Palliative Care in Improving Quality of Life in Patients With Newly Diagnosed Pancreatic Cancer
Primary Purpose
Stage IIA Pancreatic Cancer, Stage IIB Pancreatic Cancer, Stage III Pancreatic Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychosocial Assessment and Care
Palliative Therapy
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Stage IIA Pancreatic Cancer
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
Sites / Locations
- City of Hope Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supportive care (PCPI intervention)
Arm Description
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.
Outcomes
Primary Outcome Measures
Reasons for refusal to participate
Descriptive statistics will be provided.
Reasons for failure to complete study
Descriptive statistics will be provided.
Attendance at two educational sessions
Descriptive statistics will be provided.
Completion of intervention
Descriptive statistics will be provided.
Patient satisfaction with timing, content, and delivery of PCPI
Presented through summary statistics of data from the patient satisfaction tool.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT02307539
First Posted
December 2, 2014
Last Updated
June 1, 2015
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI), National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT02307539
Brief Title
Palliative Care in Improving Quality of Life in Patients With Newly Diagnosed Pancreatic Cancer
Official Title
Feasibility of an Interdisciplinary Palliative Care Planning Intervention in Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI), National Institute of Nursing Research (NINR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IIA Pancreatic Cancer, Stage IIB Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supportive care (PCPI intervention)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Psychosocial Assessment and Care
Other Intervention Name(s)
Psychosocial Assessment, Psychosocial Care, Psychosocial Care/Assessment, Psychosocial Studies, Psychosocial Support
Intervention Description
Undergo PCPI
Intervention Type
Other
Intervention Name(s)
Palliative Therapy
Other Intervention Name(s)
Comfort Care, Palliative Care, Palliative Treatment, Symptom Management
Intervention Description
Undergo PCPI
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Undergo QOL assessment
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Undergo questionnaire administration
Primary Outcome Measure Information:
Title
Reasons for refusal to participate
Description
Descriptive statistics will be provided.
Time Frame
Up to 2 months
Title
Reasons for failure to complete study
Description
Descriptive statistics will be provided.
Time Frame
Up to 2 months
Title
Attendance at two educational sessions
Description
Descriptive statistics will be provided.
Time Frame
Up to 2 months
Title
Completion of intervention
Description
Descriptive statistics will be provided.
Time Frame
Up to 2 months
Title
Patient satisfaction with timing, content, and delivery of PCPI
Description
Presented through summary statistics of data from the patient satisfaction tool.
Time Frame
Up to 2 months
Title
Qualitative interview data
Description
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.
Time Frame
Up to 2 months
Secondary Outcome Measure Information:
Title
Healthcare resource utilization, as measured by the Report of Healthcare Services Form
Description
Data will be summarized using descriptive statistics. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed.
Time Frame
Up to 2 months
Title
Overall cost, as measured by the Finances and Out of Pocket Costs Tool
Description
Data will be summarized using descriptive statistics. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed.
Time Frame
Up to 2 months
Title
Patient/family out of pocket expenses, as measured by the Finances and Out of Pocket Costs Tool
Description
Data will be summarized using descriptive statistics. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed.
Time Frame
Up to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia Sun
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Palliative Care in Improving Quality of Life in Patients With Newly Diagnosed Pancreatic Cancer
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