Medical-legal Partnership (MLP) to Support Bone Marrow Transplant

November 1, 2017 updated by: University of Minnesota

Establishing a BMT Legal Clinic to Support Patients With Cancer Undergoing Blood or Marrow Transplant

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center, Fairview

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
Behavioral: BMT Legal Clinic
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Leslie Parran, MS, RN, University of Minnesota Medical Center, Fairview

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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