Epithelial Ovarian CarcinomaNCT05470920
Genetic Testing Decision Aid
A study testing Electronic Decision Aid and Pre-Test Genetic Counseling in people with Epithelial Ovarian Carcinoma and Pancreas Adenocarcinoma, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
This is a randomized trial to evaluate the effectiveness of an electronic decision aid tool versus a traditional genetic counselor session for multi-gene panel testing for people with ovarian or pancreatic cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epithelial Ovarian Carcinoma, Pancreas Adenocarcinoma
- What is being tested?
- Electronic Decision Aid and Pre-Test Genetic Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 297 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Oct 2022to 19 May 2026
- 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 or older
- Being seen in clinic at Massachusetts General Hospital or Boston Medical Center
- Diagnosed with malignant epithelial ovarian carcinoma or malignant pancreatic adenocarcinoma.
Who cannot join
- Unable or unwilling to provide informed consent, undergo randomization, or complete the surveys associated with the study
- Previous germline genetic testing
- History of hereditary pancreatitis
- Members of the following vulnerable populations: adults unable to consent, individuals who are not yet adults
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02115
Mass General at North Shore Cancer Center
Danvers, Massachusetts, 01923
About this study
Official title: Randomized, Controlled Trial of an Electronic Decision Aid for Genetic Testing in Inherited Cancer Syndromes
This is a randomized trial to evaluate the effectiveness of an electronic decision aid tool versus a traditional genetic counselor session for multi-gene panel testing for people with ovarian or pancreatic cancer
Read the detailed description
The research study procedures include: screening for eligibility and study questionnaires that would be performed in conjunction with either the genetic counselor visit or use of the electronic decision aid. The study questionnaires include:
- Knowledge Survey
- Shared Decision Making Process Survey
- Decisional Conflict Scale
The research study will last up to 2 weeks. It is expected that about 350 people will take part in this research study.
The National Cancer Institute (NCI) is supporting this research study by providing funding for the research
- Being tested
- Electronic Decision Aid, Pre-Test Genetic Counseling
- Keywords
- pancreas adenocarcinoma., epithelial ovarian carcinoma, decision aid, inherited cancer syndrome, genetic testing
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Neoplastic Syndromes, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Decision AidBehavioural
Decision aid followed by an appointment with an oncologist. Will complete surveys/questionnaires
Pre-Test Genetic CounselingBehavioural
Receive pretest counseling with a genetic counselor. Will complete surveys/questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Electronic decision aid arm | Experimental | Receive decision aid followed by an appointment with their oncologist. Receives: Behavioral: Electronic Decision Aid |
| Genetic counselor Arm | Active comparator | Receive pretest counseling with a genetic counselor. Receives: Behavioral: Pre-Test Genetic Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict Scores
The decisional conflict score is a score ranging from 0-100 that is measured from a 10-question validated decisional conflict scale. The scale assesses participant's confidence in their decision with higher scores indicating higher decisional conflict.
Measured: 1 week after genetics session
Average change in knowledge survey score
Average change in score on a 10-question knowledge survey to assess basic information about genetics and genetic testing that was covered in their appointment. Scores on the scale range from 0-10. Higher values in the change in knowledge survey score suggest greater amount of knowledge gained in the genetics session.
Measured: baseline (prior to participant completing either genetics sessions) to 1-week following session, approximately 2 weeks
Shared Decision Making Process Scores
The shared decision making process score is a score on a scale of 1-4 based on responses on a validated 4-item shared-decision making scale. The scale assesses how well the decision aid/oncology provider, or the genetic counselor engaged in shared decision-making as perceived by the subject. Higher scores on this scale indicate more shared decision making.
Measured: 1 week after genetics session
Secondary outcomes (4)
Average time between genetic testing recommendation and sample collection
Difference between the two study arms in the time it takes between participants being recommended for genetic testing and a sample being collected.
Measured: Initial recorded recommendation/referral for genetic testing until the date of sample collection, assessed up to 6 months
Average Duration of Decision Making Process
Amount of time patients spend learning and making a decision about genetic testing in both arms of the study.
Measured: Approximately 30 minutes - 1 hour
Ratio of the number of participants who chose each of the three panels offered
Ratios of participants who choose the small, intermediate, and broad testing panel in both arms of the study.
Measured: At the conclusion of genetics session (day 1)
Percentage of participants choosing genetic testing
Percentage of participants in each arm of the study who choose to get genetic testing after the educational intervention
Measured: At the conclusion of genetics session (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start14 Oct 2022
- Primary completion19 May 2026
- Study completion19 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CarcinomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Daniel C Chung, Massachusetts General Hospital
- Investigators
- Daniel C. Chung, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470920
- Sponsor's protocol ID
- 22-155
- Other IDs
- U01CA243695
- Status last verified
- Jun 2026
- First submitted
- 15 Jul 2022
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Trial of an Electronic Decision Aid for Genetic Testing in Inherited Cancer Syndromes
- ClinicalTrials.gov ID
- NCT05470920
- Acronym / sponsor ID
- 22-155
- Keywords
- pancreas adenocarcinoma., epithelial ovarian carcinoma, decision aid, inherited cancer syndrome, genetic testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 19 May 2026 (actual)
- Study completion
- 19 May 2026 (actual)
- First posted
- 22 Jul 2022 (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.
This is a randomized trial to evaluate the effectiveness of an electronic decision aid tool versus a traditional genetic counselor session for multi-gene panel testing for people with ovarian or pancreatic cancer
Detailed description
The research study procedures include: screening for eligibility and study questionnaires that would be performed in conjunction with either the genetic counselor visit or use of the electronic decision aid. The study questionnaires include:
- Knowledge Survey
- Shared Decision Making Process Survey
- Decisional Conflict Scale
The research study will last up to 2 weeks. It is expected that about 350 people will take part in this research study.
The National Cancer Institute (NCI) is supporting this research study by providing funding for the research
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic decision aid arm | Experimental | Behavioral: Electronic Decision AidReceive decision aid followed by an appointment with their oncologist. |
| Genetic counselor Arm | Active comparator | Behavioral: Pre-Test Genetic CounselingReceive pretest counseling with a genetic counselor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Being seen in clinic at Massachusetts General Hospital or Boston Medical Center
- Diagnosed with malignant epithelial ovarian carcinoma or malignant pancreatic adenocarcinoma.
Key exclusion criteria (4 listed)
- Unable or unwilling to provide informed consent, undergo randomization, or complete the surveys associated with the study
- Previous germline genetic testing
- History of hereditary pancreatitis
- Members of the following vulnerable populations: adults unable to consent, individuals who are not yet adults
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 |
|---|---|---|
| Electronic Decision AidDecision aid followed by an appointment with an oncologist. Will complete surveys/questionnaires | Behavioural | Electronic decision aid arm |
| Pre-Test Genetic CounselingReceive pretest counseling with a genetic counselor. Will complete surveys/questionnaires | Behavioural | Genetic counselor Arm |
Primary outcome
Decisional Conflict Scores
Time frame: 1 week after genetics session
The decisional conflict score is a score ranging from 0-100 that is measured from a 10-question validated decisional conflict scale. The scale assesses participant's confidence in their decision with higher scores indicating higher decisional conflict.
Average change in knowledge survey score
Time frame: baseline (prior to participant completing either genetics sessions) to 1-week following session, approximately 2 weeks
Average change in score on a 10-question knowledge survey to assess basic information about genetics and genetic testing that was covered in their appointment. Scores on the scale range from 0-10. Higher values in the change in knowledge survey score suggest greater amount of knowledge gained in the genetics session.
Shared Decision Making Process Scores
Time frame: 1 week after genetics session
The shared decision making process score is a score on a scale of 1-4 based on responses on a validated 4-item shared-decision making scale. The scale assesses how well the decision aid/oncology provider, or the genetic counselor engaged in shared decision-making as perceived by the subject. Higher scores on this scale indicate more shared decision making.
4 secondary outcomes
Average time between genetic testing recommendation and sample collection
Time frame: Initial recorded recommendation/referral for genetic testing until the date of sample collection, assessed up to 6 months
Average Duration of Decision Making Process
Time frame: Approximately 30 minutes - 1 hour
Ratio of the number of participants who chose each of the three panels offered
Time frame: At the conclusion of genetics session (day 1)
Percentage of participants choosing genetic testing
Time frame: At the conclusion of genetics session (day 1)
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 2 Oct 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Daniel C. Chung, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Decision Aid and Pre-Test Genetic Counseling in people with Epithelial Ovarian Carcinoma and Pancreas Adenocarcinoma, run by Massachusetts General Hospital at 2 sites 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 3 inclusion and 4 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 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Decisional Conflict Scores (time frame: 1 week after genetics session). The study lists 3 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 2 Oct 2026.