- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02378597
Resiliency Program for Medical Interpreters (CARE)
March 3, 2015 updated by: Elyse Park, PhD, Massachusetts General Hospital
Developing a Resiliency Program for Medical Interpreters in Cancer Care
To develop and test a 4-session program to teach resiliency skills to Medical Interpreters.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study aims to improve quality of cancer care for LEP patients through improving medical interpreters' ability to cope with difficult encounters.
We propose to (1) identify the needs of medical interpreters working with cancer patients, and (2) develop and test a psychoeducational resiliency program at 3 DF/HCC cancer centers: MGH, DFCI, and BWH) intended to enhance interpreters' skills to effectively manage stressful encounters and to cope with the personal effects of encounters.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Interpreter employed at one of the 3 study hospitals
- >=20 hours/week
Exclusion Criteria:
1) Interpreter working <20 hours per week
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Delayed Intervention: Control
Delayed intervention: Control was a a behavioral treatment for resiliency delivered in a single 4 hour session delivered in a delayed fashion (waitlist control)
|
4 hour behavioral session including education in the relaxation response, education about stress and allostatic load, cognitive skills building, review of difficult encounters with patients.
Other Names:
|
Experimental: Experimental: Intervention
Experimental: Intervention was a 4 hour behavioral resiliency intervention.
|
4 hour behavioral session including education in the relaxation response, education about stress and allostatic load, cognitive skills building, review of difficult encounters with patients.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility and Acceptability of Intervention (participant feedback questionnaire)
Time Frame: Post-Intervention (4 weeks)
|
A participant feedback questionnaire will be completed by participants, including questions about whether the logistics and content of the intervention were feasible and acceptable to them.
Attendance to the sessions is also considered as a component of feasibility.
|
Post-Intervention (4 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychological Variables including Perceived Stress and Resiliency ( PSS-1021 is a 10-item scale)
Time Frame: Baseline, Post-Intervention (4 weeks), and 12 week follow up
|
The PSS-1021 is a 10-item scale designed to measure the degree to which situations in one's life are appraised, or considered as stressful, and how unpredictable, uncontrollable, and overloaded respondents find their lives.
Responses are on 4-item Likert scales and range from 10-40; higher score = greater stress.The Resiliency Scale is a 14-item self-report measure to assess one's ability to successfully deal with adversity.
|
Baseline, Post-Intervention (4 weeks), and 12 week follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Michele Russell-Einhorn, JD, Dana-Farber Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
June 27, 2014
First Submitted That Met QC Criteria
March 3, 2015
First Posted (Estimate)
March 4, 2015
Study Record Updates
Last Update Posted (Estimate)
March 4, 2015
Last Update Submitted That Met QC Criteria
March 3, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-524
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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