Telemedicine or Standard Care in Treating Patients With Depression and/or Pain Caused By Cancer
- Conditions
- DepressionPainUnspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00313573
- Lead Sponsor
- Indiana University Melvin and Bren Simon Cancer Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 480
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (17)
Community Regional Cancer Care at Community Hospital North
🇺🇸Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis
🇺🇸Indianapolis, Indiana, United States
Methodist Cancer Center at Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
William N. Wishard Memorial Hospital
🇺🇸Indianapolis, Indiana, United States
Community Regional Cancer Care at Community Hospital East
🇺🇸Indianapolis, Indiana, United States
Community Cancer Care at King's Daughters' Hospital
🇺🇸Madison, Indiana, United States
Schneck Medical Center
🇺🇸Seymour, Indiana, United States
Community Cancer Care at Putnam County Hospital
🇺🇸Greencastle, Indiana, United States
Community Cancer Care at Perry County Hospital
🇺🇸Tell City, Indiana, United States
Community Cancer Care at Howard Regional Health System
🇺🇸Kokomo, Indiana, United States
Community Cancer Care at Tipton County Memorial Hospital
🇺🇸Tipton, Indiana, United States
Community Cancer Center at Community Hospital of Anderson
🇺🇸Anderson, Indiana, United States
Columbus Regional Hospital Cancer Center
🇺🇸Columbus, Indiana, United States
Community Cancer Care at Bedford Oncology Specialty Clinic
🇺🇸Bedford, Indiana, United States
Community Cancer Care at Decatur County Hospital
🇺🇸Greensburg, Indiana, United States
Regenstrief Institute, Incorporated
🇺🇸Indianapolis, Indiana, United States
Community Cancer Care
🇺🇸Indianapolis, Indiana, United States