Colorectal CancerNCT00684801
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
An observational study of Colorectal Cancer and Lung Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Lung Cancer, Ovarian Cancer
- What is being tested?
- questionnaire administration and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 605 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
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 locations and contacts
1 site in 1 country.
United States1 site
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer, Lung Cancer, Ovarian Cancer, Pancreatic Cancer
- Being tested
- questionnaire administration, quality-of-life assessment
- 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
- Medical subject headings
- Colorectal Neoplasms, Lung Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Carcinoma, Ovarian Epithelial, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
Patients complete questionnaires.
quality-of-life assessmentProcedure or surgery
Patients undergo quality-of-life assessments.
| Study group | Role | What they receive |
|---|---|---|
| Usual care (control group) | Patients undergo usual care as determined by core cancer team. Receives: Other: questionnaire administration; Procedure: quality-of-life assessment | |
| 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. Receives: Other: questionnaire administration; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient resource use
Measured: at the end of the patient's participation in the study and via monthly hospital and clinical chart review.
Symptoms
Measured: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Quality of life
Measured: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Proportion of patients meeting expectations regarding care and treatment
Measured: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Patient spiritual well-being
Measured: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Caregiver mood state
Measured: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Caregiver burden
Measured: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Proportion of caregivers meeting expectations regarding care and treatment
Measured: Patients and caregivers are interviewed at baseline, 3, 9, and 15 months
Caregiver's satisfaction with end-of-life care
Measured: caregiver is interviewed at 2 months after death.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startAug 2007
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Barbara Daly, PhD, RN, Principal investigator, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684801
- Sponsor's protocol ID
- CASE6Y07
- Other IDs
- P30CA043703, CASE6Y07, CASE-6Y07-CC333
- Status last verified
- Oct 2015
- First submitted
- 23 May 2008
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23523362
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Quality of Advanced Cancer Care With Disease Management
- ClinicalTrials.gov ID
- NCT00684801
- Acronym / sponsor ID
- CASE6Y07
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 605 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care (control group) | – | Other: questionnaire administration, Procedure: quality-of-life assessmentPatients undergo usual care as determined by core cancer team. |
| DMP (experimental group) | – | Other: questionnaire administration, Procedure: quality-of-life assessmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire administrationPatients complete questionnaires. | Other | DMP (experimental group), Usual care (control group) |
| quality-of-life assessmentPatients undergo quality-of-life assessments. | Procedure or surgery | DMP (experimental group), Usual care (control group) |
Primary outcome
Patient resource use
Time frame: 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
Quality of life
Time frame: 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
Patient spiritual well-being
Time frame: 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
Caregiver burden
Time frame: 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
Caregiver's satisfaction with end-of-life care
Time frame: caregiver is interviewed at 2 months after death.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2015.
- Derived from this study: PubMed 23523362Daly 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Daly, PhD, RN principal investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Lung Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient resource use (time frame: at the end of the patient's participation in the study and via monthly hospital and clinical chart review.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00684801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2015.