Reducing Work Disability in Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Work ability, assessed by the Work Limitations Questionnaire (WLQ)
研究概览
简要总结
This randomized clinical trial studies an educational intervention for reducing work disability in breast cancer survivors. Web sites providing symptom management education may be an effective method to help breast cancer survivors reduce work disability after treatment
详细描述
PRIMARY OBJECTIVES:
I. Determine the feasibility and usability of the Work Ability Improvement Through Symptom Management and Ergonomic Strategies (WISE) and empirically evaluate its effect on short-term work ability among breast cancer survivors (BCS).
SECONDARY OBJECTIVES:
I. Explore individual and workplace factors associated with work ability in BCS.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
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
入排标准
- 年龄范围
- 25 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with breast cancer
- •Employed at time of cancer diagnosis (defined as paid employment > 20 hours/week)
- •Within six months of completion of active treatment
- •Working during treatment or intending to return to work following active treatment
- •Computer and internet access
排除标准
- •Patients who do not intend to continue/resume working following treatment
- •Develop distant metastases or progressive disease
- •Prior diagnosis of malignancy at any other site except for in situ carcinomas of the cervix or non-melanomatous skin cancers
研究组 & 干预措施
Arm I (WISE)
Patients receive access to the WISE web-based educational intervention to help BCS manage their symptoms, identify ergonomic workplace problems and risks, and implement ergonomic modifications. Patients also receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
干预措施: internet-based intervention (Other)
Arm I (WISE)
Patients receive access to the WISE web-based educational intervention to help BCS manage their symptoms, identify ergonomic workplace problems and risks, and implement ergonomic modifications. Patients also receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
干预措施: management of therapy complications (Procedure)
Arm I (WISE)
Patients receive access to the WISE web-based educational intervention to help BCS manage their symptoms, identify ergonomic workplace problems and risks, and implement ergonomic modifications. Patients also receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
干预措施: educational intervention (Other)
Arm I (WISE)
Patients receive access to the WISE web-based educational intervention to help BCS manage their symptoms, identify ergonomic workplace problems and risks, and implement ergonomic modifications. Patients also receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
干预措施: questionnaire administration (Other)
Arm I (WISE)
Patients receive access to the WISE web-based educational intervention to help BCS manage their symptoms, identify ergonomic workplace problems and risks, and implement ergonomic modifications. Patients also receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
干预措施: quality-of-life assessment (Procedure)
Arm II (control)
Patients receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
干预措施: quality-of-life assessment (Procedure)
Arm II (control)
Patients receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
干预措施: management of therapy complications (Procedure)
Arm II (control)
Patients receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
干预措施: questionnaire administration (Other)
结局指标
主要结局
Work ability, assessed by the Work Limitations Questionnaire (WLQ)
时间窗: Baseline
Work ability, assessed by the WLQ
时间窗: 6 months
Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors
时间窗: 6 months
Usability of the WISE website as assessed by responses to a 5-point Likert scale
时间窗: 6 months
The primary analysis of the effect of the WISE intervention on work ability will be performed using a Wilcoxon rank sum test.
Individual factors, including symptoms assessed using the Symptom Bother-Revised scale (SB-R) and MD Anderson Symptom Inventory (MDASI), socio-demographic factors, individual disease factors, and treatment factors
时间窗: Baseline
Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the Job Content Questionnaire (JCQ)
时间窗: Baseline
Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ
时间窗: 6 months
Work ability, assessed by the WLQ
时间窗: 3 months
Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors
时间窗: 3 months
Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ
时间窗: 3 months
Usability of the WISE website as assessed by responses to a 5-point Likert scale
时间窗: 3 months
The primary analysis of the effect of the WISE intervention on work ability will be performed using a Wilcoxon rank sum test.
次要结局
- Individuals self-reported work ability, using the Work Ability Index (WAI)(Up to 6 months)
- Employment status(Up to 6 months)
- Feasibility measures, including participation/dropout rates, patient satisfaction, usability/satisfaction with WISE, knowledge/use of self-care symptom management/ergonomic strategies, and use of ergonomic/symptom management strategies, and barriers(Up to 6 months)
- Self-car symptom management strategies used (if any), workplace strategies implemented, and barriers to implementation(Up to 6 months)
- Change in job performance or difficulty performing work tasks(Baseline to 6 months)