Back to resultsOccupational Therapist-Led Work Intervention in Facilitating Work Maintenance or Re-entry to the Workforce in Patients With Stage I to III Breast Cancer Undergoing Chemotherapy
Primary Purpose
Breast Cancer Stage I, Breast Cancer Stage III, Breast Cancer Stage II
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Occupational Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer Stage I
Eligibility Criteria
Inclusion Criteria:
- Stage I-III breast cancer patients who will be undergoing curative intent chemotherapy
- Working in a paid capacity (part or full-time) at time of diagnosis with the intent to maintain or return to work following treatment
Exclusion Criteria:
- Non-English speaking patients. This study requires completing online questionnaires that are written in English and will not be translated
- Patients with a psychiatric or neurological condition that impairs capacity to make decisions
Sites / Locations
- Fred Hutch/University of Washington Cancer Consortium
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supportive care (Occupational therapy)
Arm Description
Patients receive in-person occupational therapist-led work consultation
Outcomes
Primary Outcome Measures
Change in perceived work ability
Will be measured by the Work Abilities Index (WAI).
Secondary Outcome Measures
Change in health related quality of life
Will be measured by the Functional Assessment of Cancer Therapy General (FACT-G), a validated measure for quality of life in patients with cancer.
Change in financial toxicity
Will be measured by the Comprehensive Score for Financial Toxicity (COST-FACIT), a validated measure for financial toxicity for clinically relevant patient-centered outcomes.
Full Information
NCT ID
NCT03723863
First Posted
October 23, 2018
Last Updated
June 30, 2021
Sponsor
University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT03723863
Brief Title
Occupational Therapist-Led Work Intervention in Facilitating Work Maintenance or Re-entry to the Workforce in Patients With Stage I to III Breast Cancer Undergoing Chemotherapy
Official Title
The Evaluation of a Work Intervention to Facilitate Work Maintenance or Re-Entry to the Workforce for Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Study team determined that data collected was appropriate for study outcome goals.
Study Start Date
October 25, 2018 (Actual)
Primary Completion Date
September 22, 2020 (Actual)
Study Completion Date
September 22, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Washington
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial studies how well occupational therapy (occupational therapist-led work intervention) works in facilitating work maintenance or re-entry to the workforce for stages I to III breast cancer patients who will be undergoing curative intent chemotherapy. Occupational therapy may help cancer patients maintain employment or successfully return to work soon after treatment.
Detailed Description
Patients receive in-person occupational therapist-led work consultation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Stage I, Breast Cancer Stage III, Breast Cancer Stage II, Breast Cancer Stage IIA, Breast Cancer Stage IIB, Breast Cancer Stage IIIA, Breast Cancer Stage IIIB, Breast Cancer Stage IIIc, Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supportive care (Occupational therapy)
Arm Type
Experimental
Arm Description
Patients receive in-person occupational therapist-led work consultation
Intervention Type
Behavioral
Intervention Name(s)
Occupational Therapy
Other Intervention Name(s)
Occupational Therapy, OT
Intervention Description
Receive in-person occupational therapist-led work consultation
Primary Outcome Measure Information:
Title
Change in perceived work ability
Description
Will be measured by the Work Abilities Index (WAI).
Time Frame
Baseline up to 3 years
Secondary Outcome Measure Information:
Title
Change in health related quality of life
Description
Will be measured by the Functional Assessment of Cancer Therapy General (FACT-G), a validated measure for quality of life in patients with cancer.
Time Frame
Baseline up to 3 years
Title
Change in financial toxicity
Description
Will be measured by the Comprehensive Score for Financial Toxicity (COST-FACIT), a validated measure for financial toxicity for clinically relevant patient-centered outcomes.
Time Frame
Baseline up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage I-III breast cancer patients who will be undergoing curative intent chemotherapy
Working in a paid capacity (part or full-time) at time of diagnosis with the intent to maintain or return to work following treatment
Exclusion Criteria:
Non-English speaking patients. This study requires completing online questionnaires that are written in English and will not be translated
Patients with a psychiatric or neurological condition that impairs capacity to make decisions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Yung
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Occupational Therapist-Led Work Intervention in Facilitating Work Maintenance or Re-entry to the Workforce in Patients With Stage I to III Breast Cancer Undergoing Chemotherapy
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