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Conventional Care With or Without Specialized Cancer Care in Treating Patients Receiving Chemotherapy

This study is ongoing, but not recruiting participants.
Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Conventional Care With or Without Specialized Cancer Care in Treating Patients Receiving Chemotherapy
Official Title  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.

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.

Study Phase
Study Type  Interventional
Study Design  Supportive Care
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Breast Cancer
Colorectal Cancer
Endometrial Cancer
Lung Cancer
Lymphoma
Ovarian Cancer
Pancreatic Cancer
Psychosocial Effects/Treatment
Quality of Life
Transitional Care Planning
Intervention  Procedure: management of therapy complications
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment 
Start Date  August 2000
Completion Date
Eligibility 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

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

Gender Both
Ages 21 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00006253
Organization ID CDR0000068186
Secondary IDs †† CCUM-MSU-9906, MSU-9906, MSU-1386005984A1, MSU-IRB-96479, NCI-P00-0166
Study Sponsor  University of Michigan Cancer Center
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Barbara A. Given, PhD, RN, FAAN     Breslin Cancer Center at Ingham Regional Medical Center    
Information Provided By National Cancer Institute (NCI)
Verification Date April 2007
First Received Date  September 11, 2000
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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