CONTEXT: Pain and depression are 2 of the most prevalent and treatable cancer-related symptoms, yet they frequently go unrecognized, undertreated, or both. OBJECTIVE: To determine whether centralized telephone-based care management coupled with automated symptom monitoring can improve depression and pain in patients with cancer. DESIGN, SETTING, AND PATIENTS: Randomized controlled trial conducted in 16 community-based urban and rural oncology practices involved in the Indiana Cancer Pain and Depression (INCPAD) trial. Recruitment occurred from March 2006 through August 2008 and follow-up concluded in August 2009. The participating patients had depression (Patient Health Questionnaire-9 score > or = 10), cancer-related pain (Brief Pain Inventory [BPI] worst pain score > or = 6), or both. INTERVENTION: The 202 patients randomly assigned to receive the intervention and 203 to receive usual care were stratified by symptom type. Patients in the intervention group received centralized telecare management by a nurse-physician specialist team coupled with automated home-based symptom monitoring by interactive voice recording or Internet. MAIN OUTCOME MEASURES: Blinded assessment at baseline and at months 1, 3, 6, and 12 for depression (20-item Hopkins Symptom Checklist [HSCL-20]) and pain (BPI) severity. RESULTS: Of the 405 participants enrolled in the study, 131 had depression only, 96 had pain only, and 178 had both depression and pain. Of the 274 patients with pain, 137 patients in the intervention group had greater improvements in BPI pain severity over the 12 months of the trial whether measured as a continuous severity score or as a categorical pain responder (> or = 30% decrease in BPI) than the 137 patients in the usual-care group (P < .001 for both). Similarly, of the 309 patients with depression, the 154 patients in the intervention group had greater improvements in HSCL-20 depression severity over the 12 months of the trial whether measured as a continuous severity score or as a categorical depression responder (> or = 50% decrease in HSCL) than the 155 patients in the usual care group (P < .001 for both). The standardized effect size for between-group differences at 3 and 12 months was 0.67 (95% confidence interval [CI], 0.33-1.02) and 0.39 (95% CI, 0.01-0.77) for pain, and 0.42 (95% CI, 0.16-0.69) and 0.41 (95% CI, 0.08-0.72) for depression. CONCLUSION:Centralized telecare management coupled with automated symptom monitoring resulted in improved pain and depression outcomes in cancer patients receiving care in geographically dispersed urban and rural oncology practices. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00313573.
RCT Entities:
CONTEXT: Pain and depression are 2 of the most prevalent and treatable cancer-related symptoms, yet they frequently go unrecognized, undertreated, or both. OBJECTIVE: To determine whether centralized telephone-based care management coupled with automated symptom monitoring can improve depression and pain in patients with cancer. DESIGN, SETTING, AND PATIENTS: Randomized controlled trial conducted in 16 community-based urban and rural oncology practices involved in the Indiana Cancer Pain and Depression (INCPAD) trial. Recruitment occurred from March 2006 through August 2008 and follow-up concluded in August 2009. The participating patients had depression (Patient Health Questionnaire-9 score > or = 10), cancer-related pain (Brief Pain Inventory [BPI] worst pain score > or = 6), or both. INTERVENTION: The 202 patients randomly assigned to receive the intervention and 203 to receive usual care were stratified by symptom type. Patients in the intervention group received centralized telecare management by a nurse-physician specialist team coupled with automated home-based symptom monitoring by interactive voice recording or Internet. MAIN OUTCOME MEASURES: Blinded assessment at baseline and at months 1, 3, 6, and 12 for depression (20-item Hopkins Symptom Checklist [HSCL-20]) and pain (BPI) severity. RESULTS: Of the 405 participants enrolled in the study, 131 had depression only, 96 had pain only, and 178 had both depression and pain. Of the 274 patients with pain, 137 patients in the intervention group had greater improvements in BPI pain severity over the 12 months of the trial whether measured as a continuous severity score or as a categorical pain responder (> or = 30% decrease in BPI) than the 137 patients in the usual-care group (P < .001 for both). Similarly, of the 309 patients with depression, the 154 patients in the intervention group had greater improvements in HSCL-20 depression severity over the 12 months of the trial whether measured as a continuous severity score or as a categorical depression responder (> or = 50% decrease in HSCL) than the 155 patients in the usual care group (P < .001 for both). The standardized effect size for between-group differences at 3 and 12 months was 0.67 (95% confidence interval [CI], 0.33-1.02) and 0.39 (95% CI, 0.01-0.77) for pain, and 0.42 (95% CI, 0.16-0.69) and 0.41 (95% CI, 0.08-0.72) for depression. CONCLUSION: Centralized telecare management coupled with automated symptom monitoring resulted in improved pain and depression outcomes in cancerpatients receiving care in geographically dispersed urban and rural oncology practices. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00313573.
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