Indiana Cancer Pain and Depression (INCPAD) Trial Design of a Telecare Management Intervention for Cancer-Related Symptoms and Baseline Characteristics of Study Participants

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.