Educational Intervention for Reducing Work Disability in Breast Cancer Survivors
Primary Purpose
Breast Cancer, Cancer Survivor
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
internet-based intervention
management of therapy complications
educational intervention
questionnaire administration
quality-of-life assessment
Sponsored by

About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility Criteria
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
Sites / Locations
- University of Wisconsin Hospital and Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm I (WISE)
Arm II (control)
Arm Description
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.
Patients receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
Outcomes
Primary Outcome Measures
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.
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.
Work ability, assessed by the Work Limitations Questionnaire (WLQ)
Work ability, assessed by the WLQ
Work ability, assessed by the WLQ
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
Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors
Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors
Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the Job Content Questionnaire (JCQ)
Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ
Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ
Secondary Outcome Measures
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
Self-car symptom management strategies used (if any), workplace strategies implemented, and barriers to implementation
Individuals self-reported work ability, using the Work Ability Index (WAI)
Employment status
Change in job performance or difficulty performing work tasks
Full Information
NCT ID
NCT01799031
First Posted
February 21, 2013
Last Updated
November 14, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01799031
Brief Title
Educational Intervention for Reducing Work Disability in Breast Cancer Survivors
Official Title
Reducing Work Disability in Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cancer Survivor
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I (WISE)
Arm Type
Experimental
Arm Description
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 Title
Arm II (control)
Arm Type
Active Comparator
Arm Description
Patients receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
Intervention Type
Other
Intervention Name(s)
internet-based intervention
Intervention Description
Receive access to the WISE web-based educational intervention
Intervention Type
Procedure
Intervention Name(s)
management of therapy complications
Other Intervention Name(s)
complications of therapy, management of
Intervention Description
Receive standard of care
Intervention Type
Other
Intervention Name(s)
educational intervention
Other Intervention Name(s)
intervention, educational
Intervention Description
Receive access to the WISE web-based educational intervention
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Usability of the WISE website as assessed by responses to a 5-point Likert scale
Description
The primary analysis of the effect of the WISE intervention on work ability will be performed using a Wilcoxon rank sum test.
Time Frame
3 months
Title
Usability of the WISE website as assessed by responses to a 5-point Likert scale
Description
The primary analysis of the effect of the WISE intervention on work ability will be performed using a Wilcoxon rank sum test.
Time Frame
6 months
Title
Work ability, assessed by the Work Limitations Questionnaire (WLQ)
Time Frame
Baseline
Title
Work ability, assessed by the WLQ
Time Frame
3 months
Title
Work ability, assessed by the WLQ
Time Frame
6 months
Title
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
Title
Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors
Time Frame
3 months
Title
Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors
Time Frame
6 months
Title
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
Title
Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ
Time Frame
3 months
Title
Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
Time Frame
Up to 6 months
Title
Self-car symptom management strategies used (if any), workplace strategies implemented, and barriers to implementation
Time Frame
Up to 6 months
Title
Individuals self-reported work ability, using the Work Ability Index (WAI)
Time Frame
Up to 6 months
Title
Employment status
Time Frame
Up to 6 months
Title
Change in job performance or difficulty performing work tasks
Time Frame
Baseline to 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Sesto
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Links:
URL
https://cancer.wisc.edu/
Description
University of Wisconsin Carbone Cancer Center
Learn more about this trial
Educational Intervention for Reducing Work Disability in Breast Cancer Survivors
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