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

City of Hope

Status: Completed

Conditions: Stage III Pancreatic Cancer; Stage IIB Pancreatic Cancer; Stage IIA Pancreatic Cancer; Stage IV Pancreatic Cancer

Treatments: Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Procedure: Psychosocial Assessment and Care; Other: Palliative Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02307539

NCI-2014-02367 (Registry Identifier)

14273

U24NR014637 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Supportive care (PCPI intervention)

Experimental group

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.

Treatment:

Other: Palliative Therapy

Other: Questionnaire Administration

Procedure: Psychosocial Assessment and Care

Other: Quality-of-Life Assessment