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A stepped-care intervention to reduce disparities in mental health services among underserved lung and head and neck cancer patients and their caregivers
Investigator (PI): Borrayo, Evelinn
Performing Organization (PO): (Current): University of Colorado Denver, College of Liberal Arts and Sciences, Department of Psychology / (303) 556-8565
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2016
Final Year: 2020
Record Source/Award ID: PCORI/AD-1511-33395
Funding: Total Award Amount: $1,874,066
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Problem and background: Lung cancer (LC) is the primary cause of cancer death among men and women in the United States. A significant number of these patients also develop malignant tumors of the head and neck. LC and head and neck cancer (HNC) are among the most psychologically disturbing cancers because of the impact on basic living activities (e.g., breathing, eating, swallowing) and the potential for long-term dysfunction and disfigurement. These patients tend to have poorer quality of life (QoL), higher frequency of distress, and higher risk of suicide compared with other cancer patients. The risk of significant psychological distress among LC and HNC patients increases if they are medically underserved (e.g., low income, uninsured). With this increased patient dysfunction and distress, the patients' caregivers are also at a significant risk for a number of psychological conditions, including depression and anxiety symptoms. Underserved LC and HNC patients and their caregivers report that they suffer from depression and anxiety but lack access to proper mental health services. To our knowledge, there are no published studies that have investigated whether underserved LC and HNC patients and their caregivers benefit from evidence-based treatment aimed at decreasing psychological distress. Thus, the objective of this study is to adapt, implement, and evaluate an intervention that has the potential to more effectively and efficiently provide mental health treatment to medically underserved LC and HNC patients and their caregivers. The proposed comparative effectiveness study is a randomized controlled trial (RCT) that will compare a stepped-care intervention to enhanced usual care practices. Stepped care has been recommended as a best-practice solution to increase access to mental health care for underserved patients. Stepped care maximizes the efficiency of mental health care resources by offering the least intrusive and costly treatment first and stepping up care if patients' mental health needs change or previous treatments do not help them. It works by stepping care through 1) watchful waiting (below mild symptoms), 2) getting a self-help guide (mild symptoms), 3) getting coping skills training sessions (moderate symptoms), and 4) getting cognitive-behavioral therapy sessions (severe symptoms). The intervention will target patients' and caregivers' depression and anxiety symptoms (primary outcome); ability to cope (primary outcome); and perceived stress, health-related QoL, and caregiver burden (secondary outcomes). Clinicians, patients, and caregiver stakeholders who represent the target population will be key partners in the development, implementation, and evaluation of the intervention and throughout the conduct of the RCT. We will also work closely with the clinicians, patients, and caregiver stakeholders in planning dissemination activities that would effectively reach LC and HNC patients and their caregivers.
MeSH Terms:
  • Activities of Daily Living
  • Adaptation, Psychological
  • Anxiety
  • Caregivers
  • Cognitive Behavioral Therapy
  • Comparative Effectiveness Research
  • Depression
  • Evidence-Based Medicine
  • Head and Neck Neoplasms /psychology
  • /*therapy
  • Health Services Accessibility
  • * Healthcare Disparities
  • Humans
  • Lung Neoplasms /psychology
  • /*therapy
  • Medically Underserved Area
  • Mental Health Services /*organization & administration
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Self Care
  • Stress, Psychological
  • United States
Country: United States
State: Colorado
Zip Code: 80217
UI: 20164017
CTgovId: NCT03016403
Project Status: Ongoing
Record History: ('2018: Project extended to 2020. 2017: Project extended to 2020',)