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

December 13, 2023 updated by: Michael J. Green, Milton S. Hershey Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Other Names:
  • "Making Your Wishes Known: Planning Your Medical Future"
Active Comparator: standard care
paper/pencil living will form
Other: standard care
paper/pencil living will form

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant knowledge of advance care planning
Time Frame: Pre and post-intervention
Knowledge of advance care planning will be compared between control and intervention groups, using a true/false and multiple choice questionnaire about advance care planning.
Pre and post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant decisional conflict
Time Frame: post-intervention
Assessment of conflict associated with making end-of-life decisions will be assessed with the decisional conflict scale.
post-intervention
Participant satisfaction with decision
Time Frame: post-intervention
Assessment of satisfaction with decisions associated with advance care planning will be assessed with the satisfaction with decision scale.
post-intervention
Participant satisfaction with advance care planning
Time Frame: post-intervention
Satisfaction with with advance care planning process will be compared between intervention and control group with a satisfaction questionnaire.
post-intervention
Participant self-determination
Time Frame: pre and post-intervention
Self determination will be compared between intervention and control group with a self-determination questionnaire.
pre and post-intervention
Participant anxiety
Time Frame: pre and post-intervention
Pre and post-intervention anxiety will be compared between intervention and control group with the state trait anxiety instrument.
pre and post-intervention
Participant hopelessness
Time Frame: pre and post-intervention
Assessment of pre and post-intervention hopelessness will be compared between intervention and control group using the Beck Hopelessness scale and a measure of hopefulness.
pre and post-intervention
Physician awareness of patients' health care wishes
Time Frame: post-death chart review
Comparison will be made between intervention and control group regarding whether an advance directive is present in the patient's medical record, and whether the physician is aware of the patient's wishes.
post-death chart review
Physician adherence to patients' health care wishes
Time Frame: post-death chart review
Comparison will be made between intervention and control group regarding whether patients' wishes are followed at the end of life.
post-death chart review

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Collaborators

American Cancer Society, Inc.

Investigators

  • Principal Investigator: Michael J. Green, MD, MS, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

July 30, 2014

First Submitted That Met QC Criteria

October 10, 2014

First Posted (Estimated)

October 16, 2014

Study Record Updates

Last Update Posted (Actual)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSGHP-08-005-01-CPHPS (Other Grant/Funding Number: ACS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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