Telemedicine or Standard Care in Treating Patients With Depression and/or Pain Caused By Cancer
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|ClinicalTrials.gov 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
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|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||480 participants|
|Official Title:||TeleCare Management of Pain and Depression in Cancer|
|Study Start Date :||February 2006|
|Estimated Primary Completion Date :||January 2010|
- 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
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT00313573
|Study Chair:||Kurt Kroenke, MD||Regenstrief Institute, Incorporated|