Breast CancerNCT02451735
Genetic Counseling for Breast Cancer Survivors (GC for BC)
A study testing Video and Booklet and Factsheet in people with Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to review and evaluate the effectiveness of new educational materials (informational booklet \& DVD) that promote participation in genetic counseling among breast cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Video and Booklet and Factsheet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2012to 12 Jul 2019
- 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
- Part 1: Female breast cancer patients at Moffitt Cancer Center (MCC) are eligible to participate if they:
- are > 18 years of age;
- have no documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis);
- are capable of speaking and reading standard English;
- have not attended or scheduled an upcoming appointment for genetic counseling at the time of recruitment;
- are within 18 months of their breast cancer (BC) diagnosis;
Show all 45Show fewer
- have a previous diagnosis of breast cancer or;
- received a referral letter for GC from their MCC physician;
- breast cancer at age 50 or below;
- bilateral breast cancer;
- multiple cancers except basal cell carcinoma;
- triple negative breast cancer;
- ovarian cancer or fallopian tube cancer at any age;
- of Ashkenazi Jewish descent;
- have 2 or more blood relatives diagnosed with breast cancer;
- have any blood relatives diagnosed with bilateral breast cancer;
- a first degree relative diagnosed with breast cancer below age 50;
- have blood relatives diagnosed with ovarian cancer;
- have 2 or more family members on the same side of the family with breast, ovarian, pancreatic, or prostate cancer;
- have a known cancer gene mutation (such as BRCA 1/2;
- have any male relatives diagnosed with breast cancer ; and
- have a mailing address and working telephone number; and
- provide written informed consent.
- Part 2: Female BC patients at MCC are eligible to participate if they:
- are > 18 years of age;
- have no documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis);
- are capable of speaking and reading standard English;
- have not attended or scheduled an upcoming appointment for GC at the time of recruitment;
- have a previous diagnosis of breast cancer or;
- received a referral letter for GC from their MCC physician;
- breast cancer at age 50 or below;
- bilateral breast cancer;
- multiple cancers except basal cell carcinoma;
- triple negative breast cancer;
- ovarian cancer or fallopian tube cancer at any age
- of Ashkenazi Jewish descent;
- have 2 or more blood relatives diagnosed with breast cancer;
- have any blood relatives diagnosed with bilateral breast cancer;
- a first degree relative diagnosed with breast cancer below age 50;
- have blood relatives diagnosed with ovarian cancer;
- have 2 or more family members on the same side of the family with breast, ovarian, pancreatic, or prostate cancer;
- have a known cancer gene mutation (such as BRCA 1/2;
- have any male relatives diagnosed with breast cancer ; and
- have a mailing address and working telephone number; and
- provide written informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
The purpose of this study is to review and evaluate the effectiveness of new educational materials (informational booklet \& DVD) that promote participation in genetic counseling among breast cancer survivors.
There are two phases to this study:
Part 1 - reviewing the newly developed educational materials, and Part 2 - evaluating the effectiveness of the newly developed educational materials
Read the detailed description
Part 1: Intervention Development
Aim 1: Develop a psychoeducational intervention (PEI) for high-risk breast cancer survivors about genetic counseling (GC) and hereditary breast and ovarian cancer (HBOC).
Part 2: Intervention Pilot
Aim 2: Assess the feasibility and acceptability of a PEI from the perspective of the BC patients and health care professionals.
Exploratory Aim 3: Estimate the preliminary efficacy of the PEI compared to standard clinical care. We hypothesize that women in the intervention group will have higher uptake of GC, greater increases in knowledge, and more perceived benefits related to GC compared to the control group.
- Conditions
- Breast Cancer
- Being tested
- Video and Booklet, Factsheet
- Keywords
- female breast cancer, bilateral breast cancer, triple negative breast cancer, breast cancer diagnosis, BRCA 1, BRCA 2, psychoeducational intervention (PEI), genetic counseling, hereditary breast and ovarian cancer (HBOC), cancer education materials
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms, Hereditary Breast and Ovarian Cancer Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video and BookletBehavioural
Printed and DVD materials about Genetic Counseling. Self-reported feedback will be collected and reviewed to compare to the control group response.
FactsheetBehavioural
Patient factsheet about Genetic Counseling. Self-reported feedback will be collected and reviewed to compare to the intervention group response.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Development | No intervention | Psychoeducational Intervention (PEI) development. PEIs include printed and DVD materials, and represent a commonly used and effective approach to implement theoretically based individual-level interventions. These materials serve as important sources of information for the general public, cancer patients, and survivors from a variety of backgrounds, including populations with limited health literacy. An interview and feedback collection process will take place to provide data to improve current PEI materials. |
| Intervention Pilot - Intervention Group | Experimental | The intervention group will receive the PEI materials: video and booklet. Self-reported feedback will be collected and reviewed to compare response with the control group. Receives: Behavioral: Video and Booklet |
| Intervention Pilot - Control Group | Active comparator | The control group will receive a patient factsheet about Genetic Counseling (GC). Self-reported feedback will be collected and reviewed to compare response with the intervention group. Receives: Behavioral: Factsheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Rate of Initial Survey Responses
Intervention Development: Rate of feedback of draft materials required to complete a formative evaluation.
Measured: Up to 8 months
Part 2: Rate of Participation
Participation in the Psychoeducational Intervention (PEI) group compared to the Factsheet group.
Measured: Up to 8 months
Secondary outcomes (1)
Rate of Impact
Self-Reported Feedback Scoring Method: Frequencies and descriptives will be calculated for response options. Positive feedback rate of Psychoeducational Intervention (PEI) group compared to the Factsheet group.
Measured: Up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study start27 Jul 2012
- Primary completion11 Jul 2016
- Study completion12 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Susan Vadaparampil, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451735
- Sponsor's protocol ID
- MCC-16723
- Status last verified
- Nov 2019
- First submitted
- 18 May 2015
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Counseling for Breast Cancer Survivors (GC for BC)
- ClinicalTrials.gov ID
- NCT02451735
- Acronym / sponsor ID
- MCC-16723
- Conditions
- Breast Cancer
- Keywords
- female breast cancer, bilateral breast cancer, triple negative breast cancer, breast cancer diagnosis, BRCA 1, BRCA 2, psychoeducational intervention (PEI), genetic counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 27 Jul 2012 (actual)
- Primary completion
- 11 Jul 2016 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 22 May 2015 (estimated)
- 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 study is to review and evaluate the effectiveness of new educational materials (informational booklet \& DVD) that promote participation in genetic counseling among breast cancer survivors.
There are two phases to this study:
Part 1 - reviewing the newly developed educational materials, and Part 2 - evaluating the effectiveness of the newly developed educational materials
Detailed description
Part 1: Intervention Development
Aim 1: Develop a psychoeducational intervention (PEI) for high-risk breast cancer survivors about genetic counseling (GC) and hereditary breast and ovarian cancer (HBOC).
Part 2: Intervention Pilot
Aim 2: Assess the feasibility and acceptability of a PEI from the perspective of the BC patients and health care professionals.
Exploratory Aim 3: Estimate the preliminary efficacy of the PEI compared to standard clinical care. We hypothesize that women in the intervention group will have higher uptake of GC, greater increases in knowledge, and more perceived benefits related to GC compared to the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Development | No intervention | –Psychoeducational Intervention (PEI) development. PEIs include printed and DVD materials, and represent a commonly used and effective approach to implement theoretically based individual-level interventions. These materials serve as important sources of information for the general public, cancer patients, and survivors from a variety of backgrounds, including populations with limited health literacy. An interview and feedback collection process will take place to provide data to improve current PEI materials. |
| Intervention Pilot - Intervention Group | Experimental | Behavioral: Video and BookletThe intervention group will receive the PEI materials: video and booklet. Self-reported feedback will be collected and reviewed to compare response with the control group. |
| Intervention Pilot - Control Group | Active comparator | Behavioral: FactsheetThe control group will receive a patient factsheet about Genetic Counseling (GC). Self-reported feedback will be collected and reviewed to compare response with the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (45 listed)
- Part 1: Female breast cancer patients at Moffitt Cancer Center (MCC) are eligible to participate if they:
- are > 18 years of age;
- have no documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis);
- are capable of speaking and reading standard English;
- have not attended or scheduled an upcoming appointment for genetic counseling at the time of recruitment;
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 |
|---|---|---|
| Video and BookletPrinted and DVD materials about Genetic Counseling. Self-reported feedback will be collected and reviewed to compare to the control group response. | Behavioural | Intervention Pilot - Intervention Group |
| FactsheetPatient factsheet about Genetic Counseling. Self-reported feedback will be collected and reviewed to compare to the intervention group response. | Behavioural | Intervention Pilot - Control Group |
Primary outcome
Part 1: Rate of Initial Survey Responses
Time frame: Up to 8 months
Intervention Development: Rate of feedback of draft materials required to complete a formative evaluation.
Part 2: Rate of Participation
Time frame: Up to 8 months
Participation in the Psychoeducational Intervention (PEI) group compared to the Factsheet group.
1 secondary outcome
Rate of Impact
Time frame: Up to 8 months
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 8 Nov 2019.
- Moffitt Cancer Center Clinical Trials websiteLink provided by the sponsor.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Susan Vadaparampil principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video and Booklet and Factsheet in people with Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute 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 45 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 8 Nov 2019. 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?
Part 1: Rate of Initial Survey Responses (time frame: Up to 8 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 8 Nov 2019.