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, however, frequently go either unrecognized and/or under-treated. Four common harriers include underdetection, inadequate initial treatment, failure to monitor adherence and symptom response, and failure to adjust treatment in patients not responding or intolerant of initial therapy. Nurse-delivered care management models proven effective for depression in primary care have considerable potential for optimizing both depression and pain care in cancer patients. Therefore, we propose to conduct the Indiana Cancer Pain and Depression (INCPAD) study, a randomized clinical trial conducted in a statewide network of community-based cancer clinics located in both rural and urban oncology practices. INCPAD will enroll 480 patients with cancer-related pain (n = 240) or clinical depression (n = 240), randomizing them to either the intervention or usual care control group. The intervention will be based upon the empirically-validated Three-Component Model (TCM) which for INCPAD will involve collaboration between the oncology practice, a centralized nurse care manager, and a supervising pain-psychiatrist. In this trial, TCM will involve an innovative telemedicine approach involving automated home-based symptom monitoring coupled with telephone-based nurse care management. All subjects will undergo comprehensive outcome assessment at baseline, 1, 3, 6 and 12 months by interviewers blinded to treatment group. Our principal aim is to test whether TCM is more effective than usual care in improving the co-primary outcomes of depression and pain. Secondarily, we will test the intervention's impact on health-related quality of life, cost-effectiveness of care, and treatment satisfaction. This intervention has the potential for improving symptom management in cancer patients across a wide range of oncology practices that may be geographically dispersed and varying in location (rural or urban), health plan, payer, or other characteristics. Furthermore, if proven effective for depression and pain, TCM could readily be expanded to reducing barriers and improving care of other cancer-related symptoms.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA115369-03
Application #
7275369
Study Section
Special Emphasis Panel (ZCA1-SRRB-3 (M1))
Program Officer
O'Mara, Ann M
Project Start
2005-09-30
Project End
2010-01-31
Budget Start
2007-08-01
Budget End
2008-07-31
Support Year
3
Fiscal Year
2007
Total Cost
$460,798
Indirect Cost
Name
Indiana University-Purdue University at Indianapolis
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
603007902
City
Indianapolis
State
IN
Country
United States
Zip Code
46202
Kroenke, Kurt; Wu, Jingwei; Yu, Zhangsheng et al. (2016) Patient Health Questionnaire Anxiety and Depression Scale: Initial Validation in Three Clinical Trials. Psychosom Med 78:716-27
Choi Yoo, Sung J; Nyman, John A; Cheville, Andrea L et al. (2014) Cost effectiveness of telecare management for pain and depression in patients with cancer: results from a randomized trial. Gen Hosp Psychiatry 36:599-606
Brown, Linda F; Rand, Kevin L; Bigatti, Silvia M et al. (2013) Longitudinal relationships between fatigue and depression in cancer patients with depression and/or pain. Health Psychol 32:1199-208
Johns, Shelley A; Kroenke, Kurt; Krebs, Erin E et al. (2013) Longitudinal comparison of three depression measures in adult cancer patients. J Pain Symptom Manage 45:71-82
Kroenke, Kurt; Johns, Shelley A; Theobald, Dale et al. (2013) Somatic symptoms in cancer patients trajectory over 12 months and impact on functional status and disability. Support Care Cancer 21:765-73
Kroenke, Kurt; Theobald, Dale; Wu, Jingwei et al. (2012) Comparative responsiveness of pain measures in cancer patients. J Pain 13:764-72
Wang, Hsiao-Lan; Kroenke, Kurt; Wu, Jingwei et al. (2012) Predictors of cancer-related pain improvement over time. Psychosom Med 74:642-7
Johns, Shelley A; Kroenke, Kurt; Theobald, Dale E et al. (2011) Telecare management of pain and depression in patients with cancer: patient satisfaction and predictors of use. J Ambul Care Manage 34:126-39
Wang, Hsiao-Lan; Kroenke, Kurt; Wu, Jingwei et al. (2011) Cancer-related pain and disability: a longitudinal study. J Pain Symptom Manage 42:813-21
Brown, Linda F; Kroenke, Kurt; Theobald, Dale E et al. (2011) Comparison of SF-36 vitality scale and Fatigue Symptom Inventory in assessing cancer-related fatigue. Support Care Cancer 19:1255-9

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