Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02265601 |
| Other study ID # |
RSGHP-08-005-01-CPHPS |
| Secondary ID |
RSGHP-08-005-01- |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2008 |
| Est. completion date |
January 2017 |
Study information
| Verified date |
December 2023 |
| Source |
Milton S. Hershey Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
