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Status unknownNCT00313573Updated Sep 20, 2013

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

A Phase 3 interventional study of management of therapy complications and pain therapy in Depression, Pain and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Indiana University Melvin and Bren Simon Cancer Center. Status unknown at 17 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-20.

Sponsored by Indiana University Melvin and Bren Simon Cancer Center · Phase 3 and Interventional

The sponsor has not verified this record recently (last verified May 2009), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
480
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the effectiveness of a state-wide, telemedicine intervention with standard care in cancer patients with clinical depression and/or cancer-related pain.
  • Compare improvement in clinical depression and/or cancer-related pain in patients undergoing these interventions.

Secondary

  • Compare health-related quality of life, functional status, and patient satisfaction with treatment in patients undergoing these interventions.
  • Compare the economic benefits of these interventions in these patients.

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.

  • Arm I (standard care): Patients receive treatment for pain, depression, and other symptoms from their oncologist.
  • Arm II (telemedicine intervention): Patients undergo automated, home-based symptom monitoring either by telephone or the Internet, depending on preference, coupled with telephonic care management by a clinical specialist. Patients complete questionnaires via the Internet or undergo standardized interviews via telephone measuring depression, pain, quality of life, and other patient-reported variables twice weekly for approximately 1 month, once weekly for 2 months, twice a month for 3 months, and then once a month for 6 months. A clinical specialist trained in treating the symptoms of pain and depression also contacts the patient by phone to assess symptom severity and initiate treatment. A follow-up call is made at 1-2 weeks to assess symptom severity, adherence, and adverse effects. Patients with depression receive 2 additional follow-up calls in the first 12 weeks. The clinical specialist also calls the patient when automated monitoring indicates inadequate symptom improvement or side effects, or the patient requests to be contacted. The clinical specialist works with the patient's regular doctor in adjusting medicines and treatment for symptoms as needed. Patients who do not complete their scheduled assessments receive an automated call or e-mail message reminding them to complete the symptoms questionnaires. Patients who do not respond to this reminder within 24 hours are contacted by the clinical specialist.

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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Conditions studied

  • Depression
  • Pain
  • Unspecified Adult Solid Tumor, Protocol Specific

Keywords

  • unspecified adult solid tumor, protocol specific
  • pain
  • depression
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In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 480 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

This is the only study on the registry with Indiana University Melvin and Bren Simon Cancer Center as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
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Study design

Phase
Phase 3
Allocation
Randomized
Enrollment
480 participants (estimated)

Interventions

  • Proceduremanagement of therapy complications
  • Procedurepain therapy
  • Procedurepsychosocial assessment and care
  • Procedurequality-of-life assessment
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What researchers measure

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

  1. Health-related quality of life at baseline and 1, 3, 6, and 12 months

  2. Cost-effectiveness of care at baseline and 1, 3, 6, and 12 months

  3. Treatment satisfaction at baseline and 1, 3, 6, and 12 months

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Study locations

17 sites
  • Community Cancer Center at Community Hospital of Anderson
    Anderson, Indiana 46011, United States
  • 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
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References and documents

Publications

  • 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. PubMed 19777535 ↗
  • 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. PubMed 20628129 ↗
  • 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. PubMed 20937930 ↗
  • 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. PubMed 32559503 ↗
  • 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. PubMed 27187854 ↗
  • 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. PubMed 25130518 ↗
  • 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. PubMed 23023681 ↗
  • 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. PubMed 22753637 ↗
  • 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. PubMed 21494337 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00313573
Lead sponsor
Indiana University Melvin and Bren Simon Cancer Center
Collaborators
National Cancer Institute (NCI)
First posted
Apr 12, 2006
Start date
Feb 2006
Primary completion
Jan 2010 (estimated)
Last update
Sep 20, 2013

Study contacts

Kurt Kroenke, MD
study chair · Regenstrief Institute, Incorporated
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2009. You cannot join it, but the record below documents what was studied.

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