Clinical trial NCT00684801: 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
Official title: Improving the Quality of Advanced Cancer Care With Disease Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lung Cancer
Ovarian Cancer
Pancreatic Cancer
Keywords: 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
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-05-28
Enrollment: 605
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief 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.

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 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

Primary outcomes:
measure: Patient resource use
timeFrame: at the end of the patient's participation in the study and via monthly hospital and clinical chart review.
measure: Symptoms
timeFrame: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
measure: Quality of life
timeFrame: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
measure: Proportion of patients meeting expectations regarding care and treatment
timeFrame: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
measure: Patient spiritual well-being
timeFrame: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
measure: Caregiver mood state
timeFrame: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
measure: Caregiver burden
timeFrame: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
measure: Proportion of caregivers meeting expectations regarding care and treatment
timeFrame: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
measure: Caregiver's satisfaction with end-of-life care
timeFrame: caregiver is interviewed at 2 months after death.
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Barbara Daly, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Daly BJ, Douglas SL, Gunzler D, Lipson AR. Clinical trial of a supportive care team for patients with advanced cancer. J Pain Symptom Manage. 2013 Dec;46(6):775-84. doi: 10.1016/j.jpainsymman.2012.12.008. Epub 2013 Mar 22.