Advanced Malignant NeoplasmNCT02823652
Pre-Test Genetic Education and Remote Genetic Counseling in Communicating Tumor Profiling Results to Patients With Advanced Cancer
A study testing standard genetic education, Genetic Counseling and Genetic Testing in people with Advanced Malignant Neoplasm and Locally Advanced Malignant Neoplasm, run by ECOG-ACRIN Cancer Research Group at 1 site in United States.
Trial summary
This research trial studies how well pre-test genetic education and remote genetic counseling works in communicating tumor profiling results to patients with advanced cancer. Web-based genetic education before receiving tumor profiling results and remote genetic counseling for patients with potential germline… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Neoplasm, Locally Advanced Malignant Neoplasm
- What is being tested?
- standard genetic education, Genetic Counseling and Genetic Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 601 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2016to 26 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- (STEP 1) - PRIMARY INTERVENTION STUDY (RANDOMIZED CONTROLLED TRIAL [RCT]):
- Patients must be registered to the first screening step (Step 0) for the National Cancer Institute (NCI)-MATCH trial (EAY131)
- Patients must speak English and have an adequate ability to view a website (primary intervention study)
- (STEP 2) - SECONDARY GENETIC COUNSELING SUBSTUDY:
- Patients must have a potential germline mutation, as determined by the NCI-MATCH tumor profiling assay
- Patients must be able to speak English and hear by phone
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
ECOG-ACRIN Cancer Research Group
Philadelphia, Pennsylvania, 19103
About this study
Official title: COMET - Communication and Education in Tumor Profiling: A Randomized Study of Pre-Disclosure Genetic Education v. Usual Care in Tumor Profiling for Advanced Cancer and a Pilot Study of Remote Genetic Counseling for Participants With Potential Germline Mutations Identified on Tumor Profiling
This research trial studies how well pre-test genetic education and remote genetic counseling works in communicating tumor profiling results to patients with advanced cancer. Web-based genetic education before receiving tumor profiling results and remote genetic counseling for patients with potential germline mutations may increase genetic knowledge and reduce distress for patients with advanced cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the efficacy of web-based pre-disclosure genetic education (i.e. before receipt of tumor profile results) to increase knowledge (genetic knowledge and knowledge of test benefits and limitations). (Step 1)
II. To evaluate the efficacy of web-based pre-disclosure genetic education (i.e. before receipt of tumor profile results) to decrease distress (anxiety, depression and cancer specific worry) compared to usual care services in patients undergoing tumor profiling for advanced cancer. (Step 1)
III. To evaluate the uptake of remote genetic counseling (Step 2)
IV. To evaluate the uptake of germline testing among advanced cancer patients with a potential clinically significant incidental germline mutation identified through tumor profiling in the Molecular Analysis for Therapy Choice (MATCH) trial. (Step 2)
SECONDARY OBJECTIVES:
- To evaluate potential moderators suggested by the self-regulation theory of health behavior (SRTHB) (e.g. test result, sociodemographic factors, health literacy, baseline knowledge or distress) to changes in knowledge of genetic disease and test benefits and limitations. (Step 1)
II. To evaluate potential moderators suggested by the SRTHB (e.g test result, sociodemographic factors, health literacy, baseline knowledge or distress) to changes in distress in patients undergoing tumor profiling for advanced cancer. (Step 1)
III. To evaluate factors associated with uptake of genetic counseling and germline testing. (Step 2)
IV. To evaluate cognitive, affective and behavioral (communication to relatives) responses to confirmatory germline testing in advanced cancer patients with potential clinically significant incidental germline mutation identified in tumor profiling. (Step 2)
OUTLINE:
STEP I (PRIMARY INTERVENTION STUDY): Participants are randomized to 1 of 2 arms.
ARM A: Patients receive web-based genetic education consisting of general information about testing tumors for genetic mutations.
ARM B: Patients receive standard genetic education consisting of conversations with the treating physicians, interaction with and information from the clinical staff, and information from usual resources about testing for genetic mutations.
STEP II (SECONDARY GENETIC COUNSELING SUBSTUDY):
Patients who meet the criteria for the remote counseling substudy will receive genetic counseling over the telephone and undergo germline testing.
After completion of study treatment, patients are followed up periodically.
- Being tested
- standard genetic education, Genetic Counseling, Genetic Testing, Internet-Based Intervention, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard genetic educationOther
Also called counseling, Counseling Intervention
Undergo usual care
Genetic CounselingOther
Complete remote counseling
Genetic TestingOther
Also called genetic analysis, Genetic Examination, Genetic Test
Undergo germline testing
Internet-Based InterventionOther
Complete on-line genetic education
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Step 1: internet-based intervention) | Experimental | Patients receive web-based genetic education consisting of general information about testing tumors for genetic mutations. Receives: Other: Internet-Based Intervention; Other: Survey Administration |
| Arm B (Step 1: usual care control) | Active comparator | Patients receive standard genetic education consisting of conversations with the treating physicians, interaction with and information from the clinical staff, and information from usual resources about testing for genetic mutations. Receives: Other: standard genetic education; Other: Survey Administration |
| Step 2 - genetic counseling | Experimental | Patients who meet the criteria for the remote counseling substudy will receive genetic counseling over the telephone and undergo germline testing. Receives: Other: Genetic Counseling; Other: Genetic Testing; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education
There are 14 items in the questionnaire of Cancer Genetic Knowledge Scale. The total score ranges between 14 and 70. Higher scores indicate more/better knowledge. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and compared between the two arms (arms A and B) at Step 1.
Measured: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education
There are 4 items in the PROMIS - Depression questionnaire. The total score ranges between 4 and 20. Higher scores indicate more depression. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and compared between the two arms (arms A and B) at Step 1.
Measured: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education
There are 4 items in the PROMIS - Anxiety questionnaire. The total score ranges between 4 and 20. Higher scores indicate more anxiety. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and compared between the two arms (arms A and B) at Step 1.
Measured: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education
There are 14 items in the questionnaire of Impact of Events Scale (IES). The total score ranges between 0 and 70. Higher scores indicate more stress. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and compared between the two arms (arms A and B) at Step 1.
Measured: Assessed at baseline and up to 14 days post-baseline
Proportion of Participants Who Complete Remote Genetic Counseling in the Genetic Counseling Substudy (Step 2)
Among participants who registered in the genetic counseling substudy (Step 2), the proportion of participants who completed remote genetic counseling will be reported. The proportion is defined as "the number of participants who completed remote genetic counseling divided by the number of participants who agreed to participate in the genetic counseling study".
Measured: Assessed at baseline at Step 2
Proportion of Participants Who Complete Germline Testing in the Genetic Counseling Substudy (Step 2)
Among participants who registered in the genetic counseling substudy (Step 2), the proportion of participants who completed remote genetic counseling will be reported. The proportion is defined as "the number of participants who completed remote genetic counseling divided by the number of participants who agreed to participate in the genetic counseling study".
Measured: Assessed at baseline at Step 2
Secondary outcomes (4)
Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education by Arm and Sex
There are 14 items in the questionnaire of Cancer Genetic Knowledge Scale. The total score ranges between 14 and 70. Higher scores indicate more/better knowledge. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and interaction between arm and sex was evaluated.
Measured: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education by Arm and Sex
There are 4 items in the PROMIS - Depression questionnaire. The total score ranges between 4 and 20. Higher scores indicate more depression. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and interaction between arm and sex was evaluated.
Measured: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education by Arm and Sex
There are 4 items in the PROMIS - Anxiety questionnaire. The total score ranges between 4 and 20. Higher scores indicate more anxiety. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and interaction between arm and sex was evaluated.
Measured: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education by Arm and Sex
There are 14 items in the questionnaire of Impact of Events Scale (IES). The total score ranges between 0 and 70. Higher scores indicate more stress. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and interaction between arm and sex was evaluated.
Measured: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study start25 Oct 2016
- Primary completion26 Dec 2019
- Study completion26 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by ECOG-ACRIN Cancer Research GroupThe 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
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Angela Bradbury, Principal investigator, ECOG-ACRIN Cancer Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823652
- Sponsor's protocol ID
- EAQ152
- Other IDs
- NCI-2015-02253, EAQ152, EAQ152
- Status last verified
- Dec 2023
- First submitted
- 21 Jun 2016
- Last updated
- 28 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bradbury AR, Lee JW, Gaieski JB, Li S, Gareen IF, Flaherty KT, Herman BA, Domchek SM, DeMichele AM, Maxwell KN, Onitilo AA, Virani S, Park S, Faller BA, Grant SC, Ramaekers RC, Behrens RJ, Nambudiri GS, Carlos RC, Wagner LI. A randomized study of genetic education versus usual care in tumor profiling for advanced cancer in the ECOG-ACRIN Cancer Research Group (EAQ152). Cancer. 2022 Apr 1;128(7):1381-1391. doi: 10.1002/cncr.34063. Epub 2021 Dec 10.
PubMed 34890045
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMET - Communication and Education in Tumor Profiling: A Randomized Study of Pre-Disclosure Genetic Education v. Usual Care in Tumor Profiling for Advanced Cancer and a Pilot Study of Remote Genetic Counseling for Participants With Potential Germline Mutations Identified on Tumor Profiling
- ClinicalTrials.gov ID
- NCT02823652
- Acronym / sponsor ID
- EAQ152
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- ECOG-ACRIN Cancer Research GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Oct 2016 (actual)
- Primary completion
- 26 Dec 2019 (actual)
- Study completion
- 26 Dec 2019 (actual)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Posted 28 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research trial studies how well pre-test genetic education and remote genetic counseling works in communicating tumor profiling results to patients with advanced cancer. Web-based genetic education before receiving tumor profiling results and remote genetic counseling for patients with potential germline mutations may increase genetic knowledge and reduce distress for patients with advanced cancer.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the efficacy of web-based pre-disclosure genetic education (i.e. before receipt of tumor profile results) to increase knowledge (genetic knowledge and knowledge of test benefits and limitations). (Step 1)
II. To evaluate the efficacy of web-based pre-disclosure genetic education (i.e. before receipt of tumor profile results) to decrease distress (anxiety, depression and cancer specific worry) compared to usual care services in patients undergoing tumor profiling for advanced cancer. (Step 1)
III. To evaluate the uptake of remote genetic counseling (Step 2)
IV. To evaluate the uptake of germline testing among advanced cancer patients with a potential clinically significant incidental germline mutation identified through tumor profiling in the Molecular Analysis for Therapy Choice (MATCH) trial. (Step 2)
SECONDARY OBJECTIVES:
- To evaluate potential moderators suggested by the self-regulation theory of health behavior (SRTHB) (e.g. test result, sociodemographic factors, health literacy, baseline knowledge or distress) to changes in knowledge of genetic disease and test benefits and limitations. (Step 1)
II. To evaluate potential moderators suggested by the SRTHB (e.g test result, sociodemographic factors, health literacy, baseline knowledge or distress) to changes in distress in patients undergoing tumor profiling for advanced cancer. (Step 1)
III. To evaluate factors associated with uptake of genetic counseling and germline testing. (Step 2)
IV. To evaluate cognitive, affective and behavioral (communication to relatives) responses to confirmatory germline testing in advanced cancer patients with potential clinically significant incidental germline mutation identified in tumor profiling. (Step 2)
OUTLINE:
STEP I (PRIMARY INTERVENTION STUDY): Participants are randomized to 1 of 2 arms.
ARM A: Patients receive web-based genetic education consisting of general information about testing tumors for genetic mutations.
ARM B: Patients receive standard genetic education consisting of conversations with the treating physicians, interaction with and information from the clinical staff, and information from usual resources about testing for genetic mutations.
STEP II (SECONDARY GENETIC COUNSELING SUBSTUDY):
Patients who meet the criteria for the remote counseling substudy will receive genetic counseling over the telephone and undergo germline testing.
After completion of study treatment, patients are followed up periodically.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A (Step 1: internet-based intervention) | Experimental | Other: Internet-Based Intervention, Other: Survey AdministrationPatients receive web-based genetic education consisting of general information about testing tumors for genetic mutations. |
| Arm B (Step 1: usual care control) | Active comparator | Other: standard genetic education, Other: Survey AdministrationPatients receive standard genetic education consisting of conversations with the treating physicians, interaction with and information from the clinical staff, and information from usual resources about testing for genetic mutations. |
| Step 2 - genetic counseling | Experimental | Other: Genetic Counseling, Other: Genetic Testing, Other: Survey AdministrationPatients who meet the criteria for the remote counseling substudy will receive genetic counseling over the telephone and undergo germline testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- (STEP 1) - PRIMARY INTERVENTION STUDY (RANDOMIZED CONTROLLED TRIAL [RCT]):
- Patients must be registered to the first screening step (Step 0) for the National Cancer Institute (NCI)-MATCH trial (EAY131)
- Patients must speak English and have an adequate ability to view a website (primary intervention study)
- (STEP 2) - SECONDARY GENETIC COUNSELING SUBSTUDY:
- Patients must have a potential germline mutation, as determined by the NCI-MATCH tumor profiling assay
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| standard genetic educationAlso: counseling, Counseling InterventionUndergo usual care | Other | Arm B (Step 1: usual care control) |
| Genetic CounselingComplete remote counseling | Other | Step 2 - genetic counseling |
| Genetic TestingAlso: genetic analysis, Genetic Examination, Genetic TestUndergo germline testing | Other | Step 2 - genetic counseling |
| Internet-Based InterventionComplete on-line genetic education | Other | Arm A (Step 1: internet-based intervention) |
| Survey AdministrationAncillary studies | Other | Arm A (Step 1: internet-based intervention), Arm B (Step 1: usual care control), Step 2 - genetic counseling |
Primary outcome
Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education
Time frame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
There are 14 items in the questionnaire of Cancer Genetic Knowledge Scale. The total score ranges between 14 and 70. Higher scores indicate more/better knowledge. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and compared between the two arms (arms A and B) at Step 1.
Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education
Time frame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
There are 4 items in the PROMIS - Depression questionnaire. The total score ranges between 4 and 20. Higher scores indicate more depression. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and compared between the two arms (arms A and B) at Step 1.
Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education
Time frame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
There are 4 items in the PROMIS - Anxiety questionnaire. The total score ranges between 4 and 20. Higher scores indicate more anxiety. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and compared between the two arms (arms A and B) at Step 1.
Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education
Time frame: Assessed at baseline and up to 14 days post-baseline
There are 14 items in the questionnaire of Impact of Events Scale (IES). The total score ranges between 0 and 70. Higher scores indicate more stress. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and compared between the two arms (arms A and B) at Step 1.
Proportion of Participants Who Complete Remote Genetic Counseling in the Genetic Counseling Substudy (Step 2)
Time frame: Assessed at baseline at Step 2
Among participants who registered in the genetic counseling substudy (Step 2), the proportion of participants who completed remote genetic counseling will be reported. The proportion is defined as "the number of participants who completed remote genetic counseling divided by the number of participants who agreed to participate in the genetic counseling study".
Proportion of Participants Who Complete Germline Testing in the Genetic Counseling Substudy (Step 2)
Time frame: Assessed at baseline at Step 2
Among participants who registered in the genetic counseling substudy (Step 2), the proportion of participants who completed remote genetic counseling will be reported. The proportion is defined as "the number of participants who completed remote genetic counseling divided by the number of participants who agreed to participate in the genetic counseling study".
4 secondary outcomes
Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education by Arm and Sex
Time frame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education by Arm and Sex
Time frame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education by Arm and Sex
Time frame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education by Arm and Sex
Time frame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34890045Bradbury AR, Lee JW, Gaieski JB, Li S, Gareen IF, Flaherty KT, Herman BA, Domchek SM, DeMichele AM, Maxwell KN, Onitilo AA, Virani S, Park S, Faller BA, Grant SC, Ramaekers RC, Behrens RJ, Nambudiri GS, Carlos RC, Wagner LI. A randomized study of genetic education versus usual care in tumor profiling for advanced cancer in the ECOG-ACRIN Cancer Research Group (EAQ152). Cancer. 2022 Apr 1;128(7):1381-1391. doi: 10.1002/cncr.34063. Epub 2021 Dec 10.
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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.
Angela Bradbury principal investigator
ECOG-ACRIN Cancer Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard genetic education, Genetic Counseling and Genetic Testing in people with Advanced Malignant Neoplasm and Locally Advanced Malignant Neoplasm, run by ECOG-ACRIN Cancer Research Group 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 6 inclusion and 0 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 28 Feb 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?
Yes. Results are posted in the registry (first posted 28 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education (time frame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02823652, which also lists 1 linked publication.
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 28 Feb 2024.