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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00684801 |
RATIONALE: A disease management program may be more effective than standard therapy in improving quality of life and controlling symptoms in patients with cancer.
PURPOSE: This clinical trial is studying a disease management program to see how well it works compared with usual care in patients with stage III or stage IV lung cancer, stage III or stage IV pancreatic cancer, stage III or stage IV ovarian cancer, or stage III or stage IV colorectal cancer, and their caregivers.
Condition | Intervention |
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Colorectal Cancer Lung Cancer Ovarian Cancer Pancreatic Cancer |
Procedure: quality-of-life assessment Procedure: questionnaire administration |
Study Type: | Interventional |
Study Design: | Supportive Care, Open Label |
Official Title: | Improving the Quality of Advanced Cancer Care With Disease Management |
Estimated Enrollment: | 744 |
Study Start Date: | August 2007 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Usual care (control group): Active Comparator
Patients undergo usual care as determined by core cancer team.
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Procedure: quality-of-life assessment
Patients undergo quality-of-life assessements.
Procedure: questionnaire administration
Patients complete questionnaires.
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DMP (experimental group): Experimental
Patients undergo a systematic approach regarding specific domains related to their disease focusing on supportive care and symptom management determined by a multidisciplinary team of providers to help patients and caregivers manage.
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Procedure: quality-of-life assessment
Patients undergo quality-of-life assessements.
Procedure: questionnaire administration
Patients complete questionnaires.
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OBJECTIVES:
OUTLINE: Patients are stratified according to type of current supportive care (usual care vs comprehensive disease-management program [DMP]).
Patients and caregivers are interviewed at baseline, 3, 9, and 15 months. Patients who transfer to hospice/palliative care treatment complete an additional questionnaire at the time of transfer and 3 weeks after transfer. If a patient death occurs during study, the caregiver is interviewed at 2 months after death.
Patient resource-use data is collected via billing data from hospital or clinic charts at the end of the patient's participation in the study and via monthly hospital and clinical chart review. Hospital visits, chemotherapy use, and hospice days are also measured as patient resource use.
Healthcare team members are interviewed weekly to measure contact time with patients. Team members receive team problem solving and team collaboration tools every 4 months for up to 37 months. Key members (nurse manager and physician clinical director) are also interviewed every 4 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000583292, CASE-6Y07, CASE-6Y07-CC333 |
Study First Received: | May 23, 2008 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00684801 |
Health Authority: | Unspecified |
recurrent non-small cell lung cancer recurrent small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer extensive stage small cell lung cancer recurrent pancreatic cancer stage III pancreatic cancer stage IV pancreatic cancer recurrent ovarian epithelial cancer recurrent ovarian germ cell tumor |
stage III ovarian epithelial cancer stage III ovarian germ cell tumor stage IV ovarian epithelial cancer stage IV ovarian germ cell tumor recurrent colon cancer stage III colon cancer stage IV colon cancer recurrent rectal cancer stage III rectal cancer stage IV rectal cancer |
Thoracic Neoplasms Gonadal Disorders Gastrointestinal Diseases Rectal Neoplasms Pancreatic Neoplasms Colonic Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer Rectal Diseases Genital Diseases, Female Respiratory Tract Diseases Lung Neoplasms Rectal cancer Endocrine Gland Neoplasms |
Ovarian cancer Non-small cell lung cancer Digestive System Neoplasms Ovarian Neoplasms Genital Neoplasms, Female Endocrine System Diseases Intestinal Diseases Intestinal Neoplasms Recurrence Rectal neoplasm Carcinoma, Small Cell Digestive System Diseases Lung Diseases Pancreatic Diseases Gastrointestinal Neoplasms |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Adnexal Diseases |