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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| CASE6Y07 | Other Identifier | Case Comprehensive Cancer Center | |
| CASE-6Y07-CC333 | Other Identifier | Cancer Center IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
OUTLINE: Patients are stratified according to type of current supportive care (usual care vs comprehensive disease-management program [DMP]).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaire administration | Other | Patients complete questionnaires. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient resource use | at the end of the patient's participation in the study and via monthly hospital and clinical chart review. | |
| Symptoms | Patients and caregivers are interviewed at baseline, 3, 9, and 15 months | |
| Quality of life | Patients and caregivers are interviewed at baseline, 3, 9, and 15 months | |
| Proportion of patients meeting expectations regarding care and treatment | Patients and caregivers are interviewed at baseline, 3, 9, and 15 months | |
| Patient spiritual well-being | Patients and caregivers are interviewed at baseline, 3, 9, and 15 months | |
| Caregiver mood state | Patients and caregivers are interviewed at baseline, 3, 9, and 15 months | |
| Caregiver burden | Patients and caregivers are interviewed at baseline, 3, 9, and 15 months | |
| Proportion of caregivers meeting expectations regarding care and treatment | Patients and caregivers are interviewed at baseline, 3, 9, and 15 months | |
| Caregiver's satisfaction with end-of-life care | caregiver is interviewed at 2 months after death. |
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DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Stage III or IV disease
Receiving care at the Ireland Cancer Center
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Daly, PhD, RN | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23523362 | Derived | 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. |
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| quality-of-life assessment | Procedure | Patients undergo quality-of-life assessments. |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D008175 | Lung Neoplasms |
| D010051 | Ovarian Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| D000077216 | Carcinoma, Ovarian Epithelial |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D010182 | Pancreatic Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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