Breast Cancer Stage INCT03723863
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
A study testing Occupational Therapy in people with Breast Cancer Stage I and Breast Cancer Stage III, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Stage I, Breast Cancer Stage III, Breast Cancer Stage II
- What is being tested?
- Occupational Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2018to 22 Sep 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: The Evaluation of a Work Intervention to Facilitate Work Maintenance or Re-Entry to the Workforce for Breast Cancer Patients
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.
Read the detailed description
Patients receive in-person occupational therapist-led work consultation.
- 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
- Being tested
- Occupational Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational TherapyBehavioural
Also called Occupational Therapy, OT
Receive in-person occupational therapist-led work consultation
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (Occupational therapy) | Experimental | Patients receive in-person occupational therapist-led work consultation Receives: Behavioral: Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perceived work ability
Will be measured by the Work Abilities Index (WAI).
Measured: Baseline up to 3 years
Secondary outcomes (2)
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.
Measured: Baseline up to 3 years
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.
Measured: Baseline up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start25 Oct 2018
- Primary completion22 Sep 2020
- Study completion22 Sep 2020
Why it stopped: Study team determined that data collected was appropriate for study outcome goals.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Stage IStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Yung, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723863
- Sponsor's protocol ID
- RG1718049
- Other IDs
- NCI-2018-02059, 9993
- Status last verified
- Jun 2021
- First submitted
- 23 Oct 2018
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of a Work Intervention to Facilitate Work Maintenance or Re-Entry to the Workforce for Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03723863
- Acronym / sponsor ID
- RG1718049
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study team determined that data collected was appropriate for study outcome goals.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 22 Sep 2020 (actual)
- Study completion
- 22 Sep 2020 (actual)
- First posted
- 30 Oct 2018 (actual)
- 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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (Occupational therapy) | Experimental | Behavioral: Occupational TherapyPatients receive in-person occupational therapist-led work consultation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Occupational TherapyAlso: Occupational Therapy, OTReceive in-person occupational therapist-led work consultation | Behavioural | Supportive care (Occupational therapy) |
Primary outcome
Change in perceived work ability
Time frame: Baseline up to 3 years
Will be measured by the Work Abilities Index (WAI).
2 secondary outcomes
Change in health related quality of life
Time frame: Baseline up to 3 years
Change in financial toxicity
Time frame: Baseline up to 3 years
Results and safety
The study was stopped early (reason given: Study team determined that data collected was appropriate for study outcome goals.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Rachel Yung principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Therapy in people with Breast Cancer Stage I and Breast Cancer Stage III, run by University of Washington 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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 6 Jul 2021. 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 was stopped early (reason given: Study team determined that data collected was appropriate for study outcome goals.). Results are not available in the source record.
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?
Change in perceived work ability (time frame: Baseline up to 3 years). 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 6 Jul 2021.