Educational Materials for Cancer Radiotherapy Decisions

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Under 18, No cancer diagnosis

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

Compensation: Varies

Number of Visits: 3

51 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the attitudes and beliefs of American Indian and Alaskan Native cancer patients regarding radiation therapy. It tests two educational materials: a culturally tailored brochure (Culturally Oriented Educational Brochure) and a standard Mayo Clinic booklet. The trial seeks to determine which material better supports patients in making treatment decisions. It seeks cancer patients who have been recommended radiation therapy and can complete a survey in English.

As an unphased trial, this study offers a unique opportunity to contribute to culturally sensitive cancer care.

Will I have to stop taking my current medications?

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

What prior data suggests that these educational materials are safe for cancer patients?

Research has shown that educational brochures about cancer treatment are safe to use. These brochures help patients understand their treatment options without risk of side effects. Organizations like the American Cancer Society provide these materials to educate patients about cancer treatments. They are designed to be informative and easy to understand, not harmful.

In this study, participants will receive either a culturally tailored educational brochure or a standard booklet from the Mayo Clinic. Both materials educate patients and have not been linked to negative effects. They aim to provide information clearly and simply, helping patients make informed decisions without safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these educational approaches because they address the need for culturally sensitive information in cancer radiotherapy decision-making. The culturally oriented educational brochure stands out by tailoring treatment information to be visually engaging and culturally relevant, which can enhance understanding and comfort for patients from diverse backgrounds. This is different from the standard Mayo Clinic booklet, which, while informative, doesn't specifically cater to cultural nuances. By improving patient education through these tailored materials, the hope is to empower patients to make more informed decisions about their radiation therapy, potentially improving outcomes and satisfaction.

What evidence suggests that these educational materials are effective for cancer radiotherapy decisions?

Research has shown that personalized educational materials, such as brochures, can significantly aid patients in understanding their treatment options. In this trial, participants will receive either a culturally oriented educational brochure or the standard Mayo Clinic educational booklet. One study found that adapting these materials to fit cultural needs enhances their effectiveness in communicating with patients from diverse backgrounds. This is particularly important for groups like American Indian/Alaskan Native communities, where cultural sensitivity can improve communication. Another study highlighted that culturally sensitive materials not only provide information but also increase patients' comfort with their treatment choices. Overall, offering education in a culturally appropriate manner can lead to better decision-making and greater comfort with treatment plans. ^{1 5 6 7 8}

Who Is on the Research Team?

Samir H. Patel, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for American Indian/Alaskan Native adults with a cancer diagnosis who are recommended to undergo radiation therapy. Participants must be able to complete a survey and communicate in English well enough to give informed consent.

Inclusion Criteria

I am 18 or older and have been diagnosed with cancer.

I can complete a survey on paper by myself.

Radiation therapy is recommended for my next cancer treatment step.

Exclusion Criteria

I do not have a cancer diagnosis.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education

Participants receive either a culturally appropriate educational brochure or the standard Mayo Clinic educational booklet

2 weeks

1 visit (in-person)

Radiation Therapy

Participants undergo radiation therapy as part of their treatment plan

90 days

Follow-up

Participants are monitored for completion of radiation therapy and changes in anxiety and perception of information

2 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Culturally Oriented Educational Brochure
• Mayo Clinic Educational Booklet

Trial Overview The study is testing the effectiveness of culturally tailored educational materials versus standard Mayo Clinic booklets on influencing AI/AN patients' willingness to choose radiation therapy as part of their cancer treatment.

How Is the Trial Designed?

Group I: Culturally Oriented Education Experimental Treatment 2 Interventions

Subjects will receive a culturally appropriate educational brochure summarizing pertinent treatment information in a visual manner in addition to the standard Mayo Clinic booklet

Group II: Standard of Care Mayo Clinic booklet Active Control 1 Intervention

Subjects will receive the standard Mayo Clinic educational booklet in preparation for clinically indicated radiation therapy treatment

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Health literacy is essential for patients to understand medication instructions, and low literacy levels can lead to misunderstandings and poor medication adherence.

A new template using universal pictograms has been developed to create clear, language-independent medication instructions, which can help improve patient comprehension and communication about medication use and risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Visual Aids to Enhance Physician-Patient Discussions and Increase Health Literacy. Pratt, M., Searles, GE.[2022]

A participatory approach involving over 200 health providers and clients led to the creation of culturally targeted cancer education brochures for Native Hawaiians, focusing on various types of cancer.

The new brochures, featuring culturally relevant imagery and language, were found to be more appealing and comprehensible, especially to younger Hawaiians, suggesting they could effectively improve cancer education in this community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a participatory four-step protocol to develop culturally targeted cancer education brochures. Kulukulualani, M., Braun, KL., Tsark, JU.[2021]

Culture-sensitive patient information material was rated as significantly more useful immediately after distribution compared to standard translated material, with a mean difference of 3.65 in usefulness scores among 309 participants from diverse migration backgrounds.

However, there were no significant differences in the severity of depression, back pain, or quality of life between the two groups at follow-up, indicating that while cultural adaptation improves initial reception, it may not impact long-term health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of culture-sensitive adaptation of patient information material on usefulness in migrants: a multicentre, blinded randomised controlled trial. Hölzel, LP., Ries, Z., Kriston, L., et al.[2019]

Patient education materials used in local health settings generally required a reading level of ninth grade, which may be too high for some patients, while a parenting booklet was accessible at a fifth-grade level.

Only 4 out of 47 materials included culturally sensitive information, highlighting a significant gap in addressing the diverse beliefs and values of over 90 ethnic and cultural groups served in these clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient education materials nurses use in community health. Wilson, FL.[2017]

The Communicating the External Beam Radiation Experience (CEBRE) tool was developed to improve patient education in radiation oncology, achieving a readability level suitable for a wider audience, with a Flesch-Kincaid grade level of 5.4.

In a pilot study with 34 patients and 15 radiation oncologists, CEBRE was found to be highly usable and effective in reducing patient anxiety, with both groups rating its graphic narrative component as 'quite helpful' for understanding the radiation therapy process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communicating the External Beam Radiation Experience (CEBRE): Perceived Benefits of a Graphic Narrative Patient Education Tool. Arya, R., Ichikawa, T., Callender, B., et al.[2021]

This systematic review aims to evaluate the outcomes of patient education for adults taking oral anticancer agents, addressing a gap in the literature regarding safety and efficacy concerns raised by patients.

The review will analyze various factors such as content, methodology, and healthcare professionals involved, which could lead to improved safety and patient satisfaction in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of patient education in adult oncologic patients receiving oral anticancer agents: a systematic review protocol. Fonda, F., Cedrone, S., Sartor, I., et al.[2023]

A review of 555 patient education materials from 14 cancer centers revealed that 91% had a reading level above the recommended grade 6, indicating that most materials are too complex for many patients to understand.

Only 14% of cancer centers provided comprehensive materials covering the full range of symptoms related to radiation therapy, highlighting a significant gap in accessible and effective patient education resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Literacy and Radiation Therapy: a Current State Assessment of Patient Education Materials. Giannopoulos, E., McBain, S., Giuliani, M., et al.[2023]

The 'Learning to Live With Cancer' education program has been successfully implemented in Sweden and expanded across Europe, demonstrating its effectiveness in helping patients and families understand the cancer experience.

A study assessing cultural adaptations of the program found only minor divergences, suggesting that the core model is broadly applicable and can effectively meet the learning needs of cancer patients from diverse cultural backgrounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning to live with cancer in European countries. Grahn, G., Danielson, M., Ulander, K.[2019]

A study assessing printed cancer education materials (PCEMs) for African Americans found that over half (56.2%) were culturally insensitive, particularly in their visual messaging.

To improve effectiveness, future PCEMs should incorporate culturally sensitive visuals, and the newly developed assessment tool can help ensure these materials resonate better with African American audiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing cultural sensitivity in printed cancer materials. Guidry, JJ., Walker, VD.[2022]

Culturally appropriate health education materials on medication were developed specifically for Latino and Southeast Asian populations, highlighting the importance of tailoring health information to meet diverse community needs.

The high demand for these materials indicates a significant health education gap among linguistic minority populations, emphasizing the necessity of involving community representatives in the adaptation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of culturally appropriate health education materials. Williamson, E., Stecchi, JM., Allen, BB., et al.[2022]

Culturally sensitive cancer prevention education materials are essential for effectively reaching ethnically diverse populations, as most existing resources focus primarily on breast cancer and target African American communities.

There is a lack of standardized definitions and reliable measures for assessing cultural sensitivity in cancer education materials, highlighting the need for best practice guidelines that incorporate the specific cancer knowledge and beliefs of ethnic minority groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of culturally sensitive cancer prevention resources for ethnic minorities. Hoffman-Goetz, L., Friedman, DB.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10417173/

Effect of receiving a customizable brochure on breast cancer ... This study demonstrates a need to improve patient education and shows that customizable educational materials increase patients' understanding ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11967065/

a mixed methods systematic review - PMC - PubMed Central This review identified and evaluated the effectiveness of strategies to meet the cancer information needs of consumers and carers from CaLD backgrounds.

3. academic.oup.com academic.oup.com/nop/article/12/5/901/8124733

Nationwide evaluation of readability, quality, and cultural ... Available educational materials should be easily comprehensible, informative, reliable, culturally sensitive, and patient oriented. Methods. We ...

4. astro.org astro.org/provider-resources/shareable-resources/patient-brochures

Patient Education - Brochures ASTRO created the brochures to help physicians provide information to people with cancer and their families about the treatment options available.

5. researchgate.net researchgate.net/publication/7207023_Evaluating_patient_education_materials_about_radiotherapy

Evaluating patient education materials about radiotherapy Targeted treatment education for cancer patients has the potential to promote adjustment through assisting patients to participate in ...

6. education.cancer.org education.cancer.org/

American Cancer Society - Educational Materials, Brochures ... The American Cancer Society offers patient education flyers, brochures, and booklets on a variety of topics and you can order as many copies as you need.

7. rtanswers.org rtanswers.org/print

Print Materials - Patient Education Brochures and side effects charts are available for free download to learn more about radiation therapy treatments for your cancer.

8. 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.