Occupational Therapist-Led Work Intervention in Facilitat... | NCT03723863

Studies
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

NCT03723863

Sponsor

University of Washington

Status

Terminated

Last Update Posted

Jul 6, 2021Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

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

Interventions

Occupational Therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
NCI-2018-02059	Registry Identifier	CTRP (Clinical Trial Reporting Program)
9993	Other Identifier	Fred Hutch/University of Washington Cancer Consortium

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study team determined that data collected was appropriate for study outcome goals.

Expanded Access Info

Start Date

Oct 25, 2018Actual

Primary Completion Date

Sep 22, 2020Actual

Completion Date

Sep 22, 2020Actual

First Submitted Date

Oct 23, 2018

First Submission Date that Met QC Criteria

Oct 26, 2018

First Posted Date

Oct 30, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2021

Last Update Posted Date

Jul 6, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

Conditions

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

Keywords

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Supportive care (Occupational therapy)	Experimental	Patients receive in-person occupational therapist-led work consultation	Behavioral: Occupational Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Occupational Therapy	Behavioral	Receive in-person occupational therapist-led work consultation	Supportive care (Occupational therapy)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in perceived work ability	Will be measured by the Work Abilities Index (WAI).	Baseline up to 3 years

Secondary Outcomes

Measure	Description	Time Frame
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.	Baseline up to 3 years
Change in financial toxicity

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rachel Yung	Fred Hutch/University of Washington Cancer Consortium	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fred Hutch/University of Washington Cancer Consortium		Seattle	Washington	98109	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care
D005791	Patient Care
D013812	Therapeutics