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Disease Management Program or Usual Care in Patients With Stage III or Stage IV Lung Cancer, Pancreatic Cancer, Ovarian Cancer, or Colorectal Cancer, and Their Caregivers
This study is not yet open for participant recruitment.
Verified by National Cancer Institute (NCI), May 2008
Sponsors and Collaborators: Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00684801
  Purpose

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
Colorectal Cancer
Lung Cancer
Ovarian Cancer
Pancreatic Cancer
Procedure: quality-of-life assessment
Procedure: questionnaire administration

MedlinePlus related topics: Cancer Caregivers Colorectal Cancer Lung Cancer Ovarian Cancer Pancreatic Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Open Label
Official Title: Improving the Quality of Advanced Cancer Care With Disease Management

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

Primary Outcome Measures:
  • Patient resource use [ Designated as safety issue: No ]
  • Symptoms [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Proportion of patients meeting expectations regarding care and treatment [ Designated as safety issue: No ]
  • Patient spiritual well-being [ Designated as safety issue: No ]
  • Caregiver mood state [ Designated as safety issue: No ]
  • Caregiver burden [ Designated as safety issue: No ]
  • Proportion of caregivers meeting expectations regarding care and treatment [ Designated as safety issue: No ]
  • Caregiver's satisfaction with end-of-life care [ Designated as safety issue: No ]

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
Usual care (control group): Active Comparator
Patients undergo usual care as determined by core cancer team.
Procedure: quality-of-life assessment
Patients undergo quality-of-life assessements.
Procedure: questionnaire administration
Patients complete questionnaires.
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.
Procedure: quality-of-life assessment
Patients undergo quality-of-life assessements.
Procedure: questionnaire administration
Patients complete questionnaires.

Detailed Description:

OBJECTIVES:

  • To examine the effects of the expansion of the current disease-management program (DMP) in patients with stage III or IV lung pancreatic, ovarian, or colorectal cancer.
  • To determine whether there is a difference in resource use (number of chemotherapy treatments in the last 30 days of life, number of emergency room visits, number of days of hospice and hospitalization) among patients who have participated in a DMP compared to those receiving usual care.
  • To determine whether there is a difference in patient outcomes (health-related quality of life, spiritual well being, satisfaction with care) among patients who have participated in a DMP compared to those receiving usual care.
  • To determine whether there is a difference in caregiver outcomes (mood state, satisfaction with care, satisfaction with end-of-life care, and burden of care giving) among caregivers of patients who have participated in a DMP compared to those receiving usual care.
  • To determine whether differences in patient and caregiver outcomes remain after controlling for the influence of demographic, clinical, and organizational covariates.
  • To determine the extent of differences in patient and caregiver outcomes achieved through improvements in collaboration and problem solving.

OUTLINE: Patients are stratified according to type of current supportive care (usual care vs comprehensive disease-management program [DMP]).

  • Usual care (control group): Patients undergo usual care as determined by core cancer team.
  • DMP (experimental group): 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of 1 of the following:

    • Lung cancer
    • Pancreatic cancer
    • Ovarian cancer
    • Colorectal cancer
  • Stage III or IV disease
  • Receiving care at the Ireland Cancer Center

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-3
  • Life expectancy ≥ 3 months
  • No cognitive impairment
  • May not transfer care out of geographic area
  • Must have caregiver available to participate

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684801

Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Barbara Daly, PhD, RN Case Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009