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

Pancreas Cancer Clinical Trial

— iPC3  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01784081
• Other study ID #: J1270
• Secondary ID: 90049470NA_00074
• Status: Withdrawn
• Phase: N/A
• First received: January 23, 2013
• Last updated: June 8, 2016
• Start date: April 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2016
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Changes in the use of wills, living wills, advanced medical directives, durable power of medical attorney and preferred place of death.		1 year	No
Secondary	Changes in hospice referral, use, acceptance, and length of stay, compared to similar patients in the prior 12 months (from retrospective review)		1 year	No