Status:
UNKNOWN
Telemedicine or Standard Care in Treating Patients With Depression and/or Pain Caused By Cancer
Lead Sponsor:
Indiana University Melvin and Bren Simon Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Depression
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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/o...
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 improv...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT00313573
Start Date
February 1 2006
Last Update
September 20 2013
Active Locations (17)
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1
Community Cancer Center at Community Hospital of Anderson
Anderson, Indiana, United States, 46011
2
Community Cancer Care at Bedford Oncology Specialty Clinic
Bedford, Indiana, United States, 47421
3
Columbus Regional Hospital Cancer Center
Columbus, Indiana, United States, 47201
4
Community Cancer Care at Putnam County Hospital
Greencastle, Indiana, United States, 46135