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

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Lung Cancer; Ovarian Cancer; Pancreatic Cancer; Colorectal Cancer

Treatments: Procedure: quality-of-life assessment; Other: questionnaire administration

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00684801

P30CA043703 (U.S. NIH Grant/Contract)

CASE-6Y07-CC333 (Other Identifier)

CASE6Y07 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 605 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

605 participants in 2 patient groups

Usual care (control group)

Description:

Patients undergo usual care as determined by core cancer team.

Treatment:

Other: questionnaire administration

Procedure: quality-of-life assessment

DMP (experimental group)

Description:

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.

Treatment:

Other: questionnaire administration

Procedure: quality-of-life assessment