Palliative Care in Improving Quality of Life in Patients With Newly Diagnosed Pancreatic Cancer

Stage IV Pancreatic Cancer Clinical Trial

Official title:

Feasibility of an Interdisciplinary Palliative Care Planning Intervention in Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02307539
• Other study ID #: 14273
• Secondary ID: NCI-2014-0236714
• Status: Completed
• Phase: N/A
• First received: December 2, 2014
• Last updated: June 1, 2015
• Start date: November 2014
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Stage IIA Pancreatic Cancer
• Stage IIB Pancreatic Cancer
• Stage III Pancreatic Cancer
• Stage IV Pancreatic Cancer

Intervention

Procedure:
• Psychosocial Assessment and Care
Undergo PCPI

Other:
• Palliative Therapy
Undergo PCPI
• Quality-of-Life Assessment
Undergo QOL assessment
• Questionnaire Administration
Undergo questionnaire administration

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (3)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI), National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reasons for refusal to participate	Descriptive statistics will be provided.	Up to 2 months	No
Primary	Reasons for failure to complete study	Descriptive statistics will be provided.	Up to 2 months	No
Primary	Attendance at two educational sessions	Descriptive statistics will be provided.	Up to 2 months	No
Primary	Completion of intervention	Descriptive statistics will be provided.	Up to 2 months	No
Primary	Patient satisfaction with timing, content, and delivery of PCPI	Presented through summary statistics of data from the patient satisfaction tool.	Up to 2 months	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No