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

NCT01784081 | Withdrawn DMC

• 3 other identifiers: J127090049470NA_00074891
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Cancer

Keywords

palliative care; decision aid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes in symptoms listed in the Memorial Symptom Assessment Scale (condensed version)

  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

Study Arms (1)

palliative care with iPC3

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

Other: Palliative care with decision aids

Interventions

Palliative care with decision aids 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.

palliative care with iPC3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic pancreas cancer.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287-0005, United States

Location

Related Publications (2)

• 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.

  PMID: 20818875 BACKGROUND

• 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.

  PMID: 22312101 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Palliative Care; Decision Support Techniques

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Investigative Techniques

Study Officials

• Thomas J Smith, MD

  Johns Hopkins Medical Institutions, Sidney Kimmel Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: February 5, 2013
• Study Start: April 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 10, 2016

Record last verified: 2016-06

Locations

US (1)