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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


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
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