This revised competitive renewal application seeks to determine among family caregivers and patients with advanced (stages III or IV) disease who are undergoing a course of chemotherapy and who report both pain and fatigue during the past 7 days, the effect of an 8-week, 6-contact problem-solving, self care management intervention upon the number of symptoms, physical role impact, social function and emotional distress when compared with family caregivers and patients with identical inclusion criteria but who are exposed to an attention control intervention. The Patient Intervention for Management of Symptoms and Support (PIMSS) assists patients and their caregivers to address and manage three problem domains; symptoms, function (physical role impact and social function), and emotional distress. Problems in each domain are addressed through 4 intervention themes; self-care behaviors, communication with family and providers, information-teaching, and counseling and support. Evidenced-based intervention strategies and NCCN guidelines are selected from computer assisted documentation that allows nurses to individualize strategies for implementation and to enhance patient self-efficacy so that strategies are retained following the intervention. Patients are directed to communicate with their family caregivers to assist them to implement interventions at home and to respond to requests for assistance. Patients and caregivers in both arms of the trial receive the same number of in-person and telephone contacts. Both groups receive toolkits. The attention control intervention and toolkit provides no content related to symptoms, function or distress. Thus the effect of content provided in the experimental arm may be separated from attention alone. This research will accrue 350 patients from three cancer enters with an attrition rate of 30% to retain the needed 244 cases (122 per arm) for the final analyses. The primary outcome on which power is calculated is the number of symptoms at 9 weeks. This research builds carefully upon evidence from a current RCT which supports the impact of chemotherapy, stage, and presence of pain and fatigue upon the risk of poor outcomes. If a shorter, more intense intervention can improve the outcomes of patients at high risk, this provides theoretically based evidence of the """"""""value added"""""""" contribution of behavioral interventions towards improving outcomes important to patients and families. That would make such interventions compelling additions to clinical practice.
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