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.

Condition	Treatment or Intervention
Lung Cancer Pancreatic Cancer Endometrial Cancer Colorectal Cancer ovarian epithelial cancer Lymphoma Colon Cancer Breast Cancer	Procedure: Conventional care for cancer  Procedure: Specialized care for cancer

Further Study 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.

Ages Eligible for Study:  40 Years and above

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

Connecticut
      Yale Comprehensive Cancer Center, New Haven,  Connecticut,  06520-8028,  United States
Michigan
      Michigan State University, East Lansing,  Michigan,  48824,  United States

Study chairs or principal investigators

Barbara A. Given,  Study Chair,  Michigan State University   

Study ID Numbers:  CDR0000068186; MSU-9906; NCI-P00-0166; MSU-1386005984A1; MSU-IRB-96479
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  September 11, 2000
ClinicalTrials.gov Identifier:  NCT00006253
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08