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

NCT02265601 | Completed

• 1 other identifier: RSGHP-08-005-01-CPHPS
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Neoplasms

Keywords

advance care planning; living wills; end of life; cancer

Outcome Measures

Primary Outcomes (1)

• Participant knowledge of advance care planning

  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 Outcomes (8)

• Participant decisional conflict

  post-intervention

• Participant satisfaction with decision

  post-intervention

• Participant satisfaction with advance care planning

  post-intervention

• Participant self-determination

  pre and post-intervention

• Participant anxiety

  pre and post-intervention

Study Arms (2)

computer-based decision aid

EXPERIMENTAL

"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

standard care

ACTIVE COMPARATOR

paper/pencil living will form

Other: standard care

Interventions

computer-based decision aid 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.

Also known as: "Making Your Wishes Known: Planning Your Medical Future"

computer-based decision aid

standard care OTHER

paper/pencil living will form

standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• American Cancer Society, Inc.: collaborator

MeSH Terms

Conditions

Neoplasms; Death

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Michael J. Green, MD, MS

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Humanities

Study Record Dates

• First Submitted: July 30, 2014
• First Posted: October 16, 2014
• Study Start: March 1, 2008
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: December 14, 2023

Record last verified: 2023-12