Ovarian Cancer, EpithelialNCT04537702
Prospective Randomized Trial of Streamlined Genetic Education and Testing for Ovarian Cancer Patients
A study testing Streamlined Education and Traditional Education in people with Ovarian Cancer, Epithelial and Peritoneal Cancer, run by Duke University at 1 site in United States.
Trial summary
Current guidelines recommend universal genetic testing for all patients with ovarian, fallopian and peritoneal cancer. The purpose of this trial is to investigate the non-inferiority of streamlined genetics education and testing for this patient population when compared to the traditional model of referral to genetic… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Epithelial, Peritoneal Cancer, Fallopian Tube Cancer
- What is being tested?
- Streamlined Education and Traditional Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2019to 31 Jul 2021
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Either a) pathologically confirmed diagnosis of high-grade epithelial ovarian, fallopian or peritoneal cancer via biopsy or surgical pathology or b) cytologic diagnosis consistent with high-grade epithelial ovarian cancer.
- Presenting to Duke gynecologic oncology clinic or collaborating institution for first outpatient visit following pathologic or cytologic diagnosis. If logistic constraints prevent the patient from being enrolled at her initial visit, she will be eligible for enrollment up to initiation of her fifth cycle of chemotherapy.
Who cannot join
- Known family or personal history of an inherited cancer susceptibility mutation
- Previously received genetic counseling or testing for an inherited cancer susceptibility mutation
- Insurance provided by an insurance company that requires face-to-face genetic consultation prior to testing
- Unable to read or speak English as study design includes video assisted educational materials in English
- Blind or deaf as study design includes video assisted educational materials in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
Official title: Prospective, Randomized Non-inferiority Trial of Streamlined Genetic Education and Testing for High-grade Epithelial Ovarian, Fallopian and Peritoneal Cancer Patients
Current guidelines recommend universal genetic testing for all patients with ovarian, fallopian and peritoneal cancer. The purpose of this trial is to investigate the non-inferiority of streamlined genetics education and testing for this patient population when compared to the traditional model of referral to genetic counseling. Patients will be randomized to either the streamlined or the traditional counseling arm. Those in the streamlined group will watch a brief educational video and have the option of immediate testing; The traditional counseling arm will instead be referred for a formal genetics consultation, after which they can choose to be tested. The primary outcome will be a patient reported outcome scale that assesses patient satisfaction with genetic counseling; patient anxiety and distress and cost effectiveness when using both strategies will also be evaluated. The study poses minimal risk to the patients that would not be encountered during standard of care genetic counseling.
- Being tested
- Streamlined Education, Traditional Education
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Streamlined EducationBehavioural
After completion of the baseline surveys, the SG subjects will watch an approximately eight minute long genetics education video. This video will be made with the assistance of Duke University genetic counselors and gynecologic oncology providers. It will consist of a discussion of genes and mutations, the recommendation of universal testing for high grade epithelial ovarian cancer, a review of genes associated with ovarian cancer predisposition, the possibility of uncertain results including variants of undetermined significance, the potential for undetected mutations in known or unknown cancer susceptibility genes, the potential impact on personal treatment and on family members, the possibility of genetic discrimination and the legal protection of genetic information.
Traditional EducationBehavioural
The TG subjects will then meet with the genetic counselor at the previously scheduled appointment time. During this visit, they will receive approximately thirty to sixty minutes of counseling regarding genetic testing and potential results. The discussion is based on the American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN) guidelines of informed consent for genetic testing. After counseling, participants will be given the option to undergo a multi-gene panel genetic test either via saliva or blood sample. Those who agree to testing will also complete the standard genetic testing consent form. As per standard practice of the clinical genetic service at DCI, patients will also be asked to provide consent for somatic tumor testing of surgical specimen (non-cytologic).
| Study group | Role | What they receive |
|---|---|---|
| Tradition Counseling Group (TG) | Active comparator | After completion of baseline surveys, the TG subjects will be referred to a formal pre-test consultation with a genetic counselor. TG subjects will complete an electronic family history questionnaire (FHQ) within one week of the primary visit. A member of the genetics team will curate the results by contacting the subject to review errors and clarify any ambiguities in the pedigree. The TG subjects will then meet with the genetic counselor. After counseling, participants will be given the option to undergo a multi-gene panel genetic test. Those who agree to testing will also complete the standard genetic testing consent form. As per standard practice, patients will also be asked to provide consent for somatic tumor testing of surgical (non-cytologic) specimen. Subjects will complete a post-education distress and anxiety survey (IES) either via an email link to a confidential REDCap survey link 1-2 weeks after formal consultation. Receives: Behavioral: Traditional Education |
| Streamlined Group (SG) | Experimental | After completion of the baseline surveys, the SG subjects will watch an approximately eight minute long genetics education video. All subjects will then have the option to "opt out" and receive formal genetic counseling prior to making a decision about testing. If the subject elects to undergo genetic testing, she will fill out the standard genetic testing consent form. As per standard practice of the clinical genetic service at Duke Cancer Institute (DCI), patients will also be asked to provide consent for somatic tumor testing of surgical (non-cytologic) specimen. SG subjects will complete an FHQ within one week of the primary visit. A member of the genetics team will curate the results by contacting the subject to review common errors and clarify any ambiguities in the pedigree. Subjects will complete a post-education distress and anxiety survey (IES) via either an email link to a confidential REDCap survey link or over the phone 1-2 weeks after education. Receives: Behavioral: Streamlined Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic Information
Number of participants with children
Measured: Baseline
Numeracy assessment
Numeracy as assessed by the Newest Vital Sign survey
Measured: Baseline
Electronic Family History
Family cancer history up to past 3 generations
Measured: Completed at least 1 week prior to genetic sample being taken
Change in anxiety and depression as measured by the IES Scale
The Impact of Events Scale (IES) has been used widely as a means of measuring patient distress (particularly intrusive thoughts or avoidance) over a defined incident. This evaluation will be used to identify trends in anxiety or depression in both arms throughout the education and testing process. In this trial, the "incident" will be described as "the risk of my cancer being hereditary."
Measured: Baseline, approximately 7 days post-education, and approximately 7 days post-results disclosure
Distress as measured by MICRA
The multidimensional impact of cancer risk assessment questionnaire (MICRA) is a 25-question validated tool that measures the impact of result disclosure in patients, particularly markers of distress
Measured: Approximately 7 days post-results disclosure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start8 Aug 2019
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cancer, EpithelialStudies of the same condition, open and under way.
- More trials run by Duke 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Following consent, the clinical research coordinator will randomize the patient to either the Traditional Group (TG) or Streamlined Group (SG). The randomization process will have occurred previously using blocks of ten randomly computer-generated numbers. These numbers will be kept in individual, ordered envelopes. When a subject requires randomization, the next envelope in the sequence will be opened and the subject will be randomized according to the number listed in the envelope.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Previs, MD, MS, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537702
- Sponsor's protocol ID
- PRO00100538
- Status last verified
- Jul 2021
- First submitted
- 26 Aug 2020
- Last updated
- 26 Aug 2021
- 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 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Non-inferiority Trial of Streamlined Genetic Education and Testing for High-grade Epithelial Ovarian, Fallopian and Peritoneal Cancer Patients
- ClinicalTrials.gov ID
- NCT04537702
- Acronym / sponsor ID
- PRO00100538
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 3 Sep 2020 (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.
Current guidelines recommend universal genetic testing for all patients with ovarian, fallopian and peritoneal cancer. The purpose of this trial is to investigate the non-inferiority of streamlined genetics education and testing for this patient population when compared to the traditional model of referral to genetic counseling. Patients will be randomized to either the streamlined or the traditional counseling arm. Those in the streamlined group will watch a brief educational video and have the option of immediate testing; The traditional counseling arm will instead be referred for a formal genetics consultation, after which they can choose to be tested. The primary outcome will be a patient reported outcome scale that assesses patient satisfaction with genetic counseling; patient anxiety and distress and cost effectiveness when using both strategies will also be evaluated. The study poses minimal risk to the patients that would not be encountered during standard of care genetic counseling.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Following consent, the clinical research coordinator will randomize the patient to either the Traditional Group (TG) or Streamlined Group (SG). The randomization process will have occurred previously using blocks of ten randomly computer-generated numbers. These numbers will be kept in individual, ordered envelopes. When a subject requires randomization, the next envelope in the sequence will be opened and the subject will be randomized according to the number listed in the envelope.
| Arm | Type | Receives |
|---|---|---|
| Tradition Counseling Group (TG) | Active comparator | Behavioral: Traditional EducationAfter completion of baseline surveys, the TG subjects will be referred to a formal pre-test consultation with a genetic counselor. TG subjects will complete an electronic family history questionnaire (FHQ) within one week of the primary visit. A member of the genetics team will curate the results by contacting the subject to review errors and clarify any ambiguities in the pedigree. The TG subjects will then meet with the genetic counselor. After counseling, participants will be given the option to undergo a multi-gene panel genetic test. Those who agree to testing will also complete the standard genetic testing consent form. As per standard practice, patients will also be asked to provide consent for somatic tumor testing of surgical (non-cytologic) specimen. Subjects will complete a post-education distress and anxiety survey (IES) either via an email link to a confidential REDCap survey link 1-2 weeks after formal consultation. |
| Streamlined Group (SG) | Experimental | Behavioral: Streamlined EducationAfter completion of the baseline surveys, the SG subjects will watch an approximately eight minute long genetics education video. All subjects will then have the option to "opt out" and receive formal genetic counseling prior to making a decision about testing. If the subject elects to undergo genetic testing, she will fill out the standard genetic testing consent form. As per standard practice of the clinical genetic service at Duke Cancer Institute (DCI), patients will also be asked to provide consent for somatic tumor testing of surgical (non-cytologic) specimen. SG subjects will complete an FHQ within one week of the primary visit. A member of the genetics team will curate the results by contacting the subject to review common errors and clarify any ambiguities in the pedigree. Subjects will complete a post-education distress and anxiety survey (IES) via either an email link to a confidential REDCap survey link or over the phone 1-2 weeks after education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Either a) pathologically confirmed diagnosis of high-grade epithelial ovarian, fallopian or peritoneal cancer via biopsy or surgical pathology or b) cytologic diagnosis consistent with high-grade epithelial ovarian cancer.
- Presenting to Duke gynecologic oncology clinic or collaborating institution for first outpatient visit following pathologic or cytologic diagnosis. If logistic constraints prevent the patient from being enrolled at her initial visit, she will be eligible for enrollment up to initiation of her fifth cycle of chemotherapy.
Key exclusion criteria (5 listed)
- Known family or personal history of an inherited cancer susceptibility mutation
- Previously received genetic counseling or testing for an inherited cancer susceptibility mutation
- Insurance provided by an insurance company that requires face-to-face genetic consultation prior to testing
- Unable to read or speak English as study design includes video assisted educational materials in English
- Blind or deaf as study design includes video assisted educational materials in English
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 |
|---|---|---|
| Streamlined EducationAfter completion of the baseline surveys, the SG subjects will watch an approximately eight minute long genetics education video. This video will be made with the assistance of Duke University genetic counselors and gynecologic oncology providers. It will consist of a discussion of genes and mutations, the recommendation of universal testing for high grade epithelial ovarian cancer, a review of genes associated with ovarian cancer predisposition, the possibility of uncertain results including variants of undetermined significance, the potential for undetected mutations in known or unknown cancer susceptibility genes, the potential impact on personal treatment and on family members, the possibility of genetic discrimination and the legal protection of genetic information. | Behavioural | Streamlined Group (SG) |
| Traditional EducationThe TG subjects will then meet with the genetic counselor at the previously scheduled appointment time. During this visit, they will receive approximately thirty to sixty minutes of counseling regarding genetic testing and potential results. The discussion is based on the American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN) guidelines of informed consent for genetic testing. After counseling, participants will be given the option to undergo a multi-gene panel genetic test either via saliva or blood sample. Those who agree to testing will also complete the standard genetic testing consent form. As per standard practice of the clinical genetic service at DCI, patients will also be asked to provide consent for somatic tumor testing of surgical specimen (non-cytologic). | Behavioural | Tradition Counseling Group (TG) |
Primary outcome
Demographic Information
Time frame: Baseline
Number of participants with children
Numeracy assessment
Time frame: Baseline
Numeracy as assessed by the Newest Vital Sign survey
Electronic Family History
Time frame: Completed at least 1 week prior to genetic sample being taken
Family cancer history up to past 3 generations
Change in anxiety and depression as measured by the IES Scale
Time frame: Baseline, approximately 7 days post-education, and approximately 7 days post-results disclosure
The Impact of Events Scale (IES) has been used widely as a means of measuring patient distress (particularly intrusive thoughts or avoidance) over a defined incident. This evaluation will be used to identify trends in anxiety or depression in both arms throughout the education and testing process. In this trial, the "incident" will be described as "the risk of my cancer being hereditary."
Distress as measured by MICRA
Time frame: Approximately 7 days post-results disclosure
The multidimensional impact of cancer risk assessment questionnaire (MICRA) is a 25-question validated tool that measures the impact of result disclosure in patients, particularly markers of distress
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 26 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Rebecca Previs, MD, MS principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Streamlined Education and Traditional Education in people with Ovarian Cancer, Epithelial and Peritoneal Cancer, run by Duke 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 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 26 Aug 2021. 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?
Demographic Information (time frame: Baseline). The study lists 5 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 26 Aug 2021.