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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.

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  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care
Official Title:   Family Home Care for Cancer - A Community-Based Model

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   August 2000

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.

  Eligibility
Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006253

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

Sponsors and Collaborators
University of Michigan Cancer Center
National Cancer Institute (NCI)

Investigators
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  This link exits the ClinicalTrials.gov site
 

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

Keywords provided by National Cancer Institute (NCI):
stage I colon cancer  
stage II colon cancer  
stage III colon cancer  
stage IV colon cancer  
stage I breast cancer  
stage II breast cancer  
stage IV breast cancer  
stage IIIA breast cancer  
breast cancer in situ  
recurrent breast cancer  
occult non-small cell lung cancer
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIB breast cancer
recurrent non-small cell lung cancer
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
recurrent colon cancer
inflammatory breast cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Lymphoma, Mantle-Cell
Pancreatic Neoplasms
Colonic Diseases
Lymphoma, small cleaved-cell, diffuse
Urogenital Neoplasms
Ovarian epithelial cancer
Rectal Diseases
Lymphoma, large-cell, immunoblastic
Endometrial Neoplasms
Lung Neoplasms
Breast Diseases
Endocrine Gland Neoplasms
Lymphoma, Large B-Cell, Diffuse
Non-small cell lung cancer
Digestive System Neoplasms
Immunoproliferative Disorders
Leukemia, B-cell, chronic
Genital Neoplasms, Female
Breast Neoplasms

Additional relevant MeSH terms:
Genital Diseases, Female
Lymphatic Diseases
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Digestive System Diseases
Neoplasms by Site
Immune System Diseases
Respiratory Tract Diseases
Skin Diseases
Endocrine System Diseases
Adnexal Diseases

ClinicalTrials.gov processed this record on July 03, 2008




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