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Conventional Care With or Without Specialized Cancer Care in Treating Patients Receiving Chemotherapy Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Conventional Care With or Without Specialized Cancer Care in Treating Patients Receiving Chemotherapy conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Conventional Care With or Without Specialized Cancer Care in Treating Patients Receiving Chemotherapy Clinical research trials and Conventional Care With or Without Specialized Cancer Care in Treating Patients Receiving Chemotherapy healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Conventional Care With or Without Specialized Cancer Care in Treating Patients Receiving Chemotherapy. Conventional Care With or Without Specialized Cancer Care in Treating Patients Receiving Chemotherapy Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Conventional Care With or Without Specialized Cancer Care in Treating Patients Receiving Chemotherapy clinical trial. Human subjects often obtain the finest healthcare possible for their Conventional Care With or Without Specialized Cancer Care in Treating Patients Receiving Chemotherapy condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Conventional Care With or Without Specialized Cancer Care in Treating Patients Receiving Chemotherapy  Conventional Care With or Without Specialized Cancer Care in Treating Patients Receiving Chemotherapy
Conventional Care With or Without Specialized Cancer Care in Treating Patients Receiving Chemotherapy
For Condition: Lymphoma,Colorectal Cancer,Endometrial Cancer,Breast Cancer,ovarian epithelial cancer,Colon Cancer,Lung Cancer,Pancreatic Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Michigan State University
Synopsis: RATIONALE: Patients undergoing chemotherapy who receive specialized cancer care may have fewer symptoms and improved emotional health. PURPOSE: Randomized clinical trial to compare the effectiveness of conventional care with that of conventional care plus specialized cancer care in treating patients who are receiving chemotherapy for breast, ovarian, pancreas, endometrial, colon, or lung cancer, or for non-Hodgkin's lymphoma.
Details: OBJECTIVES: I. Compare the effect of cancer care intervention and conventional care versus conventional care alone on the experience of fewer symptoms, less bodily pain, and improved emotional health in patients with breast, ovarian, pancreatic, endometrial, colon or lung cancer or non-Hodgkin's lymphoma. II. Compare the effect of these care regimens on the experience of the following by these patients: Lower levels of symptom severity and activity limitations due to symptoms. Fewer numbers of cancer related unscheduled rehospitalizations and shorter lengths of stay. Fewer numbers of problem related unscheduled visits to surgeons, oncologists and primary care physicians and emergency services. III. Compare the effect of these care regimens on the experience of the following in caregivers of these patients: Increased preparation to care for their patients. Increased involvement in symptom control. Reduced levels of perceived burden (role overload, daily schedule, finances and social support). Reduced levels of depression and anxiety. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to comorbid conditions and site of cancer. Patients are randomized to one of two treatment arms. Arm I: Patients have an office visit with an oncology nurse at baseline and at 2, 6, 10, 14, and 20 weeks. Patients also speak with the oncology nurse by telephone on weeks 4, 8, 12, and 16. The nurse develops plans of care to meet the specific needs of each patient and caregiver targeting the following: Symptom management Coordination and mobilization of health and community resources Provision of information and education Counseling and social support Preparation of family members to assume care Arm II: Patients receive the conventional medical and nursing cancer care available at their institution. Patients will be interviewed about the following: Use of support groups Classes attended Visits to physicians Community agencies used Referrals to counselors Educational materials reviewed Patients and caregivers are interviewed at baseline and at 9, 20 and 32 weeks. The following assessments take place. Patients: Medical Outcomes Study Short Form Patient Symptom Experience Inventory Emotional health (depression) Emotional health (Spielberger State Trait Anxiety Inventory) Comorbid conditions Utilization of services Caregivers: Medical Outcomes Study Short Form Involvement with activities of daily living (eating, bathing, dressing, toileting, etc.) and instrumental activities of daily living (transportation, laundry, shopping, etc.) Caregiver symptom assistance Emotional health (depression) Emotional health (Spielberger State Trait Anxiety Inventory) Caregiver reaction PROJECTED ACCRUAL: A total of 350 patient and caregiver dyads (175 per arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 40 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Newly diagnosed breast, ovarian, pancreatic, endometrial, colon or lung cancer or non-Hodgkin's lymphoma OR Recurrent breast, colon, or lung cancer - Primary treatment includes chemotherapy - Available caregiver age 18 or over who is able to make 3 face to face contacts each week with patient --Prior/Concurrent Therapy-- - Biologic therapy: Concurrent biologic therapy allowed - Chemotherapy: See Disease Characteristics; At least 7 weeks of current chemotherapy; Less than 42 days since chemotherapy began - Endocrine therapy: Concurrent hormonal therapy allowed - Radiotherapy: Concurrent radiotherapy allowed - Surgery: Prior and concurrent surgeries allowed --Patient Characteristics-- - Age: 40 and over - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified - Other: Must have working telephone; Cognitively intact and not abusing alcohol or drugs; Speaks and understands English
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BarbaraGiven, Study Chair, Michigan State University
Michigan State University
East Lansing, Michigan, 48824
United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
United States
Additional Information:
Study ID Numbers: CDR0000068186; MSU-IRB-96479,MSU-9906,NCI-P00-0166,MSU-1386005984A1
Study Start Date: August 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006253
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Conventional Care With or Without Specialized Cancer Care in Treating Patients Receiving Chemotherapy
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