Genetic Counseling for Breast Cancer Risk

(PCS IV Trial)

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

Trial Summary

What is the purpose of this trial?

Genetic counseling and testing for hereditary breast cancer may reveal that you, and possibly your blood relatives, are at increased risk for the disease across the lifespan. This includes biological children, both male and female. We do not yet know the best ways to educate mothers who have a risk gene (are BRCA+) about whether, when, and how to share genetic information with their children or manage their thoughts and feelings. The purpose of this study is to help mothers make more informed choices about talking with children about hereditary breast cancer, provide them with age-and gender-appropriate information and emotional support, and improve their psychological well-being.

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 data supports the effectiveness of the treatment 'Genetic Counseling for Breast Cancer Risk'?

Research shows that individualized breast cancer risk counseling can reduce distress related to breast cancer, especially in women with less formal education. Additionally, psychoeducation, which includes educational and support components, has been effective in improving coping skills and medical awareness for women at genetic risk for breast cancer. ^{1 2 3 4 5}

Is genetic counseling for breast cancer risk safe for humans?

The research articles reviewed do not report any safety concerns related to genetic counseling for breast cancer risk. Participants generally found the interventions informative and helpful, with no mention of adverse effects. ^{1 2 6 7 8}

How is the treatment 'Genetic Counseling for Breast Cancer Risk' different from other treatments for breast cancer risk?

This treatment is unique because it focuses on educating and counseling individuals about their genetic risk for breast cancer, which can increase knowledge and reduce anxiety about the disease. Unlike other treatments that may involve medication or surgery, this approach provides personalized information and support to help individuals understand their risk and make informed decisions about their health. ^{7 9 10 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of breast cancer risk counseling: interacting effects of counseling, educational level, and coping style. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Psychoeducation for breast cancer: A systematic review and meta-analysis. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Family matters: examining a multi-family group intervention for women with BRCA mutations in the scope of genetic counselling. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

The impact of video-assisted education on quality of life of women with breast cancer receiving chemotherapy treatment. [2022]

6. England 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. [2021]

7. Ireland pubmed.ncbi.nlm.nih.gov

Follow-up effects of a tailored pre-counseling website with question prompt in breast cancer genetic counseling. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

The development of a psychoeducational intervention for women living with an increased risk of breast cancer. [2015]

9. Ireland pubmed.ncbi.nlm.nih.gov

Long-term outcomes of genetic counseling in women at increased risk of developing hereditary breast cancer. [2019]

10. Ireland pubmed.ncbi.nlm.nih.gov

Genetic education and counseling. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Genetic counseling and clinical cancer genetics services. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Does genetic counseling have any impact on management of breast cancer risk? [2018]