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

Not Applicable

Completed

• Conditions: Stage IIA Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IIB Pancreatic Cancer; Stage IV Pancreatic Cancer
• Interventions: Procedure: Psychosocial Assessment and Care; Other: Palliative Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT02307539
• Lead Sponsor: City of Hope Medical Center

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-04
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-01
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (PCPI intervention)	Palliative Therapy	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.
Supportive care (PCPI intervention)	Psychosocial Assessment and Care	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.
Supportive care (PCPI intervention)	Quality-of-Life Assessment	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.
Supportive care (PCPI intervention)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Completion of intervention	Up to 2 months	Descriptive statistics will be provided.
Reasons for refusal to participate	Up to 2 months	Descriptive statistics will be provided.
Attendance at two educational sessions	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.
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.
Reasons for failure to complete study	Up to 2 months	Descriptive statistics will be provided.

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States