Stage IIA Pancreatic Cancer, Stage IIB Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPsychosocial Assessment and Care
Undergo PCPI
OTHERPalliative Therapy
Undergo PCPI
OTHERQuality-of-Life Assessment
Undergo QOL assessment
OTHERQuestionnaire Administration
Undergo questionnaire administration
Sponsors
National Cancer Institute (NCI)
National Institute of Nursing Research (NINR)
City of Hope Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed, new diagnosis of borderline resectable, locally advanced resectable/unresectable, or metastatic pancreatic cancer * Patients who are scheduled to receive treatments (neoadjuvant therapy, surgery, adjuvant therapy, or palliative chemotherapy) at City of Hope (COH) * All subjects must have the ability to understand and the willingness to provide informed consent
Exclusion criteria
* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative interview data | Up to 2 months | 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. |
| Attendance at two educational sessions | Up to 2 months | Descriptive statistics will be provided. |
| Completion of intervention | Up to 2 months | Descriptive statistics will be provided. |
| Patient satisfaction with timing, content, and delivery of PCPI | Up to 2 months | Presented through summary statistics of data from the patient satisfaction tool. |
| Reasons for refusal to participate | Up to 2 months | Descriptive statistics will be provided. |
| Reasons for failure to complete study | Up to 2 months | Descriptive statistics will be provided. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall cost, as measured by the Finances and Out of Pocket Costs Tool | Up to 2 months | Data will be summarized using descriptive statistics. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed. |
| Patient/family out of pocket expenses, as measured by the Finances and Out of Pocket Costs Tool | Up to 2 months | Data will be summarized using descriptive statistics. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed. |
| Healthcare resource utilization, as measured by the Report of Healthcare Services Form | Up to 2 months | Data will be summarized using descriptive statistics. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed. |
Countries
United States
Outcome results
None listed