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

NCT ID: NCT02307539

Last Updated: 2015-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-05-31

Brief Summary

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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

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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.

Conditions

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Stage IIA Pancreatic Cancer Stage IIB Pancreatic Cancer Stage III Pancreatic Cancer Stage IV Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive care (PCPI intervention)

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.

Group Type EXPERIMENTAL

Psychosocial Assessment and Care

Intervention Type PROCEDURE

Undergo PCPI

Palliative Therapy

Intervention Type OTHER

Undergo PCPI

Quality-of-Life Assessment

Intervention Type OTHER

Undergo QOL assessment

Questionnaire Administration

Intervention Type OTHER

Undergo questionnaire administration

Interventions

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Psychosocial Assessment and Care

Undergo PCPI

Intervention Type PROCEDURE

Palliative Therapy

Undergo PCPI

Intervention Type OTHER

Quality-of-Life Assessment

Undergo QOL assessment

Intervention Type OTHER

Questionnaire Administration

Undergo questionnaire administration

Intervention Type OTHER

Other Intervention Names

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Psychosocial Assessment Psychosocial Care Psychosocial Care/Assessment Psychosocial Studies Psychosocial Support Comfort Care Palliative Care Palliative Treatment Symptom Management Quality of Life Assessment

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Virginia Sun

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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City of Hope Medical Center

Duarte, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2014-02367

Identifier Type: REGISTRY

Identifier Source: secondary_id

14273

Identifier Type: OTHER

Identifier Source: secondary_id

U24NR014637

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14273

Identifier Type: -

Identifier Source: org_study_id

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