Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Diseases and Abnormalities at or Before Birth

Symptoms and General Pathology

Rare Diseases

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Triple Negative Breast Neoplasms

Hereditary Breast and Ovarian Cancer Syndrome

Carcinoma

Syndrome

Breast Diseases

Skin Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Ovarian Cancer

Ovarian Epithelial Cancer

Joshua Staley

Josette Klaus

Kristina Sharpe-Pringle

Amy Nelson

Christy Kuechler

Melanie Leepers, RN, MBA

Joshua M Staley

Nikki Malomo

Adrienne Harris-Connell

Jennifer Feeback

Nicole Jenci

Jan Ward

Priyanka Sharma, MD

PROGECT is a registry for patients with Triple Negative breast cancer (TNBC) or patients who have an identified germline mutations (such as a mutation on the BRCA1 or BRCA2 genes).

This study is being done to collect cancer-related information from patients with triple negative breast cancer and patients with hereditary genetic mutations. This information will help us better understand the link between genetic changes and cancer outcome in patients with triple negative breast cancer.

A baseline blood draw is collected as a part of this registry. If a study participant has a personal history of cancer and a tumor sample is available, the participant may give consent for the tissue to be used as a part of the study. Additional optional specimen collection sub-studies may also be offered to participants.

Triple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry

PROspective Evaluation of GErmline Mutations, Cancer Outcome and Tissue Biomarkers: A Registry for Patients With Triple Negative Breast Cancer and Germline Mutations

University of Kansas Medical Center

Professor of Medicine

Women referred to the Clinical Cancer Genetics Program for discussion of Hereditary Breast And Ovarian Syndrome (HBOC).

1 - 2 questionnaires, lasting 10-15 minutes.

Questionnaire

Jennifer Litton, MD

Objectives:

- To evaluate the attitudes and opinions of women undergoing genetic counseling for hereditary breast and ovarian cancer syndrome, both before and after testing, in regards to pregnancy and fertility

Hypothesis:

-Factors that will increase the percentage of women endorsing prenatal diagnostic testing will include a personal history of breast or ovarian cancer, having had a mother or sister die of breast or ovarian cancer, and testing positive for a BRCA mutation.

This questionnaire is part of a study at The University of Texas M.D. Anderson Cancer Center. The purpose is to ask women who are seeking genetic testing for HBOC their viewpoints surrounding fertility, childbearing and parenting, both at the time of testing and at the time of results disclosure. The aim is to evaluate if the genetics results disclosure may influence women's views regarding these topics. Researchers hope to use this information to provide more information to the patient and the caregiver to help both parties with this very important cancer survivorship issue.

Attitudes About Childbearing And Fertility With Inherited Breast And Ovarian Cancer Syndromes (HBOC)

Attitudes About Childbearing And Fertility In Women Seeking Genetic Testing For Inherited Breast And Ovarian Cancer Syndromes (HBOC)

M.D. Anderson Cancer Center

Immediately prior to the scheduled cancer genetic counseling appointment, clients:

1. completed standardized questionnaires on self-affirmation (SA) intervention that focused on positive values of personal importance. The SA intervention required clients to rank 11 items (artistic skills, athletics, business/money, creativity, independence, music, politics, relationships with friends and family, religious values, sense of humor, spontaneity) from most important to least important and to elaborate on one that was most important to them and why;
2. 6-item standardized measure of anxiety questionnaire;
3. after the genetic counseling session, clients were required to fill out a post session questionnaire

Immediately prior to the scheduled cancer genetic counseling appointment, clients:

1. completed similar standardized questionnaire as the SA group, with a non-affirming exercise. The non-intervention required clients to rank 11 items (artistic skills, athletics, business/money, creativity, independence, music, politics, relationships with friends and family, religious values, sense of humor, spontaneity) from most important to least important and to elaborate on the 9th ranked item and why it might be important to someone else;
2. 6-item standardized measure of anxiety questionnaire;
3. after the genetic counseling session, clients were required to fill out a post session questionnaire

Clients will be asked to rank artistic skills, athletics, business/money, creativity, independence, music, politics, relationships with friends and family, religious values, sense of humor, spontaneity from most important to least important. They will then be asked to write about the item that is most important to them and why it may be important to them.

Self Affirmation (SA)

Clients will be asked to rank artistic skills, athletics, business/money, creativity, independence, music, politics, relationships with friends and family, religious values, sense of humor, spontaneity from most important to least important. The control group will rank the list and be asked to write about the 9th ranked item and why it might be important to someone else.

Control

Lori Erby, Ph.D.

Background:

Some women have a high chance of developing breast and ovarian cancer because of a change in a gene that is passed within a family from one generation to the next. These women with hereditary breast and ovarian cancer (HBOC) have to make hard choices about tests and treatments. Researchers want to study how to help women to feel ready to make those choices. A kind of writing exercise might help if it is done before genetic counseling. This writing exercise is called a self-affirmation (SA) exercise. It may lead to better communication during counseling and better behavioral outcomes.

Objective:

To see if an SA exercise done before HBOC genetic counseling could improve client communication and behavior.

Eligibility:

* Clients: Adult female \>=18 years of age with initial appointment for HBOC risk with genetic counselor at St. Luke's Health System
* Genetic Counselors: Genetic counselors \>=18 years of age providing genetic counseling to clients at risk for HBOC

Design:

Clients will be screened by phone prior to their genetic counseling appointment.

They will arrive 15 minutes early to their appointment.

They will do a 10 to 15 minute survey and writing exercise. This includes questions about:

* Things that are important to them
* How they are feeling prior to the appointment

After their genetic counseling appointment, they will take a 10- to 15-minute follow-up survey. It can be in the office or online. It will include questions about:

* How they felt about the writing exercise
* How they felt about their genetic counseling
* If they had cancer
* If they were offered and had genetic testing

Genetic counselor participants will take a 2 to 5 minute survey after each session with a client in the study. This will include questions about how the client was in the session. They also will take a 10 to 15 minute survey at the end of the study. It will be about their opinions on the process of having their clients complete the writing exercise.

The proposed study is a feasibility study to assess the viability of implementing a Self-Affirmation (SA) intervention in a Hereditary Breast and Ovarian Cancer (HBOC) genetic counseling clinic to improve client communication and behavioral outcomes. Participants will be clients and genetic counselors at the St. Luke's Hospital System HBOC clinic. This study seeks to identify outcomes that would be most informative in a large-scale research protocol. As outcomes, we will assess clients' decision self-efficacy, intention to talk with family, genetic test uptake, empowerment, and HBOC knowledge. We will also assess genetic counselors' and clients' perceived benefits, perceived harms, and acceptance of the affirmation intervention.

In this study clients will be invited to participate in an intervention before their genetic counseling appointment. The SA intervention is a short written exercise to reinforce clients' self-integrity (a global sense of personal adequacy) leading to more openness to threatening information within the genetic counseling session. Clients and genetic counselors will be surveyed to assess outcome measures and feasibility of the intervention.

Social science research has shown that when people are faced with threatening information they often seek to protect themselves and reject the threatening message. Message rejection can include minimizing the importance or discrediting the truth of the message. SA interventions aim to bolster self-integrity or esteem by focusing on aspects of participants' lives they value and thereby improving participants' self-perception and tolerance towards threatening messages. SA manipulations have been shown to increase patient communication within appointments and both intentions and actions toward behavior change.

Often in cancer genetic counseling appointments clients are confronted with the threat of having a significantly increased risk for cancers while being asked to make a decision about genetic testing. A self-affirmation intervention may facilitate greater client decision self-efficacy, empowerment, and positive behavior outcomes, such as communication with family regarding genetic risk and screening behaviors.

Is it Feasible?: Self-Affirmation for Hereditary Breast and Ovarian Cancer Genetic Counseling

Intention to have genetic testing was measured with a single survey item, "Do you plan to have genetic testing?" with response options of yes=1; maybe=2; no=3

Intention to talk with family was measured with a single categorical survey item, "Which best describes your plans to talk with your family members about genetic testing results (check the one answer that is most true for you)?"

Likelihood of talking with family members was measured with a single survey item on a 7 point scale, "How likely are you to share results with the relatives you selected?" with 1= Extremely unlikely; 7=Extremely likely

Decision Self-efficacy was measured with the 12 item Decision Self-efficacy Scale by O'Connor, 1995. Scores ranged from 1-5 with higher average scores indicating higher decision self-efficacy

Hereditary Breast and Ovarian Cancer (HBOC) Knowledge was measured with an adapted 7-question scale based on the National Center for Human Genome Research Knowledge (NCHGRK) Scale \[Scherr et al. 2015; Kaphingst et al. 2012\]. All questions in the scale were presented as True/False. Each question in the scale had a correct answer (coded as 1) and incorrect answer (coded as 0). This adapted HBOC Knowledge Scale score was calculated by summing the total value across the seven questions, with a range of 0 (minimum score, all incorrect) to 7 (maximum score, all correct). Higher score indicates higher knowledge.

Patient empowerment (client completed) was measured with the 24 item Genetic Counseling Outcomes Scale (GCOS-24; McAllister et al, 2011) using 7-point score ranging from 1=strongly disagree to 7= strongly agree. Higher scores indicate higher empowerment.

Patient empowerment (genetic counselor completed) was measured with the 24 item Genetic Counseling Outcomes Scale (GCOS-24; McAllister et al, 2011) using 7-point score ranging from 1=strongly disagree to 7= strongly agree. Higher scores indicate higher empowerment

Mammogram intention was measured with a single survey item on a 7 point scale "How likely are you to get regular mammograms?" with 1= Extremely unlikely to 7=Extremely likely

Patient anxiety was measured using the 6 item short version of the Spielberger State Anxiety Scale, a 4-point scale; 1= not at all, 2=somewhat, 3=moderately, 4= very much. Higher score indicates higher anxiety

Perceived effect of writing exercise on genetic counseling visit was measured using a single item "The values writing activity affected my appointment"; 1=yes; 2=no

Perception that writing exercise hindered the genetic counseling visit was measured using a single survey item "The values writing activity hindered my interaction with my genetic counselor"; 1=yes; 2=no

Perception that intervention improved the genetic counseling visit was measured using a single survey item "The values writing activity improved my interaction with my genetic counselor"; 1=yes; 2=no

Number of words in writing intervention was measured by counting the number of words in the essay written by the client

Number of Words in Writing Intervention Discussing Importance of Selected Value was measured by counting the number of words in the essay written by the client that were in phrases that were focused on discussing the importance of the selected value, as coded by two coders.

Number of Words in Writing Intervention Discussing How Value Was Recently Used was measured by counting the number of words in the essay written by the client that were in phrases that were focused on discussing how the value was recently used.

Number of Examples of How Value was Recently Used was measured by counting the number of unique examples offered in the essay as coded by two coders.

Essay Attitude Strength is a measure of the extent to which the participant's essay demonstrated the importance of the value selected during the writing exercise. Two independent raters read a subset of the essays and used a scoring system based on the procedure described in Harris \& Napper (2005). Each rater gave the participant's essay a numeric score between 1 and 7, and the two scores were examined for inter-rater reliability. The primary rater then rated the remaining essays and the final score was the rating assigned by the primary rater for all essays. A score of 1 (minimum) indicated that the selected value appeared to be not at all important to the participant. A score of 7 (maximum) indicated that the selected value appeared to be very important to the participant.

Self-affirmation score is a measure of the extent to which the essay appeared to be self-affirming for the participant. Two independent raters scored a subset of essays using a system based on procedures described in Harris \& Napper (2005) and Ferrer et al. (2017) using the following instructions: "Setting aside your own opinions and values, how self-affirmed would you estimate the writer of this passage to have been (at the end)?" Raters scored each essay and the two scores were examined for inter-rater reliability. The primary rater then rated the remaining essays and the final score was the rating assigned by the primary rater for all essays. A score of 1 (minimum) indicated the value was important but did not include descriptions of why the value was important to the participant. A control group participant received a score of 1 if they followed the writing activity's instructions exactly. A score of 5 (maximum) indicated that the essay elaborated on why the value was important.

National Human Genome Research Institute (NHGRI)

Immediately prior to the scheduled cancer genetic counseling appointment, clients:

1. completed standardized questionnaires on self-affirmation (SA) intervention that focused on positive values of personal importance. The SA intervention required clients to rank 11 items (artistic skills, athletics, business/money, creativity, independence, music, politics, relationships with friends and family, religious values, sense of humor, spontaneity) from most important to least important and to elaborate on one that was most important to them and why;
2. 6-item standardized measure of anxiety questionnaire;
3. after the counseling session, clients were required to fill out a post session questionnaire

Self-affirmation (SA) Group

Immediately prior to the scheduled cancer genetic counseling appointment, clients:

1. completed similar standardized questionnaire as the SA group, but was a non-affirming exercise. The non-intervention required clients to rank 11 items (artistic skills, athletics, business/money, creativity, independence, music, politics, relationships with friends and family, religious values, sense of humor, spontaneity) from most important to least important and to elaborate on the 9th ranked item and why it might be important to someone else;
2. 6-item standardized measure of anxiety questionnaire;
3. after the counseling session, clients were required to fill out a post session questionnaire

Control Group

1. Genetic Counselors (GC) provided their Standard of Care treatment, blinded to clients' enrollment in SA intervention or Control group and assessed each client's empowerment at the end of each session.
2. GC also completed a survey at the end of the study to assess the writing exercise and the feasibility of SA for larger studies.

Genetic Counselor (GC)

Total

>=18 to <65 years

>=65 years

Age Unknown (years)

Age, Customized

Male

Female

Gender unknown

Sex/Gender, Customized

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Lori Erby

Response = Yes

Response = No

Response = Maybe

The analysis included clients who were offered genetic testing in the session and completed the post-genetic counseling session survey. Two clients, one in each arm, were not offered genetic testing.

Test Uptake: Number of Clients Who Indicated Intention to Have Genetic Testing

"I don't plan to talk to anyone"

"I plan to talk to only a few people who are closest to me"

"I plan to talk to some of my family members"

"I plan to talk to most of my first and second degree relatives who are at risk for cancer"

"I plan to talk to almost all of my first and second degree relatives who are at risk for cancer"

"I plan to talk to almost all of my family members"

The analysis included clients who completed the post-genetic counseling session survey

Number of Clients Who Indicated "Intention to Talk With Family" About Genetic Testing Result

Likelihood of Talking With Family Members

Decision Self-efficacy: Ability to Confidently Make Decision About Genetic Testing

Client Knowledge: Hereditary Breast and Ovarian Cancer (HBOC) Knowledge Post Counselling Session

Patient Empowerment (Client Completed): Ability to Manage Information and Risk Associated With Hereditary Breast and Ovarian Cancer (HBOC) (Decisional Control, Cognitive Control, Behavioral Control, Emotional Regulation, and Hope)

The genetic counselor analysis included all clients who had a genetic counseling session

Patient Empowerment (Genetic Counselor Completed): Client's Ability to Manage Information and Risk Associated With HBOC (Decisional Control, Cognitive Control, Behavioral Control, Emotional Regulation, and Hope)

The analysis included clients who completed this item on the post-genetic counseling session survey. Two clients, one from each group, skipped the item.

Mammogram Intention After Counseling: Likelihood of Getting a Mammogram

The analysis included clients who completed the writing activity. One client in the control group skipped the item.

Client Anxiety After Writing Exercise and Prior to Counseling

Perceived Effect of Writing Exercise on Genetic Counseling Visit: Number of Clients With Perceived Effect of Intervention After Writing Exercise

Perception That Writing Exercise Hindered Genetic Counseling Visit: Number of Clients

Perception That Intervention Improved Genetic Counseling Visit: Number of Clients

The analysis included clients who completed the writing intervention. Two clients skipped the item.

Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention

Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention Discussing Importance of Selected Value

Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention Discussing How Value Was Recently Used

Level of Engagement With the Writing Exercise: Number of Examples of How Value Was Recently Used

Level of Engagement With the Writing Exercise: Essay Attitude Strength

Level of Engagement With the Writing Exercise: Self-affirmation Score

Overall Study

Participating Sites assigned to the active intervention cluster will receive a multi-faceted provider education and decision support intervention to improve 1) appropriate referral of breast cancer patients at risk for HBOC to genetic counseling in the community cancer center setting and 2) pre-surgical referral among newly diagnosed patients. They will also receive the National Comprehensive Cancer Network (NCCN) guidelines and Commission on Cancer definition of qualified genetics professional.

Participating Sites assigned to the passive intervention cluster will only receive the National Comprehensive Cancer Network (NCCN) guidelines and Commission on Cancer definition of qualified genetics professional.

Participating Sites assigned to the active intervention cluster will receive a multi-faceted provider education and decision support intervention to improve appropriate referral of breast cancer patients at risk for HBOC to genetic counseling and pre-surgical referral among newly diagnosed patients.

Active Provider Intervention

Rebecca Sutphen, MD

RATIONALE: Multi-faceted provider education and decision support intervention will increase the rate of appropriate referral of breast cancer patients at increased risk for hereditary breast and ovarian cancer (HBOC) to genetic counseling.

PURPOSE: This cluster randomized controlled trial will compare active and passive interventions to increase the rate of appropriate genetic counseling referrals of newly diagnosed breast cancer patients at increased risk for HBOC to genetic counseling in the community oncology setting.

Approximately 5-10% of all breast cancer patients have hereditary breast cancer, the majority due to an inherited mutation in the BRCA1 or BRCA2 genes (BRCA mutation carriers). Breast cancer patients who are BRCA mutation carriers have up to a 65% risk for a new primary breast cancer in the future. Additionally, BRCA mutation carriers have a 10-45% lifetime risk for ovarian cancer.

Effective options to decrease these high future cancer risks are available to breast cancer patients who learn they carry a BRCA mutation - including prophylactic mastectomy and oophorectomy. Prophylactic mastectomy and oophorectomy reduce the risks for future primary breast cancer and ovarian cancer, respectively, by more than 90%. Because of the high risks for future cancer and the opportunity for effective risk reduction among mutation carriers, national guidelines consistently recommend referral of breast cancer patients at increased risk for hereditary breast cancer and ovarian cancer (HBOC) to genetic counseling by a qualified genetics professional. Lack of implementation of this standard of care constitutes an error of omission and jeopardizes patient outcomes.

We propose a cluster randomized controlled trial to compare a "passive intervention" - dissemination of professional guidelines - with an "active intervention" - a multi-faceted provider education and decision support intervention to improve 1) appropriate referral of breast cancer patients at risk for HBOC to genetic counseling in the community cancer center setting and 2) pre-surgical referral among newly diagnosed patients. Ultimately, these results will lead to decreased breast and ovarian cancer incidence and mortality among breast cancer patients and their family members, as well as improved outcomes of and satisfaction with surgical decision-making.

Cluster Randomized Trial Comparing Interventions to Enhance Genetic Counseling Among Breast Cancer Patients

A Cluster Randomized Controlled Trial Comparing Interventions to Enhance Utilization of Genetics Services Among Breast Cancer Patients

Site providers will be randomized and receive either the active or passive genetic counseling intervention. Post intervention, site providers will maintain a database of all newly diagnosed breast cancer patients that meet the study eligibility criteria. One year post diagnosis, subjects will be mailed an informed consent form including questionnaires from their providers. Returned patient questionnaire data along with information provided directly from site providers will be utilized to determine the rate of appropriate referral for genetic counseling.

Secondary outcomes will be assessed by patient questionnaire and medical record documentation, where appropriate, and include evaluation of:

* The rate of pre-surgical referral of appropriate patients to genetic counseling
* The rate of referral of newly diagnosed breast cancer patients who are not appropriate for genetic counseling referral
* The rate of genetic counseling uptake
* The rate of bilateral mastectomy, including the rate of bilateral mastectomy among patients receiving different genetic test results

Psychosocial outcomes:

* Perceived risk for future primary breast cancer and for ovarian cancer will be assessed
* Knowledge of hereditary breast and ovarian cancer will be measured
* Cancer-related distress will be assessed using answers from the patient questionnaire
* Satisfaction with the decision regarding surgical treatment will be assessed
* Provider knowledge outcomes from the educational session will also be assessed

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Triple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry	NCT02302742	Breast Cancer Hereditary Brea...		-	University of Kansas Medical Center
Attitudes About Childbearing And Fertility With Inherited Breast And Ovarian Cancer Syndromes (HBOC)	NCT00829959	Breast Cancer Ovarian Cancer	Questionnaire	18 Years -	M.D. Anderson Cancer Center
Is it Feasible?: Self-Affirmation for Hereditary Breast and Ovarian Cancer Genetic Counseling	NCT03225170	Breast Cancer	Self Affirmatio... Control	18 Years -	National Institutes of Health Clinical Center (CC)
Cluster Randomized Trial Comparing Interventions to Enhance Genetic Counseling Among Breast Cancer Patients	NCT01789684	Breast Cancer	Active Provider...	18 Years -	University of South Florida
Triple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry	NCT02302742	Breast Cancer Hereditary Brea...		-	University of Kansas Medical Center

Spots Global Cancer Trial Database for hboc

Every month we try and update this database with for hboc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hboc

Every month we try and update this database with for hboc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hboc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.