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| Sponsors and Collaborators: |
University of Michigan Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006253 |
Purpose
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 | Intervention |
|
Breast Cancer Colorectal Cancer Endometrial Cancer Lung Cancer Lymphoma Ovarian Cancer Pancreatic Cancer Psychosocial Effects/Treatment Quality of Life Transitional Care Planning |
Procedure: management of therapy complications Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
| Genetics Home Reference related topics: | Colorectal Cancer breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer Colorectal Cancer Lung Cancer Lymphoma Ovarian Cancer Pancreatic Cancer |
| Study Type: | Interventional |
| Study Design: | Supportive Care |
| Official Title: | Family Home Care for Cancer - A Community-Based Model |
| Study Start Date: | August 2000 |
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.
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
| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
PATIENT CHARACTERISTICS: Age: 21 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
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
Contacts and Locations| United States, Connecticut | |||||
| Yale Comprehensive Cancer Center | |||||
| New Haven, Connecticut, United States, 06520-8028 | |||||
| United States, Michigan | |||||
| Michigan State University | |||||
| East Lansing, Michigan, United States, 48824 | |||||
| University of Michigan Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Barbara A. Given, PhD, RN, FAAN | Breslin Cancer Center at Ingham Regional Medical Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000068186, CCUM-MSU-9906, MSU-9906, MSU-1386005984A1, MSU-IRB-96479, NCI-P00-0166 |
| First Received: | September 11, 2000 |
| Last Updated: | June 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006253 |
| Health Authority: | United States: Federal Government |
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