Integrating Palliative Care and Modern Palliative Care Tools Into the Care of Patients With Pancreas Cancer (iPC3)

June 8, 2016 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

iPC3 - 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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

  • 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.

Study Type

Observational

Contacts and Locations

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

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287-0005
        • Sidney Kimmel Comprehensive Cancer Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with metastatic pancreas cancer.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 benefits and risks with the proposed chemotherapy.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in symptoms listed in the Memorial Symptom Assessment Scale (condensed version)
Time Frame: participants will be followed monthly until referred to hospice or until death, an expected average of 1 year
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.
Time Frame: 1 year
1 year
Changes in hospice referral, use, acceptance, and length of stay, compared to similar patients in the prior 12 months (from retrospective review)
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Investigators

  • Principal Investigator: Thomas J Smith, MD, Johns Hopkins Medical Institutions, Sidney Kimmel Comprehensive Cancer Center

Publications and helpful links

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

General Publications

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 Major Dates

Study Start

April 1, 2014

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

January 23, 2013

First Submitted That Met QC Criteria

February 1, 2013

First Posted (ESTIMATE)

February 5, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 10, 2016

Last Update Submitted That Met QC Criteria

June 8, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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