Genetic Counseling for Breast Cancer Risk

(PCS IV Trial)

Recruiting at 1 trial location

Overseen By Kenneth Tercyak, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Georgetown University

Disqualifiers: Does not meet inclusion criteria

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist mothers with a genetic risk for breast cancer in discussing the condition with their children. It provides education and support to facilitate more informed and easier conversations. Participants will be divided into two groups: one receiving enhanced care with additional education and counseling, including genetic counseling, and the other receiving usual care. This trial suits mothers or primary caregivers undergoing genetic testing for hereditary breast cancer who can communicate comfortably in English. As an unphased trial, it offers a unique opportunity to access valuable support and resources for navigating conversations about genetic risk.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this genetic counseling and education is safe?

Research has shown that educational programs about cancer risk are generally safe and manageable. For example, one study found that women who learned about cancer risk gained a better understanding of the disease, with no reports of harmful effects from the education itself.

Similarly, studies on genetic counseling, a form of guidance and information sharing, have shown it to be safe for participants. It helps people understand their risk without causing physical harm. Participants often learn more about hereditary cancer risks, such as BRCA mutations, without experiencing negative side effects.

Both education and counseling aim to increase awareness and help people make informed decisions. These activities focus on providing knowledge and emotional support, rather than medical treatments, making them safe options for those involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different educational approaches can impact breast cancer risk awareness and decision-making. Unlike standard care, which may involve general risk assessments, this trial investigates the added benefits of combining education with personalized genetic counseling. This method aims to empower individuals with tailored insights into their genetic risk, potentially leading to more informed and proactive healthcare decisions.

What evidence suggests that this trial's educational and counseling interventions could be effective for hereditary breast cancer risk management?

Research has shown that educational programs, one approach in this trial, can greatly enhance women's understanding and confidence regarding breast cancer. One study found that these programs improved women's skills and encouraged them to seek medical help. Additionally, increased knowledge about breast cancer can help reduce related anxiety and depression.

In this trial, some participants will receive education combined with counseling. Studies have found that genetic counseling improves understanding of inherited breast cancer, aiding individuals in making informed health decisions, especially if they have a genetic risk. Counseling also plays a crucial role in creating personalized health plans for those at higher risk. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for mothers or primary caregivers to adolescents and young adults aged 13-24 who are undergoing genetic testing for hereditary breast cancer. Participants must be able to speak and read English well.

Inclusion Criteria

Adequately speak/read English

I am the primary caregiver to someone aged 13-24.

I am undergoing genetic testing for hereditary breast cancer.

Exclusion Criteria

Does not meet inclusion criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Mothers receive genetic counseling and support to improve communication about hereditary breast cancer

6 months

Follow-up

Participants are monitored for communication effectiveness and psychological well-being

6 months

1 visit (in-person) at 1 month, 1 visit (in-person) at 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Education
• Education and counseling

Trial Overview The study aims to find the best ways for BRCA+ mothers to educate their children about hereditary breast cancer risks, manage emotions, and improve psychological well-being through counseling and education.

How Is the Trial Designed?

Group I: Enhanced Care Experimental Treatment 1 Intervention

Group II: Usual Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials

355

Recruited

142,000+

Published Research Related to This Trial

In a study of 218 women at risk for hereditary breast cancer, genetic counseling significantly increased their knowledge about breast cancer genetics and reduced anxiety related to breast cancer risk over a 12-month period.

Despite the benefits of increased knowledge and reduced anxiety, there was a notable decrease in clinical breast examinations, suggesting that the counseling content may need to be adjusted to encourage ongoing preventive health behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes of genetic counseling in women at increased risk of developing hereditary breast cancer. Meiser, B., Butow, PN., Barratt, AL., et al.[2019]

Individualized breast cancer risk counseling (BCRC) significantly reduced breast-cancer-specific distress in 239 women with a family history of breast cancer compared to a control group receiving general health education, particularly benefiting those with less formal education.

Both groups experienced increased general distress over time, especially among participants using monitoring coping styles, highlighting the need for tailored psychological support in managing distress related to breast cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of breast cancer risk counseling: interacting effects of counseling, educational level, and coping style. Lerman, C., Schwartz, MD., Miller, SM., et al.[2019]

A psychoeducational intervention was developed to provide written information on familial breast cancer risk, addressing the needs of women at increased risk, based on a review of existing resources.

The intervention includes both scientific and psychosocial information aimed at improving knowledge and reducing anxiety about cancer, and has been evaluated by health professionals and piloted with women, with further results from a randomized controlled trial to be reported later.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of a psychoeducational intervention for women living with an increased risk of breast cancer. Appleton, S., Garcia-Minaur, S., Porteous, M., et al.[2015]

This special issue highlights the importance of genetic education and counseling, focusing on psychosocial aspects such as information recall and the impact of genetic services on individuals, particularly in hereditary cancer and Huntington Disease.

The articles emphasize the need for genetic counselors to maintain a neutral attitude and use understandable language, while also discussing recommendations for breast cancer screening practices and the overall effectiveness of genetic counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic education and counseling. Visser, A., Bleiker, E.[2019]

Cancer genetic services are essential for assessing hereditary cancer risks and providing tailored management options, requiring expertise from clinicians trained in both oncology and genetics.

Genetic counselors and nurses play a crucial role in these services, as they are equipped to conduct risk assessments, educate patients, and offer psychosocial support, which can ultimately help reduce cancer-related morbidity and mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic counseling and clinical cancer genetics services. Stopfer, JE.[2019]

Genetic counseling significantly increased the rates of breast self-examination, clinical breast examination, and mammography among 293 women attending Cancer Family Clinics, indicating improved management of breast cancer risk (p < 0.001).

Despite increased screening rates, women under 35 faced limited access to screening, and there was no evidence that anxiety about breast cancer hindered the uptake of health surveillance methods, suggesting that genetic counseling positively influences risk management without increasing anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does genetic counseling have any impact on management of breast cancer risk? Watson, M., Kash, KM., Homewood, J., et al.[2018]

Psychoeducation significantly reduced anxiety levels and improved the quality of life (QoL) for women with breast cancer, based on a meta-analysis of 27 randomized controlled trials involving 7742 participants.

However, psychoeducation did not show a significant impact on adherence to diagnostic procedures, treatment, depression, or breast cancer knowledge, indicating its benefits may be more focused on emotional support rather than treatment compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychoeducation for breast cancer: A systematic review and meta-analysis. Setyowibowo, H., Yudiana, W., Hunfeld, JAM., et al.[2022]

A psychoeducational intervention (PEI) was developed to improve the uptake of genetic counseling among high-risk breast cancer survivors, based on feedback from 57 individuals with a personal or family history of breast cancer.

The final booklet, refined through focus group feedback, was found to be visually appealing and informative, suggesting it could effectively aid decision-making regarding genetic counseling in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From observation to intervention: development of a psychoeducational intervention to increase uptake of BRCA genetic counseling among high-risk breast cancer survivors. Vadaparampil, ST., Malo, TL., Nam, KM., et al.[2021]

Counselees who received pre-counseling education through a tailored website and question prompt reported higher satisfaction and more positive experiences during their breast cancer genetic counseling compared to those who received usual care, with significant improvements noted at both 1 week and 1 year post-counseling.

The intervention group also felt a greater sense of personal control one year after counseling, indicating that pre-counseling education can enhance the overall counseling experience, although it did not significantly affect recall, knowledge, or anxiety levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-up effects of a tailored pre-counseling website with question prompt in breast cancer genetic counseling. Albada, A., van Dulmen, S., Spreeuwenberg, P., et al.[2022]

Video-assisted education significantly improved the quality of life for women undergoing their first chemotherapy treatment for breast cancer, as evidenced by reduced breast and arm symptoms from the first to the fourth cycle of chemotherapy.

In contrast to the control group, which experienced worsening symptoms, the education group showed better management of nausea, vomiting, and loss of appetite, highlighting the importance of educational interventions in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of video-assisted education on quality of life of women with breast cancer receiving chemotherapy treatment. Ünal Toprak, F., Uysal, N., Kutlutürkan, S., et al.[2022]

A multi-family group intervention for women with BRCA mutations and their families showed positive outcomes, improving coping skills and medical awareness regarding hereditary cancer.

Participants found the program well-structured and effective, highlighting the importance of integrating psychosocial support into genetic counseling to address the holistic needs of families affected by genetic illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family matters: examining a multi-family group intervention for women with BRCA mutations in the scope of genetic counselling. Mendes, A., Chiquelho, R., Santos, TA., et al.[2021]

Cancer patient education should go beyond just providing information; it must also include teaching coping skills and new strategies to manage the disease, which can lead to better treatment adherence and reduced anxiety.

Focusing on the different phases of cancer care can help identify essential educational content, and ongoing research is crucial for developing effective teaching methods and evaluating their impact on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Information and education across the phases of cancer care. Adams, M.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8862195/

Effectiveness of educational intervention on breast cancer ... The results of the post-test of this study suggest that women's knowledge was significantly increased after providing an educational ...

2. bmcwomenshealth.biomedcentral.com bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-023-02816-z

The effectiveness of educational intervention based on the ... The present study was designed to determine the effect of educational intervention based on the Health Action Model in improving breast cancer screening ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10521838/

An educational intervention study to enhance breast ... Hence, the educational intervention proved to be successful in improving the confidence, skills, and health-seeking behavior among the women.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749208122000857

Effect of Psycho-Educational Intervention to Reduce ... A significant effect of the psycho-education intervention was found to reduce anxiety and depressive symptoms in women with breast cancer. Such service was ...

5. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1446225/full

The impact of cancer prevention education on the mental ... This study demonstrates that systematic and scientific cancer prevention education has a significant positive impact on the mental health of college students.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11211999/

Cancer health awareness through screening and education We found that women showed greater improvement in cancer knowledge compared to men regarding overweight and obesity risk with cancer, colorectal ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1098360025002205

Implementing interventions to increase genetic testing for ... Moreno, et al. A pilot randomized trial of an educational intervention to increase genetic counseling and genetic testing among Latina breast cancer survivors.

8. cinj.org cinj.org/study-finds-education-and-navigation-increased-cancer-genetic-counseling-andor-testing

Study Finds Education and Navigation Increased Cancer ... Researchers at Rutgers Cancer Institute of New Jersey explored informing patients of their potentially increased risk for generically-inherited cancers.

9. ebccp.cancercontrol.cancer.gov ebccp.cancercontrol.cancer.gov/programDetails.do?programId=277363

Breast Cancer Risk & Genetic Testing Read the Evidence-Based Cancer Control Programs (EBCCP) summary about the program Breast Cancer Risk & Genetic Testing.