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.
- 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
- 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
- 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
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.
- 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
- 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
Barbara Daly, PhD, RN
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center