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| Tracking Information | |||||
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| First Received Date ICMJE | September 11, 2000 | ||||
| Last Updated Date | August 19, 2009 | ||||
| Start Date ICMJE | August 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00006253 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Conventional Care With or Without Specialized Cancer Care in Treating Patients Receiving Chemotherapy | ||||
| Official Title ICMJE | Family Home Care for Cancer - A Community-Based Model | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Supportive Care | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00006253 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000068186, CCUM-MSU-9906, MSU-9906, MSU-1386005984A1, MSU-IRB-96479, NCI-P00-0166 | ||||
| Study Sponsor ICMJE | University of Michigan Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | April 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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