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

NCT ID: NCT01784081

Last Updated: 2016-06-10

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-06-30

Brief Summary

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.

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.

Conditions

Pancreas Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

palliative care with iPC3

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

Palliative care with decision aids

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas J Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Medical Institutions, Sidney Kimmel Comprehensive Cancer Center

Locations

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20818875 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22312101 (View on PubMed)

Other Identifiers

90049470

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NA_00074891

Identifier Type: OTHER

Identifier Source: secondary_id

J1270

Identifier Type: -

Identifier Source: org_study_id