Breast CancerNCT01799031
Educational Intervention for Reducing Work Disability in Breast Cancer Survivors
A study testing internet-based intervention, management of therapy complications and educational intervention in people with Breast Cancer and Cancer Survivor, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 25 to 64 years, women only
- Conditions the study is for
- Breast Cancer, Cancer Survivor
- What is being tested?
- internet-based intervention, management of therapy complications and educational intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Official title: 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
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Breast Cancer, Cancer Survivor
- Being tested
- internet-based intervention, management of therapy complications, educational intervention, questionnaire administration, quality-of-life assessment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internet-based interventionOther
Receive access to the WISE web-based educational intervention
management of therapy complicationsProcedure or surgery
Also called complications of therapy, management of
Receive standard of care
educational interventionOther
Also called intervention, educational
Receive access to the WISE web-based educational intervention
questionnaire administrationOther
Ancillary studies
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (WISE) | 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. Receives: Other: internet-based intervention; Procedure: management of therapy complications; Other: educational intervention; Other: questionnaire administration; Procedure: quality-of-life assessment |
| Arm II (control) | Active comparator | Patients receive standard of care comprising symptom management therapies and a pamphlet on employment rights. Receives: Procedure: management of therapy complications; Other: questionnaire administration; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Work ability, assessed by the Work Limitations Questionnaire (WLQ)
Measured: Baseline
Work ability, assessed by the WLQ
Measured: 3 months
Work ability, assessed by the WLQ
Measured: 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
Measured: Baseline
Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors
Measured: 3 months
Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors
Measured: 6 months
Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the Job Content Questionnaire (JCQ)
Measured: Baseline
Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ
Measured: 3 months
Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ
Measured: 6 months
Secondary outcomes (5)
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
Measured: Up to 6 months
Self-car symptom management strategies used (if any), workplace strategies implemented, and barriers to implementation
Measured: Up to 6 months
Individuals self-reported work ability, using the Work Ability Index (WAI)
Measured: Up to 6 months
Employment status
Measured: Up to 6 months
Change in job performance or difficulty performing work tasks
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startJul 2015
- Primary completionOct 2015
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mary Sesto, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799031
- Sponsor's protocol ID
- OS12115
- Other IDs
- NCI-2012-03055, 2012-0729, A536130, SMPH\ORTHOPEDIC&REHAB\PT
- Status last verified
- Jul 2017
- First submitted
- 21 Feb 2013
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Work Disability in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT01799031
- Acronym / sponsor ID
- OS12115
- Conditions
- Breast Cancer, Cancer Survivor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 26 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (WISE) | Experimental | Other: internet-based intervention, Procedure: management of therapy complications, Other: educational intervention, Other: questionnaire administration, Procedure: quality-of-life assessmentPatients 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 (control) | Active comparator | Procedure: management of therapy complications, Other: questionnaire administration, Procedure: quality-of-life assessmentPatients receive standard of care comprising symptom management therapies and a pamphlet on employment rights. |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| internet-based interventionReceive access to the WISE web-based educational intervention | Other | Arm I (WISE) |
| management of therapy complicationsAlso: complications of therapy, management ofReceive standard of care | Procedure or surgery | Arm I (WISE), Arm II (control) |
| educational interventionAlso: intervention, educationalReceive access to the WISE web-based educational intervention | Other | Arm I (WISE) |
| questionnaire administrationAncillary studies | Other | Arm I (WISE), Arm II (control) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm I (WISE), Arm II (control) |
Primary outcome
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.
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.
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Sesto principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing internet-based intervention, management of therapy complications and educational intervention in people with Breast Cancer and Cancer Survivor, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the WISE website as assessed by responses to a 5-point Likert scale (time frame: 3 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.