Aggressive care in Intensive Care Units (ICUs) has been shown to impair the quality of life of patients with advanced cancer and increase the risk of Posttraumatic Stress Disorder (PTSD) among the family and friends who serve as informal caregivers. Because a majority of cancer patients in the ICU are unable to communicate, caregivers must often serve as the patient’s surrogate and make life-and-death decisions on the patient’s behalf while experiencing intense grief and extreme distress. Unfortunately, recent data found that palliative care interventions in the ICU increased, rather than decreased, the caregiver’s risk of PTSD at 3-month follow-up. Thus, there is a pressing need for an intervention to assist caregivers in coping with this extremely stressful and potentially psychologically traumatic situation. We propose here to develop further and pilot test a brief mental health intervention called “Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience of Caregivers of ICU Cancer Patients” (EMPOWER). EMPOWER is a cognitive-behavioral, acceptance-based intervention delivered by a trained social worker to informal caregivers in the ICU. Because it is delivered in the ICU, caregiver concerns about leaving the patient are minimized. EMPOWER uses discrete ~15-minute modules that can be delivered flexibly to a vulnerable set of caregivers and can accommodate multiple interruptions and unexpected crises. The EMPOWER intervention targets caregiver symptoms of “peritraumatic stress” (e.g., feeling in shock) and anticipatory grief (e.g., separation distress evoked by the patient’s impending death) to reduce “experiential avoidance” (i.e., avoidance of unpleasant thoughts and feelings). Reducing this type of avoidant behavior removes a substantial barrier to appropriate advance care planning for the patient. To refine and pilot EMPOWER, this application seeks to: 1) obtain feedback on EMPOWER from key informants using the Delphi Method; 2) determine the feasibility, tolerability, acceptability, and preliminary effects of EMPOWER on caregiver PTSD symptom severity 3 months from baseline; and 3) determine preliminary effects of EMPOWER on patient outcomes (e.g., intensity of care, quality of life/death) 1 month from baseline. These 3 aims will be accomplished in 2 phases. In Phase 1, bereaved ICU cancer patient caregivers (n=12) and ICU clinicians (n=12) will critique EMPOWER Version 1.0 to inform improvements. In Phase 2, 60 caregivers of critically ill and uncommunicative ICU cancer patients will be randomized to either EMPOWER Version 2.0 (n=30) or usual care (n=30). EMPOWER is expected to: a) reduce experiential avoidance; b) increase rates of advance care planning; c) reduce intensity of patient care/increase palliative care; d) improve patient quality of life/death; and e) reduce severity of caregivers’ PTSD symptoms. Hitting any of these targets alone is expected to significantly improve cancer patient and caregiver outcomes; hitting more than one would be a boon to public health.
Holly G. Prigerson, Paul K. Maciejewski and Wendy Lichtenthal
American Cancer Society