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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01629 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 13270 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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Study was not funded
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized clinical trial studies palliative care in improving quality of life and symptoms in patients with stage III-IV pancreatic or ovarian cancer. Palliative therapy may help patients with advanced pancreatic or ovarian cancer live more comfortably.
PRIMARY OBJECTIVES:
I. Test the effects of a concurrent palliative care planning intervention (PCPI) on overall quality of life (QOL) and symptom burden.
II. Test the effects of a concurrent PCPI on anxiety and depression. III. Test the effects of a concurrent PCPI on overall survival. IV. Test the effects of a concurrent PCPI on health care resource use.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo a comprehensive physical, psychological, social, and spiritual palliative care assessment. Patients also receive a workbook that covers physical and psychological well-being and social and spiritual well-being, delivered over 2 educational sessions.
ARM II: Patients receive standard care plus attention comprising two telephone contacts.
After completion of study, patients are followed up at 1, 3, and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (PCPI) | Experimental | Patients undergo a comprehensive physical, psychological, social, and spiritual palliative care assessment. Patients also receive a workbook that covers physical and psychological well-being and social and spiritual well-being, delivered over 2 educational sessions. |
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| Arm II (standard care plus attention control) | Active Comparator | Patients receive standard care plus attention comprising two telephone contacts. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| palliative care | Other | Receive PCPI |
| |
| educational intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Overall QOL, assessed by the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) or the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) | The analysis will be a 2x2x3 repeated measures analysis of covariance (ANCOVA) statistical design. | Up to 6 months |
| Symptom burden using the FACT-Trial Outcome Index (TOI) | Compared between groups and by diagnoses using two-way contingency table analysis, two way analysis of variance (ANOVA) according to level of measurement. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in anxiety | Compared demographically by group according to completeness of the intervention using t-tests or one-way ANOVAs according to the level of measurement of the variables. Tested using a 2x2 contingency table analysis and the McNemar test statistic. | Up to 6 months |
| Reduction in depression |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Virginia Sun | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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| Behavioral |
Receive education sessions |
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| quality-of-life assessment | Procedure | Ancillary studies |
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| questionnaire administration | Other | Ancillary studies |
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| telephone-based intervention | Behavioral | Receive telephone contacts |
|
Compared demographically by group according to completeness of the intervention using t-tests or one-way ANOVAs according to the level of measurement of the variables. Tested using a 2x2 contingency table analysis and the McNemar test statistic. |
| Up to 6 months |
| Overall survival | Compared demographically by group according to completeness of the intervention using t-tests or one-way ANOVAs according to the level of measurement of the variables. | At 6 months |
| Health care resource use including presence of advanced care planning, chemotherapy in the last 14 days of life, and length of time between hospice referral and death | Two way (2x2) ANOVAs will be conducted to test the differences between groups. | Up to 6 months |
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| D018479 | Early Intervention, Educational |
| D008722 | Methods |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D011314 | Preventive Health Services |
| D008919 | Investigative Techniques |
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