Breast Cancer, Cancer Survivor
Conditions
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.
Interventions
PROCEDUREquality-of-life assessment
Ancillary studies
OTHERquestionnaire administration
Ancillary studies
OTHERinternet-based intervention
Receive access to the WISE web-based educational intervention
PROCEDUREmanagement of therapy complications
Receive standard of care
OTHEReducational intervention
Receive access to the WISE web-based educational intervention
Sponsors
National Cancer Institute (NCI)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 64 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ | 3 months | — |
| Work ability, assessed by the Work Limitations Questionnaire (WLQ) | Baseline | — |
| Work ability, assessed by the WLQ | 3 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 | — |
| Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the Job Content Questionnaire (JCQ) | Baseline | — |
| Usability of the WISE website as assessed by responses to a 5-point Likert scale | 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
United States
Outcome results
None listed