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

October 8, 2015 updated by: Case Comprehensive Cancer Center

Improving the Quality of Advanced Cancer Care With Disease Management

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

605

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

primary care clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient resource use
Time Frame: at the end of the patient's participation in the study and via monthly hospital and clinical chart review.
at the end of the patient's participation in the study and via monthly hospital and clinical chart review.
Symptoms
Time Frame: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Quality of life
Time Frame: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Proportion of patients meeting expectations regarding care and treatment
Time Frame: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Patient spiritual well-being
Time Frame: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Caregiver mood state
Time Frame: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Caregiver burden
Time Frame: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Proportion of caregivers meeting expectations regarding care and treatment
Time Frame: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Caregiver's satisfaction with end-of-life care
Time Frame: caregiver is interviewed at 2 months after death.
caregiver is interviewed at 2 months after death.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Barbara Daly, PhD, RN, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

May 23, 2008

First Submitted That Met QC Criteria

May 23, 2008

First Posted (Estimate)

May 28, 2008

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

October 8, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE6Y07 (Other Identifier: Case Comprehensive Cancer Center)
  • P30CA043703 (U.S. NIH Grant/Contract)
  • CASE-6Y07-CC333 (Other Identifier: Cancer Center IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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