Integrating Palliative Care And Modern Palliative Care Tools Into The Care Of Patients With Pancreas Cancer

Study Overview

Integrating Palliative Care and Modern Palliative Care Tools Into the Care of Patients With Pancreas Cancer

The main purpose of this study is to evaluate the acceptance by patients with metastatic pancreas cancer of integrating palliative care with usual cancer treatment. Palliative care intervention will involve use of pancreas cancer-specific decision aides (iPC3)about prognosis, treatment choices, and advance care planning for patients facing a treatment decision as well as symptom assessments. We hypothesize that palliative care consultations with iPC3 will be accepted, symptoms can be diminished, information can be received in a way that improves choices, and that the quality of care can be improved.

* Each patient undergoing treatment at Johns Hopkins for metastatic pancreas cancer will receive palliative care support during their course to include: palliative care consultation early in their treatment course; patient decision aids that give survival, treatment benefits and risks; suggestions to complete such tasks as advance directives, durable power of medical attorney, wills, family and spiritual reviews as recommend by the American Society of Clinical Oncology; and when indicated, transition to hospice. * Patient will have an iPad for their visit, and a corresponding website to print information. * Each patient will assess their distress with the Distress thermometer; symptoms with the Condensed Memorial Symptom Assessment Scale and a depression screen. This information will be given to the health care practitioner before the patient visit. * Patients facing a treatment decision will receive a Patient Information Program link (or paper for those unable to work on the iPad) to review the diagnosis, prognosis, specific benefits and risks with the proposed chemotherapy. This will then give transition "prompts" to encourage thinking about advance directives, durable power of medical attorney, use of hospice, and doing a life review. * We will also offer a hospice information visit when patient has - in the projection of the team or treating physician - 3 to 6 months to live. * The palliative care team will meet at least monthly with each of the enrolled patients. * Participants will be followed for as long as he or she is alive before receiving hospice care.

Pancreas Cancer

OTHER: Palliative care with decision aids

J1270
90049470 (OTHER_GRANT Identifier) (OTHER_GRANT: Ho-Chiang Foundation)
NA_00074891 (OTHER Identifier) (OTHER: JHMIRB)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-01-23	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-06-08
First Submitted that Met QC Criteria 2013-02-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-06-10
First Posted (ESTIMATED) 2013-02-05	Results First Posted N/A	Last Verified 2016-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: palliative care with iPC3 Palliative care with decision aids will be administered at each palliative care visit.	OTHER: Palliative care with decision aids Participant is followed by the palliative care team, and at each visit, patient will assess their distress and symptoms. Patients facing a treatment decision will receive a Patient Information Program link to review the diagnosis, prognosis, specific bene

Participant Group/Arm

Intervention/Treatment

: palliative care with iPC3

Palliative care with decision aids will be administered at each palliative care visit.

OTHER: Palliative care with decision aids

Participant is followed by the palliative care team, and at each visit, patient will assess their distress and symptoms. Patients facing a treatment decision will receive a Patient Information Program link to review the diagnosis, prognosis, specific bene

Primary Outcome Measures	Measure Description	Time Frame
Feasibility of the patients with metastatic pancreas cancer to meet with the palliative care team and to complete symptom assessments.		participants will be followed monthly until referred to hospice or until death, an expected average of 1 year

Secondary Outcome Measures	Measure Description	Time Frame
Changes in symptoms listed in the Memorial Symptom Assessment Scale (condensed version)	The condensed Memorial Symptom Assessment Scale evaluates 14 symptoms: lack of energy, lack of appetite, pain, dry mouth, weight loss, feeling drowsy, shortness of breath, constipation, difficulty sleeping, difficulty concentrating, nausea, worrying, feeling sad, and feeling nervous.	participants will be followed monthly until referred to hospice or until death, an expected average of 1 year
Changes in the use of wills, living wills, advanced medical directives, durable power of medical attorney and preferred place of death.		1 year
Changes in hospice referral, use, acceptance, and length of stay, compared to similar patients in the prior 12 months (from retrospective review)		1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

All patients with metastatic pancreas cancer will be eligible, ages 18 and above.
There is no limit to the amount of prior therapy for metastatic disease.
Ability to understand and the willingness to sign a written informed consent document and to answer a questionnaire.
English speakers.

Patients who have tumors other than metastatic pancreas cancer.
Patients who actively decline participation or who are judged to be in distress before the interview.
Patients who are pregnant.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Thomas J Smith, MD, Johns Hopkins Medical Institutions, Sidney Kimmel Comprehensive Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.
Smith TJ, Temin S, Alesi ER, Abernethy AP, Balboni TA, Basch EM, Ferrell BR, Loscalzo M, Meier DE, Paice JA, Peppercorn JM, Somerfield M, Stovall E, Von Roenn JH. American Society of Clinical Oncology provisional clinical opinion: the integration of palliative care into standard oncology care. J Clin Oncol. 2012 Mar 10;30(8):880-7. doi: 10.1200/JCO.2011.38.5161. Epub 2012 Feb 6.

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