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Mental Health Assessment and Dynamic Referral for Oncology (MHADRO)

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42MH078432-02A1
Agency Tracking Number: MH078432
Amount: $1,446,420.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: N/A
Solicitation Number: PHS2009-2
Solicitation Year: 2009
Award Year: 2009
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
Langhorne, PA -
United States
DUNS: 143621105
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (508) 334-3817
Business Contact
Phone: (215) 359-3901
Research Institution
United States

 Nonprofit College or University

DESCRIPTION (provided by applicant): According to the American Cancer Society, approximately 1.3 million people are diagnosed with cancer each year, with the annual cost of treating cancer exceeding 60.9 billion. Mental health and psychosocial factors associated with cancer are poorly recognized and under-treated. The Mental Health Assessment and Dynamic Referral for Oncology (MHADRO) enables oncology treatment providers to efficiently screen for and monitor five important patient care domains, including: (1) mental health functioning; (2) cancer-related physical symptoms/side effects; (3) the patient-provider partnership; (4) barriers to treatment; and (5) adherence with medical regimen and lifestyle change recommendations. The MHADRO's individualized summary reports help oncology treatment providers to decide whether and how to intervene when clinically elevated mental health symptoms are present or when a patient reports a desire for treatment or support. Patients who choose the dynamic referral have their summary report, an authorization to release information, and their personal contact information electronically transmitted to a credentialed mental health provider, who is then responsible for contacting the patient to discuss treatment options. This process utilizes secure, HIPAA-compliant transmittal technologies. Phase 2 specific aims are: (1) Make design improvements based on Phase 1 results; (2) Test the improved MHADRO with a field trial of 30 patients selected from three participating oncology treatment centers; and (3) Evaluate the effectiveness of the MHADRO during a single blind, randomized controlled trial of 1,000 mixed cancer patients. Patients will be randomly assigned to the Intervention Group (n=500) or the Control Group (n=500). All subjects, regardless of group assignment, will undergo the same assessment procedures at baseline and at 2, 4, 6, and 12 months post-baseline. Those assigned to the Intervention Group will have their Healthcare Provider Reports printed at each of the five assessments. These reports will be reviewed by their oncology treatment team and a treatment plan will be developed for distressed patients. The patient will receive a Patient Feedback Report, which will be reviewed with him or her by a trained research coordinator (a healthcare professional). During the assessment, the Intervention Group subjects will be given the opportunity to obtain more information on available psychosocial support groups and offered a dynamic referral to a psychiatrist, mental health counselor, and/or smoking cessation program. Subjects assigned to the Control Condition will undergo the same five MHADRO assessments. However, their reports will not be printed, nor will they be offered the mental health referrals or psychosocial support group information. Rather, they will be managed using the standard of care provided at the site (i.e., treatment-as-usual). We will use Generalized Estimating Equations (GEE) and Linear Mixed Modeling (LMM) to examine group differences in distress over time, while adjusting for potential confounding variables such as illness severity and phase of treatment. PUBLIC HEALTH RELEVANCE: Several national organizations, including the National Comprehensive Care Network, the National Cancer Institute, and the Institute of Medicine, have advocated routine screening for psychological distress among cancer patients and have emphasized the central role of building a collaborative patient-provider partnership to address psychosocial issues. The lack of consistent assessment of psychosocial factors and the patient-provider partnership is a significant problem with far-reaching consequences, including excess suffering, impaired quality of life, treatment dissatisfaction, and treatment non-adherence. The MHADRO has the potential to impact these outcomes through identifying distressed patients, helping the team decide what action should be taken, strengthening the patient-provider partnership, producing a personalized patient feedback report, facilitating mental health treatment engagement, and monitoring patients' response to treatment.

* Information listed above is at the time of submission. *

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