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

Colorectal Cancer Clinical Trial

Official title:

Improving the Quality of Advanced Cancer Care With Disease Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684801
• Other study ID #: CASE6Y07
• Secondary ID: P30CA043703CASE6
• Status: Completed
• Phase: N/A
• First received: May 23, 2008
• Last updated: October 8, 2015
• Start date: August 2007
• Est. completion date: December 2011

Study information

• Verified date: October 2015
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 605
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Lung Cancer
• Lung Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Other:
• questionnaire administration
Patients complete questionnaires.

Procedure:
• quality-of-life assessment
Patients undergo quality-of-life assessments.

Locations

Country	Name	City	State
United States	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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