Counseling with Pictorial Aid for Breast Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: OHSU Knight Cancer Institute

Disqualifiers: Ultra-hypofractionated, Partial breast radiation, others

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

Compensation: Varies

Number of Visits: 4

62 Participants Needed

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are planned to receive concurrent radiosensitizing chemotherapy, you are excluded from the trial.

What data supports the idea that Counseling with Pictorial Aid for Breast Cancer is an effective treatment?

The available research shows that Counseling with Pictorial Aid for Breast Cancer is effective in several ways. For example, a study on nurse navigator services found that more than 90% of participants understood the information provided and were satisfied with the support they received. This suggests that the treatment helps patients feel informed and supported. Additionally, a study on spouse caregivers highlighted perceived gains in self-care and interpersonal support skills, indicating that the treatment also benefits those supporting breast cancer patients. These findings suggest that Counseling with Pictorial Aid is effective in improving understanding, satisfaction, and support for both patients and their caregivers. ^{1 2 3 4 5}

What safety data exists for counseling with pictorial aid for breast cancer?

The research provided does not directly address safety data for counseling with pictorial aid for breast cancer. However, it discusses the development and testing of decision aids and educational tools, which are generally considered safe as they focus on improving patient education, decision-making, and communication. These tools have been evaluated for clarity, usefulness, and ease of understanding, but specific safety data is not mentioned. ^{6 7 8 9 10}

Is the treatment in the trial 'Counseling with Pictorial Aid for Breast Cancer' promising?

Yes, the treatment is promising because pictorial aids can help improve decision-making and outcomes for breast cancer patients, especially those from lower socioeconomic backgrounds. ^{1 5 11 12 13}

What is the purpose of this trial?

This clinical trial studies the effect of standard verbal counseling with or without a pictorial educational tool for the reduction of psychological morbidity in patients with stage 0-IIIA breast cancer receiving radiation therapy. Beginning radiation therapy for breast cancer can be stressful. Education about what to expect often reduces the stress, anxiety, and depression experienced by these patients. This study is being done to see how effective photos are in reducing stress, anxiety, and depression associated with radiation therapy for patients with breast cancer.

Research Team

Carl Post

Principal Investigator

OHSU Knight Cancer Institute

Eligibility Criteria

This trial is for English-speaking breast cancer patients with stage 0-IIIA disease, who are about to start standard or hypofractionated radiation therapy. It's not for those getting ultra-hypofractionated or partial breast radiation, nor for patients receiving chemotherapy alongside radiation.

Inclusion Criteria

Patients must have the ability to read and understand English

I have breast cancer at stage 0 to IIIA and will get radiation therapy.

Exclusion Criteria

I am scheduled for chemotherapy that works with radiation to treat my cancer.

I am scheduled for partial breast radiation treatment.

I am scheduled for a short, intense course of radiation therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants receive verbal counseling with or without a pictorial educational tool and undergo radiation therapy

2 weeks

1 visit (in-person)

Follow-up

Participants complete questionnaires to assess anxiety, depression, and understanding of radiation therapy side effects

12 months

3 visits (in-person or virtual) at 2 weeks, 6 months, and 12 months

Treatment Details

Interventions

• Counseling
• Educational Intervention
• Questionnaire

Trial Overview The study compares the effectiveness of standard verbal counseling alone versus counseling combined with a pictorial educational tool in reducing stress, anxiety, and depression in patients undergoing radiation therapy for early-stage breast cancer.

Participant Groups

Group I: Arm I (counseling, photo guide) Experimental Treatment 3 Interventions

Patients undergo verbal counseling and view a photo guide. Patients also complete questionnaires at 2 weeks, 6 and 12 months.

Group II: Arm II (counseling) Active Control 2 Interventions

Patients undergo verbal counseling. Patients also complete questionnaires at 2 weeks, 6 and 12 months.

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials

239

Recruited

2,089,000+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

Findings from Research

Counselees who received the pre-visit education through the E-info geneca website had significantly better recall of information and knowledge about breast cancer and heredity compared to those who received usual care, indicating that tailored pre-visit education can enhance understanding.

The intervention particularly benefited those who did not receive an indication for DNA testing, as they showed greater improvements in information recall and reduced anxiety levels, suggesting that pre-visit education can help alleviate concerns for patients facing uncertain outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a pre-visit educational website on information recall and needs fulfilment in breast cancer genetic counselling, a randomized controlled trial. Albada, A., van Dulmen, S., Bensing, JM., et al.[2021]

Spouse caregivers of women with breast cancer reported significant benefits from a 5-session educational counseling program, including improved self-care skills and enhanced ability to support their partners, based on interviews conducted 7 months post-program with 81 participants.

The program, Helping Her Heal, provided structured support and practical strategies, leading caregivers to gain valuable insights into their own needs and their wives' experiences, demonstrating the effectiveness of a manualized approach in delivering counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spouse caregivers' attributed gains from a skill-based counseling program. Zahlis, EH., Lewis, FM.[2022]

A quality improvement project involving 154 breast cancer patients showed that over 90% were satisfied with the information and support provided by breast cancer care navigators (BCCN), indicating high effectiveness in addressing patients' informational and emotional needs.

The study highlighted the importance of ongoing support, recommending that navigators contact patients after their initial clinic visit and during treatment to enhance continuity of care and improve patient experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation report of the nurse navigator services for the breast cancer support program. Trevillion, K., Singh-Carlson, S., Wong, F., et al.[2019]

A multimedia training module was developed to help breast cancer survivors communicate effectively with their healthcare providers after treatment, using a systematic and evidence-based approach that included user testing and usability improvements.

Preliminary data showed that 59% of participants accessed the module, spending an average of 7 minutes per session, indicating a positive reception and potential feasibility for such web-based training programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development and preliminary testing of a multimedia patient-provider survivorship communication module for breast cancer survivors. Wen, KY., Miller, SM., Stanton, AL., et al.[2022]

The study involved 12 women aged 38-68 who shared their experiences with decisional support aids during their breast cancer journey, highlighting the emotional stress and urgency they felt in making treatment decisions.

Key themes included the importance of trusting physician advice, the need for family support, and the lack of nurse involvement, indicating that oncology nurses should improve their support and communication to enhance the decision-making process for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The experience of using decisional support aids by patients with breast cancer. Lacey, MD.[2016]

A new educational decision aid was developed for women who are carriers of pathogenic BRCA mutations to help them make informed choices about cancer risk management, ensuring it aligns with clinical guidelines and addresses psychosocial issues.

The decision aid was positively received in a pilot test with 23 participants, scoring above 3 on a scale of 1-4 for clarity and usefulness, indicating it effectively supports shared decision-making in cancer risk management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Testing of a Decision Aid for Unaffected Women with a BRCA1 or BRCA2 Mutation. Jabaley, T., Underhill-Blazey, ML., Berry, DL.[2021]

Clinicians identified a need for standardized decision support tools to better assess breast cancer risk, particularly for women at moderate risk, as current tools are lacking.

Participants emphasized that any new tool should be evidence-based, easily accessible, and present absolute risk in various formats, while also being mindful of the potential to cause anxiety in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing and managing breast cancer risk: clinicians' current practice and future needs. Collins, IM., Steel, E., Mann, GB., et al.[2022]

The Breast Cancer Navigation Kit, developed through interdisciplinary collaboration and patient feedback, effectively addresses the information needs of breast cancer patients and their families, making it easy to understand and informative for users.

While the kit is a valuable resource, all participants emphasized that it should complement, not replace, conversations with healthcare professionals, highlighting the importance of direct communication in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The breast cancer patient navigation kit: development and user feedback. Skrutkowski, M., Saucier, A., Meterissian, S.[2021]

A study involving 34 patients and 10 providers identified key barriers to effective communication about breast cancer risk, including time constraints, lack of knowledge, low health literacy, and language barriers.

Facilitators for better communication included the need for personalized information and the desire for patient autonomy, which will help shape tools aimed at improving patient-provider discussions about breast cancer prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and Facilitators to Patient-Provider Communication When Discussing Breast Cancer Risk to Aid in the Development of Decision Support Tools. Yi, H., Xiao, T., Thomas, PS., et al.[2022]

The BreastCARE intervention, a tablet-based risk assessment tool, was well-received by both patients and physicians, indicating its potential to enhance understanding of breast cancer risk and promote discussions about risk reduction strategies.

The study highlighted that patient satisfaction varied by race/ethnicity, suggesting that tailored communication and education strategies may be necessary to improve acceptability and effectiveness across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of an mHealth breast cancer risk-reduction intervention promoting risk assessment, education, and discussion of risk in the primary care setting. Kaplan, CP., Karliner, L., Lee, A., et al.[2022]

A pictorial conversation aid for breast cancer surgery and reconstruction was successfully adapted for use in France, receiving positive feedback from both patients and health professionals regarding its usability and acceptability.

The implementation of these aids in clinical practice faced challenges, particularly in recruiting surgeons for participation, highlighting the need for strategies to address time constraints in busy medical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation and Implementation of Pictorial Conversation Aids for Early-Stage Breast Cancer Surgery and Reconstruction: A Quality Improvement Study. Durand, MA., Bannier, M., Aim, MA., et al.[2023]

Pretest genetic counseling significantly increased cancer-related knowledge for both before definitive surgery (BDS) and after definitive surgery (ADS) breast cancer patients, with notable median changes in knowledge scores (4.2 for BDS and 2.7 for ADS).

BDS patients experienced a significant decrease in overall cancer-related distress after counseling, while ADS patients showed improvements in informed decision-making regarding treatment options, indicating that genetic counseling can enhance understanding and reduce anxiety in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive and psychological impact of BRCA genetic counseling in before and after definitive surgery breast cancer patients. Christie, J., Quinn, GP., Malo, T., et al.[2021]

The Interactive Breast Cancer CDROM did not change the treatment decisions of patients with early-stage breast cancer, but it significantly increased their satisfaction with the information received and the decision-making process over a 9-month period.

Patients using the CDROM reported better quality of life outcomes, including improved physical functioning, less pain, and fewer arm symptoms, indicating that while it didn't alter treatment choices, it positively impacted their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision support for patients with early-stage breast cancer: effects of an interactive breast cancer CDROM on treatment decision, satisfaction, and quality of life. Molenaar, S., Sprangers, MA., Rutgers, EJ., et al.[2017]

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of a pre-visit educational website on information recall and needs fulfilment in breast cancer genetic counselling, a randomized controlled trial. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Spouse caregivers' attributed gains from a skill-based counseling program. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

An evaluation report of the nurse navigator services for the breast cancer support program. [2019]

4. Ireland pubmed.ncbi.nlm.nih.gov

The development and preliminary testing of a multimedia patient-provider survivorship communication module for breast cancer survivors. [2022]

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

The experience of using decisional support aids by patients with breast cancer. [2016]

6. England pubmed.ncbi.nlm.nih.gov

Development and Testing of a Decision Aid for Unaffected Women with a BRCA1 or BRCA2 Mutation. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Assessing and managing breast cancer risk: clinicians' current practice and future needs. [2022]

8. England pubmed.ncbi.nlm.nih.gov

The breast cancer patient navigation kit: development and user feedback. [2021]

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

Barriers and Facilitators to Patient-Provider Communication When Discussing Breast Cancer Risk to Aid in the Development of Decision Support Tools. [2022]

10. China pubmed.ncbi.nlm.nih.gov

Acceptability of an mHealth breast cancer risk-reduction intervention promoting risk assessment, education, and discussion of risk in the primary care setting. [2022]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Adaptation and Implementation of Pictorial Conversation Aids for Early-Stage Breast Cancer Surgery and Reconstruction: A Quality Improvement Study. [2023]

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

Cognitive and psychological impact of BRCA genetic counseling in before and after definitive surgery breast cancer patients. [2021]

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

Decision support for patients with early-stage breast cancer: effects of an interactive breast cancer CDROM on treatment decision, satisfaction, and quality of life. [2017]