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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.
First Received: September 11, 2000   Last Updated: August 19, 2009   History of Changes
Sponsor: University of Michigan Cancer Center
Collaborator: 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 of Cancer and Its Treatment
Transitional Care Planning
Procedure: management of therapy complications
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment

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

Resource links provided by NLM:


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
Investigators
Study Chair: Barbara A. Given, PhD, RN, FAAN Breslin Cancer Center at Ingham Regional Medical Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068186, CCUM-MSU-9906, MSU-9906, MSU-1386005984A1, MSU-IRB-96479, NCI-P00-0166
Study First Received: September 11, 2000
Last Updated: August 19, 2009
ClinicalTrials.gov Identifier: NCT00006253     History of Changes
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
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
limited stage small cell lung cancer
extensive stage small cell lung cancer
recurrent small cell lung cancer
stage I endometrial carcinoma
stage II endometrial carcinoma
stage III endometrial carcinoma

Additional relevant MeSH terms:
Thoracic Neoplasms
Gonadal Disorders
Gastrointestinal Diseases
Pancreatic Neoplasms
Colonic Diseases
Urogenital Neoplasms
Ovarian Diseases
Rectal Diseases
Genital Diseases, Female
Endometrial Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lymphoma, Large-Cell, Immunoblastic
Uterine Neoplasms
Lymphoma
Breast Diseases
Endocrine Gland Neoplasms
Respiratory Tract Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Ovarian Neoplasms
Digestive System Neoplasms
Immune System Diseases
Skin Diseases
Genital Neoplasms, Female
Uterine Diseases
Endocrine System Diseases
Breast Neoplasms
Intestinal Diseases

ClinicalTrials.gov processed this record on November 27, 2009