. Participants in the control group (n=82) will receive care as usual. All participants will be asked to complete questionnaires, at baseline (T0), and after three (T1), six (T2) and 12 months (T3) follow-up. The primary outcome is obtainment of paid employment. Secondary outcomes are employment status, time until paid employment, change in working hours, importance of work, RTW expectations, work ability, quality of (working) life, and self-efficacy regarding RTW. Process evaluation and cost-effectiveness analysis will be performed.
It is expected that that a significantly higher proportion of participants in the intervention group will obtain paid employment at any point during 12-month follow-up compared to participants in the control group. Additionally, their health, financial situation and quality of life will be improved. If proven effective, the intention is to implement the intervention in usual rehabilitation care.
The study is funded by the Dutch Cancer Society (KWF) and in collaboration with the Netherlands comprehensive cancer organisation (IKNL) and the social security agency (SSA)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The analyses will be performed blinded after one researcher codes the intervention and control group to either 0 or 1.
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
- 是
入选标准
- •In order to be eligible for participation, participants must meet all of the following criteria:
- •Of working age (18-65 years);
- •Diagnosed with cancer between 6 months and 10 years ago;
- •Unemployed and either partially or fully work-disabled
- •They have completed their primary treatment (except long-term treatment such as hormone therapy);
- •An approved reintegration trajectory at the SSA;
- •Seeking paid employment and motivated to initiate work promptly.
- •Cancer survivors who are unable to speak, read or understand the Dutch language and cancer survivors who got diagnosed with basal cell carcinoma will be excluded from participation.
排除标准
- 未提供
研究组 & 干预措施
PLACES intervention
Participants in the intervention group will receive the PLACES intervention during 12-months after randomization.
干预措施: PLACES (Behavioral)
Care as usual
Participants in the control group will receive usual care from the SSA.
结局指标
主要结局
Paid employment (yes/no)
时间窗: 12 months
The primary outcome measure is paid employment (yes/no) at any point during the 1-year-follow-up. Being in paid employment is operationalised as working in a paid job for at least one hour per week as defined by the central statistics office.
次要结局
- Employment status(Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3))
- Time until paid employment(Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3))
- Quality of life(Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3))
- Work ability(Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3))
- Self-efficacy regarding RTW(Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3))
- Change in working hours(Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3))
- Importance of work(Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3))
- RTW expectations(Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3))
- Quality of working life(Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3))
研究者
Fenna van Ommen
Prof. dr. Angela de Boer, Professor in Chronic Disease and Work Participation at the Faculty of Medicine at Amsterdam UMC.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)