Educational Intervention for Reducing Work Disability in Breast Cancer Survivors

Reducing Work Disability in Breast Cancer Survivors

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Cancer Survivor
• Intervention / Treatment: Other: questionnaire administration; Procedure: quality-of-life assessment; Other: internet-based intervention; Procedure: management of therapy complications; Other: educational intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Mary Sesto, University of Wisconsin, Madison

Publications and helpful links

Helpful Links

• University of Wisconsin Carbone Cancer Center

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: February 21, 2013
• First Submitted That Met QC Criteria: February 21, 2013
• First Posted (Estimate): February 26, 2013

Study Record Updates

• Last Update Posted (Actual): November 18, 2019
• Last Update Submitted That Met QC Criteria: November 14, 2019
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: OS12115; A536130 (Other Identifier: UW Madison); NCI-2012-03055 (Registry Identifier: NCI Trial ID); 2012-0729 (Other Identifier: Institutional Review Board); SMPH\ORTHOPEDIC&REHAB\PT (Other Identifier: UW Madison)