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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02087787
Other study ID # 2013NTLS112
Secondary ID
Status Withdrawn
Phase N/A
First received March 12, 2014
Last updated November 1, 2017
Start date March 2014
Est. completion date February 2016

Study information

Verified date November 2017
Source University of Minnesota - Clinical and Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to develop and test the effects of a marrow transplant (BMT) Legal Clinic established through a medical-legal partnership (MLP) in an adult blood and marrow (BMT) transplant setting. This will be a 2-arm randomized, controlled clinical trial, in which the intervention group of patients will participate in a BMT Legal Clinic and the control group is provided standard information regarding legal resources.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 2016
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
BMT Legal Clinic
2 hour consultation with an attorney in the BMT Legal Clinic with potential follow-up as needed.

Locations

Country Name City State
United States University of Minnesota Medical Center, Fairview Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference between Concern and Well-being score The difference between the Concern and Well-being score from baseline to post-transplant (MyCaW scale) 100 days
Secondary Proportion of patients with specific legal concerns Proportion of patients with specific legal concerns 100 days
Secondary Mean cost of legal services Cost of legal services over 100 days post transplant 100 days
Secondary Proportion of patients satisfied 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
Secondary Average PSS-10 score Average score on PSS-10 stress scale 100 days
Secondary Number of hours on legal service Number of hours spent on legal service for 100 days post transplant 100 days