The Indiana Cancer Pain and Depression (INCPAD) trial Design of a telecare management intervention for cancer-related symptoms and baseline characteristics of study participants

印第安纳州癌症疼痛和抑郁症 (INCPAD) 试验:针对癌症相关症状的远程医疗管理干预措施的设计及研究参与者的基线特征

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Abstract

OBJECTIVE: Pain and depression are two of the most prevalent and treatable cancer-related symptoms, each present in at least 20-30% of oncology patients. Both symptoms are frequently either unrecognized or undertreated, however. This article describes a telecare management intervention delivered by a nurse-psychiatrist team that is designed to improve recognition and treatment of pain and depression. The enrolled sample is also described. METHODS: The Indiana Cancer Pain and Depression study is a National Cancer Institute-sponsored randomized clinical trial. Four hundred five patients with cancer-related pain and/or clinically significant depression from 16 urban or rural oncology practices throughout Indiana have been enrolled and randomized to either the intervention group or to a usual-care control group. Intervention patients receive centralized telecare management coupled with automated home-based symptom monitoring. Outcomes will be assessed at 1, 3, 6 and 12 months by research assistants blinded to treatment arms. RESULTS: Of 4465 patients screened, 2185 (49%) endorsed symptoms of pain or depression. Of screen-positive patients, about one-third were ineligible (most commonly due to pain or depression not meeting severity thresholds or to pain that is not related to cancer). Of the 405 patients enrolled, 32% have depression only, 24% have pain only and 44% have both depression and pain. At baseline, participants reported an average of 16.8 days out of the past 4 weeks during which they were confined to bed or had to reduce their usual activities by > or =50% due to pain or depression. Also, 176 (44%) reported being unable to work due to health reasons. CONCLUSIONS: When completed, the Indiana Cancer Pain and Depression trial will test whether centralized telecare management coupled with automated home-based symptom monitoring improves outcomes in cancer patients with depression and/or pain. Findings will be important for both oncologists and mental health clinicians confronted with oncology patients' depression or pain.

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