Advance Care PlanningNCT03251976
CPR Decision Aid For Patients With Advanced Gynecologic Malignancies
A study testing video in people with Advance Care Planning, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this research is to assess the effect of a cardiopulmonary resuscitation (CPR) decision aid video on CPR knowledge and end-of-life preferences in women with advanced gynecologic malignancy. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Advance Care Planning
- What is being tested?
- video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2018to 6 May 2019
- 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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with stage III or greater cervical, ovarian, or uterine malignancies
- receiving chemotherapy at UAB gynecologic oncology infusion center
Who cannot join
- early stage gynecologic cancer
- receiving chemotherapy at a different location
- Non-English speaking
- deafness
- blindness
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: The Effect of a CPR Decision Aid on CPR Knowledge and Code-Status Preferences in Patients With Advanced Gynecologic Malignancies
The purpose of this research is to assess the effect of a cardiopulmonary resuscitation (CPR) decision aid video on CPR knowledge and end-of-life preferences in women with advanced gynecologic malignancy. We will assess the baseline CPR knowledge in our research population, gauge the improvement after viewing a decision aid video, and evaluate its effects on patient preferences regarding CPR.
- Conditions
- Advance Care Planning
- Being tested
- video, usual care
- Keywords
- ovarian cancer, cardiopulmonary resuscitation, end of life care, endometrial cancer, cervical cancer
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
videoBehavioural
informational video
usual careBehavioural
usual physician counseling on end of life care
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | video decision aid Receives: Behavioral: video |
| Usual care | Active comparator | Not described Receives: Behavioral: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPR knowledge
Patient CPR knowledge assessment score (0-4)
Measured: one month after intervention
Secondary outcomes (3)
CPR preference
Patient CPR preference (Yes, No, Unsure)
Measured: baseline
CPR preference
Patient CPR preference (Yes, No, Unsure)
Measured: one month after intervention
CPR knowledge
Patient CPR knowledge assessment score (0-4)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start6 Nov 2018
- Primary completion6 May 2019
- Study completion6 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advance Care PlanningStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerri Bevis, University of Alabama at Birmingham
- Investigators
- Kerri Bevis, MD, MSPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251976
- Sponsor's protocol ID
- F12345678
- Status last verified
- Aug 2019
- First submitted
- 14 Aug 2017
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a CPR Decision Aid on CPR Knowledge and Code-Status Preferences in Patients With Advanced Gynecologic Malignancies
- ClinicalTrials.gov ID
- NCT03251976
- Acronym / sponsor ID
- F12345678
- Conditions
- Advance Care Planning
- Keywords
- ovarian cancer, cardiopulmonary resuscitation, end of life care, endometrial cancer, cervical cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 6 May 2019 (actual)
- Study completion
- 6 May 2019 (actual)
- First posted
- 16 Aug 2017 (actual)
- 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.
The purpose of this research is to assess the effect of a cardiopulmonary resuscitation (CPR) decision aid video on CPR knowledge and end-of-life preferences in women with advanced gynecologic malignancy. We will assess the baseline CPR knowledge in our research population, gauge the improvement after viewing a decision aid video, and evaluate its effects on patient preferences regarding CPR.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: videovideo decision aid |
| Usual care | Active comparator | Behavioral: usual care |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with stage III or greater cervical, ovarian, or uterine malignancies
- receiving chemotherapy at UAB gynecologic oncology infusion center
Key exclusion criteria (5 listed)
- early stage gynecologic cancer
- receiving chemotherapy at a different location
- Non-English speaking
- deafness
- blindness
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 |
|---|---|---|
| videoinformational video | Behavioural | Intervention |
| usual careusual physician counseling on end of life care | Behavioural | Usual care |
Primary outcome
CPR knowledge
Time frame: one month after intervention
Patient CPR knowledge assessment score (0-4)
3 secondary outcomes
CPR preference
Time frame: baseline
CPR preference
Time frame: one month after intervention
CPR knowledge
Time frame: baseline
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 19 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Advance Care Planning
Active, not recruiting
ACP Video Intervention for Patients With Life-Limiting Illness
Health Care Utilization, End Stage Disease
Recruiting
Patient Navigation and the Planning Advance Care Together Website to Improve Goals of Care Conversations in Hematopoietic Cell Transplant Survivors, IMPACT-HCT Trial
Hematopoietic and Lymphatic System Neoplasm
Not yet recruiting
Using a Conversation Game to Engage Native American Washoe Tribe Members in Advance Care Planning: Preparation for a Clinical Trial
Advance Care Planning, American Indian or Alaska Native
Not yet recruiting
Development and Evaluation of a Disease-oriented Scenario Game to Promote ACP Among Older Adults and Family Caregivers
Heart Failure, Older Adults (65 Years and Older)
Active, not recruiting
Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program: An Exploratory Study in Adolescents and Young Adults (AYAs) Receiving Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplantation
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.
Kerri Bevis, MD, MSPH principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video in people with Advance Care Planning, run by University of Alabama at Birmingham at 1 site in United States.
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 2 inclusion and 5 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 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
CPR knowledge (time frame: one month after 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 19 Aug 2019.