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 has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00684801
First received: May 23, 2008
Last updated: July 5, 2012
Last verified: July 2012
  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
Other: questionnaire administration
Procedure: quality-of-life assessment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Improving the Quality of Advanced Cancer Care With Disease Management

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Patient resource use [ Time Frame: at the end of the patient's participation in the study and via monthly hospital and clinical chart review. ] [ Designated as safety issue: No ]
  • Symptoms [ Time Frame: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months ] [ Designated as safety issue: No ]
  • Proportion of patients meeting expectations regarding care and treatment [ Time Frame: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months ] [ Designated as safety issue: No ]
  • Patient spiritual well-being [ Time Frame: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months ] [ Designated as safety issue: No ]
  • Caregiver mood state [ Time Frame: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months ] [ Designated as safety issue: No ]
  • Caregiver burden [ Time Frame: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months ] [ Designated as safety issue: No ]
  • Proportion of caregivers meeting expectations regarding care and treatment [ Time Frame: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months ] [ Designated as safety issue: No ]
  • Caregiver's satisfaction with end-of-life care [ Time Frame: caregiver is interviewed at 2 months after death. ] [ Designated as safety issue: No ]

Enrollment: 605
Study Start Date: August 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Usual care (control group)
Patients undergo usual care as determined by core cancer team.
Other: questionnaire administration
Patients complete questionnaires.
Procedure: quality-of-life assessment
Patients undergo quality-of-life assessments.
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.
Other: questionnaire administration
Patients complete questionnaires.
Procedure: quality-of-life assessment
Patients undergo quality-of-life assessments.

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
Sampling Method:   Probability Sample
Study Population

primary care clinic

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684801

Locations
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Barbara Daly, PhD, RN Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided by Case Comprehensive Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00684801     History of Changes
Other Study ID Numbers: CASE6Y07, P30CA043703, CASE6Y07, CASE-6Y07-CC333
Study First Received: May 23, 2008
Last Updated: July 5, 2012
Health Authority: United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Colorectal Neoplasms
Lung Neoplasms
Ovarian Neoplasms
Pancreatic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Pancreatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014