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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01784081
First received: January 23, 2013
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Pancreas Cancer
Other: Palliative care with decision aids

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: iPC3 - Integrating Palliative Care and Modern Palliative Care Tools Into the Care of Patients With Pancreas Cancer

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with metastatic pancreas cancer.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01784081

Contacts
Contact: Thomas J Smith, MD 410-955-2091 tsmit136@jhmi.edu
Contact: Mok-Chung J Cheng, MD 410 955 8308 mcheng12@jhmi.edu

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21287-0005
Contact: Thomas J Smith, MD    410-955-2091    tsmit136@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Thomas J Smith, MD Johns Hopkins Medical Institutions, Sidney Kimmel Comprehensive Cancer Center
  More Information

Publications:
Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01784081     History of Changes
Other Study ID Numbers: J1270, 90049470, NA_00074891
Study First Received: January 23, 2013
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
palliative care
decision aid

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases

ClinicalTrials.gov processed this record on October 29, 2014