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| ID | Type | Description | Link |
|---|---|---|---|
| IUMC-051009 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Telemedicine may help in the treatment of depression and/or pain caused by cancer. It is not yet known whether telemedicine is more effective than standard care in treating depression and/or pain caused by cancer.
PURPOSE: This phase III randomized clinical trial is studying telemedicine to see how well it works compared to standard care in treating patients with depression and/or pain caused by cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, longitudinal, multicenter study. Patients are stratified according to study site and type of symptom (pain only vs depression only vs pain and depression). Patients are randomized to 1 of 2 treatment arms.
In both arms, patients are interviewed at baseline, 1, 3, 6, and 12 months. Patients are asked questions about pain, depression, other physical and emotional symptoms, work activities, quality of life, and satisfaction with treatment.
PROJECTED ACCRUAL: A total of 480 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| management of therapy complications | Procedure | |||
| pain therapy | Procedure | |||
| psychosocial assessment and care | Procedure | |||
| quality-of-life assessment | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Compare efficacy of 3-component model telemedicine intervention to standard care in terms of depression and pain at baseline and 1, 3, 6, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life at baseline and 1, 3, 6, and 12 months | ||
| Cost-effectiveness of care at baseline and 1, 3, 6, and 12 months | ||
| Treatment satisfaction at baseline and 1, 3, 6, and 12 months |
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DISEASE CHARACTERISTICS:
Diagnosis of cancer AND 1 or both of the following:
Clinical depression
Depression must be of at least moderate severity (PHQ-9 score ≥ 10)
No depression directly precipitated by cancer therapy for which depression is a well known side effect (e.g., interferon, corticosteroids)
Cancer-related pain
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Kurt Kroenke, MD | Regenstrief Institute, Incorporated | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Cancer Center at Community Hospital of Anderson | Anderson | Indiana | 46011 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19777535 | Result | Brown LF, Kroenke K, Theobald DE, Wu J, Tu W. The association of depression and anxiety with health-related quality of life in cancer patients with depression and/or pain. Psychooncology. 2010 Jul;19(7):734-41. doi: 10.1002/pon.1627. | |
| 20628129 | Result | Kroenke K, Theobald D, Wu J, Norton K, Morrison G, Carpenter J, Tu W. Effect of telecare management on pain and depression in patients with cancer: a randomized trial. JAMA. 2010 Jul 14;304(2):163-71. doi: 10.1001/jama.2010.944. |
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| Community Cancer Care at Bedford Oncology Specialty Clinic |
| Bedford |
| Indiana |
| 47421 |
| United States |
| Columbus Regional Hospital Cancer Center | Columbus | Indiana | 47201 | United States |
| Community Cancer Care at Putnam County Hospital | Greencastle | Indiana | 46135 | United States |
| Community Cancer Care at Decatur County Hospital | Greensburg | Indiana | 47240 | United States |
| Regenstrief Institute, Incorporated | Indianapolis | Indiana | 46202-2872 | United States |
| Community Cancer Care | Indianapolis | Indiana | 46202 | United States |
| Veterans Affairs Medical Center - Indianapolis | Indianapolis | Indiana | 46202 | United States |
| William N. Wishard Memorial Hospital | Indianapolis | Indiana | 46202 | United States |
| Methodist Cancer Center at Methodist Hospital | Indianapolis | Indiana | 46206-1367 | United States |
| Community Regional Cancer Care at Community Hospital East | Indianapolis | Indiana | 46219 | United States |
| Community Regional Cancer Care at Community Hospital North | Indianapolis | Indiana | 46256 | United States |
| Community Cancer Care at Howard Regional Health System | Kokomo | Indiana | 46902 | United States |
| Community Cancer Care at King's Daughters' Hospital | Madison | Indiana | 47250 | United States |
| Schneck Medical Center | Seymour | Indiana | 47274 | United States |
| Community Cancer Care at Perry County Hospital | Tell City | Indiana | 47586 | United States |
| Community Cancer Care at Tipton County Memorial Hospital | Tipton | Indiana | 46072 | United States |
| 20937930 | Result | Kroenke K, Zhong X, Theobald D, Wu J, Tu W, Carpenter JS. Somatic symptoms in patients with cancer experiencing pain or depression: prevalence, disability, and health care use. Arch Intern Med. 2010 Oct 11;170(18):1686-94. doi: 10.1001/archinternmed.2010.337. |
| 41436014 | Derived | He A, Kroenke K, Stump T, Monahan PO, Connors J, Chernyak Y, Musey P. The patient health questionnaire somatization-anxiety-depression scale: Validation of the PHQ-SAD in 4 clinical trials. J Affect Disord. 2026 Apr 1;398:120906. doi: 10.1016/j.jad.2025.120906. Epub 2025 Dec 21. |
| 32559503 | Derived | Cohee AA, Kroenke K, Vachon E, Wu J, Tu W, Johns SA. Predictors of depression outcomes in adults with cancer: A 12 month longitudinal study. J Psychosom Res. 2020 Sep;136:110169. doi: 10.1016/j.jpsychores.2020.110169. Epub 2020 Jun 11. |
| 27187854 | Derived | Kroenke K, Wu J, Yu Z, Bair MJ, Kean J, Stump T, Monahan PO. Patient Health Questionnaire Anxiety and Depression Scale: Initial Validation in Three Clinical Trials. Psychosom Med. 2016 Jul-Aug;78(6):716-27. doi: 10.1097/PSY.0000000000000322. |
| 25130518 | Derived | Choi Yoo SJ, Nyman JA, Cheville AL, Kroenke K. Cost effectiveness of telecare management for pain and depression in patients with cancer: results from a randomized trial. Gen Hosp Psychiatry. 2014 Nov-Dec;36(6):599-606. doi: 10.1016/j.genhosppsych.2014.07.004. Epub 2014 Jul 19. |
| 23023681 | Derived | Hayano J, Carney RM, Watanabe E, Kawai K, Kodama I, Stein PK, Watkins LL, Freedland KE, Blumenthal JA. Interactive associations of depression and sleep apnea with adverse clinical outcomes after acute myocardial infarction. Psychosom Med. 2012 Oct;74(8):832-9. doi: 10.1097/PSY.0b013e31826d2c81. Epub 2012 Sep 28. |
| 22753637 | Derived | Wang HL, Kroenke K, Wu J, Tu W, Theobald D, Rawl SM. Predictors of cancer-related pain improvement over time. Psychosom Med. 2012 Jul-Aug;74(6):642-7. doi: 10.1097/PSY.0b013e3182590904. Epub 2012 Jun 28. |
| 21494337 | Derived | Dube P, Kurt K, Bair MJ, Theobald D, Williams LS. The p4 screener: evaluation of a brief measure for assessing potential suicide risk in 2 randomized effectiveness trials of primary care and oncology patients. Prim Care Companion J Clin Psychiatry. 2010;12(6):PCC.10m00978. doi: 10.4088/PCC.10m00978blu. |
| ID | Term |
|---|---|
| D003863 | Depression |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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