Blood or Marrow TransplantNCT02087787
Medical-legal Partnership (MLP) to Support Bone Marrow Transplant
A study testing BMT Legal Clinic in people with Blood or Marrow Transplant, run by University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood or Marrow Transplant
- What is being tested?
- BMT Legal Clinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Feb 2016
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, 55455
About this study
Official title: 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.
Read the 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.
- Conditions
- Blood or Marrow Transplant
- Being tested
- BMT Legal Clinic
- Keywords
- bone marrow transplant, hematologic malignancies
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMT Legal ClinicBehavioural
2 hour consultation with an attorney in the BMT Legal Clinic with potential follow-up as needed.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| Intervention | Experimental | 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. Receives: Behavioral: BMT Legal Clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between Concern and Well-being score
The difference between the Concern and Well-being score from baseline to post-transplant (MyCaW scale)
Measured: 100 days
Secondary outcomes (5)
Proportion of patients with specific legal concerns
Proportion of patients with specific legal concerns
Measured: 100 days
Mean cost of legal services
Cost of legal services over 100 days post transplant
Measured: 100 days
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
Measured: 100 days
Average PSS-10 score
Average score on PSS-10 stress scale
Measured: 100 days
Number of hours on legal service
Number of hours spent on legal service for 100 days post transplant
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood or Marrow TransplantStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leslie Parran, MS, RN, Principal investigator, University of Minnesota Medical Center, Fairview
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087787
- Sponsor's protocol ID
- 2013NTLS112
- Status last verified
- Nov 2017
- First submitted
- 12 Mar 2014
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a BMT Legal Clinic to Support Patients With Cancer Undergoing Blood or Marrow Transplant
- ClinicalTrials.gov ID
- NCT02087787
- Acronym / sponsor ID
- 2013NTLS112
- Conditions
- Blood or Marrow Transplant
- Keywords
- bone marrow transplant, hematologic malignancies
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 14 Mar 2014 (estimated)
- 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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| Intervention | Experimental | Behavioral: BMT Legal ClinicThe intervention group will be provided with a 2 hour consultation with an attorney in the BMT Legal Clinic with potential follow-up as needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| BMT Legal Clinic2 hour consultation with an attorney in the BMT Legal Clinic with potential follow-up as needed. | Behavioural | Intervention |
Primary outcome
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)
5 secondary outcomes
Proportion of patients with specific legal concerns
Time frame: 100 days
Mean cost of legal services
Time frame: 100 days
Proportion of patients satisfied
Time frame: 100 days
Average PSS-10 score
Time frame: 100 days
Number of hours on legal service
Time frame: 100 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
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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.
Leslie Parran, MS, RN principal investigator
University of Minnesota Medical Center, Fairview
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BMT Legal Clinic in people with Blood or Marrow Transplant, run by University of Minnesota 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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 6 Nov 2017. 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 withdrawn before enrolling participants, so there are no results.
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?
Difference between Concern and Well-being score (time frame: 100 days). 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 Nov 2017.