Reducing Work Disability in Breast Cancer Survivors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Work ability, assessed by the Work Limitations Questionnaire (WLQ)
Study Overview
Brief Summary
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
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 64 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: quality-of-life assessment (Procedure)
Arm II (control)
Patients receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
Intervention: quality-of-life assessment (Procedure)
Arm II (control)
Patients receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
Intervention: management of therapy complications (Procedure)
Arm II (control)
Patients receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
Intervention: questionnaire administration (Other)
Outcomes
Primary Outcomes
Work ability, assessed by the Work Limitations Questionnaire (WLQ)
Time Frame: Baseline
Work ability, assessed by the WLQ
Time Frame: 6 months
Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors
Time Frame: 6 months
Usability of the WISE website as assessed by responses to a 5-point Likert scale
Time Frame: 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
Time Frame: Baseline
Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the Job Content Questionnaire (JCQ)
Time Frame: Baseline
Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ
Time Frame: 6 months
Work ability, assessed by the WLQ
Time Frame: 3 months
Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors
Time Frame: 3 months
Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ
Time Frame: 3 months
Usability of the WISE website as assessed by responses to a 5-point Likert scale
Time Frame: 3 months
The primary analysis of the effect of the WISE intervention on work ability will be performed using a Wilcoxon rank sum test.
Secondary Outcomes
- 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)