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End-of-Life Health Care Decisions by Patients With Advanced Cancer

Information source: Milton S. Hershey Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neoplasms

Intervention: computer-based decision aid (Other); standard care (Other)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Milton S. Hershey Medical Center

Official(s) and/or principal investigator(s):
Michael J. Green, MD, MS, Principal Investigator, Affiliation: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Summary

This study is designed to help the investigators understand more about how people plan for their future medical needs, a process known as "advance care planning." The study is under the direction of Michael J. Green, M. D., and Benjamin Levi, M. D. physicians at Penn State Hershey Medical Center. Participation in the project takes place during a single visit to the Medical Center campus. During this one-to-three hour visit, participants complete several questionnaires and use a computer program that produces a printed advance directive that can be shared with their physicians and loved ones. Participants will receive compensation toward travel expenses.

Clinical Details

Official title: End-of-Life Health Care Decisions by Patients With Advanced Cancer

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)

Primary outcome: Participant knowledge of advance care planning

Secondary outcome:

Participant decisional conflict

Participant satisfaction with decision

Participant satisfaction with advance care planning

Participant self-determination

Participant anxiety

Participant hopelessness

Physician awareness of patients' health care wishes

Physician adherence to patients' health care wishes

Detailed description: Background: Despite widespread agreement that individuals ought to plan for their medical futures, few people (even seriously ill patients with cancer) actually complete advance directives, fewer yet understand key elements, and even when advance directives do exist, there are often barriers to their being implemented. Objectives: The investigators innovative, multimedia, interactive, computer-based decision aid, "Making Your Wishes Known: Planning Your Medical Future," offers tailored education, values clarification exercises, and a sophisticated decision aid that translates an individual's goals and preferences into a specific medical plan that can be implemented by a health care team. This project aims to evaluate its impact on decision-making and health care received by individuals at the end of life in a randomized clinical trial among a population of patients with advanced cancer who have life expectancies of < 12 months. Specific Aims: Aim 1: To evaluate the impact of a computer-based advance care planning intervention on end-of-life decision-making by cancer patients with estimated life expectancies < 12 months. The investigators hypothesize that, compared to standard care (paper/pencil living will form), use of the computer-based intervention will: H1: Improve individuals' decision-making about end-of-life health care H2: Improve individuals' experience with the process of advance care planning H3: Not increase individuals' hopelessness or anxiety, nor harm the doctor-patient relationship Aim 2: To evaluate the impact of the investigators intervention on end-of-life health care received by cancer patients with estimated life expectancies < 12 months. The investigators hypothesize that, compared to standard care, use of the computer intervention will: H4: Increase physician awareness of individuals' health care wishes H5: Increase physician adherence to individuals' health care wishes Study Design: Randomized, controlled pre-intervention/post-intervention trial comparing a computer-based educational intervention with standard care Cancer Relevance: Patients with advanced cancer face many medical decisions, some of which must be made when the patient cannot speak for him or herself. Helping these individuals to effectively articulate and communicate their wishes, in advance, can help assure that treatment they receive is consistent with their values, goals and wishes. This study aims to test the effectiveness of the investigators' computer-based intervention. If successful, this intervention can help improve the quality of health care received by cancer patients at the end of life.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 18 years of age or older

- able to give informed consent

- interested in participating in advance care planning

- able to read and understand English at an 8th grade level (per WRAT-3 screening test)

- advanced cancer (primary or metastatic), with estimated lifespan < 6 months (as

determined by their treating physician)

- cognitively able to engage in advance care planning (Mini Mental State Exam (MMSE)

score >23)

- absence of moderate or severe depression (BDI-II score <20/63)

Exclusion Criteria:

- unable to read and understand English at an 8th grade level (per Wide Range

Achievement Test (WRAT-3))

- not cognitively able to engage in advance care planning (Mini Mental State Exam

(MMSE) score < 23)

- moderate or severe depression (BDI-II score >20/63)

Locations and Contacts

Additional Information

Starting date: March 2008
Last updated: October 21, 2014

Page last updated: August 23, 2015

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