Overview

This trial is active, not recruiting.

Conditions breast cancer, cancer survivor
Treatments internet-based intervention, management of therapy complications, educational intervention, questionnaire administration, quality-of-life assessment
Sponsor University of Wisconsin, Madison
Collaborator National Cancer Institute (NCI)
Start date July 2015
End date October 2015
Trial size 44 participants
Trial identifier NCT01799031, NCI-2012-03055, OS12115

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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.
internet-based intervention
Receive access to the WISE web-based educational intervention
management of therapy complications complications of therapy, management of
Receive standard of care
educational intervention intervention, educational
Receive access to the WISE web-based educational intervention
questionnaire administration
Ancillary studies
quality-of-life assessment quality of life assessment
Ancillary studies
(Active Comparator)
Patients receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
management of therapy complications complications of therapy, management of
Receive standard of care
questionnaire administration
Ancillary studies
quality-of-life assessment quality of life assessment
Ancillary studies

Primary Outcomes

Measure
Usability of the WISE website as assessed by responses to a 5-point Likert scale
time frame: 3 months
Usability of the WISE website as assessed by responses to a 5-point Likert scale
time frame: 6 months
Work ability, assessed by the Work Limitations Questionnaire (WLQ)
time frame: Baseline
Work ability, assessed by the WLQ
time frame: 3 months
Work ability, assessed by the WLQ
time frame: 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
time frame: Baseline
Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors
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: 6 months
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: 3 months
Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ
time frame: 6 months

Secondary Outcomes

Measure
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
Self-car symptom management strategies used (if any), workplace strategies implemented, and barriers to implementation
time frame: Up to 6 months
Individuals self-reported work ability, using the Work Ability Index (WAI)
time frame: Up to 6 months
Employment status
time frame: Up to 6 months
Change in job performance or difficulty performing work tasks
time frame: Baseline to 6 months

Eligibility Criteria

Female participants from 25 years up to 64 years old.

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

Additional Information

Official title Reducing Work Disability in Breast Cancer Survivors
Principal investigator Mary Sesto
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.