This new section of U.S. Medicine will bring to our readers highlights from the peer-reviewed literature and clinical trials of topics that are of most universal interest to the readers of this multidisciplinary magazine. While it is virtually impossible to address the needs of every specialist in every issue, our editors are committed to reviewing the most topical and relevant studies in journals that you may not receive. We welcome your input on this new section
Pain, Psychiatric Disorders, and Disability Among Veterans With and Without Polytrauma; Department of Veterans Affairs
Purpose: We believe information to be obtained from this proposed study will prove critical for planning future VA healthcare strategies and developing effective and efficient treatments targeting pain and emotional adjustment difficulties among individuals with polytrauma and returning Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) personnel. More specifically, this study will be the first to provide systematic data regarding pain and emotional problem prevalence, course, associated impairments, risk factors, and barriers to care and community reintegration among returning OEF and OIF service members with and without polytrauma.
James A. Haley Veterans Hospital, Tampa Recruiting
Tampa, Florida, United States, 33612
Contact: Michael E Clark, PhD MA
Psychiatric Advance Directives for Improved Mental Health Care; Department of Veterans Affairs
(Completed; Data still being analyzed)
Purpose: During a psychiatric crisis, persons with severe mental illness (SMI) confront complex challenges concerning treatment choices and are often ill equipped or unable to make mental health care decisions. Psychiatric Advance Directives (PADs) are legal documents that allow competent persons to declare their treatment preferences in advance of a mental health crisis, when they may lose capacity to make reliable health care decisions. The use of PADs is consistent with recommendations of the President’s New Freedom Commission on Mental Illness and the Patient Self-Determination Act; 25 states have now adopted PAD legislation. VA does not have a specific policy for PADs or mechanisms to notify veterans of their right to prepare PADs. The downstream effects of PADs on patient care, crisis management, service use, and clinical outcomes are unknown.
Durham VA Medical Center
Durham, North Carolina, United States, 27705
Jennifer L. Strauss, BA MS PhD
Do Treatment Improvements in PTSD Severity Affect Substance Use Outcomes? A Secondary Analysis from a Randomized Clinical Trial in NIDA’s Clinical Trials Network
(Completed; published in American Journal of Psychiatry, Jan 2010)
Purpose: The purpose of the analysis was to examine the temporal course of improvement in Posttraumatic Stress Disorder (PTSD) and substance use disorder symptoms among women in outpatient substance abuse treatment.
Results: Non-responders, substance use responders and global responders tended to maintain original classification; PTSD responders were significantly more likely to transition to global responders over time, indicating maintained PTSD improvement was associated with subsequent substance use improvement. Trauma-focused treatment was significantly more effective in achieving substance use improvement compared to the health education group, but only among those who were heavy substance users at baseline and had achieved significant PTSD reductions.
Conclusions: PTSD severity reductions were more likely to be associated with substance use improvement, with minimal evidence of substance use symptom reduction improving PTSD symptoms. Results support the self-medication model of coping with PTSD symptoms and an empirical basis for integrated interventions for improved substance use outcomes in patients with severe symptomatology.
Denise A. Hien, PhD
Cancer Care in the National Cancer Institute Center for Cancer Research
(This study is currently recruiting participants.)
Verified by National Institutes of Health Clinical Center (CC), September 2009 Purpose: This study provides cancer care through the National Cancer Institute’s Medical Oncology Branch (MOB) to patients who are not enrolled in an active treatment research protocol. Patients receive standard treatments only; no investigational therapies are provided on this protocol.
Patients 18 years of age and older may be eligible for this protocol. Candidates are patients for whom an NCI investigator decides that the interests of the patient and the NCI are best served by the patient’s enrollment in this protocol to receive care and follow-up within the MOB. This includes patients in the following categories:
- Patients previously enrolled in NCI trials whose participation in this protocol may continue to provide researchers important scientific information
- Patients who will be eligible for a research protocol within the foreseeable future
- Patients whose medical welfare will be seriously compromised by referral back to the community, such as patients with a rare or complex disease for which community resources are inadequate or unavailable
- Terminally ill patients who have received most of their specialized medical care at the Clinical Center and for whom humanitarian considerations dictate that they continue to receive their medical care at NIH after going off study for the remaining weeks or months of life
- Patients with cancer or HIV, or people at risk for cancer or HIV for whom cancer treatments at the NCI are requested through the MOB consult service
- Patients who are participating in a non-treatment NCI research protocol and require standard-of-care therapy
- Patients with cancer or HIV or people at risk for cancer for whom cancer treatment or management at the NCI would add significant value to the institute’s cancer training program
Participants receive standard medical care, including periodic routine laboratory tests, diagnostic x-rays, and nuclear medicine scans to monitor the course of illness and the effects of any treatment. Contacts and Locations: Please refer to this study by its ClinicalTrials.gov identifier: NCT00923065. Contact is NCI Referral Office, 1-888-NCI1937, firstname.lastname@example.org.
A Correlative Study for Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer
(This study is currently recruiting participants.)
Verified by Hoosier Oncology Group, November 2009
Purpose: The proposed trial provides a unique opportunity in that it combines genomic, proteomic, and pharmacogenomic assessments in patients receiving the most commonly used chemotherapies for advanced breast cancer. To date no other trial has analyzed gene and protein expression at the same time points in the same patient, combined with clinical outcome. Similar to previous attempts to predict response based on expression of a single gene or protein, the researchers expect that neither genomic or proteomic profiling alone will be sufficient to optimize therapy. Rather, the researchers expect an iterative process that combines information gleaned from both platforms, modified to avoid toxicity based on pharmacogenomics.
Primary Outcome Measures: To correlate tumor gene expression (genomic profile) with response to commonly used chemotherapies in patients with advanced breast cancer (Time Frame: 36 months; Designated as safety issue: No)
Secondary Outcome Measures:
To correlate serum and tumor proteomic profiles with response to commonly used chemotherapies. (Time Frame: 36 months; (Designated as safety issue: No)
To compare serum and tissue proteomic analyses. (Time Frame: 36 months; Designated as safety issue: No)
To compare genomic and proteomic profiles. (Time Frame: 36 months; Designated as safety issue: No)
To correlate toxicity and/or response with drug-specific pharmacogenomic parameters. (Time Frame: 36 months; Designated as safety issue: Yes)
Estimated Enrollment: 160
Study Start Date: September 2005
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: September 2010
Sponsors and Collaborators: Hoosier Oncology Group, Department of Defense, Indiana University School of Medicine, Walther Cancer Institute
Study Chair: Kathy Miller, M.D., Hoosier Oncology Group, LLC
Principal Investigator: George Sledge, M.D., Hoosier Oncology Group, LLC