Educational Intervention for Reducing Work Disability in Breast Cancer Survivors

Study Overview
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Brief Summary
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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
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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. ARM I: 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. ARM II: Patients receive standard of care comprising symptom management therapies and a pamphlet on employment rights. After completion of study treatment, patients are followed up at 3 and 6 months.

Official Title
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Reducing Work Disability in Breast Cancer Survivors

Conditions
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Breast Cancer, Cancer Survivor

Intervention / Treatment
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* Other: internet-based intervention
* Procedure: management of therapy complications
* Other: educational intervention
* Other: questionnaire administration
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (WISE)<br>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. | Other: internet-based intervention<br>* Receive access to the WISE web-based educational intervention<br>Procedure: management of therapy complications<br>* Receive standard of care<br>* Other names: complications of therapy, management of;Other: educational intervention<br>* Receive access to the WISE web-based educational intervention<br>* Other names: intervention, educational;Other: questionnaire administration<br>* Ancillary studies<br>Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;|
| Active Comparator: Arm II (control)<br>Patients receive standard of care comprising symptom management therapies and a pamphlet on employment rights. | Procedure: management of therapy complications<br>* Receive standard of care<br>* Other names: complications of therapy, management of;Other: questionnaire administration<br>* Ancillary studies<br>Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability of the WISE website as assessed by responses to a 5-point Likert scale | The primary analysis of the effect of the WISE intervention on work ability will be performed using a Wilcoxon rank sum test. | 3 months | 
| Usability of the WISE website as assessed by responses to a 5-point Likert scale | The primary analysis of the effect of the WISE intervention on work ability will be performed using a Wilcoxon rank sum test. | 6 months | 
| Work ability, assessed by the Work Limitations Questionnaire (WLQ) |  | Baseline | 
| Work ability, assessed by the WLQ |  | 3 months | 
| Work ability, assessed by the WLQ |  | 6 months | 
| 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 |  | Baseline | 
| Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors |  | 3 months | 
| Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors |  | 6 months | 
| Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the Job Content Questionnaire (JCQ) |  | Baseline | 
| Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ |  | 3 months | 
| Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Individuals self-reported work ability, using the Work Ability Index (WAI) |  | Up to 6 months | 
| Employment status |  | Up to 6 months | 
| Change in job performance or difficulty performing work tasks |  | Baseline to 6 months |