Telemedicine or Standard Care in Treating Patients With Depression and/or Pain Caused By Cancer

NCT00313573 | Unknown Phase 3

• 2 other identifiers: CDR0000466348IUMC-051009
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Depression; Pain; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific; pain; depression

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Interventions

management of therapy complications PROCEDURE

pain therapy PROCEDURE

psychosocial assessment and care PROCEDURE

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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) * Depressed mood and/or anhedonia endorsed * No depression directly precipitated by cancer therapy for which depression is a well known side effect (e.g., interferon, corticosteroids) * Cancer-related pain * Pain must be at least moderate in severity (Brief Pain Inventory score ≥ 6), persisted despite using ≥ 2 analgesics, and cancer-related * If the only pain is due to a pre-existing condition (e.g., migraine, headache, arthritis, etc), the patient may not be eligible PATIENT CHARACTERISTICS: * Life expectancy ≥ 6 months * Must speak English * Not pregnant * Fertile patients must use effective contraception * No moderately severe cognitive impairment * No schizophrenia or other psychosis * No disability claim currently being adjudicated for pain PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Not in hospice care

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Indiana University Melvin and Bren Simon Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (17)

Community Cancer Center at Community Hospital of Anderson

Anderson, Indiana, 46011, United States

Location

Community Cancer Care at Bedford Oncology Specialty Clinic

Bedford, Indiana, 47421, United States

Location

Columbus Regional Hospital Cancer Center

Columbus, Indiana, 47201, United States

Location

Community Cancer Care at Putnam County Hospital

Greencastle, Indiana, 46135, United States

Location

Community Cancer Care at Decatur County Hospital

Greensburg, Indiana, 47240, United States

Location

Regenstrief Institute, Incorporated

Indianapolis, Indiana, 46202-2872, United States

Location

Community Cancer Care

Indianapolis, Indiana, 46202, United States

Location

Veterans Affairs Medical Center - Indianapolis

Indianapolis, Indiana, 46202, United States

Location

William N. Wishard Memorial Hospital

Indianapolis, Indiana, 46202, United States

Location

Methodist Cancer Center at Methodist Hospital

Indianapolis, Indiana, 46206-1367, United States

Location

Community Regional Cancer Care at Community Hospital East

Indianapolis, Indiana, 46219, United States

Location

Community Regional Cancer Care at Community Hospital North

Indianapolis, Indiana, 46256, United States

Location

Community Cancer Care at Howard Regional Health System

Kokomo, Indiana, 46902, United States

Location

Community Cancer Care at King's Daughters' Hospital

Madison, Indiana, 47250, United States

Location

Schneck Medical Center

Seymour, Indiana, 47274, United States

Location

Community Cancer Care at Perry County Hospital

Tell City, Indiana, 47586, United States

Location

Community Cancer Care at Tipton County Memorial Hospital

Tipton, Indiana, 46072, United States

Location

Related Publications (10)

• 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.

  PMID: 19777535 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.

  PMID: 20628129 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.

  PMID: 20937930 RESULT

• 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.

  PMID: 41436014 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.

  PMID: 32559503 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.

  PMID: 27187854 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.

  PMID: 25130518 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.

  PMID: 23023681 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.

  PMID: 22753637 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.

  PMID: 21494337 DERIVED

MeSH Terms

Conditions

Depression; Pain

Interventions

Analgesia; Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Rehabilitation; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kurt Kroenke, MD

  Regenstrief Institute, Incorporated

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 11, 2006
• First Posted: April 12, 2006
• Study Start: February 1, 2006
• Primary Completion: January 1, 2010
• Last Updated: September 20, 2013

Record last verified: 2009-05

Locations

US (17)