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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-02367 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 14273 | Other Identifier | City of Hope Medical Center | |
| U24NR014637 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institute of Nursing Research (NINR) | NIH |
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This pilot clinical trial studies a palliative care program in improving the quality of life of patients with newly diagnosed pancreatic cancer. Palliative care is care given to patients who have a serious or life-threatening disease, and focuses on managing disease symptoms, side effects of treatment or the disease, and improving patient quality of life. Studying a palliative care program used for other types of cancer may help doctors learn whether it can improve the quality of life of patients with pancreatic cancer.
PRIMARY OBJECTIVES:
I. To pilot-test an interdisciplinary Palliative Care Planning Intervention (PCPI) in pancreatic cancer. Specifically, to describe patients' satisfaction with the timing, content, and delivery of the PCPI intervention.
SECONDARY OBJECTIVES:
I. To pilot-test all selected measures for the study, including measures for healthcare resource utilization, overall cost, and patient/family out of pocket expenses.
II. The long-term objective of this pilot study is to conduct a larger PCPI intervention study for pancreatic cancer patients and evaluate its impact on quality of life (QOL), symptom intensity, healthcare resource utilization, and healthcare costs.
OUTLINE:
Patients receive a handbook titled "Supporting You During Cancer Treatment" with educational material on QOL issues. Patients undergo 2 education sessions on handbook material in-person or by telephone, with session 1 focusing on physical and social well-being issues and session 2 focusing on psychological and spiritual well-being issues. At the beginning of each session, patients select 3 priority topics from a list, and content is tailored to patient needs.
After completion of study, patients are followed up at 1 and 2 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (PCPI intervention) | Experimental | Patients receive a handbook titled "Supporting You During Cancer Treatment" with educational material on QOL issues. Patients undergo 2 education sessions on handbook material in-person or by telephone, with session 1 focusing on physical and social well-being issues and session 2 focusing on psychological and spiritual well-being issues. At the beginning of each session, patients select 3 priority topics from a list, and content is tailored to patient needs. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychosocial Assessment and Care | Procedure | Undergo PCPI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reasons for refusal to participate | Descriptive statistics will be provided. | Up to 2 months |
| Reasons for failure to complete study | Descriptive statistics will be provided. | Up to 2 months |
| Attendance at two educational sessions | Descriptive statistics will be provided. | Up to 2 months |
| Completion of intervention | Descriptive statistics will be provided. | Up to 2 months |
| Patient satisfaction with timing, content, and delivery of PCPI | Presented through summary statistics of data from the patient satisfaction tool. | Up to 2 months |
| Qualitative interview data | Each interview transcript will be initially reviewed to provide a glimpse of potential domains and targets. Content analysis will be conducted on the transcribed qualitative data. Transcripts will be assigned codes. Content analysis occurring through coding consisting of line-by-line analysis with themes identified will be initiated. The research team will independently analyze selected segments of the data to verify themes. Coding will be checked and validated by the principal investigator and research team. | Up to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare resource utilization, as measured by the Report of Healthcare Services Form | Data will be summarized using descriptive statistics. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed. | Up to 2 months |
| Overall cost, as measured by the Finances and Out of Pocket Costs Tool |
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Inclusion Criteria:
Exclusion 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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| Palliative Therapy | Other | Undergo PCPI |
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| Quality-of-Life Assessment | Other | Undergo QOL assessment |
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| Questionnaire Administration | Other | Undergo questionnaire administration |
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Data will be summarized using descriptive statistics. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed. |
| Up to 2 months |
| Patient/family out of pocket expenses, as measured by the Finances and Out of Pocket Costs Tool | Data will be summarized using descriptive statistics. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed. | Up to 2 months |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000067250 | Psychiatric Rehabilitation |
| D010166 | Palliative Care |
| D000070659 | Patient Comfort |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D005791 | Patient Care |
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