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Clinical Trials/NCT02307539
NCT02307539
Completed
N/A

Feasibility of an Interdisciplinary Palliative Care Planning Intervention in Pancreatic Cancer

City of Hope Medical Center1 site in 1 country10 target enrollmentNovember 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stage IIA Pancreatic Cancer
Sponsor
City of Hope Medical Center
Enrollment
10
Locations
1
Primary Endpoint
Completion of intervention
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
May 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
City of Hope Medical Center
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Completion of intervention

Time Frame: Up to 2 months

Descriptive statistics will be provided.

Reasons for refusal to participate

Time Frame: Up to 2 months

Descriptive statistics will be provided.

Attendance at two educational sessions

Time Frame: Up to 2 months

Descriptive statistics will be provided.

Patient satisfaction with timing, content, and delivery of PCPI

Time Frame: Up to 2 months

Presented through summary statistics of data from the patient satisfaction tool.

Qualitative interview data

Time Frame: 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

Time Frame: Up to 2 months

Descriptive statistics will be provided.

Secondary Outcomes

  • Healthcare resource utilization, as measured by the Report of Healthcare Services Form(Up to 2 months)
  • Overall cost, as measured by the Finances and Out of Pocket Costs Tool(Up to 2 months)
  • Patient/family out of pocket expenses, as measured by the Finances and Out of Pocket Costs Tool(Up to 2 months)

Study Sites (1)

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