NeoplasmsNCT02265601
End-of-Life Health Care Decisions by Patients With Advanced Cancer
A study testing computer-based decision aid in people with Neoplasms, run by Milton S. Hershey Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- computer-based decision aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
About this study
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.
Read the 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.
- Conditions
- Neoplasms
- Being tested
- computer-based decision aid, standard care
- Keywords
- advance care planning, living wills, end of life, cancer
- Medical subject headings
- Neoplasms, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer-based decision aidOther
Also called "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.
standard careOther
paper/pencil living will form
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: computer-based decision aid |
| standard care | Active comparator | paper/pencil living will form Receives: Other: standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre and post-intervention
Secondary outcomes (8)
Participant decisional conflict
Assessment of conflict associated with making end-of-life decisions will be assessed with the decisional conflict scale.
Measured: post-intervention
Participant satisfaction with decision
Assessment of satisfaction with decisions associated with advance care planning will be assessed with the satisfaction with decision scale.
Measured: post-intervention
Participant satisfaction with advance care planning
Satisfaction with with advance care planning process will be compared between intervention and control group with a satisfaction questionnaire.
Measured: post-intervention
Participant self-determination
Self determination will be compared between intervention and control group with a self-determination questionnaire.
Measured: pre and post-intervention
Participant anxiety
Pre and post-intervention anxiety will be compared between intervention and control group with the state trait anxiety instrument.
Measured: pre and post-intervention
Participant hopelessness
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.
Measured: pre and post-intervention
Physician awareness of patients' health care wishes
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.
Measured: post-death chart review
Physician adherence to patients' health care wishes
Comparison will be made between intervention and control group regarding whether patients' wishes are followed at the end of life.
Measured: post-death chart review
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startMar 2008
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Michael J. Green, Milton S. Hershey Medical Center
- Investigators
- Michael J. Green, MD, MS, Principal investigator, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265601
- Sponsor's protocol ID
- RSGHP-08-005-01-CPHPS
- Other IDs
- RSGHP-08-005-01-CPHPS
- Status last verified
- Dec 2023
- First submitted
- 30 Jul 2014
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End-of-Life Health Care Decisions by Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT02265601
- Acronym / sponsor ID
- RSGHP-08-005-01-CPHPS
- Conditions
- Neoplasms
- Keywords
- advance care planning, living wills, end of life, cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Mar 2008
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 16 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| computer-based decision aid | Experimental | Other: 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. |
| standard care | Active comparator | Other: standard carepaper/pencil living will form |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computer-based decision aidAlso: "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 carepaper/pencil living will form | Other | standard care |
Primary outcome
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.
8 secondary outcomes
Participant decisional conflict
Time frame: post-intervention
Participant satisfaction with decision
Time frame: post-intervention
Participant satisfaction with advance care planning
Time frame: post-intervention
Participant self-determination
Time frame: pre and post-intervention
Participant anxiety
Time frame: pre and post-intervention
Participant hopelessness
Time frame: pre and post-intervention
Physician awareness of patients' health care wishes
Time frame: post-death chart review
Physician adherence to patients' health care wishes
Time frame: post-death chart review
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J. Green, MD, MS principal investigator
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing computer-based decision aid in people with Neoplasms, run by Milton S. Hershey Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant knowledge of advance care planning (time frame: Pre and post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.