- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02087787
Medical-legal Partnership (MLP) to Support Bone Marrow Transplant
Establishing a BMT Legal Clinic to Support Patients With Cancer Undergoing Blood or Marrow Transplant
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Blood or marrow transplant patients (BMT) may experience legal support needs through their transplant process. Specific examples of medical-legal issues impacting BMT patients include social security disability benefits, Will/estate issues, employment concerns, and creditor issues. At the beginning of the transplant process, BMT patient-families are often overwhelmed by the stress of transplant, and their focus is usually on their care and treatment needs. Legal planning that may be important to patient-families may not be considered or deferred.
Presently, the process of referral to legal services is predominantly a reactive process. Once a patient identifies a legal issue or concern to a BMT social worker, this is often after the issue escalates to the point where it creates significant stress for the patient-family. The BMT social workers have prolonged contact with these patients and frequently spend many hours trying to assist patients to resolve these issues.
Cancer Legal Line (CALL) provides caring and compassionate pro bono legal consultation and other referral or pro-bono legal services based on income guidelines to Minnesotans affected by cancer. CALL has provided this support based on Blood and Marrow Transplant (BMT) social work referral for the past 5 years. To our knowledge, there have been no medical-legal partnerships established within hospitals for patients undergoing blood or marrow transplant with cancer.
It is hypothesized that by establishing an onsite BMT Legal Clinic through a Medical-Legal Partnership (MLP), that patient-and families can be better served through proactive legal consultation. The BMT Legal Clinic would serve to connect the CALL staff with the BMT care team to better serve patients to address patients' concerns, promote well-being, and reduce stress related to medical-legal issues.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Medical Center, Fairview
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients who are at least 18 years old, who have been identified by the BMT social worker as having a cancer or pre-cancer diagnosis and are Minnesota residents with potential legal needs (see the list below), expected to proceed to transplant, considered the primary client for legal services or are at least 18 years old and have a legal-designate.
- The patient or legal designate must be able to complete study tools by the BMT social workers. Interpreters will be provided by UMMC for non-English speaking pt's and BMT social workers will assist patients who cannot read.
- Patients must have interest in a legal consultation as specified by the I-Help model to receive free legal consultation.
Exclusion Criteria:
- Patients who do not have any identified any potential legal needs, or whose legal needs are beyond those covered in the I-Help model.
- Patients with non-cancer diagnoses, as CALL only provides services for cancer or pre-cancer diagnoses.
- Patients who are not residents of Minnesota as CALL attorneys are only licensed to practice law in Minnesota.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
The control group will be provided the standard method, which is providing the Cancer Legal Line (CALL) brochure with a short explanation of the resource.
|
|
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Experimental: Intervention
The intervention group will be provided with a 2 hour consultation with an attorney in the BMT Legal Clinic with potential follow-up as needed.
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2 hour consultation with an attorney in the BMT Legal Clinic with potential follow-up as needed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference between Concern and Well-being score
Time Frame: 100 days
|
The difference between the Concern and Well-being score from baseline to post-transplant (MyCaW scale)
|
100 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of patients with specific legal concerns
Time Frame: 100 days
|
Proportion of patients with specific legal concerns
|
100 days
|
|
Mean cost of legal services
Time Frame: 100 days
|
Cost of legal services over 100 days post transplant
|
100 days
|
|
Proportion of patients satisfied
Time Frame: 100 days
|
Self-reported assessment of patient satisfaction using the proportion of patients who were satisfied or very satisfied with the legal services by day 100 post transplant
|
100 days
|
|
Average PSS-10 score
Time Frame: 100 days
|
Average score on PSS-10 stress scale
|
100 days
|
|
Number of hours on legal service
Time Frame: 100 days
|
Number of hours spent on legal service for 100 days post transplant
|
100 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leslie Parran, MS, RN, University of Minnesota Medical Center, Fairview
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2013NTLS112
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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