Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00313573
Recruitment Status : Unknown
Verified May 2009 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : April 12, 2006
Last Update Posted : September 20, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Depression Pain Unspecified Adult Solid Tumor, Protocol Specific Procedure: management of therapy complications Procedure: pain therapy Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Phase 3

Detailed Description:



  • 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.


  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Official Title: TeleCare Management of Pain and Depression in Cancer
Study Start Date : February 2006
Estimated Primary Completion Date : January 2010

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • See Disease Characteristics
  • Not in hospice care

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00313573

Show Show 17 study locations
Sponsors and Collaborators
Indiana University Melvin and Bren Simon Cancer Center
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Kurt Kroenke, MD Regenstrief Institute, Incorporated

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Kurt Kroenke, Regenstrief Institute, Incorporated Identifier: NCT00313573    
Other Study ID Numbers: CDR0000466348
First Posted: April 12, 2006    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: May 2009
Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders