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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether visual aids, such as photos, can reduce stress, anxiety, and depression in breast cancer patients beginning radiation therapy. Participants will receive either standard verbal counseling or counseling with a photo guide to determine which method is more effective. The goal is to make the treatment process less stressful. This trial suits patients with stage 0-IIIA breast cancer who can read English and are about to start radiation treatment. As an unphased trial, it offers a unique opportunity to contribute to innovative approaches in patient care.

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 prior data suggests that this educational intervention is safe for patients with breast cancer?

Research has shown that using pictures during counseling is generally well-received. While specific safety data for using pictures in breast cancer counseling is lacking, these educational tools are commonly used and considered safe. They help patients understand their treatment better and reduce stress.

Counseling is non-invasive, involving no medication or physical procedures, so it has no known physical side effects. Adding pictures is unlikely to cause harm and can make information easier to understand.

Overall, this approach is considered safe and aims to make the treatment experience less stressful and more supportive. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of using a pictorial aid alongside verbal counseling for breast cancer patients, which is not typical in current treatment protocols. While traditional approaches often rely solely on verbal counseling, this method introduces visual aids to potentially enhance understanding and retention of information. The trial aims to determine if these photo guides can improve patient engagement and satisfaction compared to verbal counseling alone. By evaluating these new techniques, researchers hope to find more effective ways to support breast cancer patients through their treatment journey.

What evidence suggests that this trial's interventions could be effective for reducing stress, anxiety, and depression in breast cancer patients?

Research has shown that using pictures along with spoken guidance can help breast cancer patients better understand their treatment. In this trial, participants in Arm I will receive verbal counseling and view a photo guide, while those in Arm II will receive verbal counseling alone. One study found that visual aids improved patients' knowledge about their condition and treatment process. Another study discovered that using pictures and guided imagery helped reduce stress and anxiety in cancer patients. These findings suggest that adding pictures to counseling sessions might make it easier for patients to understand information, lowering their stress and anxiety. Overall, visual tools in counseling have proven effective in improving understanding and reducing stress among patients. ^{1 2 4 6 7}

Who Is on the Research Team?

Carl Post

Principal Investigator

OHSU Knight Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-breast-neoplasms-7-2021-83383

Counseling with Pictorial Aid for Breast Cancer 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3644257/

The effectiveness of a graphical presentation in addition ... The present study showed that intentions regarding screening among women with a low to slightly increased breast cancer risk actually decreased ...

3. link.springer.com link.springer.com/article/10.1007/s12144-025-07606-4

The effect of guided imagery based on health promotion ... The study implemented training and counseling, utilizing guided imagery practices grounded in the health promotion model, among breast cancer ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11632560/

Evaluating the efficacy of genetic counseling visual aids These results indicate that visual aids improve knowledge of specific genetic counseling concepts such as inheritance patterns; the education of ...

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

Implementing interventions to increase genetic testing for ... A review by Nelson et al from 2019 found that women who had received genetic counseling had a better understanding of their breast cancer risk while ...

6. cancer.org cancer.org/health-care-professionals/patient-education-materials-for-professionals.html

Education Materials for Your Patients Inform your patients about cancer, treatment, side effects, and more with these easy-to-read materials.

7. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT02341820?keyword=%22Cosmesis%22

San Mateo Clinical Trial PICTURE Breast L: Patient Information ... A good aesthetic outcome is an important endpoint for breast cancer treatment and is closely related to psychosocial recovery and quality of life.~When a woman ...