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2014-11
2015-05
2015-05
10
NCT02307539
City of Hope Medical Center
City of Hope Medical Center
INTERVENTIONAL
Palliative Care in Improving Quality of Life in Patients With Newly Diagnosed Pancreatic Cancer
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2014-12-02 | N/A | 2015-06-01 |
2014-12-02 | N/A | 2015-06-03 |
2014-12-04 | N/A | 2015-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Supportive care (PCPI intervention) 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- | PROCEDURE: Psychosocial Assessment and Care
OTHER: Palliative Therapy
OTHER: Quality-of-Life Assessment
OTHER: Questionnaire Administration
|
| Primary Outcome Measures | 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 |
| Secondary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
21 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
