QualityNCT05132868
Assessments of Genetic Counseling Augmented With an Educational Video or Pamphlet Versus Traditional Counseling
A study testing Educational video and pamphlet and Traditional genetic counseling in people with Quality and Prostate Cancer, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this research study is to understand the impact of an educational video or pamphlet on the patient experience in a hereditary cancer genetic counseling program. In order to make this assessment, it is necessary to perform qualitative and quantitative research among patients in a hereditary cancer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality, Prostate Cancer, Gastrointestinal Cancer
- What is being tested?
- Educational video and pamphlet and Traditional genetic counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2021to 28 Jun 2023
- 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
- Inclusion criteria for: Limited English Proficiency (LEP), primarily Spanish speaking cohort
- Preferred language for receiving medical information is Spanish
- Has a personal or family history of cancer
- If assigned to the arm where they need to be pre-educated with a video or pamphlet, attests that they viewed the video or pamphlet
- Inclusion criteria for: Individuals with a personal or family history of breast cancer cohort
- Personal or family history of breast cancer
Show all 26Show fewer
- English is preferred language
- If assigned to the arm where they need to be pre-educated with a video or pamphlet, attests that they viewed the video or pamphlet
- Inclusion criteria for: Individuals with a personal or family history of prostate cancer cohort
- Personal or family history of prostate cancer
- English is preferred language
- If assigned to the arm where they need to be pre-educated with a video or pamphlet, attests that they viewed the video or pamphlet
- Inclusion criteria for: Individuals with a personal or family history of any type of cancer referred for germline testing based on a genetic variant identified during tumor genomic analysis for the patient or affected family member cohort.
- Personal or family history of any type of cancer
- Referred based on a variant identified during tumor genomic analysis
- English is preferred language
- If assigned to the arm where they need to be pre-educated with a video or pamphlet, attests that they viewed the video or pamphlet
- Inclusion criteria for: Individuals with a personal or family history of gastrointestinal or gynecologic cancer, referred because they or their affected relative screened positive for Lynch Syndrome based on either an immunohistochemistry test or evidence of mismatch repair deficiency in their tumor cohort.
- Personal or family history of gastrointestinal or gynecologic cancer
- Screened positive for Lynch Syndrome based on IHC or MMR testing
- English is preferred language
- If assigned to the arm where they need to be pre-educated with a video or pamphlet, attests that they viewed the video or pamphlet
- Inclusion criteria for: Individuals with a personal or family history of ovarian and/or pancreatic cancer cohort
- Personal or family history of ovarian, and/or pancreatic cancer
- English is preferred language
- If assigned to the arm where they need to be pre-educated with a video or pamphlet, attests that they viewed the video or pamphlet
Who cannot join
- Individuals who are minors
- Individuals who are decisionally impaired
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to understand the impact of an educational video or pamphlet on the patient experience in a hereditary cancer genetic counseling program. In order to make this assessment, it is necessary to perform qualitative and quantitative research among patients in a hereditary cancer genetic counseling clinic.
- Conditions
- Quality, Prostate Cancer, Gastrointestinal Cancer, Gynecologic Cancer, Ovarian Cancer, Pancreatic Cancer
- Being tested
- Educational video and pamphlet, Traditional genetic counseling
- Keywords
- cancer genetic counseling, educational video, pamphlet
- Medical subject headings
- Prostatic Neoplasms, Gastrointestinal Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational video and pamphletOther
The primary intervention in this study is watching the video or reading the pamphlet in advance of the genetic counseling session, which overview the same information that we currently provide in-person/via telehealth during the genetic counseling session.
Traditional genetic counselingOther
Patients will receive traditional genetic counseling
| Study group | Role | What they receive |
|---|---|---|
| pre-educated with educational video | Experimental | Participants will receive a message to view educational videos prior to their genetic counseling appointment if they are assigned to a pre-educated arm. The video will be shared with patients via MyHealth in the "education" tab in advance of the genetic counseling session Receives: Other: Educational video and pamphlet; Other: Traditional genetic counseling |
| pre-educated with pamphlet | Experimental | Participants will receive a message to view a pamphlet prior to their genetic counseling appointment if they are assigned to a pre-educated arm. The pamphlet will be sent to patients who cannot access the video via regular mail in advance of the genetic counseling session Receives: Other: Educational video and pamphlet; Other: Traditional genetic counseling |
| educated during the session | Other | Participants will receive traditional genetic counseling. . After the genetic counseling session, they will fill out a validated survey called the Multi-dimensional Measure of Informed Choice (MMIC) that assesses attitudes, knowledge, and uptake of genetic testing Receives: Other: Traditional genetic counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient impact with educational information prior to genetic counseling
Impact will be defined as the number of questions asked by patient during the counseling.
Measured: 36 months
Patient impact without any educational information prior to genetic counseling
Impact will be defined as the number of questions asked by patient during the counseling.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start25 May 2021
- Primary completion28 Jun 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for QualityStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Ford, Stanford University
- Investigators
- James Ford, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132868
- Sponsor's protocol ID
- IRB-61374
- Other IDs
- VAR0214, NCI-2022-00606
- Status last verified
- Aug 2024
- First submitted
- 25 Oct 2021
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessments of Genetic Counseling Augmented With an Educational Video or Pamphlet Versus Traditional Counseling
- ClinicalTrials.gov ID
- NCT05132868
- Acronym / sponsor ID
- IRB-61374
- Conditions
- Quality, Prostate Cancer, Gastrointestinal Cancer, Gynecologic Cancer, Ovarian Cancer, Pancreatic Cancer
- Keywords
- cancer genetic counseling, educational video, pamphlet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 24 Nov 2021 (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 study is to understand the impact of an educational video or pamphlet on the patient experience in a hereditary cancer genetic counseling program. In order to make this assessment, it is necessary to perform qualitative and quantitative research among patients in a hereditary cancer genetic counseling clinic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pre-educated with educational video | Experimental | Other: Educational video and pamphlet, Other: Traditional genetic counselingParticipants will receive a message to view educational videos prior to their genetic counseling appointment if they are assigned to a pre-educated arm. The video will be shared with patients via MyHealth in the "education" tab in advance of the genetic counseling session |
| pre-educated with pamphlet | Experimental | Other: Educational video and pamphlet, Other: Traditional genetic counselingParticipants will receive a message to view a pamphlet prior to their genetic counseling appointment if they are assigned to a pre-educated arm. The pamphlet will be sent to patients who cannot access the video via regular mail in advance of the genetic counseling session |
| educated during the session | Other | Other: Traditional genetic counselingParticipants will receive traditional genetic counseling. . After the genetic counseling session, they will fill out a validated survey called the Multi-dimensional Measure of Informed Choice (MMIC) that assesses attitudes, knowledge, and uptake of genetic testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Inclusion criteria for: Limited English Proficiency (LEP), primarily Spanish speaking cohort
- Preferred language for receiving medical information is Spanish
- Has a personal or family history of cancer
- If assigned to the arm where they need to be pre-educated with a video or pamphlet, attests that they viewed the video or pamphlet
- Inclusion criteria for: Individuals with a personal or family history of breast cancer cohort
Key exclusion criteria (2 listed)
- Individuals who are minors
- Individuals who are decisionally impaired
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 |
|---|---|---|
| Educational video and pamphletThe primary intervention in this study is watching the video or reading the pamphlet in advance of the genetic counseling session, which overview the same information that we currently provide in-person/via telehealth during the genetic counseling session. | Other | pre-educated with educational video, pre-educated with pamphlet |
| Traditional genetic counselingPatients will receive traditional genetic counseling | Other | educated during the session, pre-educated with educational video, pre-educated with pamphlet |
Primary outcome
Patient impact with educational information prior to genetic counseling
Time frame: 36 months
Impact will be defined as the number of questions asked by patient during the counseling.
Patient impact without any educational information prior to genetic counseling
Time frame: 36 months
Impact will be defined as the number of questions asked by patient during the counseling.
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 9 Aug 2024.
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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.
James Ford, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational video and pamphlet and Traditional genetic counseling in people with Quality and Prostate Cancer, run by Stanford University 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 26 inclusion and 2 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 9 Aug 2024. 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?
Patient impact with educational information prior to genetic counseling (time frame: 36 months). The study lists 2 primary outcomes in all. 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 9 Aug 2024.