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

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01784081
Collaborator
(none)
0
1
14
0

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Palliative care with decision aids

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 Design

Study Type:
Observational
Actual Enrollment :
0 participants
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
Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. 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]

    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.

  2. Changes in the use of wills, living wills, advanced medical directives, durable power of medical attorney and preferred place of death. [1 year]

  3. Changes in hospice referral, use, acceptance, and length of stay, compared to similar patients in the prior 12 months (from retrospective review) [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland United States 21287-0005

Sponsors and Collaborators

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier:
NCT01784081
Other Study ID Numbers:
  • J1270
  • 90049470
  • NA_00074891
First Posted:
Feb 5, 2013
Last Update Posted:
Jun 10, 2016
Last Verified:
Jun 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 10, 2016