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

NCT ID: NCT02265601

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neoplasms

Keywords

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advance care planning living wills end of life cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

computer-based decision aid

Intervention Type OTHER

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.

standard care

paper/pencil living will form

Group Type ACTIVE_COMPARATOR

standard care

Intervention Type OTHER

paper/pencil living will form

Interventions

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computer-based decision aid

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.

Intervention Type OTHER

standard care

paper/pencil living will form

Intervention Type OTHER

Other Intervention Names

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"Making Your Wishes Known: Planning Your Medical Future"

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Michael J. Green

Professor of Humanities

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael J. Green, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Other Identifiers

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RSGHP-08-005-01-CPHPS

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RSGHP-08-005-01-CPHPS

Identifier Type: -

Identifier Source: org_study_id