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| ID | Type | Description | Link |
|---|---|---|---|
| U01CA243695 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electronic decision aid arm | Experimental | Receive decision aid followed by an appointment with their oncologist. |
|
| Genetic counselor Arm | Active Comparator | Receive pretest counseling with a genetic counselor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Decision Aid | Behavioral | Decision aid followed by an appointment with an oncologist. Will complete surveys/questionnaires |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline (prior to participant completing either genetics sessions) to 1-week following session, approximately 2 weeks |
| 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. | 1 week after genetics session |
| 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. | 1 week after genetics session |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Initial recorded recommendation/referral for genetic testing until the date of sample collection, assessed up to 6 months |
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Inclusion Criteria:
Exclusion Criteria :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel C. Chung, MD | Contact | (617) 726-8687 | Chung.daniel@mgh.harvard.edu | |
| Danielle A Lynch, BS | Contact | (617) 726-1355 | dlynch22@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Daniel C. Chung, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Partners Innovations team at http://www.partners.org/innovation
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| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D009386 | Neoplastic Syndromes, Hereditary |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Pre-Test Genetic Counseling | Behavioral | Receive pretest counseling with a genetic counselor. Will complete surveys/questionnaires |
|
| 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. | 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. | 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 | At the conclusion of genetics session (day 1) |
| Mass General at North Shore Cancer Center | Recruiting | Danvers | Massachusetts | 01923 | United States |
|
| D010051 |
| Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |