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Completed

NCT Number: NCT01799031

Educational Intervention for 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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cancer Survivor Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-Based Intervention

Other

Receive access to the WISE web-based educational intervention

management of therapy complications

Procedure

Receive standard of care

Other names: complications of therapy, management of

Educational Intervention

Other

Receive access to the WISE web-based educational intervention

Other names: intervention, educational

Questionnaire Administration

Other

Ancillary studies

quality-of-life assessment

Procedure

Ancillary studies

Other names: quality of life assessment

Primary outcomes

  1. Usability of the WISE website as assessed by responses to a 5-point Likert scale

    Time frame: 3 months

    The primary analysis of the effect of the WISE intervention on work ability will be performed using a Wilcoxon rank sum test.

  2. Usability of the WISE website as assessed by responses to a 5-point Likert scale

    Time frame: 6 months

    The primary analysis of the effect of the WISE intervention on work ability will be performed using a Wilcoxon rank sum test.

  3. Work ability, assessed by the Work Limitations Questionnaire (WLQ)

    Time frame: Baseline

  4. Work ability, assessed by the WLQ

    Time frame: 3 months

  5. Work ability, assessed by the WLQ

    Time frame: 6 months

  6. 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

  7. Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors

    Time frame: 3 months

  8. Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors

    Time frame: 6 months

  9. 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

  10. Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ

    Time frame: 3 months

  11. 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

  1. 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

  2. Self-car symptom management strategies used (if any), workplace strategies implemented, and barriers to implementation

    Time frame: Up to 6 months

  3. Individuals self-reported work ability, using the Work Ability Index (WAI)

    Time frame: Up to 6 months

  4. Employment status

    Time frame: Up to 6 months

  5. Change in job performance or difficulty performing work tasks

    Time frame: Baseline to 6 months

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Reducing Work Disability in Breast Cancer Survivors

Important dates

Study start
2015
Primary completion
2015
Study completion
2017
First posted
Feb 26, 2013
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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